RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
“It is clear to me that he has a basic flaw in his thinking regarding the Doctor – Pharmacist relationship. “
Joe Webster, MD
THIS PRESENTATION CONTAINS MUST SEE WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE: CONGRESS MUST DEFUND DEA
INTRODUCTION
On May 5, 2020, Mark D. Dowd, U.S. Administrative Law Judge, in the matter of Pronto Pharmacy, LLC Docket No. 19-42 issues RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE in a rambling decision of 148 pages, to be found so ridicules it overturned nearly 200 years of medical and pharmacy law(s) and protocols.
A group has filed Professional and Academic Fraud charges against the Ohio State University College of Pharmacy, DEA Expert, Clinical Professor Donald Sullivan. Who, in sworn testimony, admitted to not having interviewed any of the patients, nor their prescribing physicians, neither saw nor reviewed any of the patient’s prescriptions. Professor Sullivan opined every prescription to be illegitimate.(1)
A.NON-ACUTE PAIN B.UNINSURED
It is further clear, on this day U.S. Administrative Law Judge Mark D. Dowd, was so busy trying to be a bigot, so busy trying to be a racist, so busy trying to be the toughest man on the Federal bench he forgot how to be fair.
Judge Dowd’s decision in which the respondent, Pronto Pharmacy LLC., and the owner Norman J Clement,( a pharmacist and dentist) who had written in his blog, youarewithinthenorms.com, that he is not authorized or qualified to challenge a “physician’s diagnosis and treatment.” Judge Dowd, ruled against Clement basing his opinion in part, on the testimony of Donald Sullivan. Judge Mark D. Dowd wrote in his endnotes on page 44, of the Recommended Ruling:
22 Mr. Clement, Jr.’s, testimony that the Respondent verified the medical legitimacy of the prescriptions it filled runs counter to Mr. Clement, Sr.’s, view, as written in his blog, that he is “not authorized or qualified to challenge a physician’s diagnosis and treatment.”. If that is the case, it seems inconsistent that the Respondent would call a doctor’s office at all, let alone to confirm a diagnosis. Furthermore, it is difficult to understand how the Respondent ensured that prescriptions were medically legitimate if the Respondent believed it could not question a doctor’s decision to prescribe a certain medication. The Respondent’s vetting process, as described by Mr. Clement, Jr., seems superfluous if the Respondent’s pharmacists are unable to question a diagnosis and treatment.
JOSEPH L.WEBSTER, SR., MD, MBA, FACP, BS.PHARMACY
I have reviewed the pertinent materials that were provided regarding the testimony of Dr. Sullivan. It is clear to me that he has a basic flaw in his thinking regarding the Doctor – Pharmacist relationship. The respective regulatory bodies, including the various “Boards” of Pharmacy, Medicine, Dentistry, Nursing, etc. clearly outline the ‘scope of practice’ for each of those disciplines.
The orderly flow of a prescription “from” the doctor to the patient – via the Pharmacist – clearly outlines where the ‘diagnosis’ has to come from. It is statutorily the purview of the pharmacist to ‘inspect and assure’ that the drug that is being given is safe and has no known incompatibilities with the patient and its holistic environment.
DX; MSI.26 M48.0, NONACUTE PAIN
It is not the purview nor is the pharmacist trained to ‘challenge the diagnosis’ of the physician and to do so verbally or otherwise with the patient. It erodes the ‘doctor-patient’ relationship and destroys the ‘confidence’ of the patient in his/her physician. At the very least it is ‘unethical’ and may very well be a HIPPA violation and beneath the standard of care as a pharmacist.
Any healthcare provider that is licensed to ‘prescribe’ is governed by the set of conditions and circumstances under which a prescription can be written. Thus it is illegal to write a prescription for a person that the prescriber has not conducted the ‘chain of authority’ that would qualify him/her to write a prescription: history and physical examination, formulation of a diagnosis and discussing such with the patient as well as the proposed manner of treatment in a culturally sensitive and ethically appropriate manner; and provision of an opportunity for the patient to ‘question and discuss alternative forms of treatment; etc.
DEA EXPERT DONALD SULLIVAN TESTIFIED HE NEVER LOOKED AT ANY PATIENT PRESCRIPTION OR SPOKE WITH THE TREATING PHYSICIAN
Once the provider has met all of the aforementioned and other ‘requirements to write a prescription, then and then ONLY should a healthcare practitioner write a prescription. I do not see where Dr. Sullivan obtained his evidence that the pharmacist in question attempted to do any of these steps in the ‘chain of authority’ in the cases in question. Furthermore, as stated above, a pharmacist IS NOT AUTHORIZED TO WRITE A CONTROL PRESCRIPTIONS by any of the regulatory boards of health.
WE ARE TO BE UNSEEN
It is my professional opinion that the pharmacist in question had ‘no reason’ and more importantly the pharmacist had ‘no power’ to question or interrogate each provider on ‘each prescription’ that is received as long as the ‘safety, efficacy and convenience’ of the medications being prescribed meet the standards of Medication Dispensing. Any given medication can be and certainly will be given for multiple different diagnoses and it is not even feasible for the pharmacist to ‘contact and question’ each and every diagnosis.
WHEN WHITE PRIVILEGE AND BIAS TAKES THE STAND
DEA expert Don Sullivan must be brought before the Academic and Standard Review Committee at The Ohio State University for academic fraud. Donald Sullivan, never interviews the patients nor their prescribing physicians in his narrative of irrevocable flags. Clearly his opinion was base on a tacit bias.
In preparation for his testimony in this proceeding, and as the basis for his analyses and opinions in this case, Dr. Sullivan reviewed the Respondent’s Pre-Hearing Statement, a portion of the Government’s Pre-Hearing Statement, the PDMP data, and three (3) months of dispensing data from Respondent’s computer system.
Furthermore, while we have been extremely critical of Mark D. Dowd, U.S. Administrative Law Judge, his opinion of May 5, 2020, in the matter of Pronto Pharmacy, LLC Docket No. 19-42 issues RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE, he states;(2) (page 40-41)
” I find Dr.Sullivan’s subject conclusion more in the nature of speculation. I don’t believe the record provides sufficient factual foundation to support this expert opinion. I also find it inconsistent with the facts of the case. Accordingly, on the basis of the instant record, I find Dr. Sullivan’s subject conclusion unjustified.
Dr. Sullivan made a similar conclusion regarding the prescribing of non- controlled substances and of controlled substances not subject to abuse or diversion. Again, he deemed such prescriptions as an apparent subterfuge on the part of the prescriber, designed to mask the improper prescribing of controlled substances highly subject to abuse and diversion, and creating a red flag, which went unaddressed by the Respondent. I question the sufficiency of the factual foundation for Dr. Sullivan’s expert opinion that the above prescriptions were an apparent attempt to mask scores of improper opioid prescriptions. The relevant medical records were not reviewed, the prescriber’s justification for the prescriptions were not considered by Dr. Sullivan, nor was the patient’s input as to the subject prescriptions considered. I find Dr. Sullivan’s subject opinion, on the basis of this record, to be improperly speculative and unjustified as an expert opinion.”
Yet, Judge Mark D. Dowd appears to freely admit he accepted Dr. Sullivan’s testimony solely on his “White Privilege” stating,
” This finding does not affect the probity of Dr. Sullivan’s opinions as to the therapeutic effect of the subject medications, their contraindication with other prescribed medications, or the justification of their prescription.”
CONCLUSION: CONGRESS MUST DEFUND THE DRUG ENFORCEMENT AGENCY (DEA)
We find Judge Mark D. Dowds, analysis troubling. One can never prevail in any court system or environment, even when supported with science and facts, against bias and prejudice, or when privilege is permitted to take the stand.
Yet, it is not Judge Mark D. Dowd’s bias/racism that is troublesome. It is his stupidity in his recommended ruling, findings of facts and his conclusion of law which eviscerates nearly two hundred years of medical and pharmacy law and protocols.
For everyone’s benefit, please see attached the correspondence we sent to Mr. Clement. We consider this matter closed.
Thank you,
NOTES AND UPDATES
THIS MATTER WAS CLOSED BY THE OHIO STATE UNIVERSITY 7/2/2020
Colleagues:
For everyone’s benefit, please see attached the correspondence we sent to Mr. Clement. We consider this matter closed.
Thank you,
Chris
Mr. Clement, 7/2/2020
Thank you again for reporting your concern, and for taking the time to speak with me about it recently. Our review determined that the concerns you raised about the accuracy of Dr. Sullivan’s expert testimony do not implicate any Ohio State University policy, and therefore they are not able to be investigated as a potential policy violation. However, we have sent your concerns and all of the information you provided to the College of Pharmacy for their awareness.
RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
“Dozens of retired black narcotics agents say their former agency, the U.S. Drug Enforcement Administration, has discriminated against its African-American employees for decades.”
ABC NEWS-
CONGRESS MUST DEFUND THE DEA
According to ABC News Jim Mustian of Associate Press and the Baltimore Sun Times Justin Fenton June 18, 2020;
The group of retired agents said in a statement sent to news organizations this week that Attorney General William Barr was out of touch with racial disparities that permeate not only local police departments but federal law enforcement. (5)
“This is a culture,” said Karl Colder, who previously oversaw the DEA’s Washington field division, served on the agency’s diversity committee and was one of 76 former agents involved in drafting the statement. “You still don’t have African Americans in positions to really monitor and ensure things are equal.
Gary Tuggle, who was a special agent in charge of the Baltimore field office and served as interim Baltimore Police commissioner in 2018, said he thinks the problem has worsened in recent years.
Ernie Howard, who was the special agent in charge in Houston from 1997 to 2001, said there is “not an even playing field.”
“The DEA hasn’t had an African American female special agent in charge in years,” Tuggle said. “That’s ridiculous.”
June Werlow Rogers, who previously led the DEA’s New England field office from 2002 to 2008. “I’m really glad we’re at a point now where people are listening, but in order for us to change things, we’ve got to change minds and hearts.”
” Rogers recalled while an agent in Baltimore she was pulled over and questioned despite showing her DEA credentials until a white DEA supervisor intervened and that a magistrate judge once confused her for a defendant in court.“
We can easily relate with former Agent Rogers and share our experience with a privileged Judges. Transcripts from January 28, 2020, DEA v Pronto Pharmacy LLC Tampa Florida. DOCKET 19-42, before Judge Mark D. Dowd held in Tampa, Fl.
MR. SISCO: No objection.
JUDGE DOWD: Thank you, Mr. Sisco.
THE WITNESS (DEA Richard James Albert): Mr. Clement, one question. When you
served that document on the pharmacy, were these printed out for you at that time or were these maintained at the pharmacy in a logbook, or do you know where these actually came from?
DEA RICHARD JAMES ALBERT
THE WITNESS (DEA Richard James Albert): They will be maintained
in a logbook. But when I requested a subpoena, I would think that they made copies of them.
And one correction —
JUDGE DOWD: Okay. So you weren’t there when they were produced, you came back for them?
THE WITNESS: (MR. ALBERT) W ell, they was — I either picked them up or they were sent to me.
JUDGE DOWD: Okay.
THE WITNESS(DEA Richard James Albert):: But one c o r r e c t . I ‘m Mr. Albert. You called me Mr. Clement.
JUDGE DOWD: Oh, I’m sorry. Excuse me. It’s old age creeping up. “Old Age,”
No, from the elders we have learned just let him keep talking, give him time, and the truth will come out. Times have changed very little. Once a Black Federal employee reaches GS-13 any promotion beyond that point becomes extremely difficult.
The DEA was first held liable in the early 1980s for discriminating against black agents in salary, promotions, supervisory evaluations, and discipline.
SUSAN LANGSTON DEA VS. WALTER R. CLEMENT
While Black Agents in the DEA were continually denied, promotions, unqualified people like Susan Langston received promotion after promotion and recently was promoted to DEA Head Quarters in Washington DC. Ms. Langston has only a BS in Arts and Training as a paralegal with no law enforcement background.
According to LinkedIn reporting, she became in charge of the DEA Field office in Los Angeles and Miami and received a promotion within the DEA headquarters in Washington D.C. Ms. Langston appears to have no background, training nor certifications in the knowledge of drug substance abuse and treatment and appears to have no advanced certificates in law enforcement.
Susan Langston was the Program Manager for the DEA Miami Field Division’s Diversion Regulatory Program. Overall supervision of Diversion Groups located in Miami (Weston), West Palm Beach, Tampa, Orlando, Jacksonville, and Tallahassee, Florida. She has since been promoted to a position in Washington DC. (1)(2)
SUSAN LANGSTON
Ms. Langston’s qualifications and educational background are both troubling and alarming. She has no law enforcement background, no medical, dental, or pharmaceutical science background. Yet she heads to head the DEA Miami Field Division’s Diversion Regulatory Program. Ms. Langston has attained only a bachelor’s degree beyond that trained as a paralegal. (9)
Ms. Langston orchestrates the attacks against licensed physicians, pharmacists, and dentists, and yet her qualifications, background, and tactics such as redefining, misclassification of long-standing medical/pharmacy/dental protocols are further troubling. Such as:
Defining Pharmacy Compounding as Manufacturing and requiring a separate registration when no registration exists.
Pushing for a pharmacist to challenge medical/dental practitioners’ diagnosis and treatment, which is outside the authority and scope of a pharmacist. (11)
Strong arming Pharmacies/Pharmacists into being an arm of law enforcement (supporting the misuse of Google Maps and the PDMP systems) which encourages bias, discrimination, and profiling.
WALTER R CLEMENT
Walter R. Clement, Bachelor of Science, Criminal Justice, Eastern Michigan University, 1996
Master’s Business, Business Management, Colorado Technical University, Colorado Springs, CO, 2006. Master’s Business Administration, Human Resource Management, Colorado Technical University, Colorado Springs, CO, 2007
Home E-mail: Range1274@comcast.net
Police Officer, Detroit Police Department 1977-1980 Corrections Specialist,Michigan Department of Corrections, Phoenix Correctional Facility,1980-1985
Resident Unit Officer, Promoted 1982-1985, Supervised inmates in correctional unit housing blocks (Full time)
Police Officer, Detroit Police Department 1985-1995
1.)Underwater Recover Team 1985-1994
2.) Special Response Team 1986-1993
3.) Criminal Sex Crime Investigator 1993-1995
Sergeant, Detroit Police Department, 1995-2013
4.)Patrol Supervisor, investigate use of force complaints.
5.)Financial Management Department, Supervisor/Manager Grant Writer Team
6.)Community Policing finance/operations manager
6.)Supervisor/Trainer Detroit Police Underwater Recovery
7.)Field Training Officer (FTO) Supervisor
8.)Training Instructor, Detroit Police Academy
Officer in Charge of Firearms Range
9.) Criminal Justice Instructor, University of Phoenix, Southfield Michigan, Instructor, 2006-2007 (Part-time)
Licensures/Certificates (include licensure/certificate name, issuing organization, original year obtained, and current/non-current):
11.) Certificate of Training, National Standard of First Official Response to a Critical Environment training, United States National Standards of Training Association, 2010
12.) Underwater crime Scene Preservation and Investigation Techniques,Michigan Justice Institute, Macomb Community College,1999
Faculty: The Role
TRAINING OF OTHER OFFICERS
Formal Teaching Experience (Indicate delivery formats as appropriate)
Bachelor’s/Associate’s Subject Areas Taught: Introduction to Criminal Justice, Classroom and Online
Criminal Investigations, Online
13.)Law Enforcement Operations and Report Writing, Classroom and Online
14.) Ethics in Criminal Justice, Classroom and Online
15.) Criminology, Online
16.) Criminal Procedure, Online
17.) Interview and Interrogation, Online
18.) Victimology, Online
19.) Grant Writing, Classroom and Online
20.) Report Writing, Online
21.) Introduction to Criminal Profiling, Online
Other Teaching Experience:
22.)Detroit Police Academy (Inservice training for police supervisors) 2008-2013
23.) Use of Force, Leadership, Police Customers Service, Supervisor Report Writing, Job Satisfaction
24.) Detroit Police Academy (Recruit Training classes) 2008-2013
26.) Nation Black Police Association, Instructing on Grant Writing, throughout the United States 2009-2012;
This is only 1/3 of Walter R. Clement’s credentials and what more Black Law Enforcement officer have attained in the year of services to their communities and country. Further, these are the amount of credentialing the Federal Courts have taking their time (40 years) to slow walk and act upon. The actions of the Federal Courts are disgraceful. Walter R, Clement is more than qualified to be in the Senior Executive Level of the DEA.
Walter R. Clement, comes from a family of mud, grit, and adventurers, he enjoys riding his Aspencade Motor Cycle throughout the United States of America and Canada, just like Val Demmings. He enjoys teaching Law Enforcement. Walter R. Clement, was born the 4th child into parents Erlin and Rose Elaine Clement from Panama. His grandparents were from Barbados and migrated to Panama to build the Panama Canal. He is most proud to say that all of his 5 brothers, finished college and our dad is still standing at 103 years old and loves his Golf Game.
ERLIN CLEMENT SR., AGE 98 TUCAN COUNTRY GOLF CLUB, BALBOA, PANAMA 2015
SUSAN LANGSTON DEA VS. VAL DEMINGS
Val Demings, began her career in Jacksonville as a social worker, working with foster children. Despite seeing a few women in the ranks of law enforcement in the early 1980s, Val was inspired to move to Orlando to join the police force. She graduated from the police academy as class president, receiving the Board of Trustees’ Award for Overall Excellence, and quickly earned the reputation of a tenacious, no-nonsense cop. (published resume online google search)
CONGRESSWOMAN VAL DEMINGS
Val Demings, took these lessons seriously, getting her first job at age 14, and became the first in her family to graduate from college. With her parents proudly at her side, she received a B.S. in Criminology from Florida State University.
It was that reputation that helped her work her way up the ranks while raising a family. During her 27-year career, she served in virtually every department, including serving as Commander of the Special Operations, where she was responsible for some of Orlando’s highest-profile tasks, including special events and dignitary protection.
In 2007, Val Demings made history when she was appointed to serve as Orlando’s first female Chief of Police.
Chief Demings was widely praised for her dynamic leadership and a significant drop in crime. She shepherded the department through the financial crisis and despite budgetary constraints kept the same number of officers on the streets. Remarkably, the Orlando Police Department reduced violent crime by more than 40 percent while she was Chief.
Chief Demings founded innovative programs like Operation Positive Direction, a mentoring program that empowers at-risk students through tutoring, community service, and positive incentives. She also launched Operation Free Palms, a project focusing on rejuvenating Orlando’s most crime-ridden housing complex, the Palms Apartments. Collaborating with city officials and faith leaders, this initiative included increasing access to childcare, building playgrounds, a GED program, and job skills training to improve the quality of life in Orlando’s most distressed community.
VAL DEMINGS ON LINE PUBLISHED BACKGROUND
According to Wikipedia;
In 1983, Demings applied for a job with the Orlando Police Department (OPD); her first assignment was on patrol on Orlando’s west side.[5] Demings was appointed as Chief of the Orlando Police Department in 2007, becoming the first woman to lead the department.[8][9]
According to a 2015 article in The Atlantic, the Orlando Police Department “has a long record of excessive-force allegations, and a lack of transparency on the subject, dating back at least as far as Demings’s time as chief.”[10] A 2008 Orlando Weekly exposé described the Orlando Police Department as “a place where rogue cops operate with impunity, and there’s nothing anybody who finds himself at the wrong end of their short fuse can do about it.”[11] Demings responded with an op-ed in the Orlando Sentinel, arguing that “Looking for a negative story in a police department is like looking for a prayer at church” and added that “It won’t take long to find one.” In the same op-ed, she cast doubt on video evidence that conflicts with officers’ statements in excessive force cases, writing, “a few seconds (even of video) rarely capture the entire set of circumstances.”[10]
In 2010, an Orlando police officer flipped 84-year-old Daniel Daley over his shoulder after the man became belligerent, throwing him to the ground and breaking a vertebra in his neck.[12] Daley alleged excessive force and filed a lawsuit. The police department cleared the officer as “justified” in using a “hard takedown” to arrest Daley, concluding he used the technique correctly even though he and the other officer made conflicting statements. Demings said “the officer performed the technique within department guidelines” but also said that her department had “begun the process of reviewing the use of force policy and will make appropriate modifications.” A federal jury ruled in Daley’s favor and awarded him $880,000 in damages.
VAL DEMINGS EARLY LIFES
According to Wikipedia;
Valdez Venita Butler was born on March 12, 1957,[4] one of seven children born to a poor family; her father worked in orange groves, while her mother was a housekeeper. They lived in Mandarin, a neighborhood in Jacksonville, Florida. She attended segregated schools in the 1960s, graduating from Wolfson High School in the 1970s.[5]
CONGRESSWOMAN VAL DEMINGS
According to her online Biography;
Congresswoman Val Demings represents Florida’s 10th District. The first in her family to graduate college, she became a social worker, then a police officer.
1.)Rep. Demings is married to Orange County Sheriff Jerry Demings, is a proud mother to three sons, and proud grandmother to five.
2.) Rep. Demings holds an honorary doctorate of laws from Bethune-Cookman University. (oh no!!, “FAMU, FAMU I LOVE THEE”)
3.) Rep. Demings is an active member of St. Mark A.M.E., Delta Sigma Theta Sorority, Inc., Orlando Chapter of The Links, Inc., NAACP Silver Life Member, Florida Bar Citizens Advisory Committee, Florida Police Chiefs, National Organization of Black Law Enforcement Executives, National Association of Women Law Enforcement Executives, National Congress of Black Women, and numerous other affiliations.
4.) Rep. Demings enjoys spending her very limited free time riding her Harley-Davidson Road King Classic motorcycle (just like Walter R. Clement). She has completed the O.U.C. half marathon as well as the Walt Disney marathon.
5.) Congresswoman Val Demings more than qualified to be a DEA special agent, or head of DEA Southeast Region, or Director of the DEA. Congresswoman Demings is absolutely qualified United States Supreme Court Associate Justice or Chief Justice or Vice-President of the United States.
Congresswoman Val Demings, Former Police Chief, sits on the Judiciary Committee and the Committee on Homeland Security.
SUSAN LANGSTON DEA VS. LAURA COATES
According to Laura Coates online Biography “ABOUT LAURA COATES;”
” Laura Coates is a well-respected attorney, commentator, law Professor, author, and radio talk show host. A native of Saint Paul, Minnesota, Laura graduated from Princeton University’s Woodrow Wilson School of Public and International Affairs and the University of Minnesota Law School before beginning her legal career in private practice. (3)
Ms. Coates practiced law in Minnesota and New York handling cases ranging from intellectual property litigation and First Amendment issues to Defamation and Media law. Called to public service, she transitioned from private practice to the United States Department of Justice, thriving as a federal prosecutor. (3)
LAURA COATES ESQ.
She served as a Trial Attorney in the Civil Rights Division of the Department of Justice during the Bush and Obama administrations, specializing in the enforcement of voting rights throughout the country. She also served as an Assistant United States Attorney for the District of Columbia, prosecuting a myriad of violent felony offenses, including drug trafficking, armed offenses, domestic violence, child abuse, and sexual assault.(3)
Laura’s depth of experience and broad expertise has earned her acclaim across all media platforms. Easily branded a constitutional expert, her diversified expertise is both timely and topical. She is lauded across the globe for her persuasive objectivity and ability to break down complex and emotionally-charged topics plainly and without partisanship. Her opinions and analysis can be found in national publications such as The Washington Post, USA Today, and are prominently featured on CNN, where she has long served as a Senior Legal Analyst.
Recognizing the dire need for increased police accountability and improved police-community relations, she wrote the bestselling 2016 book, You Have the Right: A Constitutional Guide to Policing the Police. In the book, Laura removes the legalese and helps ordinary citizens know and understand their 4th, 5th and 6th Amendment rights.”(3)
Laura Coates comes from solid family background. Her father is a Dentist, and he too enjoys riding his motorcycle throughout, just like Walter R. Clement and Congresswoman Val Demings. Ms. Coates can easily serve as head of DEA, or United States Appeal Court Judge, Washington DC., or Governor of The State of Minnesota, or United States Supreme Court Justice. Ms. Coates is too qualified to run for Prosecutor of Hennepin County, or Ramsey County Minnesota because those positions are beneath her grade.
WAITING 40 YEARS FOR JUSTICE AND NO PROGRESS
Justin Fenton, Baltimore Sun Times article concludes.
“There’s racism in the United States still, but I don’t think that the law enforcement system is systemically racist.” (4)
“The retired agents say that just 8% of nearly 4,500 special agents as of last fall were black. Similarly, just four of the 50 senior executives are black. Last year, a federal judge ruled in the class-action suit first brought in 1977 that the DEA needed to take more steps to cure systemic race bias in promotions to the detriment of black agents.”(4)(5)
“This begs the question that if the DOJ will not abolish the 40-plus years of racism in one of its component law enforcement agencies, how can they expect police departments to do the same?”(4)(5)
JACK FOLSON RPH, WALTER R. CLEMENT MS., MBA., RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
I HAVE A PHYSICIAN-PATIENT RELATIONSHIP
“I cannot live in fear, we must live by the law,”
THE MANIFESTO OF THE NORTH STAR PROJECT
When you see THROUGHOUT LIFE most of your friends, colleagues, and classmates who are of degree being defiled, sanctioned, terminated, harassed, arrested, jailed, and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do Then at some point, you are compelled to ask yourself when
ENOUGH IS ENOUGH.
At some point in your life, you have to say and proclaim enough is enough and what are you going to do about it. Then we must stand and fight as soldiers together or die like mice.
ENOUGH IS ENOUGH. To me, that idea that some United States Attorney is going to tell me pharmaceutical compounding is manufacturing makes it’s worth the fight.
WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY TO THE UNITED STATES HOUSE COMMITTEE ON THE JUDICIARY, UNITES STATES HOUSE OVERSIGHT ON OVERSIGHT SUBCOMMITTEE ON GOVERNMENT OPERATIONS AND UNITED STATES SENATE COMMITTEE ON THE JUDICIARY TO DEFUND AND DISBAND THIS AGENCY OF GOVERNMENT.
ENOUGH IS ENOUGH.
THIS PRESENTATION CONTAINS MUST SEE VIDEOS WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE
INTRODUCTION
DIVERSION INVESTIGATOR RICHARD JAMES ALBERTAND HIS HANDLERS
RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR
So, when Diversion Investigator Richard James Alpert, in May of 2019 returned to Pronto Pharmacy for his 5th visit, make no mistake, his actions as directed by his handlers, Susan Langston, DEA Divisional Director State of Florida located in Miami, Florida Aimee Hickerson Diversion Supervisor, Florida assigned to Pharmacies, John Beerbower Esq., United States Attorney for the DEA. was laser-targeted on finally disrupting, dismantling and destroying the business of Pronto Pharmacy LLC. In a similar manner as Superior Pharmacy of Tampa, Florida, or in West Virginia, Oak Hill Home Town Pharmacy, Oak Hill, WV.
It should noted, Richard James Albert is a black man who is a functionary of the Drug Enforcement Agency, and moves solely at the direction of the handlers. Albert, whose full mission has been disguised in his hue thus to remove any inference by DOJ and DEA history of racial injustice and profiling.
EXPOSING THE CORRUPTION OF THE UNITED STATES DRUG ENFORCEMENT AGENCY AND ITS COURT SYSTEM THE NEED TO HAVE THEM DEFUNDED AND DISBAND BY THE CONGRESS OF UNITED STATES
The Drug Enforcement Agency (DEA) and prosecutors have been successful in their court proceedings with their counter spin “pill mills.” While it never dawns upon the juries or the public that a pill is a unique dosage form in pharmacy, the only commonality it has is it rhymes with mill. Richard James Albert’s handlers never thought was that these Black Pharmacists of Pronto, At Cost, Gulf Med Pharmacies, Oak Hill Hometown Pharmacy would fight back and that it would be business as usual.
A PICTURE OF THE WHO ARE OUT TO SILENCE BLACK HEALTHCARE
Diversion Investigator Richard Albert,(DI) testified that he did not “Know or understand the law(s) or how any law applies to the practice of Pharmacy. On January 28, 2020, Richard Albert (DI Albert) under cross-examination by Pronto Pharmacy Attorney Dale Sisco of Tampa, Fl, in summary, stated
In reviewing the respondent’s prescription data, he became suspicious because certain prescriptions were written for tablets but filled in capsules. However, DI Albert admitted that he is not familiar with FDA guidelines regarding compounding and, further, that he did not analyze the records he obtained from the respondent to compare the patients who received capsules that were compounded at respondent’s pharmacy to the anticipated patient’s need. Likewise, DI Albert did not compare the number of doses of capsules documented as having been compounded by the batch reports to the number of drugs dispensed by the respondent.
DI Albert admitted that speaking with the prescribing physicians identified in the E-FORCE data would have been a simple and straightforward method to ascertain whether any of those prescribers had, in fact, authorized the substitution of capsules for tablets for a particular prescription. He testified further that there was nothing to prevent him from contacting all but one of the physicians who wrote the prescriptions for the patients at issue. However, DI Albert never contacted, spoke with, or attempted to contact or speak with any of the prescribing physicians.
DI Albert did not know of any federal or state law or regulation that limits the geographic area in which a pharmacy can dispense medications.
DEA AGENT DISABLING SECURITY CAMERA AT PRONTO PHARMACY LLS DURING AUGUST 29, 2019 RAID
VIDEO THE DEA IS COMING AFTER PHARMACIST AND HAVING NO GUIDELINES
The DEA sets arbitrary parameter according to Pharmacist Association CEO Michael Jackson in June 2017 Conference of the Florida A&M Alumni, New Orleans (SEE BELOW VIDEO MICHAEL JACKSON RPH, CEO FLORIDA PHARMACIST ASSOCIATION CE PROGRAM WITH THE FLORIDA A&M UNIVERSITY PHARMACIST ALUMNI JUNE 2017, NEW ORLEANS, LA,
The DEA agent Richard Albert prepared a warrant that “opinion based on a red flag that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy. Pronto Pharmacy is a licensed pharmaceutical company by law that can compound medications. The below chart demonstrates Richard James Albert nor his handlers know existing laws and/or rules guiding the practicing of Pharmacy. More specifically control medications and this chart under (iv) practitioners, hospitals retail pharmacies are permitted under their DEA Federal Registry certificate to process Schedule medications II-V. This chart specifically outlines:
” A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.“
DEA’s argument has been Pronto Pharmacy compounding of control medications was concluded as manufacturing and Pronto Pharmacy needed a separate manufacturing registration. This was because their retail registration license does not cover for manufacturing. The chart of guidelines more than contradicts all DEA assertions made by both DI Albert and his handlers against Pronto Pharmacy.
Yet, what is more, troublesome it that these guidelines are from the DEA’s own website under 21 USC 1301.13 under certificate new license and renewal (224&224a) and the cost for this license is $731.00 and it is good for 3 years. The importance is DI Albert didn’t know laws, never looked for the law and his handlers, Aimee Hickerson, Susan Langston, John Beerbower kept him ignorant of the laws.
DEA WEBSITE UNDER 21USC 1301.13
(iv) Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)
Schedules II–V
New–224 Renewal–224a
731
3
May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.
COMPOUNDING IS NOT MANUFACTURING. NEVER HAS AND NEVER WILL BE!!
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Compounding is defined in several ways according to the Guidelines for Compounding Practices we quote these definitions verbatim from Chapter 795 of the United States Pharmacopeia (USP)
Compounding can be as simple as the addition of a liquid to a manufactured drug powered or as complex as the preparation of a multicomponent parenteral nutrition solution. In general, compounding differs from manufacturing in that compounding involves a specific practitioner-patient-pharmacist relationship, the preparation of relatively small quantity of medication, and different conditions of sale.
Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observed prescribing patterns. (5)
Manufacturing is the production, preparation, propagation, conversion and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or indecently through means of chemical or biological synthesis; the terms include any packaging or repackaging of the substances(s) or labeling or relabeling of its container and the promotion and marketing of such drug devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons. (5)
GUIDELINES FOR DISTINGUISHING BETWEEN COMPOUNDING AND MANUFACTURING ARE ASFOLLOWS:
Pharmacists may compound, in reasonable quantities, drug preparations the are commercially available in the mar place if a pharmacist-patient-prescriber relationship exist and a valid prescription is presented.
DEA takes the position:
(1) compound only for a specific patient; and
(2) cannot compound drugs that are otherwise commercially available.
However, the ( FDA)Food Drug & Cosmetic Act to this email. While it may allow a licensed pharmacist to compound “limited quantities” before the receipt of an actual prescription, such “limited quantities” must be based upon a history of valid prescription orders for the compounded products for a specific patient.
Pharmacist may compound nonprescription medications in commercially available dosage forms or in alternative dosage form to accommodate patients needs called by individual state boards of pharmacy.
Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription, on the basis of a history receiving valid prescriptions that have, on basis of a history of receiving valid prescriptions that been generated solely within an established pharmacist-patient prescriber relationship, and provided that the prescriptions are maintained on file for all such preparations dispensed at the pharmacy.
Pharmacist should not offer compounded medication to other pharmacies for resale; however, a practitioner may obtain compounded medication to administer to patients, but it should be labeled with the following: “For Office Use Only,” date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by a hospital to contract compounding pharmacies.
Compounding pharmacies and pharmacist may advertise or otherwise promote the fact that there provide prescription compounding service.
RICHARD ALBERT’S CROSS-EXAMINATION TESTIMONY JANUARY 28, 2020 DEMONSTRATED LACK OF KNOWLEDGE OF PHARMACY LAW AND PHARMACY PROTOCOLS
The transcripts clearly demonstrate the DEA agent’s lacked knowledge and deliberate indifference toward licensed pharmaceutical businesses.
“Mr. Sisco: Based on the investigation that you conducted, did you attempt to determine what the volume was of prescriptions that were being dispensed at Pronto Pharmacy?
DI Albert: No, sir.
Mr. Sisco: But you could tell from the dispensing records, for instance, how many prescriptions were being dispensed each day, each week, each month or each year; right?
DI Albert: I would be able to tell that, yes.
Mr. Sisco: But you never made an attempt to do that?
DI Albert: No, sir
Mr. Sisco: And did you analyze thee records, the prescribing records that you obtained via the administrative inspection warrant to compare the patients who received capsules that were compounded at Pronto Pharmacy to the anticipated patient need?
DI Albert: No, sir.
Mr. Sisco: Are you familiar with FDA guidelines with regard to compounding?
DI Albert: No, sir
Mr. Sisco: As part of your training, the 12-week diversion investigator training, did you receive training with regard to the compounding of medication and the laws that apply to it?
DI Albert: Not specifically compounding.
Mr. Sisco All right. And one of the things that you’re trained on in that 12-weeks course is law right?
DI Albert: Yes
Mr. Sisco: And Federal Law, I presume?
Di. Albert: Yes
Mr.Sisco: And have you educated yourself on Florida law that applies to pharmacy operation?
DI Albert: Myanswer will be no on that.
Mr. Sisco: So in your analysis of this case, you looked solely to federal law.
DI Albert: Correct
Mr. Sisco: Even though, for instance, your subpoena reference specific Florida Administrative Code provisions?
DI Albert: Correct.
Mr. Sisco: You drafted the subpoena , didn’t you?
DI Albert: Yes
Mr. Sisco: Okay. So when you put those codes provisions in there, they had some significance to didn’t?
DI Albert: Yes
Mr. Sisco: Okay What was the significance that they had?
DI Albert: I don’t know sir.
Mr. Sisco: Okay. So looking at Exhibit Number 6 did you determine–did you compare the number of doses of capsules that were documented as having been compounded by these batch reports to the amount of drugs dispensed by Pronto Pharmacy?”
DI Albert: No, I did not.
Mr. Sisco: Based upon your training, education and experience, is there a federal statute or regulation that geographically limits the area in which a pharmacy can dispense?
DI Albert: Not to my Knowledge.
Mr. Sisco: To your knowledge based on your training, education and experience, is there a Florida statue that limits the geographic are in which a Florida pharmacy can dispense prescription?
DI Albert: Not to my Knowledge.
It is within DI Richard Albert’s own statement that “conceded that he did not know what significance the Florida Administrative Code (FAC) which guides Pharmacy in the State of Florida.” Agent Richard Alpert said, “ FAC provisions were already included in his subpoena template, and that he did not know what those provisions meant.”
DEA FORCING PATIENT’S TO DRIVE HUNDREDS OF MILES TO GET PRESCRIPTION FILLS THEN USING CRIMINALIZING THEM BY MISUSING GOOGLE MAPS
The DEA has developed criminal elements on free commerce by criminalizing distance travel as elements of criminal conduct. Whereby a pharmacist is a licensed practitioner who has advanced knowledge of the chemical-physical properties of medications, mechanism of actions, their dosage forms design, will likely not refer to GOOGLE MAPS as an element of patient treatments. More dangerously, as a result of the DEA’s aggressive policing of community pharmacies many are reluctant to fill any legitimate narcotic analgesic medication prescriptions for non-acute pain patients.
REBBECCA
Some patients are known to spend days on end looking for a pharmacy to fill their prescriptions to no avail. This has caused massive concerns in the chronic pain disease medical/dental community, where one of the most important goals of any therapy is continuing staple treatment without disruptions.
CANCER OF LEG 9/29/17 PRONTO PHARMACY
It is well understood amongst medical/dental practitioners when disruptions in therapy occur, many of the deleterious effects are likely to happen. For example, patients diagnosed with Sickle Cell Anemia are many times profiled as addicts, rather than as persons with a chronic disease condition needing treatment for pain.
PATIENT APPEARED NORMAL, STATES HE WAS SHOT 9 TIMES
ABDOMINAL WOUND
Other examples include persons who have survived traumatic accidents such as automobile accidents, gunshot wounds (civilian and military), notwithstanding leukemia and other cancers.
BULLET WOUND WHERE RIGHT ELBOW WAS DESTROYED (PRONTO PHARMACY 05/18)
Indeed, pain management becomes even much more difficult when anxiety and diminished mobility complicates the treatment plans.
Further, it is well understood, when both medical/dental practitioners and patients can locate a Pharmacy that will fill pain control prescriptions with dignity and respect, both parties will often share that information with others.
DEA’s Pharmacy expert, Don Sullivan, interviewed no physicians/dentist, no patient receiving prescriptions, nor reviewed any prescriptions of any patients from Pronto PHARMACY. Further DEA, expert Don Sullivan reviewed no radiographs, performed no physical examinations on patient of Pronto Pharmacy to impeach the primary physician initial diagnosis.
What DEA expert Don Sullivan a Pharmacy Clinical Professor at The Ohio State University College of Pharmacy, do is profiling each patient forming an opinion base on bias by cleverly eviscerating the physician-patient relationship. Then erroneously supports his conclusion of bias with tools such as GOOGLE MAPS were he claims he can effectively conclude the distance patient travels to fills a concluding prescription establish they are illegitimate medical purposes.
Ironically Professor Don Sullivan, works in the vicinity of the James Cancer Hospital Solve Research Institute at The Ohio State University (right next to the College of Pharmacy at The Ohio State University).
DONALD SULLIVAN RPH., PHD
Patients travel great distances from all over the world to receive services and have their prescriptions filled, utilizing their hospital pharmacy and neighboring pharmacies. Yet, there is no judgement by the mile marker or suggestions of unresolvable “red flags being opined by Professor Don Sullivan pertaining to prescriptions being written at the James Cancer Hospital. These pharmacies are far exceeding the 30 mile limitation of many these patients being treated at the James Cancer Center; as Professor Sullivan testified to as being RED FLAGGS in DEA’s Order To Show Cause Hearing in Tampa Florida January 28-29, 2020.
What further serves to undermines the credibility of both Don Sullivan and DEA Diversion Investigator Richard Alpert are the 11 patients they identified as unresolvable ‘RED FLAGGS,” are still being treated today, by the same doctor for the same amounts at non- black own Pharmacies. Most importantly, prescriptions filled at these other pharmacies and the physicians are no longer classified RED FLAGGS. Both DEA Diversion Investigator Richard Albert and Pharmacy Expert Don Sullivan could have easily verified this by using the PDMP. So what happened to the RED FLAG?????
These patients continue to contact Pronto Pharmacy to inquire when are we resuming services. They are concerned under this current hostile environment aboutthe increase cost they are now paying for their medications at other Pharmacies.
HISTORIC CENTRE OF SALVADOR De BAHIA,SALVADOR,BAHIA, BRAZIL AUGUST 17, 2017
THE DEA’S JUDGEMENT BY THE MILE MARKER
Currently, the DEA has no statistical guidelines or law to support or establish boundary levels, which are indicative of criminal acts when filling any Control prescription written for patients by a physician who has performed a thorough physical examination, diagnoses supported by medical/dental radiographs and treatment plan. The DEA guidelines are tactic acts that specifically target American pharmacist.
In the case of AARRIC Pharmacy, Ft. Myers, Fl., the DEA reasoned that the pharmacist regularly filled controlled substance prescriptions for individuals who traveled an unusual distance. The DEA further stated that “Obtain or fill a controlled substance is indicative of diversion and/or abuse, and
“IS THERE ANY PLACE I CAN GO TO GET MY PRESCRIPTION FILL
that such behavior is a red flag that must be addressed prior to dispensing.” The DEA reasoned that traveling 78 miles round trip and over 53 miles round trip is a red flag that must be addressed prior to dispensing. The DEA also claimed that traveling 45 miles round trip and or 44 miles round trip is a red flag that must be addressed prior to dispensing.
JACK FOLSON RPH, WALTER R. CLEMENT MS., MBA., RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
CHINESE DISSIDENT: ARTIST AL WEIWEI
“I cannot live in fear, we must live by the law,”
THE MANIFESTO OF THE NORTH STAR PROJECT
When you see THROUGHOUT LIFE most of your friends, colleagues, and classmates who are of degree being defiled, sanctioned, terminated, harassed, arrested, jailed, and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do Then at some point, you are compelled to ask yourself when
ENOUGH IS ENOUGH.
At some point in your life, you have to say and proclaim enough is enough and what are you going to do about it. Then we must stand and fight as soldiers together or die like mice.
ENOUGH IS ENOUGH. To me, that idea that some United States Attorney is going to tell me pharmaceutical compounding is manufacturing makes it’s worth the fight.
WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY TO THE UNITED STATES HOUSE COMMITTEE ON THE JUDICIARY, UNITES STATES HOUSE OVERSIGHT ON OVERSIGHT SUBCOMMITTEE ON GOVERNMENT OPERATIONS AND UNITED STATES SENATE COMMITTEE ON THE JUDICIARY TO DEFUND AND DISBAND THIS AGENCY OF GOVERNMENT.
ENOUGH IS ENOUGH.
WARNING: THIS PRESENTATION CONTAINS DISTURBING MUST SEE VIDEOS WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE
INTRODUCTION
The year is 1959, the great trumpeter Miles Davis, stepped outside of the Bird Land Theater in New York City, where he was top billing, to smoke a cigarette. Then a rookie cop walking the beat approached him and said, “You can’t stand there, move along.” Miles stated, “I’ve done nothing wrong. I’m not going anywhere..my name is on the Marquee…” A tussle ensued. Miles was struck over the head with a billy club by a drunk New York City detective and arrested. The great writer and Chairperson of Institute for Research in African-American Studies (IRAAS), Columbia, University, Dr. Farah Griffin, so eloquently put it, “No matter how much you have accomplished or what you have achieved, the system of racism in America will remind you what you are.” iii ( ft note PBS miles) The great trumpeter Dizzy Gillespie was asked in 1984 to access the incident of Miles Davis, he stated “no matter how big you get racism will appear like a dragon with steam rolling out its nose.
The year is 2020, in the 21st Century, 60 years removed from 1959. As a highly trained Medical Practitioner (Physician, Dentist, Pharmacist), your reputation means everything, especially when individuals are of an international cultural background; they are further held in high esteem by their entire village, family name, and their nation of birth. We are role models, having aspired against great odds and barriers, achieving a degree marking great success and accomplishments. Thus when the United States Drug Enforcement Agency (DEA) targets any healthcare practice, particularly those owned by African Americans and people of color, the public through media perceptions, is programmed to believe one to be is guilty.
AS A BLACK PHARMACIES OWNER WE ARE LOW HANGING FRUIT
We are, but role models and low hanging fruit who are praised and paraded before our congregations of elementary and high school children and churches but trained to remain silent and to have no opinion, offer no ideas or input, go along just to get along. yet remain both invisible, and silent.
Your professional colleagues and organizations become non-engaged, intimated by your presence, and failing, to bring light on the sheer incompetence and lawlessness of these DEA Diversion Investigators.
Like any Black Person we are but invisible men/women and are Black medical practitioners who possess the education, knowledge, achievements, and loyalty to address the needs of people> That makes us dangerous and viewed with disdain stain from those whose goals are to restrict our wisdom. We are but low hanging fruit for the DEA, Your professional license, for what it is worth, as a physician, dentist, or pharmacist, is now that of a common drug street dealer.
(A POWERFUL VIDEO(SEE VIDEO TARGETING OF LOW HANGING FRUIT, CALL AL SHARPTON)
You are but low hanging fruit. Don’t bring attention to yourself, you know how it is. Invisible, filtered. And like any people to protect what’s left of your reputation, most would rather fold than fight. Like their black counterparts, it’s better to remain silent, and do as you’re told. But to this group, their attitudes are reflective of Frederick Douglas’ speech of 1857:
“Let me give you a word of the philosophy of reform. The whole history of the progress of human liberty shows that all concessions yet made to her august claims have been born of earnest struggle. The conflict has been exciting, agitating, all-absorbing, and for the time being, putting all other tumults to silence. It must do this or it does nothing. If there is no struggle there is no progress. Those who profess to favor freedom and yet deprecate agitation are men who want crops without plowing up the ground; they want rain without thunder and lightning. They want the ocean without the awful roar of its many waters.”
THE TARGETING
Pronto Pharmacy LLC, At Cost Pharmacy of Fort Myers, Fl, Gulf Med Pharmacy of Cape Coral, Florida, Oak Hill Pharmacy of Oak Hill, West Virginia to this date have neither violated nor broken any laws. All control medications in theses Pharmacies have been dispensed according to CSA guidelines, and all prescriptions filled by these pharmacies were legally written by licensed medical/dental practitioners. Most interesting, all the black pharmacist had never encountered anything within the criminal justice law enforcement system until after they got their degrees and opened up their businesses.
dale sisco esq; attorney for Pronto Pharmacy
“….Norman – I have reviewed the new DOH complaint. One of the individuals present, Amie Hickerson, is the new Diversion Group Supervisor in the Tampa DEA Office. She replaced Roberta Goralczyk. Her participation in this inspection is particularly troubling because the DEA is cracking down on compounding pharmacies. Two important aspects of the distinction between “dispensing” and “manufacturing” are that retail pharmacies are permitted to….”
Yet it is clear that the DEA agents were operating in absence from the law whereby Richard Albert, testified on January 28, 2020, in a DEA Federal Court Hearing that he did not “Know or understand the law(s) or how any law apply to the practice of Pharmacy.” There is no evidence that any medication was being diverted.
According to Leo Beletsky and Jeremy Goulka September 2018 article, “The Federal Agency That Fuels the Opioid Crisis,” in the New York Times:(1)
“The Drug Enforcement Administration, the agency that most directly oversees access to opioids, deserves much of the blame for these deaths. Because of its incompetence, the opioid crisis has gone from bad to worse. The solution: overhauling the agency, or even getting rid of it entirely.” (see link below)
DEA Diversion Investigator Richard James Albert so entered the premises of Pronto Pharmacy LLC., based on an assumption that lead Pharmacist Norman J Clement, his family and those employed were illegally manufacturing Oxycodone and Hydromorphone based on suspicion and dispensing high doses of illegally controled prescriptions.
All medications, controlled and non-control, have been properly prescribed by a licensed physician, for treatment of a disease state, supported by radiographs, physical examination, and treatment plan, all part of the patient’s medical/dental records. DI Albert, purposely withheld relevant facts by eviscerating the patient-practitioner relationship, by using Google Maps to track distance traveled by theses patients to have their prescriptions filled, and the patients paying in cash. This is negligence. His handlers have taught him well. Jack Folson Pharmacist Expert writes:
“Currently, the DEA has no statistical guidelines or law to support or establish boundary levels, which are indicative of criminal acts when filling any Control prescription written for patients by a physician who has performed a thorough physical examination, diagnoses supported by medical/dental radiographs and treatment plan. The DEA guidelines are tactic acts that specifically target African American pharmacists.”
THE DEA AND THE MIS-EDUCATION OF THE PUBLIC
The DEA, its with cleverness has redefined Narcotic Analgesic Medications(NAM) into the word Opioids. Neither are accepted are for recreational or experimentation use. There are dangers associated with Narcotic Analgesic Medication(NAM) for the treatment of pain, as with any medication used therapeutically. As a pharmacist, we learn all medications are dangerous, every last one them. Importantly, all medications taken for the treatment of any disease conditions in order to sustain life will result in dependency (addiction) and when taken beyond their therapeutic dose will cause harm and possibly death.
“As Black practitioners I early found myself treating disease pathology and the pathology of oppression”…norm rph.,dds.
NAM’s are a very important class of medications for the control and treatment of pain. Most importantly, when NAM’s are selected for the use of pain, they may and will cause dependency. Further, unless in the case of anaphylaxis (allergic) reaction, there are very few recordings of death from this class of medications when NAMs are properly prescribed, monitored, and given at a therapeutic dose level. Perhaps it is if death that the DEA has been looking then chemotherapy should be their focus when asking how many people die each day when given a therapeutic dose of chemotherapy.
PHARMACY COMPOUNDING WHILE BLACK!!!
The DEA investigation was an act of brazen misconduct against a licensed retail pharmacy that is licensed by law to compound medications. These cases are not only about bad science but bad law and poor training. Diversion Investigator Richard Albert prepared a warrant that was “opinion based on a red flag,” that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy, wherein a licensed pharmaceutical company by law, that can compound medication. Diversion Investigator wrote,
ILLEGAL MANUFACTURING :
Between January 2018 and May 2019, the Respondent was engaged in manufacturing controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing it tomanufacture controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28.
“In addition, the Government previewed that its evidence will show that the Respondent unlawfully manufactured controlled substances, specifically oxycodone and hydromorphone, without a manufacturer’s registration.”
To support this allegation, the Government intended to show that in May 2012 the Respondent’s owner, Mr. Norman J. Clement, Sr., told DEA investigators that he compounded oxycodone and hydromorphone because it was cheaper than obtaining them from distributors.
THE MANUFACTURING OF OXYCODONE
Pronto Pharmacy does not manufacture Oxycodone nor Hydromorphone, which is a far more complex process. Pronto would have to:
Acquire large tons of harvested opium paste from Tasmania, India, or Afghanistan, transporting these volumes to Tampa, Fl., for processing.
Process the opium paste, large volumes of agents, reagents, equipment, and space would be needed, notwithstanding the fact that to bring the product Oxycodone and Hydromorphone to a pharmaceutical-grade that meets FDA purity standards.
The water bill and electrical bill at Pronto Pharmacy would be enormous.
The manufacturing of Oxycodone into a bulk product is an extremely complex procedure and would involve: (see google scholar manufacture Oxycodone footnote 4)
Oxycodone is manufactured in high yields and with high purity using codeine or salt of codeine as the starting material. The manufacturing process involves the following steps:
(a) codeine or a codeine salt (e.g., codeine phosphate) is converted into the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine,
(b) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine resulting from step (a) is oxidized to yield the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone;
(c) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone resulting from step (b) is enolized with a base and the resultant enolate is thereafter methylated to yield the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine;
(d) the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine resulting from step (c) is reduce to yield thebaine;
(e) the thebaine resulting from step (d) is oxidized to yield the intermediate 14-hydroxycodeinone; and
(f) the intermediate 14-hydroxycodeinone resulting from step (e) is hydrogenated to yield oxycodone.
THERE WAS NOT ONE SINGLE CAPSULE EVER MANUFACTURED AT PRONTO PHARMACY
1. There is not one piece of equipment that the DEA seized from Pronto that was used in manufacturing. All equipment taken was for compounding 2. All medications compounded was purchase from two wholesalers (Fagron and B&B)
3. There is not a single controlled substance compounded for encapsulation at Pronto Pharmacy which was manufactured at the pharmacy or by a Pronto pharmacist and/or their technicians. Here are the containers. ( see below) 4. The containers of powders were obtained from B&B Pharmaceutical and were recorded into the CSOS system which reported back to the DEA and wholesalers. Therefore, Richard James Albert should have known this but chose to falsify his warrant in order to put Pronto out of business and its owners in prison.
HYDROMORPHONE HCL 100GRAMS
OXYCODONE HCL 100 GRAMS
DEA MOVING THE GOAL POST BACKWARD AND FORWARD AND SETTING QUOTAS
We see this early in the case of Pronto Pharmacy when Diversion Investigator Richard James Albert (DI Albert) came upon compounding, and when he could not repeatedly find anything wrong with the pharmacy’s records His handlers instructed him to redefine this long-standing pharmaceutical methodology as manufacturing.
It is more than clear that the DEA Diversion Investigators were operating in absent the law based on mis-facts, lies, distortions. DEA has learned well. When there is no evidence of wrongdoing, DI Richard James Albert’s handlers cleverly instructed him to redefine the meaning of pharmaceutical procedures to accomplish their goals. The Diversion Investigator’s charges and findings were easily scientifically debunked.
It became clear from his court testimony he did not understand compounding or its procedures. But likely learned from his handlers like Amy Hickerson, who was guiding him on how to divert both meanings to convince a Federal Administrative Judge to secure a warrant to shut Pronto Pharmacy LLC down. Additionally, he testified that he did not “know or understand the law(s) or how any law applies to the practice of Pharmacy. Florida Statue 499.1.2 states the wholesaler must assess the purchases of control medication by an individual pharmacy. (SEE BELOW VIDEO MICHAEL JACKSON RPH, CEO FLORIDA PHARMACIST ASSOCIATION CE PROGRAM WITH THE FLORIDA A&M UNIVERSITY PHARMACIST ALUMNI JUNE 2017, NEW ORLEANS, LA)
DEA, supported by its unique unconstitutional court systems permits the agency to operate as rogues in the spirit of impunity in the violation of patients’ rights to privacy and treatment by imposing upon a licensed Pharmacist to conduct criminal background checks. DEA agents can get away with this because they have the power to remove Control Substance Registration, open an investigation, or frequent your business until they get the pharmacist to do what they want. This practice is known by the DEA Agents as Skull Fucking, which amounts to abuse and all DEA supervisors are well aware and encourage these practices. (SEE BELOW VIDEO MICHAEL JACKSON RPH, CEO FLORIDA PHARMACIST ASSOCIATION CE PROGRAM WITH THE FLORIDA A&M UNIVERSITY PHARMACIST ALUMNI JUNE 2017, NEW ORLEANS, LA, ON CRIMINAL BACKGROUND CHECKS)
THE PAINFUL DISCUSSION OF BEING UNDERESTIMATED, UNDERVALUED AND MARGINALIZED
Let it be clear the poor training and limited comprehension, lack of understanding of pharmaceutical science, pharmacy law, and pharmacy protocols of DI Richard James Albert are deliberate, yet essential, and purposefully crafted by his handlers to perform his mission. Richard James Albert does not perform without their command. His handlers know they can prevail with him in spight of their dismissiveness toward medical science and protocols. DI Albert could never be used successfully against a large Chain Drug Store or a Jewish, or White-owned pharmacy because the quality of his knowledge and training would quickly be exposed in a legal proceeding.
However, DI Richard James Albert can prevail against a Black-owned Pharmacy despite any facts or laws we present because the built-in institution of racial injustice, particularly within the Judicial System or in the field of medical science, sports, politics or the military, will default to all knowledgeable, educated Black persons as arrogant and uppity. We see this in our history, particularly in the United States, when one is right and dares to challenges the morae within the system.
Arrogance is rate-limiting, defined all by a preconceived standard of what we are expected to know and further based on a preconceived level of knowledge, expectation, and skill of what one should have obtained. This is likely an eighth-grade education. Anything beyond that becomes suspicious, surprise, unearned, and requires further examination of one’s credentials, instead of being well versed, you are detested. Arrogance stops one in their tracks to be undervalued, underestimated, and marginalized. (7) This is a reality that all Black professionals face, especially those who are licensed in any profession, which we only quietly discuss this among ourselves.
YET, THE PEOPLE AREN’T AS STUPID AS THE DEA THINKS WE ARE!
The authors of this article have learned one thing:
” in America, you either stand for something or nothing at all.”
If standing against DEA’s abuses by redefining medical science procedures, their lies, and deceptions perpetrated by this Federal Institution (DEA), then we are one more set of uppity arrogant Black N-Word SOB’s the DEA, DOJ or anyone else just don’t have to like.
Because we stand and rise against to oppose this system of injustice, which treats licensed Black pharmacists as common drug dealers, we will put an end to the United States Drug Enforcement as an agency of Government, through Congressional Oversight and wisdom and put an end automatically defining degree people of color as arrogant. We have learned from our ancestors, “just to sit still would be a sin:”
“There is no human activity you can ever perform that will ever lift the shroud of this racial constructs in this system the restraint is the color of your skin”
DEA FUELING THE DRUG CRISIS
However, it is well understood by a law professor, and medical practitioners that the DEA is incompetent and its actions have fueled the drug crisis.(2) According to Nabarun Dasgupta, Ph.D., MPH, Leo Beletsky, Jd, MPH and Daniel Ciccarone, MD, MPH, in February 2018 article OPIOID CRISIS: No easy Fix to Its Social and Economic Determinants;(2)
” The accepted wisdom about the US opioid crisis singles out opioid analgesics as causative agents of harm, with physicians as unwitting conduits and pharmaceutical companies as selfish promoters.1 Although invaluable for infection control, this vector model2 of drug-related harm ignores root causes. Eroding economic opportunity, evolving approaches to pain treatment,1,3 and limited drug treatment have fueled spikes in problematic substance use, of which opioid overdose is the most visible manifestation.”
” By ignoring the underlying drivers of drug consumption, current interventions are aggravating its trajectory. The structural and social determinants of health framework is widely understood to be critical in responding to public health challenges. Until we adopt this framework, we will continue to fail in our efforts to turn the tide of the opioid crisis.”
EXCLUDING PHYSICIAN- PATIENT RELATIONSHIP
The operations and activities of performance displayed by the DEA Diversion Investigators show the inadequacy of training and contempt for the African American Pharmacy business. Both the DEA agents and the Directors of the DEA Regional Offices lack understanding in the scientific methodologies of pharmacology adequately to enforce rules and regulations by excluding the physician’s relationship to their patients.
WOMAN SHOT 11 TIMES SHOWS SITE OF COLOSTOMY SHE WORE FOR 1 YEAR
The DEA told a non-black owner of a pharmacy, it would cost them millions to shut down a doctor, so it is easier to shut down a pharmacy. Therefore, Black-owned pharmacies like At Cost Pharmacy, Ft. Meyers, Fl., Gulf Med Pharmacy, Cape Coral, Fl. et al. become easier enforcement targets, which allows the DEA to justify their existence.
Leo Beletsky and Jeremy Goulka reported in September 2018 article, “The Federal Agency That Fuels the Opioid Crisis,” in the New York Times:(1)
The Diversion Investigators merely rely upon unquantified suspicions. Assuming arguendo, the behaviors characterized as red flags by the DEA are indicators of criminal conduct for some and yet do not prove the substantial likelihood of “imminent harm to public health and safety” required by the statute.
The Drug Enforcement Agency (DEA) are determined to criminalize legal practices of the Pharmacist, physicians, and their patients and specifically Pharmacies owned by ethnic people of color. Hundreds of people, physicians, dentists, nurses, pharmacists sit in prison today because of DEA’s massive targetting. Like Musician Miles Davis standing outside The Bird Land Theater,1959 in New York City, we must resist being defiled. (1)(2)(8)
GUNSHOT WOUNDS TO ABDOMEN
THE ECONOMICS OF MEDICAL RED LINING
One cannot ignore race or the factors of race in the decision-making process or ignore the economic injuries when Black doctors (physicians and dentists) are reimbursed by third-party insurance payors differently based solely on zip code. This is precisely why an increasing number of medical/dental/pharmacy providers are electing to do business solely in cash, credit cards, or debits to ensure their healthcare practice economic stability.
BEING BLACK BY ZIP CODE
Physicians, dentists, pharmacists who are black owners and display their shingle in certain zip codes are further humiliated and challenged by third-party payors to justify their diagnoses and treatment plans. These practitioners are likely to be reimbursed slower and at lower payment rates based solely on zip code which further undermines the practice of medicine/dentistry/pharmacy service in their communities. They are more likely to be audited, sanctioned by third-party payors, and reviewed by State and Federal licensing authorities.
WHEN THOSE WHO ARE BLACK AND CARE FOR THOSE WHO ARE BLACK ARE TARGETED, WHO DO YOU EXPECT TO LOSE ??
Translating into a broader sense for the everyday community, for every $10 a white person makes, black folk get $1 and this includes your black professionals of any medical/dental/ pharmacy filed who dare to complain too loudly risk being sanctioned. This type of institutional disparity ensures that generational wealth will never be passed along within any black community. SEE THE VIDEO SANCTION BY ZIP CODEMEDICAL RED LINING
Diversion Investigator Richard James AlBertAND HIS HANDLERS
RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR
So, when Diversion Investigator Richard James Alpert, in May of 2019 returned to Pronto Pharmacy for his 5th visit, make no mistake, his actions as directed by his handlers, Susan Langston, DEA Divisional Director State of Florida located in Miami, Florida Aimee Hickerson Diversion Supervisor, Florida assigned to Pharmacies, John Beerbower Esq., United States Attorney for the DEA. was laser-targeted on finally disrupting, dismantling and destroying the business of Pronto Pharmacy LLC. In a similar manner as Superior Pharmacy of Tampa, Florida, or in West Virginia, Oak Hill Home Town Pharmacy, Oak Hill, WV.
It should noted, Richard James Albert is a black man who is a functionary of the Drug Enforcement Agency, and moves solely at the direction of the handlers. Albert, whose full mission has been disguised in his hue thus removes any inference by DOJ and DEA history of racial injustice and profiling. (3)
“THUS BEGINS THE MISSION OF THE FILTERED negroe (s)“
EXPOSING THE CORRUPTION OF THE UNITED STATES DRUG ENFORCEMENT AGENCY AND ITS COURT SYSTEM THE NEED TO HAVE THEM DEFUNDED AND DISBAND BY CONGRESS OF UNITED STATES
The Drug Enforcement Agency (DEA) and prosecutors have been successful in their court proceedings with their counter spin “pill mills.” While it never dawns upon the juries or the public that a pill is a unique dosage form in pharmacy, the only commonality it has is it rhymes with mill. Richard James Albert’s handlers never thought was that these Black Pharmacists of Pronto, At Cost, Gulf Med Pharmacies, Oak Hill Hometown Pharmacy would fight back and that it would be business as usual.
A PICTURE OF THE WHO ARE OUT TO SILENCE BLACK HEALTHCARE
Diversion Investigator Richard Albert,(DI) testified that he did not “Know or understand the law(s) or how any law applies to the practice of Pharmacy. On January 28, 2020, Richard Albert (DI Albert) under cross-examination by Pronto Pharmacy Attorney Dale Sisco of Tampa, Fl, in summary, stated
In reviewing the respondent’s prescription data, he became suspicious because certain prescriptions were written for tablets but filled in capsules. However, DI Albert admitted that he is not familiar with FDA guidelines regarding compounding and, further, that he did not analyze the records he obtained from the respondent to compare the patients who received capsules that were compounded at respondent’s pharmacy to the anticipated patient’s need. Likewise, DI Albert did not compare the number of doses of capsules documented as having been compounded by the batch reports to the number of drugs dispensed by the respondent.
DI Albert admitted that speaking with the prescribing physicians identified in the E-FORCE data would have been a simple and straightforward method to ascertain whether any of those prescribers had, in fact, authorized the substitution of capsules for tablets for a particular prescription. He testified further that there was nothing to prevent him from contacting all but one of the physicians who wrote the prescriptions for the patients at issue. However, DI Albert never contacted, spoke with, or attempted to contact or speak with any of the prescribing physicians.
DI Albert did not know of any federal or state law or regulation that limits the geographic area in which a pharmacy can dispense medications.
THE ISSUE OF WHAT AGENCIES DEFINES COMPOUNDING, FDA OR DEA DIVERSION INVESTIGATOR RICHARD JAMES ALPERT?
DI Alpert of DEA stated in his testimony, he did not know state law or federal law as it pertains to Pronto Pharmacy LLC alleged in order to show cause. DI Alpert further stated he use a form default letter which is located in DEA’s Computer system to write the Order to Show Cause which he had started in April, 20019, 3-months prior to their raid of August 29, 2019.
The jurisdiction on who defines compounding or manufacturing is that of the FDA. Had DI Alpert consulted with the FDA, or understood the rules on Pharmaceutical perhaps the outcome would be far different. Had DI Alpert reviewed the DOH Administrative finding of 2018 and our response he may have been better educated in the subject matter as to not proceeded with a criminal complaint. See administration 20017-18 case: ph201705581 also, Atty dale Sisco response and DOH, findings.
2. Dr. Martin Luther King jr states; the 2 greatest danger we face as people in any society is: “Sincere ignorance and conscientious Stupidity”, in this case by failing to research the laws of STATE AND/OR FEDERAL procedures that govern Community Pharmacy compounding DEA DI Alpert chose to be both “sincerely ignorant” and consciously stupid.
GROOT CONSTANIA WINERY, SOUTHERN SUBURB, WESTERN CAPE SOUTH AFRICA
3. Federal Law and Florida State Law clearly allows and has always allowed that a licensed pharmacist can compound “in limited quantities before the receipt of a valid prescription order for such individual patient.”
More importantly President Donald J Trump addressed this issue and signed into law H.R 244 which clarifies several compounding regulations implemented in the Drug Quality and Security Act(DOSA 2013).
The law clarifies that Congress did not intend to redefine “distribution” to include “dispensing,” specifying Congress only intended FDA to regulate distribution– not “dispensing” to a patient over state lines.
Pronto Pharmacy Workers Compensation Insurance classifies them as Class code 8045, Class Description Store: Drug Retail of which compounding is covered under our community license.
Manufacturing comes under the jurisdiction of the FDA, not a DEA diversion inspector. Alpert never consulted the FDA.
The actions of the DEA and DI Albert were clearly malicious and were targeted at shutting Pronto Pharmacy down at whatever cost. To exact financial hardship on Pronto Pharmacy and it owners. There is no finding of facts that support Pronto Pharmacy as an “imminent danger” with no facts to support Pronto as illegally manufacturing, no fact to support continuing the ISO.
The DEA sets arbitrary parameter according to Pharmacist Association CEO Michael Jackson in June 2017 Conference of the Florida A&M Alumni, New Orleans (SEE BELOW VIDEO MICHAEL JACKSON RPH, CEO FLORIDA PHARMACIST ASSOCIATION CE PROGRAM WITH THE FLORIDA A&M UNIVERSITY PHARMACIST ALUMNI JUNE 2017, NEW ORLEANS, LA, NO CLEAR GUIDELINES)
The DEA agent Richard Albert prepared a warrant that “opinion based on a red flag that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy. Pronto Pharmacy is a licensed pharmaceutical company by law that can compound medications. The below chart demonstrates Richard James Albert nor his handlers know existing laws and/or rules guiding the practicing of Pharmacy. More specifically control medications and this chart under (iv) practitioners, hospitals retail pharmacies are permitted under their DEA Federal Registry certificate to process Schedule medications II-V. This chart specifically outlines:
” A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.“
DEA’s argument has been Pronto Pharmacy compounding of control medications was concluded as manufacturing and Pronto Pharmacy needed a separate manufacturing registration. This was because their retail registration license does not cover for manufacturing. The chart of guidelines more than contradicts all DEA assertions made by both DI Albert and his handlers against Pronto Pharmacy.
Yet, what is more, troublesome it that these guidelines are from the DEA’s own website under 21 USC 1301.13 under certificate new license and renewal (224&224a) and the cost for this license is $731.00 and it is good for 3 years. The importance is DI Albert didn’t know the laws, never looked for the laws, and his handlers, Aimee Hickerson, Susan Langston, John Beerbower kept him ignorant of the laws.
(iv) Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)
Schedules II–V
New–224 Renewal–224a
731
3
May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.
DEA WEBSITE UNDER 21USC 1301.13
COMPOUNDING IS NOT MANUFACTURING. NEVER HAS AND NEVER WILL BE!!
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Compounding is defined in several ways according to the Guidelines for Compounding Practices we quote these definitions verbatim from Chapter 795 of the United States Pharmacopeia (USP)
Compounding can be as simple as the addition of a liquid to a manufactured drug powered or as complex as the preparation of a multicomponent parenteral nutrition solution. In general, compounding differs from manufacturing in that compounding involves a specific practitioner-patient-pharmacist relationship, the preparation of relatively small quantity of medication, and different conditions of sale.
Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observed prescribing patterns. (5)
Manufacturing is the production, preparation, propagation, conversion and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or indecently through means of chemical or biological synthesis; the terms include any packaging or repackaging of the substances(s) or labeling or relabeling of its container and the promotion and marketing of such drug devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons. (5)
GUIDELINES FOR DISTINGUISHING BETWEEN COMPOUNDING AND MANUFACTURING ARE ASFOLLOWS:
Pharmacists may compound, in reasonable quantities, drug preparations the are commercially available in the mar place if a pharmacist-patient-prescriber relationship exist and a valid prescription is presented.
DEA takes the position:
(1) compound only for a specific patient; and
(2) cannot compound drugs that are otherwise commercially available.
However, the ( FDA)Food Drug & Cosmetic Act to this email. While it may allow a licensed pharmacist to compound “limited quantities” before the receipt of an actual prescription, such “limited quantities” must be based upon a history of valid prescription orders for the compounded products for a specific patient.
Pharmacist may compound nonprescription medications in commercially available dosage forms or in alternative dosage form to accommodate patients needs called by individual state boards of pharmacy.
The FDA takes the position that when differences of these types ((Generic Substitution: Generic-Substitution Laws) are important in the care of a particular patient, it may be appropriate for the prescribing physician to require that a particular brand be dispensed (“dispense as written”) as a medical necessity (“brand medically necessary”). With this limitation, however, the FDA believes that products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.
Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription, on the basis of a history receiving valid prescriptions that have, on basis of a history of receiving valid prescriptions that been generated solely within an established pharmacist-patient prescriber relationship, and provided that the prescriptions are maintained on file for all such preparations dispensed at the pharmacy.
Pharmacist should not offer compounded medication to other pharmacies for resale; however, a practitioner may obtain compounded medication to administer to patients, but it should be labeled with the following: “For Office Use Only,” date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by a hospital to contract compounding pharmacies.
Compounding pharmacies and pharmacist may advertise or otherwise promote the fact that there provide prescription compounding service.
The CSA clearly permits pharmacies to compound controlled substances as part of the act of dispensing and exempts such compounding from the definition of manufacture. The FD&C similarly exempts pharmacies that compound as part of retail pharmacy practice from the manufacturing requirements of that statute. However, in recent years some pharmacies have increased their compounding activities to such an extent that the Food and Drug Administration (FDA) became concerned that some pharmacies are using compounding as a guise to manufacture drugs.
In response to that concern, in 1997 Congress passed the Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115. Included in the statute at Section 127 was a provision that amended the FD&C at 21 U.S.C. 353a. This provision was entitled “Application of Federal Law to the Practice of Pharmacy Compounding,” which exempted pharmacies from drug approval provisions of the FD&C relating to manufacturing when they compounded drugs under certain circumstances.
This clearly notes that Agent Albert, and his supervisor were unaware of pharmaceutical procedures and laws. They later provided information that Pronto’ s Pharmacy was manufacturing illegal drugs and issues a subpoena for records and batch records of schedule II-controlled substances prescriptions that were for original and receiving.
RICHARD ALBERT’S CROSS-EXAMINATION TESTIMONY JANUARY 28, 2020 DEMONSTRATED LACK OF KNOWLEDGE OF PHARMACY LAW AND PHARMACY PROTOCOLS
The transcripts clearly demonstrate the DEA agent’s lacked knowledge and deliberate indifference toward licensed pharmaceutical businesses.
“Mr. Sisco: Based on the investigation that you conducted, did you attempt to determine what the volume was of prescriptions that were being dispensed at Pronto Pharmacy?
DI Albert: No, sir.
Mr. Sisco: But you could tell from the dispensing records, for instance, how many prescriptions were being dispensed each day, each week, each month or each year; right?
DI Albert: I would be able to tell that, yes.
Mr. Sisco: But you never made an attempt to do that?
DI Albert: No, sir
Mr. Sisco: And did you analyze thee records, the prescribing records that you obtained via the administrative inspection warrant to compare the patients who received capsules that were compounded at Pronto Pharmacy to the anticipated patient need?
DI Albert: No, sir.
Mr. Sisco: Are you familiar with FDA guidelines with regard to compounding?
DI Albert: No, sir
Mr. Sisco: As part of your training, the 12-week diversion investigator training, did you receive training with regard to the compounding of medication and the laws that apply to it?
DI Albert: Not specifically compounding.
Mr. Sisco All right. And one of the things that you’re trained on in that 12-weeks course is law right?
DI Albert: Yes
Mr. Sisco: And Federal Law, I presume?
Di. Albert: Yes
Mr.Sisco: And have you educated yourself on Florida law that applies to pharmacy operation?
DI Albert: Myanswer will be no on that.
Mr. Sisco: So in your analysis of this case, you looked solely to federal law.
DI Albert: Correct
Mr. Sisco: Even though, for instance, your subpoena reference specific Florida Administrative Code provisions?
DI Albert: Correct.
Mr. Sisco: You drafted the subpoena , didn’t you?
DI Albert: Yes
Mr. Sisco: Okay. So when you put those codes provisions in there, they had some significance to didn’t?
DI Albert: Yes
Mr. Sisco: Okay What was the significance that they had?
DI Albert: I don’t know sir.
Mr. Sisco: Okay. So looking at Exhibit Number 6 did you determine–did you compare the number of doses of capsules that were documented as having been compounded by these batch reports to the amount of drugs dispensed by Pronto Pharmacy?”
DI Albert: No, I did not.
Mr. Sisco: Based upon your training, education and experience, is there a federal statute or regulation that geographically limits the area in which a pharmacy can dispense?
DI Albert: Not to my Knowledge.
Mr. Sisco: To your knowledge based on your training, education and experience, is there a Florida statue that limits the geographic are in which a Florida pharmacy can dispense prescription?
DI Albert: Not to my Knowledge.
WARRANT FABRICATION
Richard Albert’s testimony was a stunningly profound admission of wrongdoing because each and every Black-owned pharmacy business that was raided, had their Federal Control Registration removed and suspended, charged as being a threat to public safety, along with the recommendation for revocation, based on non-existent distance travel laws. DI Alberts admission further undermines the of the testimony of DEA Pharmacy expert Donald Sullivan who testified to a limit of 35 miles on January 29, 2020 hearing in the matter of Pronto Pharmacy.
DEA EXPERT DON SULLIVAN DOESN’T REVIEW PATIENTS’ PRESCRIPTION NOR INTERVIEWS THEIR PHYSICIAN
What’s more, striking has been DEA Court tribunals have rubber-stamping the removal of Pharmacy Control Registration on these non-existing laws. This practice on the part of DI Albert amounts to the deliberate fabrication of both Search Warrants and Orders to Show Causes against these pharmacies. More, importantly these findings support the Academic and Professional Fraud complaint against Donald Sullivan, submitted to the Compliance and Integrity Committee headed by Provost Executive Vice-President Bruce McPherson at The Ohio State University, Columbus, Ohio.
It is within DI Richard Albert’s own statement that he “conceded that he did not know what significance the Florida Administrative Code (FAC) which guides Pharmacy in the State of Florida.” Agent Richard Alpert said, “ FAC provisions were already included in his subpoena template, and that he did not know what those provisions meant.”
These findings are extremely important for the Senate Judiciary Committee, House Committee on the Judiciary and House Committee on Government Operation to bring oversight and investigation and expose DEA’s level of corruption.
DIVERSION INVESTIGATOR RICHARD JAMES ALBERT MEETS WITH FLORIDA PHARMACY INSPECTOR CHERYL ELSHAER AND WITH SAFE CHAIN SOLUTION WHOLESALER, ABBIE DIVILIO STATE REGULATION COORDINATOR TO UNDERMINE AND TERMINATE PRONTO PHARMACY BUSINESS RELATIONSHIP
Interference with Wholesalers
Pronto Pharmacy is a specialty compounding Pharmacy and has been for 10 years. Pronto Pharmacy compounds Oxydone, Hydromorphone capsule as well as other pain medications, based on a history of a physician-patient relationship.
DEA has conspired to engage in interferences of interstate/intrastate commerce based on enforcing laws that have never existed such as distance travel. This was done by voiding the legitimacy of a person’s right to seek medical care and the pharmacy’s legal authority to dispense medical services.
The DEA goes further to criminalize their medical and payment methodologies without conducting any investigation.
According to Susan Langston, the DEA has no control over pharmacies’ pricing of drugs.
“They can charge what they want. That’s not against the law. But when a pharmacist will do that, it’s very telling. Very telling,” she said.
However, in the Order To Show Cause Warrant for Pronto Pharmacy Attorney Dale Sisco, on August 29, 2019, it specifically targeted pricing of medications and these statements were opined by DEA’s pharmacist expert Donald Sullivan.
DONALD SULLIVAN OPINION WAS THE SUPPORTIVE FOUNDATION OF AUGUST 29, 2019 RAID ON PRONTO PHARMACY
Agent Richard James Albert, Jr stated that on approximately May of 2017, “We got a call from the Department of Health(Florida) about a pharmacy was compounding hydromorphone and oxycodone.” It must be noted that it is within the scope of Pronto Pharmacy’s retail license to compound hydromorphone and oxycodone. The call to DI Albert came directly from Chery Elshear, Florida Pharmacy Board Inspector from the State of Florida Department of Health.
Agent Richard James Albert, Jr summoned his supervisor, and they served Notice of Inspection.
AMIE HICKERSON AND RICHARD ALBERT DEA DIVERSION
On or about May 4, 2017, Amie Hickerson and Richard Albert of the DEA entered the premises of Pronto Pharmacy. Both Agent Albert and his supervisor, Cheryl Elshaer, and her supervisor were asked to leave because Pronto Pharmacy was instructed by their Attorney, Dale Sisco, to allow no type of inspection to commence without his or someone from his staff’s presence. Agent Albert later opened up an investigation into Pronto Pharmacy and eventually issued a subpoena.
STEPHEN VARITEK INVESTIGATION SPECIALIST II
Cheryl Elshaer Florida Pharmacy Inspector
Florida Department of Health(FDOH) regulates professional licensing in the State of Florida for all pharmacies. their motto is:
“Our mission is to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts”
In the State of Florida, a Pharmacy can see any person from anywhere in Florida. There is no restriction as to where a prescription comes from, not even controlled medications as long as it’s valid and written by a licensed practitioner who has a practitioner-patient relationship, and a physical exam had been conducted.
However, this mission statement conflicts with Ms. Langston’s practice where distance travel and the use of mail-order is not a problem for some pharmacies but raises suspicion for a black own pharmacy.
According to wholesalers, the DEA directs them to adhere to an 80-20 rule which the DEA denies. The rule is enforced arbitrarily by wholesalers who permit certain mom and pop pharmacies to operate around the rules and others must adhere differently and are charged a higher price by the wholesaler.
PUTTING IT WHERE THE GOATS CAN GET IT
When, Ms. Elshaer, came to Pronto Pharmacy for the annual inspection, which is required by the State of Florida for every pharmacy. Ms. Elsheaer informed us, she was new and didn’t know anything about compounding, pharmacy laws, and was not a pharmacist. She, further informed us that she didn’t know anything about control medications and wasn’t inspecting our control records which are normally done. However, when she saw our cleanroom and learned as part of our compounding we do control medications, instead of Ms. Elshear, asking simple questions, she took a few pictures of our cleanroom area, left and called the DEA. (Cheryl Elshaer and Stephen Varitek should be terminated for wrongdoing)
To put this sequence where the goats can get it, Ms. Cheryl Elshaer saw a Pharmacy owned by a Black Family that had the capability of compounding control medications, (she did a Karen) and called the police (DEA). (7)
CHERYL ELSHAER FLORIDA INVESTIGATIVE SPECIALIST II
ABBIE DIVILIO SAFE CHAIN STATE REGULATION COORDINATOR
The process begins with DEA investigators like Richard Albert interfering with wholesalers, by calling and suggesting they close the merchant account of the targeted pharmacy, under the DEA’s “Know Your Customer Program.” In the case of Pronto Pharmacy, the wholesaler was Safe Chain Solutions. DI Albert instructed Safe Chain to close Pronto Pharmacy’s control medication account in June of 2019, making the products commercially unavailable to them. Therefore, Pronto Pharmacy continued its compounding in order to meet the demand of its patient base.
Ms. Divilio and the DEA worked together with the intent to undermine and destroy the business of Pronto Pharmacy, using distance travel from the physician’s office under know your customer program. Again, no such law exists in either the Federal and State statute.
Sometime in June 2019, Ms. Divilio made an onsite visit to Pronto Pharmacy and spoke with Pharmacist Guy Decker. Video recordings show Ms. Divilio stayed approximately 7.3 minutes. She examine no records, asked Mr. Decker one question, and reviewed no profiles. Approximately, a week later Pronto Pharmacy’s control medication account was closed. Ms. Divilio informed that they were concern regarding distance traveled between the physician’s office and Pharmacy.
COMPLIANCE COORDINATOR OF SAFE CHAIN SOLUTIONS
35 AGENTS OF DEA RAID PRONTO PHARMACY AUGUST 29, 2019.
PHOTO CAPTURING AUGUST 29, 2019 RAID ON PRONTO PHARMACY TAKEN BY AN EMPLOYEE WITHIN THE PLAZA LOCATED ON WEST BUSCH BLVD., TAMPA FLORIDA
On August 29, 2019, a well-coordinated attack implemented by both the DEA and Florida Department of Health was waged on Pronto Pharmacy. Their actions were beyond the scope of service of a certified law enforcement agency. Upon entering, a DEA Agent is videotaped removing and disabling Pronto Pharmacy’s camera systems wherein they damaged and destroyed several articles of equipment. (10) (See below videos)
DEA AGENT DISABLING PRONTO PHARMACIES SECURITY CAMERAS DURING AUGUST 29, 2018 RAID
RICHARD JAMES ALBERT WITH OTHER AGENTS RAID of PRONTO PHARMACY 8/29/2019RAID of PRONTO PHARMACYJOHN BEERBOWER US ATTORNEY, AND SUSAN LANGTON, PROGRAM MANAGER DEA MIAMI FIELD OFFICE, SHOWN OUTSIDE PRONTO PHARMACY AUGUST 29, 2019, SUPERVISING THE DESTRUCTION AND SEIZURE OF PRONTO PHARMACY EQUIPMENT
SUSAN LANGSTON, THE CHIEF HANDLER
The public has very little understanding of how so-called drug policy directly affects their daily life until they contract some chronic illness or a loved one faces death. Then the importance of chronic illness and disease states is ever so critical. These warnings remain ever so obliterated, and one cannot ignore the function of how race works in these proceedings.
Susan Langston was the Program Manager for the DEA Miami Field Division’s Diversion Regulatory Program. Overall supervision of Diversion Groups located in Miami (Weston), West Palm Beach, Tampa, Orlando, Jacksonville, and Tallahassee, Florida. She has since been promoted to a position in Washington DC.
Ms. Langston is the central figure behind DEA’s incompetence and criminal corruption within the State of Florida. Her policies have resulted in the needless death of patients being treated for chronic pain and denied their medications.
“Fear of DEA was a recurring theme at Florida’s Board of Pharmacy hearing Monday, and agency officials are attempting to respond to concerns voiced at the event held August 15, 2015.” (see below link Susan Langston before Florida Board of Pharmacy)
One should never be fooled by her tears for a 40-year-old woman who had struggled with cancer for a decade before a Fort Myers pharmacy refused to fill a prescription for pain medication or her Barbie Doll looks. Susan Langston is evil with the mindset of a Hendrik Frensch Verwoerd as Minister of Native Affairs South Africa responsible for developing the Bantu Education Act. (9)
It was reported in the Orlando Weekly October 15, 2015, “Susan Langston wiped away tears as she spoke of a prescription was rejected because it was written by a doctor at the Cleveland Clinic, a facility 100 miles away from the woman’s home and where she sought cancer treatment after her own doctors told her she was going to die.”
” But, according to the chain pharmacy’s policies, the prescription was flagged because it wasn’t ordered by the woman’s regular doctor, the woman traveled a long distance to obtain the prescription, and it came from South Florida, a part of the state once considered the pill-mill capital of the nation.”
According to Langston, the pharmacist quit.
“The cancer patient’s plight is one of many stories Langston has fielded in her job as the U.S. Drug Enforcement Administration diversion program manager in the Miami office.”
Langston Stated:
“This girl is being labeled a drug seeker, a doctor shopper. She went to a different doctor. She got a different pain medicine. She drove a long distance, and she paid cash. But she also walked in there with a bald head to a pharmacist that she’s been going to for 10 years, who knows she’s none of those. And that’s awful. That’s not what we’re about. No one has ever gotten in trouble with the DEA in Florida from filling a cancer person’s prescription,” an emotional Langston said in an extended interview this week via Skype with The News Service of Florida.”
“Florida patients like the Fort Myers woman are caught in the crosshairs of a state and national crackdown on prescription pill abuse that’s morphed into a dreaded “pharmacy crawl” by people suffering from cancer, chronic pain, and other illnesses but who can’t get their doctors’ orders for pain medications filled.” (see below link from quotes from Susan Langston Orlando weekly.com)
“Pharmacists blame an overzealous Drug Enforcement Administration for the problem. Doctors -– and the DEA – point the finger back at the pharmacists charged with filling prescriptions or at the corporations that have developed checklists to screen out dubious patients
Meanwhile, some patients are checking into hospice care early – or even committing suicide – in search of relief.” (6)
Nor should we be fooled by Susan Langston’s statement before the Florida Board of Pharmacy in which citizens began complaining:
“I want to make myself perfectly clear. Pharmacists do not need to fear the DEA,” said Susan Langston, DEA diversion program manager. The lead DEA agents told the Board of Pharmacy that the agency has stripped licenses from less than one half of 1% of all Florida pharmacies. They do not set quotas or interfere in the business decisions of wholesalers and pharmacists. “The DEA does not give a checklist or tell a pharmacist his or her job is black and white because it’s not,” said Langston. One of the themes of Monday’s meeting was the better education of pharmacists and wholesalers when it comes to DEA practices. “
Pharmacists have a lot to fear:
DEA does have quotas, yet denies that they do.
DEA does interfere in the business decision of wholesaler and pharmacists (see Safe Chain Solutions)
Ms. Langston’s statement “better education of pharmacists and wholesalers” when it comes to DEA practices are troubling.
SUSAN LANGSTON IS NEITHER COMPETENT, KNOWLEDGABLE NOR QUALIFIED
Ms. Langston’s qualifications and educational background are both troubling and alarming. She has no law enforcement background, no medical, dental, or pharmaceutical science background. Yet she heads to head the DEA Miami Field Division’s Diversion Regulatory Program. Ms. Langston has attained only a bachelor’s degree beyond that trained as a paralegal. (9)
According to LinkedIn reporting, she became in charge of the DEA Field office in Los Angeles and Miami and received a promotion within the DEA headquarters in Washington D.C. Ms. Langston appears to have no background, training nor certifications in the knowledge of drug substance abuse and treatment and appears to have no advanced certificates in law enforcement.
Ms. Langston orchestrates the attacks against licensed physicians, pharmacists, and dentists, and yet her qualifications, background, and tactics such as redefining, misclassification of long-standing medical/pharmacy/dental protocols are further troubling. Such as:
Defining Pharmacy Compounding as Manufacturing and requiring a separate registration when no registration exists.
Pushing for a pharmacist to challenge medical/dental practitioners’ diagnosis and treatment, which is outside the authority and scope of a pharmacist. (11)
Strong arming Pharmacies/Pharmacists into being an arm of law enforcement (supporting the misuse of Google Maps and the PDMP systems) which encourages bias, discrimination, and profiling.
Langston and John Beerbower, United States Attorney for the DEA, were clearly captured on-site August 29,2019, with more than 35 DEA agents. Their intent to destroy Pronto Pharmacy and their misdeeds were caught on camera for all to see. Ms. Langston is oftentimes present at certain types of pharmacy raids and her racial attitude is well known. At one particular raid near Tampa, she was said to them “we are putting you dirty Egyptians out of business.”. The Pharmacist were not Egyptians, but her tactics eventually work in causing the downfall of this Pharmacy. Ms. Langston has an intrinsic hatred for Attorney Dale Sisco and his law firm or anyone who challenges or exposes her corruption. Eventually, they did close down. Congress Must Investigate
CORRUPTION OF DEA BEGINS WITH SUSAN LANGSTON AND THE DEA COURTS
This is where the House Judiciary Committee, Sub-committee on Federal Court activity, needs to focus their attention. Ms. Langston’s criminal corruption goes further because she well understands that after a pharmacy is raided, under the fictitious orchestration of working to control the so-called opioid crisis, the DEA court supports her corruption by believing her dishonest activity.
The DEA tribunal operates outside the Federal Rule of Evidence and civil procedures. Their final decision is made by the DEA administrator, who is confirmed by the United States Senate. Ninety-Nine percent of the time cases are held in Arlington, Va. Therefore, clients and their witnesses must travel all the way to Virginia to seek so-called justice, except in the winter months, and client is from Florida. The DEA level of corruption goes all the way to the top of the political chain in the Justice Department and political structure in America. The House Committee on Judiciary and the House Committee on Government Operation must give oversight. (12)
Susan Langston’s actions further support the findings of Leo Beletsky and Jeremy Goulka as the “DEA is the Federal Agency that has fueled the drug crisis in America and around the world.”
The United States Drug Enforcement Agency has controlled and permitted non-medical illegal opioid drug substances to flourish in some neighborhoods, destroying the viability of these communities.
This then fuels orchestration of undermining the public school systems. It thwarts the ability of achievement in pursuing higher education for the majority of children in those communities, and for those few who manage to achieve in spite of, ( proceed to higher tradecraft or college education) achieving educational success, it ensures generational wealth will never be passed down.
According to Professor Leo Beletsky and Jeremiah Goulka,
“ We ought to reinvent the Drug Enforcement Administration. Considering its lack of public health and health care orientation, the agency’s regulatory authority over the pharmaceutical supply could be transferred to a strengthened and independent Food and Drug Administration, while the regulation of medical and pharmacy practice can be ceded to the states.
Parts of the D.E.A.’s law enforcement mandate should be transferred to the F.B.I., delegated back to the local or state, or eliminated. A significant portion of the D.E.A.’s budget should be reinvested in lifesaving measures like access to high-quality treatment.”
AND WE CONCUR. And we also say IF THERE ARE ANY POLICE AGENCIES WHICH NEED DEFUNDING, IT IS THE UNITED STATES DRUG ENFORCEMENT AGENCY…and their courts disbanded. CONGRESS MUST INCREASE THE NUMBER OF FEDERAL JUDGES.
Denying to fill a prescription to a patient can result in death(SEE VIDEO Micheal Jackson CEO of Florida Pharmacy Association.)
What does a law enforcement background look like?? In this case, we have displayed the law enforcement credentials of two individuals this writer is familiar with. My fellow FAMUAN, and Kappa Alpha Psi Nupe that I made in the Alpha Xi Chapter in Tallahassee Fl., known as Brother Track Down, and my younger brother Walter R. Clement. We have further highlighted that both of these individuals have exceedingly far more qualifications to be Statewide Director of DEA Diversion.
WHO WOULD YOU HIRE?
We ask, of the 3 individuals resumes, Susan Langston, Walter R. Clement, Dr. Cedric L.(Track Down) Alexander, which one of these persons is best qualified, to be selected The Director of The United States Drug Enforcement Agency.
First, Brother Track Down of Florida A&M University is also known by a few people as Cedrick Alexander with 42 years of law enforcement.
Dr. Cedric L. Alexander, a 42-year law enforcement veteran, has an exemplary and proven record of working with diverse populations and of innovation in dealing with major challenges.
From 2006 to 2007, Dr. Alexander was Deputy Commissioner of the New York State Division of Criminal Justice Services. From 2005 to 2006, he was Chief of the Rochester Police Department (RPD) in Rochester, New York, where he previously served as Deputy Chief of Police from 2002 to 2005. Before joining the RPD, Dr. Alexander was a faculty member in the Department of Psychiatry at the University of Rochester Medical Center from 1997 to 2002.
Dr. Alexander began his career as a Deputy Sheriff in Florida from 1977 to 1980, before joining the Orange County Sheriff’s Department and then the Miami-Dade Police Department, where he was as an Officer and Detective from 1981 to 1992. He received a B.A. and a master’s degree from St. Thomas University in Miami, Florida, and a doctorate from Wright State University. (13) [see below Yale Law Journal Link]
Second, Walter R. Clement, Bachelor of Science, Criminal Justice, Eastern Michigan University, 1996
Master’s Business, Business Management, Colorado Technical University, Colorado Springs, CO, 2006. Master’s Business Administration, Human Resource Management, Colorado Technical University, Colorado Springs, CO, 2007
Home E-mail: Range1274@comcast.net
Police Officer, Detroit Police Department 1977-1980 Corrections Specialist, Michigan Department of Corrections, Phoenix Correctional Facility,1980-1985
Resident Unit Officer, Promoted 1982-1985, Supervised inmates in correctional unit housing blocks (Full time)
Police Officer, Detroit Police Department 1985-1995
Underwater Recover Team 1985-1994
Special Response Team 1986-1993
Criminal Sex Crime Investigator 1993-1995
Sergeant, Detroit Police Department, 1995-2013
Patrol Supervisor, investigate use of force complaints.
Financial Management Department, Supervisor/Manager Grant Writer Team
Community Policing finance/operations manager
Supervisor/Trainer Detroit Police Underwater Recovery
Field Training Officer (FTO) Supervisor
Training Instructor, Detroit Police Academy
Officer in Charge of Firearms Range
Criminal Justice Instructor, University of Phoenix, Southfield Michigan, Instructor, 2006-2007 (Part time)
Licensures/Certificates (include licensure/certificate name, issuing organization, original year obtained, and current/non-current):
Certificate of Training, National Standard of First Official Response to a Critical Environment training, United States National Standards of Training Association, 2010
Underwater crime Scene Preservation and Investigation Techniques,Michigan Justice Institute, Macomb Community College,1999
Faculty: The Role
Formal Teaching Experience (Indicate delivery formats as appropriate)
Bachelor’s/Associate’s Subject Areas Taught: Introduction to Criminal Justice, Classroom and Online
Criminal Investigations, Online
Law Enforcement Operations and Report Writing, Classroom and Online
Ethics in Criminal Justice, Classroom and Online
Criminology, Online
Criminal Procedure, Online
Interview and Interrogation, Online
Victimology, Online
Grant Writing, Classroom and Online
Report Writing, Online
Introduction to Criminal Profiling, Online
Other Teaching Experience:
Detroit Police Academy (Inservice training for police supervisors) 2008-2013
Use of Force, Leadership, Police Customers Service, Supervisor Report Writing, Job Satisfaction
Detroit Police Academy (Recruit Training classes) 2008-2013
DEA SEIZED HARD DRIVE PRONTO PHARMACY ‘S AND RETURNED TO DALE SISCO Esq LAW OFFICEEXTERNAL HARD DRIVE
DEA BROKEN MONITOR SCREENS
IN PRONTO OFFICE
EXPENSIVE LASER GUIDED PRECISION SCALE SEIZED
Below, specialized Laser-Guided Ohaus precision pharmaceutical scale used for compounding was seized by DEA as part of their false manufacturing allegation. We demand the return of this equipment.
LASER GUIDED OHAUS PRECISION PHARMACEUTICAL SCALE
EXPENSIVE MIXER USED FOR COMPOUNDING SEIZED
MIXER USED FOR COMPOUNDING
PHARMACEUTICAL MIXER
DEA wins because of their tactics of intimidation (Skull Fucking) and illegally seizing property, including money, cars, homes, bank accounts, cell phones, disabling computers breaking equipment as seen here in photos from Pronto Pharmacy. This includes types of equipment that are not associated with control substance compounding, such as an Ugunator, a piece of equipment used for compounding ointment preparations. This is DEA’s calling/ Susan Langston calling card.
That Pronto Pharmacy manufactured these controlled substances without being registered with the DEA as a “manufacturer,” is false, especially when no such registry exists. Pronto Pharmacy is a facility licensed to compound control medications under its retail license.
UGINATOR USED TO MAKE ONITMENTS
DEA’S CALLING CARD MISSION IS TO DESTROY PRONTO PHARMACY THE TESTIMONY FORMER DEA DIVERSION INVESTIGATOR SHEAR JANUARY 28, 2020
Destroying the economic viability of Pronto Pharmacy LLC was the plan during the execution of the DEA’s May 2012 search warrant. Former, DEA’s Diversion Investigator, Mr. Shearer, seized Pronto Pharmacy inventory (valued at 4.8 million dollars). Mr. Shearer was certain that the seized inventory had significant value.
However, Mr. Shearer testified that the inventory was never returned to Pronto Pharmacy, as well as their equipment though Dr. Clement was never charged with any crime or offense, or joined as a defendant in a False Claims Act or similar civil action.
Shear’s testimony reveals DEA has been on a virtual witch hunt of Pronto Pharmacy.
1.DEA Diversion algorithm showed Pronto Pharmacy, in a 5 year period, ending in 2012, had the lowest of all pharmacies in a 5-mile radius. Pronto Pharmacy dispensed 363,000 control meds while other pharmacies in the same area, for the same period, dispensed 44 million control medications. The nearest ranking Pharmacies close to Pronto Pharmacy dispensed 10 million control medication.
2. DEA chose to raid Pronto Pharmacy according to the indictment in an attempt to arrest Christopher Switlyk whom they knew he was not an owner. Yet they took over 4.5 million dollars of medication and equipment and they were never returned it.
3. Shear stated in his testimony, these were very expensive amounts seized.
4. The intent of this DEA raid was two-prong; a) to wreck Pronto Pharmacy financially and b.) Instill a state of fear into the Pronto Pharmacy LLC ownership(skull fucking).
5. Both Shear and Albert were poorly trained nor knew Florida State law as it relates to compounding. The law permits an anticipatory dose of less than 10 day supply. Again Shear and Albert lack the fundamental understanding of pharmaceutical procedures related to compounding dosages, such as expiration dates, lot numbers, batching and yields, or even the difference between manufacturing and compounding. They rushed to judgment prepared a fraudulent warrant which was executed these fraudulent warrants on at least 2 occasions
There is a clear distinct difference between manufacturing and compounding. The DEA used their power of the badge to raid and enforce their perception of wrongdoing.
AGENT OUTSIDE CLEANROOM USED FOR COMPOUNDINGCLEANROOM PRONTO PHARMACYATTORNEY DALE SISCO SPEAKING WITH RAIDING PARTY
DEA CRIMINALIZES CASH PAYMENTS FOR PHARMACY SERVICES WHEN there IS NO LAW IN AMERICA SUPPORTING THIS
A man who is Asian with excessive cash is called Honda, Nissan or Fuji. A man who is white with excessive cash in this society is called Amazon, Walgreens or CVS. A black man with excessive cash is called a criminal or Bill Cosby. In fact a large percentage of healthcare providers:
have opted out of insurance or have found themselves pushed out of insurances, as the market consolidates under PBM, as large chains buy health insurance companies and restrict the number of provider participants.
The providers’ further site insurance has failed to pay in a timely manner and score payments to AWP(Average Wholesale Price), keeping reimbursement below their wholesale purchase price. In other words wholesale cheating.
It becomes extremely difficult for a small pharmacy (family-owned) to compete with large chains offering comprehensive services.
The small guy must either specialize or go out of business
If cash is a problem in the small pharmacy, then it should be regulated in the dental office, physician or for that matter McDonalds
Missing through his entire discussion is the absence of clinical disease state of the patient and Pathology. The DOJ Attorney is even more clever to eviscerate the patient-physician relationship by removing the practitioner from the discussion. This is classic cognitive dissonance. Dr. Joy Degrury, points out: “QUOTE QUOTE”
Both the patients and the pharmacist are dehumanized, and this dehumanization is further supported by pseudoscience and pseudo theory and expanded to a conclusion which is drawn on their foundation of rubbish. It is further exacerbated by politics, to which laws are erroneously created. One contemporary example is the 3-day laws for acute pain. In actually the maximum discomfort occurs in 4 days.
DISTANCE TRAVEL
DEA that acts as an unregulated medical agency policing the medical profession without legal standards and grounds. The DEA Diversion Investigator claims are arbitrary. Their actions are erroneously based on “traveling long distances,” to fill prescriptions can be a red flag of abuse and diversion if a patient travels a significant distance to a particular pharmacy.
Again, Distance travel is simply based upon a foundation of rubbish. I had cancer, my treatment was at the Henry Ford Health System in Detroit, this was quite a further than the 30-mile limit in which there is no law. The policy is clearly an intrusion on the healthcare of citizens.
If distance of traveling to obtain a prescription is a criminal factor only in the minds of the DEA and its agents. Michael Jackson. traveling DEA policy forces
PHARMACIES ON THE RIGHT SIDE OF THE LAWS OF HEALTHCARE AND ON THE WRONG SIDE OF THE SO-CALLED DRUG ENFORCEMENT AGENCY
A DEA registry is a Federal license and anyone who writes a prescription in America can have it filled anywhere.
The Department of Justice’s job is to enforce the law not manufacture the law. According to Leo Beletsky and Jeremy Gouka,
“The United States was ill-equipped to navigate the worst drug crisis in its history with the D.E.A. at the vanguard. Starting in the late 1990s the manufacturing, distribution, and prescribing of opioids began to increase rapidly. Overdose deaths soared since so many people were prescribed opioids and many mixed them with alcohol and other sedative drugs. The D.E.A. could have marshaled a calibrated response, expanding evidence-based treatment and reducing the prescription of, especially risky drug combinations.
Instead, the agency pushed for surveillance of prescription records and electronic communication, doubled down on prosecuting prescribers, and helped to tighten the screws on patients seeking pain relief. Meanwhile, lifesaving opioid treatments that the D.E.A. closely regulates, like methadone, have remained extremely difficult to obtain. Indeed, these problems were much broader than the alleged industry machinations to muzzle the agency. (8)
A decade into the crisis, more and more prescription drug users turned to the black market. Even though the D.E.A. had tried to “eradicate” illicit drugs for nearly 50 years, users could easily buy stolen and counterfeit pills, along with a cheaper option, heroin. Soon, some began injecting. Outbreaks of H.I.V. and hepatitis C followed. Meanwhile, people who sought evidence-based treatment were rarely able to access it because of the agency’s evolving regulatory and enforcement strategies, like blocking the expansion of mobile methadone clinics and shutting down addiction treatment providers without arranging alternatives for affected patients.
Despite the investment of hundreds of billions of taxpayer dollars and the earnest efforts of thousands of employees, the D.E.A.’s track record is abysmal. The agency has been unable to balance legitimate access to and control of prescription drugs. The widespread over-reliance on opioids, along with benzodiazepines, amphetamines, and other scheduled medications, has created a booming black market.”(2)(8)
The governing policies of DOJ/DEA are antiquated…..so that they enjoy authority by criminalizing routine healthcare.
THE SAGA OF OAK HILL HOMETOWN PHARMACY, OAK HILL, WEST VIRGINIA
The DEA uses a little-known technique – the Immediate Suspension Order (ISO) – to force them into bankruptcy or even prison, based upon suspicion alone with absolutely no evidence of wrongdoing. Martin Ndjou a pharmacist/owner of Oak Hill Hometown Pharmacy says,
“We face a different standard in this society and there are no repercussions and its poor treatment. Even though I have won I have lost. It has been battle after another. I’m only the same product mail order if you are black you are prone to commit a crime. As a Black Pharmacist ‘m being economically lynched by the DEA and it is deliberate. We are like the jogger running down the street waiting to be harvested and they didn’t want to take action until people started to speak out.“
The DEA applied their distance rule on Pronto Pharmacy, At Cost Pharmacy, Gulf Med Pharmacy, Oak Hill Hometown Pharmacy when there is no such statute or law.
DEA TARGETING BLACK OWNED PHARMACY BUSINESSES IN FLORIDA
On January 7, 2020, owner Aaron Howard, PharmD, of At Cost Pharmacy, Fort Meyers, Florida, found himself surrounded by seven DEA agents ordering an Immediate Suspension of his Control Substance license and seizing his property. The order was signed by Acting DEA Chief Uttam DHilllion, who has in previous orders issued to other Black-owned pharmacies to be deemed “an imminent danger to public health and safety.”
Pharmacist, Aaron Howard, says, “this whole issue is based on an erroneous presumption of Red Flags…..that we are improperly dispensing control medications. This is totally ridiculous. We check all prescriptions in my pharmacy. I’ve been a pharmacist for more than 15 years and I am definitely not a “PILL MILL.”
Currently, the DEA is concentrating most of its efforts on small, non-white pharmacy establishments. But don’t be fooled, these actions are but the first salvo of a much larger picture. The intent is to destroy black people by systematically destroying those who provide healthcare services to those communities.
DEA, in their written complaint against Pronto Pharmacy and At Cost Pharmacy of Fort Myers, begin by categorizing non-white pharmacies as “Red Flags.” The DEA algorithm includes distance travel, paying cash, and excessive dosage. Each patient is then profiled as an abuser and a federal criminal statute is assigned to them, their physician, nurse, pharmacist, dentist, and any other healthcare provider involved in their care with a spirit of impunity.
AT COSTRX, FORT MYERS FLORIDA
.
Lincourt Pharmacy, Clearwater, Florida
Lincourt Pharmacy, Clearwater Florida
Lincourt Pharmacy of Clearwater, Florida has been in business for nearly 40 years. They are a specialty pharmacy in compounding sterile and non-sterile products and was doing over $15 million per year with sales all over the world. Louis Lassiter, who is the pharmacist-owner states that “his business dropped dramatically when the DEA came around and began targeting and harassing his wholesalers.” Let’s not be fooled. This the work of Susan Langston and demonstrates how the DEA begins to target Black Own Pharmacy Businesses.
REMEMBER DISTRICT SIX, CAPE TOWN, SOUTH AFRICA
CIVIL DISOBEDIENCE MEANS EXPOSING MEDICAL INJUSTICE OR REMAINING SILENT
Who would have thought the next Civil Rights movement exposing economic disparity would start in a dental chair and a pharmacy dispensing counter?
The audience of Black professionals and my colleagues are trained to shut up by the system or by our own peers. They are trained to express no opinion other than to add input. However, our observation is one cannot win if they are not willing to fight. And when you fight you fight to win, and you don’t allow your enemy to tell you how to fight.
REV AL SHARPTON, HOUSE CANDIDATES STEPHANIE DUKES, NORMAN J CLEMENT RPH, DDS TALLAHASSEE, FLORIDA JANUARY 13, 2020
BLACK LIVES DON’T MATTER WHEN BLACK POLITICIANS AND PROFESSIONAL ORGANIZATIONS REMAIN SILENT
Silence is a part of fear and silence also gives support to the enemy. The enemy will never give up easily because the enemy has a lot to lose. The DEA has a lot to lose because they have been successful until now in taking the legal pharmaceutical operations owned by non-whites (specifically black-owned pharmacies) and making them illegal by not having to go through the regular court in which Federal Civil Rules and Evidence and procedures of law would apply. We should remember the words of Frederick Douglas,
FREDERICK DOUGLAS 1857:
“This struggle may be a moral one, or it may be a physical one, and it may be both moral and physical, but it must be a struggle. Power concedes nothing without a demand. It never did and it never will. Find out just what any people will quietly submit to and you have found out the exact measure of injustice and wrong which will be imposed upon them, and these will continue till they are resisted with either words or blows or with both. The limits of tyrants are prescribed by the endurance of those whom they oppress. In the light of these ideas, Negroes will be hunted at the North and held and flogged at the South so long as they submit to those devilish outrages and make no resistance, either moral or physical. Men may not get all they pay for in this world, but they must certainly pay for all they get. If we ever get free from the oppressions and wrongs heaped upon us, we must pay for their removal. We must do this by labor, by suffering, by sacrifice, and if needs be, by our lives and the lives of others.”
ATTY BENJAMIN CRUMP AND REVEREND AL SHARPTON TALLAHASSEE FL., JANUARY 13, 2020
Yet, the words of Frederick Douglas are inclusive of all medical, dental, pharmaceutical societies. We must fight and cannot remain silent.
FACING THE PEOPLE OUT TO IMPRISON NORMAN J CLEMENT RPH., DDS AND BLACK OWNED PHARMACIES
However, if we choose not to fight and remain “make no resistance, either moral or physical and submit to this devilish outrage” …Thus the Rise and The Mission of the Filtered Negroe(s) will be completed.
FOR NOW, YOU’RE WITHIN THE NORMS
ENDNOTES
From The New York Times: The Federal Agency That Fuels the Opioid Crisis “The Drug Enforcement Administration has proved itself incompetent for decades.”
2). Am J Public Health. 2018 February; 108(2): 182–186. Published online 2018 February. doi: 10.2105/AJPH.2017.304187PMCID: PMC5846593PMID: 29267060, Opioid Crisis: No Easy Fix to Its Social and Economic Determinants, Nabarun Dasgupta, Ph.D., MPH, Leo Beletsky, JD, MPH, and Daniel Ciccarone, MD, MPH
3) Jack Riley is director of RAND Public Safety and Justice, 2002, Racial Profiling lessons from the Drug Wars, How Drug Profiling Did Not Work, In the 1980s, the U.S. Drug Enforcement Agency (DEA) and customs agents developed profiles of U.S. land-based distribution networks by observing how drugs moved out of source countries
5) Good compounding practice applicable to state-licensed pharmacies. In: Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Park Ridge, Ill: national Assocciationof Boards of Pharmacy; 1993;C-1-C-5.
7) Joseph Madison “The Black Eagle” XM 126, THE URBAN VIEW, Thank you, Joe if I’m a celebrity then let it be for Obamacare which saved my life from Invasive Early Stage Colon Cancer through an eye exam 2016. Thank you, Joe, for the Goats.
8) White Opioids: Pharmaceutical Race and The War on Drugs, that wasn’t , released April 2017 by The United States Department Health and Human Services (HHS) a 25 page study (with broad foot notes) on White Opioids see url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501419/#R28/
10) it was during this Raid of August 29, 2019, Norman J Clement wrote: “THE MANIFESTO OF THE NORTH STAR PROJECT“…..(defiled, enough is enough).
11) Pronto Pharmacy LLC., May 5, 2020, Judge Mark D. Dowd, end notes page 44.,
22 Mr. Clement, Jr.’s, testimony that the Respondent verified the medical legitimacy of the prescriptions it filled runs counter to Mr. Clement, Sr.’s, view, as written in his blog, that he is “not authorized or qualified to challenge a physician’s diagnosis and treatment.” Tr. 538, 566. If that is the case, it seems inconsistent that the Respondent would call a doctor’s office at all, let alone to confirm a diagnosis. Tr. 551. Furthermore, it is difficult to understand how the Respondent ensured that prescriptions were medically legitimate if the Respondent believed it could not question a doctor’s decision to prescribe a certain medication. Tr. 538, 566. The Respondent’s vetting process, as described by Mr. Clement, Jr., seems superfluous if the Respondent’s pharmacists are unable to question a diagnosis and treatment.
12) UNITED STATES DEPARTMENT OF JUSTICE Drug Enforcement Administration;DOCKET 19-42 RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE, Mark M. Dowd U.S. Administrative Law Judge, May 5, 2020,/ PG 35.,
EXPERT OPINION
Although these proceedings are not bound by the Federal Rules of Evidence, they are often instructive in the evaluation of the admissibility of evidence herein. Rule 702 states as follows:
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.
Fed. R. Evid. 702. The tribunal should ensure that any and all scientific testimony or evidence admitted is not only relevant but reliable. Daubert v. Merrell Dow
JACK FOLSON RPH, WALTER R. CLEMENT MS., MBA., RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
THE MANIFESTO OF THE NORTH STAR PROJECT
When you see THROUGHOUT LIFE most of your friends, colleagues, and classmates who are of degree being defiled, sanctioned, terminated, harassed, arrested, jailed, and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do Then at some point, you are compelled to ask yourself when
ENOUGH IS ENOUGH.
At some point in your life, you have to say and proclaim enough is enough and what are you going to do about it. Then we must stand and fight as soldiers together or die like mice.
ENOUGH IS ENOUGH. To me, that idea of an Administrative Judge Federal showing such destain to a Respondent would so overturn nearly 200 years of medical and pharmaceutical practice makes this court worthy of oversight and disillusionment
WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY TO THE UNITED STATES HOUSE COMMITTEE ON THE JUDICIARY, UNITES STATES HOUSE OVERSIGHT ON OVERSIGHT SUBCOMMITTEE ON GOVERNMENT OPERATIONS AND UNITED STATES SENATE COMMITTEE ON THE JUDICIARY TO DEFUND AND DISBAND THIS AGENCY OF GOVERNMENT.
ENOUGH IS ENOUGH.
THIS PRESENTATION CONTAINS MUST SEE VIDEOS WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE
INTRODUCTION
On May 5, 2020, Mark D. Dowd, U.S. Administrative Law Judge, in the matter of Pronto Pharmacy, LLC Docket No. 19-42 issues RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE in a rambling decision of 148 pages, to be found so ridicules it overturned nearly 200 years of medical and pharmacy law(s) and protocols.
A group has filed Professional and Academic Fraud charges against the Ohio State University College of Pharmacy, DEA Expert, Clinical Professor Donald Sullivan. Who, in sworn testimony, admitted to not having interviewed any of the patients, nor their prescribing physicians, neither saw nor reviewed any of the patient’s prescriptions. Professor Sullivan opined every prescription to be illegitimate.
A.NON-ACUTE PAIN B.UNINSURED
It is further clear, on this day U.S. Administrative Law Judge Mark D. Dowd, was so busy trying to be a bigot, so busy trying to be a racist, so busy trying to be the toughest man on the Federal bench he forgot how to be fair.
Judge Dowd’s decision in which the respondent, Pronto Pharmacy LLC., and the owner Norman J Clement,( a pharmacist and dentist) who had written in his blog, youarewithinthenorms.com, that he is not authorized or qualified to challenge a “physician’s diagnosis and treatment.” Judge Dowd, ruled against Clement basing his opinion in part, on the testimony of Donald Sullivan. Judge Mark D. Dowd wrote in his endnotes on page 44, of the Recommended Ruling:
22 Mr. Clement, Jr.’s, testimony that the Respondent verified the medical legitimacy of the prescriptions it filled runs counter to Mr. Clement, Sr.’s, view, as written in his blog, that he is “not authorized or qualified to challenge a physician’s diagnosis and treatment.”. If that is the case, it seems inconsistent that the Respondent would call a doctor’s office at all, let alone to confirm a diagnosis. Furthermore, it is difficult to understand how the Respondent ensured that prescriptions were medically legitimate if the Respondent believed it could not question a doctor’s decision to prescribe a certain medication. The Respondent’s vetting process, as described by Mr. Clement, Jr., seems superfluous if the Respondent’s pharmacists are unable to question a diagnosis and treatment.
Joseph L.Webster, Sr., MD, MBA, FACP, Bs.Pharmacy
I have reviewed the pertinent materials that were provided regarding the testimony of Dr. Sullivan. It is clear to me that he has a basic flaw in his thinking regarding the Doctor – Pharmacist relationship. The respective regulatory bodies, including the various “Boards” of Pharmacy, Medicine, Dentistry, Nursing, etc. clearly outline the ‘scope of practice’ for each of those disciplines.
The orderly flow of a prescription “from” the doctor to the patient – via the Pharmacist – clearly outlines where the ‘diagnosis’ has to come from. It is statutorily the purview of the pharmacist to ‘inspect and assure’ that the drug that is being given is safe and has no known incompatibilities with the patient and its holistic environment.
DX; MSI.26 M48.0, NONACUTE PAIN
It is not the purview nor is the pharmacist trained to ‘challenge the diagnosis’ of the physician and to do so verbally or otherwise with the patient. It erodes the ‘doctor-patient’ relationship and destroys the ‘confidence’ of the patient in his/her physician. At the very least it is ‘unethical’ and may very well be a HIPPA violation and beneath the standard of care as a pharmacist.
Any healthcare provider that is licensed to ‘prescribe’ is governed by the set of conditions and circumstances under which a prescription can be written. Thus it is illegal to write a prescription for a person that the prescriber has not conducted the ‘chain of authority’ that would qualify him/her to write a prescription: history and physical examination, formulation of a diagnosis and discussing such with the patient as well as the proposed manner of treatment in a culturally sensitive and ethically appropriate manner; and provision of an opportunity for the patient to ‘question and discuss alternative forms of treatment; etc.
DEA EXPERT DONALD SULLIVAN TESTIFIED HE NEVER LOOKED AT ANY PATIENT PRESCRIPTION OR SPOKE WITH THE TREATING PHYSICIAN
Once the provider has met all of the aforementioned and other ‘requirements to write a prescription, then and then ONLY should a healthcare practitioner write a prescription. I do not see where Dr. Sullivan obtained his evidence that the pharmacist in question attempted to do any of these steps in the ‘chain of authority’ in the cases in question. Furthermore, as stated above, a pharmacist IS NOT AUTHORIZED TO WRITE A CONTROL PRESCRIPTIONS by any of the regulatory boards of health.
WE ARE TO BE UNSEEN
It is my professional opinion that the pharmacist in question had ‘no reason’ and more importantly the pharmacist had ‘no power’ to question or interrogate each provider on ‘each prescription’ that is received as long as the ‘safety, efficacy and convenience’ of the medications being prescribed meet the standards of Medication Dispensing. Any given medication can be and certainly will be given for multiple different diagnoses and it is not even feasible for the pharmacist to ‘contact and question’ each and every diagnosis.
JACK FOLSON
CLINICAL PHARMACIST Expert in Pharmacy Practice: Hospital, Retail Chain, Retail Independent, Sterile Compounding, Non-Sterile Compounding, Former Director of Pharmacy.
As it pertains to corresponding responsibility we do not have primary responsibility and this is because we do not have the training in Diagnostics that would be required to proffer a second opinion
NO INSURANCE NON ACUTE PAIN
Once a diagnosis is given the only thing that the pharmacist can do is make a recommendation as to the proper drug therapy for that particular patient within that particular diagnosis and at best it can only be a recommendation that lacks a full understanding of the diagnostic criteria
To require the pharmacist to be the final arbiter what is or is not reasonable therapy based upon inferior knowledge of Diagnostics would be erroneous
DIAGNOSIS NON ACUTE PAIN
THE HOUSE JUDICIARY COMMITTEE MUST BEGIN OVERSIGHT THIS COURT SYSTEM
Therefore, it is incumbent for Chair of the Subcommittee of Federal Court Operation, Congressman Hank Johnson of Georgia’s 4th district to give Oversight on the DEA Court System which operates outside the Federal Rules Evidence and of Civil Procedures.
CONCLUSION
One can never prevail in any court system or environment, even when supported with science and facts, against bias and prejudice, or when privilege is permitted to take the stand. Yet still, it is not Judge Mark D. Dowd, bias/racism that is troublesome, it is his stupidity in his recommended ruling, findings of facts, the conclusion of law which eviscerates nearly two hundred years of medical and pharmacy law and protocols.
I have been retained by the respondent to review this case.
The decision in this case will have far-reaching deleterious effects on the professions of Medicine, Nursing and other Mid-Level Practitioners and Pharmacists
June 4, 2020
After reading the TRIAL TRANSCRIPT and ALJ DECISION many glaring errors became apparent. This document is intended to enlighten the court as to the true nature of the STANDARD of CARE as it pertains to the practice of PHARMACY. The practice of Pharmacy has many traditional and emerging roles and a one size fit all standard cannot apply. The proof of this is that certain facets are known as retail establishments, institutional establishments, healthcare organizations, and others. Within these broad categories, there are subdivisions.
What is clear here is that Pronto Pharmacy is acting as a specialty pharmacy that specializes in pain management as well as non-sterile compounding. Since Dr. Donald Sullivan seems not to have any experience in pain management nor non-sterile compounding it is understandable that he does not grasp the fine nuances in these fields. Since I have experience in the fields listed above the following is submitted to enlighten the court.
DONALD SULLIVAN “DOES NOT GRASP THE FINE NUANCES”
RED FLAGS OF DIVERSION
BACKGROUND
As far as can be determined as a practicing Pharmacist who is not an attorney the Red Flags of Diversion gained the most traction in the Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195 cases. However, in that case, the Pharmacies in question were regular chain drug stores but Pronto Pharmacy is a specialty pharmacy that specializes in pain management and compounding. Therefore, they are in different classes. It’s like the difference between a general practitioner and a surgeon.
True, they are both doctors, but their level of training is not the same and the selection of patients is not the same. A general practitioner might be able to stitch you up after a fall but removing your gall bladder would clearly be beyond his scope of practice. With that in mind consider that Dr. Clement has advanced training in therapeutics, pain management, Dentistry, Forensics, and more than 45 years, experience, and the typical CVS Pharmacist has less than 5 years, experience.
The business model for CVS focuses on high-speed production and Pronto Pharmacy is focused on disease state management. And, just like people might travel long distances to seek out a surgeon that has a high level of training and a history of positive outcomes the same would be true of Pronto Pharmacy. You would be hard-pressed to find a CVS Pharmacist that could have the time to investigate chronic pain treatment modalities and how they impact severely compromised patients.
However, Dr. Clement has numerous sources of information that the typical Pharmacist would not be aware of. As a Clinical Pharmacist, I have seen some of his vast library of information and was suitably impressed. So, things that might be a “red flag” to the inexperienced Pharmacist are little more than a footnote for us. Many of our patients have been on service for many years so the red flags may have been resolved years or even decades ago. Therefore, the documentation of the same might not be captured by an investigator that does not interview the patient, the Physician, or the Pharmacist. Often, the pertinent information is archived.
In the Holliday CVS case one issue was the dispensing of narcotic prescriptions from prescribers with expired or revoked DEA registrations. This did not happen at Pronto Pharmacy.
HIGH DOSE OPIOIDS
At trial, the expert witness for the DEA, Dr. Donald Sullivan contended that the Oxycodone and Hydrocodone were the highest available dosage form. However, this is misleading in the world of pain management. Many states require that the prescriptions for C-2 narcotics contain a maximal daily dose, and in the Holliday CVS case, the maximum daily dose for Oxycodone was 6 tablets of 30mg which is 180 mg per day. I have seen this dose in several states, and it is considered the top of the Oxycodone range for severe pain.
DONALD SULLIVAN “IS MISLEADING THE WORLD
However, at Pronto Pharmacy the maximum daily dose of Oxycodone was a mere 90 mg. In fact, the equivalent dose in Morphine Milligram Equivalents in hospitalized patients can top 210 mg per day in acute cases. In certain cancer patients, the dose could be even higher. So, in the overall scheme of things the current standard of care for these types of patients is to keep them at 90 mg per day or less if in chronic pain. It is understandable that a professor of diversion would not know about the clinical ramifications of the specialist level of pain management. However, he correctly stated that the practice of Pharmacy is moving more towards disease state management, which correctly describes Pronto Pharmacy and its practice.
THE SCARS OF THE FIGHT FOR FREEDOM, JOHANNESBURG
A similar example would be for Vancomycin which is an antibiotic with a narrow therapeutic index. Typically, the dose in the hospital is 500 mg twice a day for 3 days. However, in Lyme Disease, the dose is titrated by peak and trough levels and can be as high as 2000 mg intravenously every 12 hours. With careful titration and attention to the appropriate blood levels and presenting symptoms a clinical pharmacist who is in charge of the therapy can ensure safe and effective outcomes for these patients that require this medication for about 6 weeks at home.
So, no. These are not excessively high doses in the patient population that is being treated. Remember, these patients have been stabilized on these medications for years and continue to get the same doses from other Pharmacies currently. To single Pronto Pharmacy out of all the drug stores in America and by way of immediate suspension order without a hearing could be seen as Unconstitutional. His right to make a living (life, liberty, and pursuit of happiness) was taken away many months before the hearing began.
DONALD SULLIVAN “DEA EXPERT CRIMINALIZES PAIN MANAGMENT“
Just like in the CVS case in which Professor Doering testified that he could not foresee anything that would change his opinion we see that Professor Sullivan who is also a teacher, but not a practitioner in the specialty of pain management, also could not foresee anything that could enlighten him either. However, in neither case were the patients considered. But to close the avenues for patient care without considering the patients would be improper. Presently, because of the criminalization of pain management suffering has increased and has led, to an increase in Heroin use. Due to the dangers associated with heroin use this, more than anything else in this case is an immediate threat to public safety. To put it plainly the actions by the DEA are causing the thing that they are trying to avoid.
According to the Office of the Inspector General’s report on the DEA as prescription opioids has remained relatively flat the increase of heroin use has been skyrocketing. Death by fentanyl, which was once a rarity, is becoming a big player in the death of Americans due to opioids. If Pronto Pharmacy were actually in the business of diversion, I would applaud the DEA’s effort to rid the profession of bad actors. However, in this case it seems that there are too many irregularities to come to that conclusion. Not only is there no evidence to the level of “more likely than not” but the level of “preponderance of evidence” has not been met either.
MULTIPLE PRESCRIBERS
Although the case glossed over this red flag, a patient going to multiple prescribers to obtain high dose opioid medications is a well-established red flag of diversion. The basis of this is that the patient, prescriber, pharmacy relationship is not present. Although the presence of this is not proof of diversion, it has been highly touted as suspicious. However, there are many reasons that this could be explained or cleared. On the PDMP dataset if a patient goes to a clinic and sees several prescribers in that clinic it will show up as multiple prescribers, but, on closer examination, the fact that the prescribers are at the same address could be determined. If the prescriber has multiple offices and the patient is seen at different offices or the information is entered into the computer incorrectly the PDMP data could appear to be that of drug seeking behavior or merely that of convenience for the patient or the prescriber.
What is glaring in this case is that every patient noted in the allegation only got medications from one specific prescriber for that individual patient. So, this firmly establishes for each patient the prescriber, patient, pharmacy relationship and should be the firm foundation that this case should be based upon. This is important for several reasons because when relationships are formed it causes variations in behavior that do not happen without a relationship.
If a pharmacy acts only as a source of medication for a particular patient, then they are more likely to obtain whatever they need wherever they find convenient. Often, such a patient will seek out the lowest cost. On other occasions that type of patient will be concerned specifically with service. However, when there is a relationship such as with a specialist, that patient will reasonably travel higher distances, and avoid other specialists in the field. Pronto Pharmacy is a compounding pharmacy which is a specialty. Pronto Pharmacy is a pain management pharmacy which is a specialty. A reasonable and prudent medical observer of the actions of the patients, prescribers and pharmacists involved would see this relationship as normal everyday specialty practice.
DISTANCE
The red flag of distance serves as a discussion point in Pharmacy. If a patient travels so far that they pass several Pharmacies to get to a specific Pharmacy many issues may be in play. One is the cost. Since many patients have insurance and many Pharmacies take most insurances the cost to the patient is most likely the same. However, more than 8.5 % of Americans are without insurance now and 13.5 % were at the time of the Affordable Care Act according to the census bureau (https://khn.org/news/number-of-americans-without-insurance-rises-in-2018/ ). Coupled with that are the increasing number of American Nationals that are not counted and the illegal immigrants who for the most part do not have insurance would make this red flag an unreliable indicator of actual diversion. In fact, in light of the current trend of insurance companies, bolstered by the Pharmacy Benefit Managers (PBM’s) this is likely to become increasingly irrelevant if it is not already.
GREAT IS OUR FAITHFULNESS
The business practices of these near-monopolies are akin to those of Standard Oil before it was broken up by the Sherman Antitrust Act ( https://en.wikipedia.org/wiki/Standard_Oil ). The PBM’s attack smaller retail Pharmacies with substandard reimbursement while paying their larger Pharmacy chain operations a premium for the same medications on the same day (https://communityoncology.org/march-30-what-cvs-is-doing-to-mom-and-pop-pharmacies-in-the-us-will-make-your-blood-boil/ ). This effectively leads to small retail Pharmacies being forced to charge larger copayments and the chains being able to charge lower copayments. Kickbacks and Rebates between wholesalers, insurers, and PBM’s which are hidden in convoluted pricing schemes all the while under the secrecy of “Trade Secrets” threaten to undermine the patient’s overall Freedom of Choice (42 CFR sec 431.51).
According to the Pharmacy trade publication which is one authority in standard of care in Pharmacy practice:
“Of late, some community pharmacy chains have changed policies that have been developed around the pretext of patient safety.Such policies include a limited-day supply of opioids for acute pain. However, this may present a bitter inconvenience for patients who legitimately require opioids for a major acute injury and also maximizes the profitability associated with multiple copays and dispensing fees for drugs that cost pennies. To our knowledge, there is no evidence to support that limited supplies for legitimate patients to improve safety or mitigate risk. In fact, there is sufficient data to support that placing such barriers, at least for patients requiring long-term opioids, may actually contribute to the heroin epidemic.”
THANK YOU PHARMACIST ADOU OF CLICK’S PHARMACY FOR NOT JUDGING ME BY THE MILE MARKER IN CAPE TOWN SOUTH AFRICA
It would be reasonable for a patient to travel outside of their local area when faced with such discrimination by the Chain Pharmacies such as CVS, Walgreens, Rite-Aid and others if they have chronic pain. With their combined market share it would be, almost impossible for such a patient to be, treated properly at all times.
Because Pronto Pharmacy is a specialty pharmacy that specializes in pain management and compounding it is reasonable for their clientele to travel distances that normal Pharmacy patients without intractable pain and are low income or without insurance would travel. As Director of Pharmacy in Home Infusion companies, I have personally needed to send delivery prescriptions for pain management medications as much as 4 hour drives away. This has been a common practice in the specialty of pain management for over 25 years. There is one company that I worked for that sent hemophilia patients various clotting factors nationwide. To single out pain management as a criminal while ignoring the vast number of therapies is an improper intrusion of government into a patient’s constitutionally guaranteed right of life, liberty, and the pursuit of happiness.
PHARMACIST TAUBO CLICKS PHARMACY SOUTH AFRICA
The State of Florida is a big player in the practice of Mail Order Pharmacy and as such provides medications (controlled and non-controlled) to patients in other states. This in and of itself should invalidate the red flag of distance since this practice is condoned and supported by the Florida State Legislature and the Florida Board of Pharmacy. To discriminate against Florida Pharmacies treating Florida patients is grotesque.
In terms of documentation, I have personally seen patient interviews that were conducted between Dr. Clement and his patients that were in intractable pain. As an expert in the field of diversion as well as pain management, it is clear that without clear cut guidelines from the DEA, FDA, JCAHO, or ISMP the steps were reasonable and prudent. Other similarly practicing Pharmacists would concur with my conclusions.
DISTANCE TRAVEL, PHARMACIST TAUBO CLICK’S PHARMACY IN JOHANNESBURG HELPED ME
The DEA removed all of the documentation from Pronto Pharmacy as well as the backups but did not return them to Dr. Clement intact. In fact, because of the negligence of the DEA some of the data was never retrievable, thus making it impossible for Dr. Clement to present the necessary notations on the prescription images, patient notes, patient profiles, and physician notes therein. Then accused him of not having the proper documentation. In some circles this would be considered tampering with evidence. This is a very suspicious activity on the part of the DEA.
EARLY FILLS
Narcotic prescriptions are not refillable and thus cannot be refilled early. There has never been a C-2 narcotic refilled at Pronto Pharmacy. That said, let’s look at early fills. Intractable pain is a very complex syndrome complete with changing dynamic clinical states. These changes in morbidity can mean that a patient may be stabilized on a particular regimen and suddenly fall out of pain control and as such need higher doses of pain medications. The opposite is true also. A patient may find that after reaching steady-state blood levels they would find that they could tolerate the pain for longer times between medication.
Drug interactions play an important role in these changes. Therefore, for a patient to require an early fill of their medication is not uncommon, nor is a gap in treatment for several months. The goal of therapy is the reduction of pain to tolerable levels. If a patient runs out of medication anxiety can often lead to an increased sensation of pain. This is why patients, especially ones that have to travel far for their medications often come in 2 – 7 days early from time to time. In fact, the insurance companies have set up override codes for this very fact. Every Pharmacy system in America has the ability to track override codes.
THANK YOU BROTHER PHARMACIST TAUBO OF CLICK’S PHARMACY FOR NOT PROFILING ME
However, since the DEA destroyed the data in the Pronto Pharmacy computer these codes, which are no more than 6 characters spread out over 3 different fields cannot be presented. The malfeasance of the DEA could be considered contributory negligence in this case. Other places that such documentation could be found are on the front or back of the original prescriptions. Not to mention the electronic patient profiles, all of which were available to the DEA but not presented at trial.
DRUG COCKTAILS
In this case, the DEA continually referred to combinations of medications as Drug Cocktails, which has no basis in clinical pharmacy nor medicine. It might be a street term but since we as Pharmacists do not operate in the street the use of that terminology is more akin to propaganda than actual medical practice. Many patients with chronic pain have comorbidities and as such require medications to treat other issues. To cherry-pick out two or three conditions and to assign criminality to them without the benefit of knowing what the patient’s condition rises to the height of absurdity and should be discounted.
There are a plethora of double-blind, prospective and retrospective studies that conclude that the combination of several combinations of oxycodone, hydrocodone, gabapentin, cyclobenzaprine, ibuprofen, ketoprofen, alprazolam, temazepam, oxazepam, baclofen, and others have increased efficacy in terms of pain management and the management of comorbidities commonly associated with inflammation, pain, and paralysis. There are competing step care protocols as well as empirical therapy in use in hospitals, home infusion, and community Pharmacy and therefore to criminalize the ones being used in these cases without the benefit of the patient interview or prescriber input would raise serious doubts about this red flag. The current information that the DEA uses to evaluate the use of opioids in the treatment of chronic pain is geared towards primary care practitioners and not specialists.
Even still because of the fear of retribution by the DEA most prescribers went too conservative in their approach. Indeed, the CDC, as well as the FDA, agree that these standards may be too constricting in a majority of pain patients.
Feds issue new warning to doctors: Don’t skimp too much on opioid pain pills
This has left too many patients not getting the pain relief that they deserve. In fact, pain relief is a fundamental human right according to the International Treaty on Human Rights that the United States is a signatory to.
One of the most exciting developments in pain management is opioid rotation. In this technique, short-acting opioids are rotated or alternated in patients that have developed tolerance. Analgesic tolerance is defined pharmacologically as a reduced potency of the analgesic effects of opioids after repeated administration or the need for higher doses to maintain the same effect. Tolerance is such a factor that State Legislatures nationwide and Congress are grappling with the clinical ramifications of their directives, for example, The Intractable Pain Treatment act of Texas indicates that there is overwhelming evidence that all types of pain, either of malignant or nonmalignant origin, are undertreated and reluctance to use narcotics for selected patients with nonmalignant painful medical conditions stems from the mistaken belief that they will become narcotic “addicts.” Data from the medical literature do not support such a contention. Since Dr. Sullivan is not practicing in the field of pain management or hospital or long-term care it is not unexpected that these new treatment modalities are not on his radar.
n 2009 Clinical Guidelines from the American Pain Society and the American Academy of Pain Medicine on the use of chronic opioid therapy in chronic noncancer pain: what are the key messages for clinical practice?https://www.ncbi.nlm.nih.gov/pubmed/19776687
As was stated before suspicion of diversion is not an actual diversion. However, as a diversion expert, I am aware that there are people who attempt to fraudulently obtain narcotics from Pharmacies and one thing that tips a Pharmacist off is that the patient attempts to purchase the medication by using cash. This is particularly concerning when it is known that the patient has insurance available. But there are many reasons that this so-called “red flag” may be investigated and cleared. By checking the PDMP data it is possible to see that a patient has, in the past, obtained the medication in question by using insurance. If this is found to be true it is possible that the patient is trying to divert, especially in the face of other red flags such as distance, early fill, unreasonable therapy, and the like. However, in this case, the historical PDMP data was not produced by the DEA at trial, so it is impossible to say for sure that this condition of ignoring past payment methods existed for any of the patients in question.
This is crucial information. There are so many legitimate reasons that a patient would pay cash that was not addressed at trial. The patient in question could not have insurance at all. The patient could have a lapse in coverage. The patient might have insurance that is provided by their employer and they might not want the employer to know that they have chronic pain. Examples of that might be truck drivers or medical personnel or heavy equipment operators.
WHEN WE TALK TO EACH OTHER WE WILL KNOW EACH OTHER SO, I WENT GOLFING AT THE DURBANVILLE GOLF CLUB IN CAPE TOWN HOWEVER LEFT HANDED GOLFING IS VERY RARE I WAS STUCK, THEN THIS GENTLEMAN PAUL MCKENZIE SUDDENLY APPEARED AND BROUGHT ME SOME LEFT-HAND CLUBS.
The local pharmacies might not accept their insurance. Pronto Pharmacy could not have a contract with the patient’s insurance. This item was proven at trial. If there is no PBM contract there is no insurance contract. It is common knowledge that Pronto Pharmacy’s business model includes the principle of not accepting insurance company contracts.
It is also proven at trial that there is no law, Federal, State, or Local that requires contracting with a PBM for a Pharmacy. In fact, I used to be the Supervising Pharmacist of a place called Cash Rx Plus Pharmacy in New York City, who did not take insurances either. Many Pharmacies take a few insurances and not others. With the shrinking margins that are forced upon community pharmacies nationwide many are cherry-picking which insurance companies to contract with. Some are avoiding them altogether. This is an increasing trend in the marketplace.
The USD or United States Dollar, which is the fiat currency of THE UNITED STATES OF AMERICA has a statement on every denomination. It says, “THIS NOTE IS LEGAL TENDER FOR ALL DEBTS PUBLIC AND PRIVATE.” According to 31 U.S. Code § 5103, United States coins and currency (including Federal reserve notes and circulating notes of Federal reserve banks and national banks) are legal tender for all debts, public charges, taxes, and dues. Foreign gold or silver coins are not legal tender for debts. The prevailing sentiment on this is that all United States money as identified above are a valid and legal offer of payment for debts when tendered to a creditor. There is, however, no Federal statute mandating that a private business, a person or an organization must accept currency or coins as for payment for goods and/or services. Private businesses are free to develop their own policies on whether or not to accept cash unless there is a State law that says otherwise. For example, a bus line may prohibit payment of fares in pennies or dollar bills. In addition, movie theaters, convenience stores, and gas stations may refuse to accept large denomination currency (usually notes above $20) as a matter of policy.
Currently, there is no law in this country that contravenes 31 U.S. Code § 5103. Therefore, if a patient offers to pay in cash it might seem suspicious but does not necessarily rise to the level of actual diversion. This is important because any patient has the right to expect that the Pharmacy will act within the law in this matter and in light of their freedom of choice and fundamental human right suspicion may be present but does not require that the patients, themselves be subject to this requirement.
HECTOR PIETERSON 12 YEARS KILLED IN SOWETO UPRISING
If a Pharmacist does not reasonably believe that the medication is going to be diverted there is no reason not to accept cash. Currently, the PDMP system at present cannot distinguish between cash, credit, debit, or healthcare payment cards. All, of these things, come up on the system as cash. With the growing cost of medications, the payment of copayments, as well as full prices by credit or debit cards, is increasing. Healthcare payment cards often are the form that employers use to decrease their overall healthcare costs by limiting the benefit to their employees. The employer matches contributions to the funds made through payroll deductions with specific limitations and these are in fact insurance in a broad sense. It removes the bureaucracy of insurance companies, PBM’s, and switches from the overall cost of healthcare.
COMPOUNDING VS MANUFACTURING
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, was legislatively negotiated to strike “a balance between two potentially competing policy interests—inducing pioneering development of pharmaceutical formulations and methods and facilitating an efficient transition to a market with low-cost, generic copies of those pioneering inventions at the close of a patent term.” The Hatch-Waxman Act was, at least according to two economists, the first change in patent terms since 1861. So, one of the pillars of the generic drug push by Congress was to ensure that patients had low-cost alternatives to brand name drugs.
Compounding has been a primary facet of the practice of Pharmacy since the beginning of the profession. Prior to that, it was only done legally by physicians or their assistants. In the United States, compounding pharmacies are licensed and regulated by their respective states like all other pharmacies. National standards have been created by the Pharmacy Compounding Accreditation Board (PCAB). However, accreditation is not mandatory and inspections for compliance occur only every three years for particular facets of compounding. As mentioned, some confusion has arisen when the traditionally patient-specific nature of compounding gets blurred by the making the multi-product “batches” such as in anticipation of similar orders. Notably, the Food and Drug Administration (FDA) has always had the authority to regulate “manufacturing” – which is when drug products are not made or modified as to be tailored in some way to the individual patient – regardless of whether this is done at a factory or at a pharmacy. And conversely, truly legitimate/traditional compounding does not cease to be so merely by having a high frequency of occurrence – indeed, progressing towards more prevalent drug product customization is an appealing aspect of personalized medicine. https://en.wikipedia.org/wiki/Compounding
Since I have experience in Manufacturing (Schering-Key) as well as sterile compounding (Director of Pharmacy of several Home Infusion Pharmacies) along with non-sterile compounding (more than 30 years in Retail Pharmacy) very few Pharmacists nationwide have my level of experience and as such I could be thought of as an authority on the subjects. It was apparent that the Administrative Law Judge (Mr. Dowd), the Diversion Expert (Mr. Alpert), the Prosecutor (Mr. Beerbower), as well as the Expert Witness (Mr. Sullivan) are not likely to understand the level of care and clinical issues, in this case, better than myself. Additionally, since I have extra training in reading and understanding the law, although I am not an attorney, I could be considered a Lawyer (a person learned in the law) as defined in Black’s Law Dictionary 3rd Edition. However, I do not delude myself into thinking that my knowledge of the law is all-encompassing or greater than that of a Lawful Man acting in the course of the profession of Pharmacy. But I do maintain that my interpretation of all these sometimes apparently conflicting laws and regulations are understandable to myself.
DEFINITION OF MANUFACTURING:
21 U.S. Code § 802
(15) The term “manufacture” means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term “manufacturer” means a person who manufactures a drug or other substance.
DEFINITION OF COMPOUNDING:
Section 503A of the Federal Food, Drug, and Cosmetic Act SEC. 503A.
PHARMACY COMPOUNDING.
(a) In General.–Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding–
(1) is by–
(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or
(2) (A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between–
(i) the licensed pharmacist or licensed physician; and
(ii) (I) such individual patient for whom the prescription order will be provided; or
(II) the physician or other licensed practitioner who will write such prescription order.
At trial, Mr. Sullivan indicated his opinion that compounding should be narrowly drawn. This flies in the face of 200 years of Pharmacy Practice standards. In fact, what he defines as when it is proper to compound is based upon his opinion and that of the manufacturers. However, Pharmacists nationwide would not agree. If a patient is unable to afford their medication their clinical outcomes are less than optimal. Price can be a major factor in compliance, so when Pronto Pharmacy minimizes the impact of price, they are acting within the spirit of the law that created generics in the first place. Because the batches are small it could be inferred that the danger is also decreased. Manufacturers’ errors lead to nationwide recalls (Cimetidine), but small-batch compounding can only affect a few people, and therefore safer for the public. When I started in the profession all Pharmacies were required to have compounding supplies as a condition of registration in every state in the union. However, as the manufacturers gained more of a stranglehold on the government with their bribes and corruption, compounding in Pharmacy began to diminish. We found that as insurance penetration into the profession increased the reimbursement for compounding decreased. But Congress and the State Boards of Pharmacy have not totally abandoned the profession and compounding still has its place as a pillar of Pharmacy. Without compounding there will be no intravenous admixtures, specialized solutions to complex problems, or innovation.
In this case all the things that are required for compounding instead of manufacturing are present. Each prescription for a compound is for a specific patient. There is a Physician – Pharmacist relationship. There is a Patient – Pharmacist relationship. In the anticipatory compounding reasonable, limited quantities are being compounded and the necessary prescriptions do actually show up in reasonable time frames. All over the country anticipatory compounding is done and a typical limit is about 3 weeks but may actually loom as high as 3 months in some cases. This is the standard of care in compounding Pharmacy. For Mr. Sullivan not to realize this is further proof of his lack of experience and thus, he is not an expert in this realm. Diversion Expert Alpert admitted at trial that he has absolutely no understanding of compounding. The DEA did not produce even one piece of evidence that shows mastery of the subject of compounding.
ANTICIPITORY COMPOUNDING OF CONTROLLED SUBSTANCES
The DEA contended that Pronto Pharmacy illegally manufactured controlled substances. However, without mastery of the laws concerning compounding their contention fails on its face. Let’s look at the pertinent statutes:
21 U.S. Code § 841.Prohibited acts
(a)Unlawful acts Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—
Taken by itself I could see their point. However, there are exceptions in play.
This information is available on the DEA website, Findlaw, website and elsewhere. Since the wording in this part is particularly voluminous and Pronto Pharmacy was in possession of a valid DEA license at the time that was without blemish and not expired this is the only pertinent part that might be under question.
21 USC § 1301.13 Application for registration; time for application; expiration date; registration for independentactivities; application forms, fees, contents and signature; coincident activities
(iii) Dispensing or Instructing (includes… Retail Pharmacy…) A Pharmacist may manufacture aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound or mixture,
Business Activity – (iv) Dispensing or instructing (includes Practitioner, Hospital/Clinic, Retail Pharmacy, Central Fill Pharmacy, Teaching institution)
Controlled substances Schedules ll-V
DEA Application Forms New – 224 Renewal – 224a
Application Fee $731
REGISTRATION PERIOD 3 years
Coincident Activities allowed May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A Pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form consisting a narcotic controlled substance in Schedule ll – V in a proportion not exceeding 20% of the complete solution, compound or mixture. A Retail Pharmacy may perform central fill activities
As can be seen when the DEA contended that Pronto Pharmacy needed to be registered as a manufacturer the law says otherwise. Compounding of controlled substances takes place in every state of the union and has since the beginning. If the prohibition is against a certain substance the law could be changed such as it was in the case of heroin, laudanum, opium, and so many others. If it were meant to restrict C-2 medications the law could have been changed long before now. The reporting of the C-2 medications in question to PDMP was proper according to the silence on the part of the DEA who brought this case. The question of exceeding the 20% maximum was not a point of contention in the case and therefore is not in question here.
To remove anticipatory compounding from Pharmacy Practice would have many far-reaching negative consequences for patient care and an exponential increase in unnecessary waste. After all, to pierce anticipatory compounding would too broadly define the issue. It would include antibiotics, antipsychotics, neuroleptics, vitamins, tablets, capsules, pills, troches, solutions, emulsions, creams, lotions, macerations, decoctions, ointments, suppositories and all the other dosage forms that exist. It is highly unlikely that the Legislature would have as its intent such an egregious threat to public safety or such burdensome costs to be placed on the American people. The FDA regulates compounding and manufacturing. The DEA is in charge of administration and enforcement of the Controlled Substances Act. The State Boards of Pharmacy regulate compounding. Therefore, a practicing pharmacist would need to be abreast of sometimes overlapping jurisdictions and subsequently possibly contradictory information.
Conclusion
These are but a few indicators that the search for truth was not existent in this procedure. Everything presented here is common knowledge and available to the DEA and was available before the proceedings. It seems that prosecutorial myopathy was in play here. But, because the DEA has an agenda which is based upon incomplete information and a desire to combat the so called “Opioid Epidemic” and has had their feet held to the fire by the Office of the Inspector General’s Report on the DEA https://oig.justice.gov/reports/2019/e1905.pdf their focus on diversion could be seen as overzealous. Unfortunately, individual practitioners have been made the scapegoat of this misguided witch hunt. The biggest issue is that suspicion of diversion is not necessarily actual diversion.
Before starting this case, the DEA could have interviewed the prescribers and found out about the individual patient’s needs. However, they did not. Had they done so, and wrongdoing was found they could have censured the prescriber and notified the Pharmacists in the state to avoid the narcotic prescriptions of that prescriber. If no wrongdoing had been found the DEA could have concentrated its resources in other areas.
Before starting this case, the DEA could have looked at the PDMP data and surmised that these patients were stabilized on pain management therapies. Even if they didn’t fully understand the effects of enzyme induction, drug interactions, tolerance, or comorbidity protocols there is ample information to figure these things out in the public space. However, they did not focus their gaze on the possible treatment of patients but rather on suspicion and innuendo.
A reasonable and prudent individual might conclude that discovering the truth was not the goal in this investigation.
RESPECTFULLY SUBMITTED
Jack Folson, Jr – Clinical Pharmacist Owner – THE CALYX GROUP
28228 Warren Road
Westland, Michigan 48185
908-327-7322
Expert in Pharmacy Practice
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on June 9, 2020, a true and correct copy of the foregoing was electronically filed via ECF and/or served via e-mail upon the following:
John E. Beerbower, Esq.Diversion & Regulatory Litigation SectionDrug Enforcement AdministrationOffice of Chief Counsel8701 Morrissette DriveSpringfield, VA 22152 John.E.Beerbower@usdoj.govDEA.Registration.Litigation@usdoj.gov
Dale R. Sisco // Dominic A. Isgro SISCO- LAW 1110 N. Florida AvenueTampa, FL 33602(813) 224-0555(813) 221-9736 FAX dsisco@sisco-law.com Florida Bar No. 559679 disgro@sisco-law.com Florida Bar No. 113318Attorneys for the Respondent
Hearing Clerk Office of Administrative Law JudgesDrug Enforcement Administration8701 Morrissette DriveSpringfield, VA 22152 ECF-DEA@usdoj.gov
THE CALYX GROUP Jack Folson, Jr calyxgroup@yahoo.com 28228 Warren Road Westland, Michigan 48185 (908) 327-7322 (269) 659-0814 Facsimile
JACK FOLSON RPH, WALTER R. CLEMENT MS., MBA., RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
THE CONGRESS MUST DEFUND THE DRUG ENFORCEMENT AGENCY
THE MANIFESTO OF THE NORTH STAR PROJECT
When you see THROUGHOUT LIFE most of your friends, colleagues, and classmates who are of degree being defiled, sanctioned, terminated, harassed, arrested, jailed, and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do Then at some point, you are compelled to ask yourself when
ENOUGH IS ENOUGH.
At some point in your life, you have to say and proclaim enough is enough and what are you going to do about it. Then we must stand and fight as soldiers together or die like mice.
ENOUGH IS ENOUGH. To me, that idea of an Administrative Judge Federal showing such destain to a Respondent would so overturn nearly 200 years of medical and pharmaceutical practice make this court worthy of oversight and disillusionment
WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY TO THE UNITED STATES HOUSE COMMITTEE ON THE JUDICIARY, UNITES STATES HOUSE OVERSIGHT ON OVERSIGHT SUBCOMMITTEE ON GOVERNMENT OPERATIONS AND UNITED STATES SENATE COMMITTEE ON THE JUDICIARY TO DEFUND AND DISBAND THIS AGENCY OF GOVERNMENT.
ENOUGH IS ENOUGH.
THE CONGRESS MUST DEFUND THE DEA
THIS PRESENTATION CONTAINS MUST SEE VIDEOS WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE
INTRODUCTION
The DEA has acted as an unregulated medical agency policing medical facilities and medical practices without legal standards and grounds and the DEA Administration Court System body, which operates within the Department of Justice (DOJ), as a runaway unconstitutionally entity, and immune to all laws of governance of all courts within the Justice System.
Therefore, it is incumbent for Chair of the Subcommittee of Federal Court Operation, Congressman Hank Johnson of Georgia’s 4th district to give Oversight on the DEA Court System which operates outside the Federal Rules Evidence and of Civil Procedures.
On May 5, 2020, Mark D. Dowd, U.S. Administrative Law Judge, in the matter of Pronto Pharmacy, LLC Docket No. 19-42 issues RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE in a rambling decision of 148 pages, to be found so ridicules it overturned nearly 200 years of medical and pharmacy law(s) and protocols.
THE HOUSE JUDICIARY COMMITTEE MUST BEGIN OVERSIGHT THIS COURT SYSTEM
Yet, it is further clear, on this day U.S. Administrative Law Judge Mark D. Dowd, was so busy trying to be a bigot, so busy trying to be a racist, so busy trying to be the toughest man on the Federal bench he forgot how to be fair. You Are Within The Norms has decided to publish the last 50 pages of Judge Dowd’s decision in which the respondent never spoke one word.
DEA RAID ON PRONTO PHARMACY AUGUST 29, 2019
One can never prevail in any court system or environment, even when supported with science and facts, against bias and prejudice, or when privilege is permitted to take the stand. Yet still, it is not Judge Mark D. Dowd, bias/racism that is troublesome, it is his stupidity in his recommended ruling, findings of facts, the conclusion of law which eviscerates nearly two hundred years of medical and pharmacy law and protocols.
THE PAINFUL DISCUSSION OF BEING UNDERESTIMATED, UNDERVALUED AND MARGINALIZED
Let it be clear the poor training and limited comprehension, lack of understanding of pharmaceutical science, pharmacy law, and pharmacy protocols of DI Richard James Albert are deliberate, yet essential, and purposefully crafted by his handlers to perform his mission. Richard James Albert does not perform without their command. His handlers know they can prevail with him in spight of their dismissiveness toward medical science and protocols. DI Albert could never be used successfully against a large Chain Drug Store or a Jewish, or White-owned pharmacy because the quality of his knowledge and training would quickly be exposed in a legal proceeding.
However, DI Richard James Albert can prevail against a Black-owned Pharmacy despite any facts or laws we present because the built-in institution of racial injustice, particularly within the Judicial System or in the field of medical science, sports, politics or the military, will default to all knowledgeable, educated Black persons as arrogant and uppity. We see this in our history, particularly in the United States, when one is right and dares to challenges the morae within the system.(1)
Arrogance is rate-limiting, defined all by a preconceived standard of what we are expected to know and further based on a preconceived level of knowledge, expectation, and skill of what one should have obtained. This is likely an eighth-grade education. Anything beyond that becomes suspicious, surprise, unearned, and requires further examination of one’s credentials, instead of being well versed, you are detested. Arrogance stops one in their tracks to be undervalued, underestimated, and marginalized. (1) This is a reality that all Black professionals face, especially those who are licensed in any profession, which we only quietly discuss this among ourselves.
YET, THE PEOPLE AREN’T AS STUPID AS THE DEA THINKS WE ARE!
The authors of this article have learned one thing:
” in America, you either stand for something or nothing at all.”
If standing against DEA’s abuses by redefining medical science procedures, their lies, and deceptions perpetrated by this Federal Institution (DEA), then we are one more set of uppity arrogant Black N-Word SOB’s the DEA, DOJ or anyone else just don’t have to like.
Because we stand and rise against to oppose this system of injustice, which treats licensed Black pharmacists as common drug dealers, we will put an end to the United States Drug Enforcement as an agency of Government, through Congressional Oversight and wisdom and put an end automatically defining degree people of color as arrogant. We have learned from our ancestors, “just to sit still would be a sin:”
“There is no human activity you can ever perform that will ever lift the shroud of this racial constructs in this system the restraint is the color of your skin”
COMPOUNDING IS NOT MANUFACTURING NEVER HAS AND NEVER WILL BE!!
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Compounding is defined in several ways according to the Guidelines for Compounding Practices we quote these definitions verbatim from Chapter 795 of the United States Pharmacopeia (USP)
NELSON MANDELA, RIVON A TRIAL 1964 SENTENCE TO LIFE IN PRISON
Compounding can be as simple as the addition of a liquid to a manufactured drug powered or as complex as the preparation of a multicomponent parenteral nutrition solution. In general, compounding differs from manufacturing in that compounding involves a specific practitioner-patient-pharmacist relationship, the preparation of relatively small quantity of medication, and different conditions of sale.
Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observed prescribing patterns. (2)
MANUFACTURING INCLUDES THE PREPARATION AND THE PROMOTION OF A COMMERCIALLY AVAILABLE PRODUCT
Manufacturing is the production, preparation, propagation, conversion and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or indecently through means of chemical or biological synthesis; the terms include any packaging or repackaging of the substances(s) or labeling or relabeling of its container and the promotion and marketing of such drug devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons. (2)
GUIDELINES FOR DISTINGUISHING BETWEEN COMPOUNDING AND MANUFACTURING ARE ASFOLLOWS:
Pharmacists may compound, in reasonable quantities, drug preparations the are commercially available in the mar place if a pharmacist-patient-prescriber relationship exist and a valid prescription is presented.
Pharmacist may compound nonprescription medications in commercially available dosage forms or in alternative dosage form to accommodate patients needs called by individual state boards of pharmacy.
PAY DISPARITY FOR THE SAME WAR SERVICE SOUTH AFRICA
Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription, on the basis of a history receiving valid prescriptions that have, on basis of a history of receiving valid prescriptions that been generated solely within an established pharmacist-patient prescriber relationship, and provided that the prescription are maintained on file for all such preparations dispensed at the pharmacy.
WARRANT OF DEATH ANDREW S ZONDO
Pharmacist should not offer compounded medication to other pharmacies for resale; however, a practitioner may obtain compounded medication to administer to patients, but it should be labeled with the following: “For Office Use Only,” date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by a hospital to contract compounding pharmacies.
Compounding pharmacies and pharmacist may advertise or otherwise promote the fact that there provide prescription compounding service.
YOU ARE LOW HANGING FRUIT
Judge Mark Dowd’s decision of May 5, 2020, has labeled ridiculous by Pronto Pharmacy Attorney Dale Sisco and more than demonstrates his incompetents and fails as a Juris. Most importantly, had Judge Dowd simply took a look at the DEA website under 21 USC 1301.13 which he deliberately goes out his way to mis-interpreted this law:
” A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.“
DEA’s argument has been Pronto Pharmacy compounding of control medications was concluded as manufacturing and Pronto Pharmacy needed a separate manufacturing registration. This was because their retail registration license does not cover for manufacturing. The chart of guidelines more than contradicts all DEA assertions made by both DI Albert and his handlers against Pronto Pharmacy.
The DEA Diversion Investigator Richard James Albert prepared a warrant that “opinion based on a red flag that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy. Pronto Pharmacy is a licensed pharmaceutical company by law that can compound medications. The below chart demonstrates Richard James Albert nor his handlers know existing laws and/or rules guiding the practicing of Pharmacy. Judge Mark Dowd is just as complicit in their ignorants.
1964 INCIDENT AND FOR THE STRUGGLE OF ALL ST.AUGUSTINE, FLORIDA
More specifically control medications and this chart under (iv) practitioners, hospitals retail pharmacies are permitted under their DEA Federal Registry certificate to process Schedule medications II-V. This chart specifically outlines:
Yet, what is more, troublesome it that these guidelines are from the DEA’s own website under 21 USC 1301.13 under certificate new license and renewal (224&224a) and the cost for this license is $731.00 and it is good for 3 years. The importance is DI Albert didn’t know laws, never looked for the law and his handlers, Aimee Hickerson, Susan Langston, John Beerbower kept him ignorant of the laws.
DEA WEBSITE UNDER 21USC 1301.13
(iv) Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)
Schedules II–V
New–224 Renewal–224a
731
3
May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.
JUDGE MARK DOWD’S 4O PAGE RULING RULING
Analysis of Unlawful Manufacturing Allegation
Finally, the Government alleges that the Respondent engaged in “manufacturing” controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing the manufacture of controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28. Specifically, the Government alleges that the Respondent compounded oxycodone and hydromorphone capsules in such large quantities that this activity constituted manufacturing rather than permissible compounding for individual patients. Id.
DEA regulations require registrants to obtain a separate registration for each regulated business activity in which they engage. 21 C.F.R. § 1301.13(e). Section 1301.13(e) provides ten separate business activities, to include manufacturing and dispensing.44 Id. at (e)(1)(i), (iv). Each business activity is “deemed to be independent of each other.” 21 U.S.C. § 1301.13(e). In other words, a registration for one activity does not authorize the registrant to engage in another activity. Id. To engage in both dispensing and manufacturing, a registrant would need to apply for and obtain separate registrations for each activity. No person or entity may engage in a regulated business activity “until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person [or entity].” 21 C.F.R. § 1301.13(a).
STEVE BIKO MURDERED, APARTHEID MUSEUM JOHANNESBURG, SOUTH AFRICA
Requiring separate registrations for manufacturing and dispensing is more than mere formality. In fact, the CSA imposes stricter requirements on manufacturers than dispensers, not to mention a different standard for issuing a sanction. Wedgewood Village Pharm., 71 Fed. Reg. 16593, 16594 (2006); compare 21 U.S.C. § 823(a) (setting forth six public interest factors for manufacturers of
44 Although not relevant to this case, the other business activities include distributing, reverse distributing, research (Schedule I), research (Schedules II-V), narcotic treatment programs, importing, exporting, and chemical analysis. 21 U.S.C. § 1301.13(e)(1).
101
Schedule I and II controlled substances), with 21 U.S.C. § 823(f) (establishing five similar, yet different, public interest factors for practitioners, which includes pharmacies engaged in dispensing). Additionally, the CSA imposes higher standards for recordkeeping, reporting, and security on manufacturing than it does on dispensing. 71 Fed. Reg. at 16594. Manufacturers are also required to obtain a registration annually, whereas dispensers are only required to obtain a registration every three years. Id. (citing 21 U.S.C. § 822(a)(1)-(2)).
STATESMAN
The Respondent is registered with the DEA as a “retail pharmacy.” GX 1. Pursuant to this registration, the Respondent may dispense controlled substances in Schedules II-V. Id.; 21 C.F.R. § 1301.13(e)(1)(iv). The Respondent’s registration as a retail pharmacy authorizing it to engage in the regulated activity of dispensing does not permit the Respondent to manufacture controlled substances; thus, any manufacturing it performed would be unlawful. To prevail on its claim that the Respondent manufactured controlled substances, the Government must show by a preponderance of the evidence that the Respondent engaged in an activity that met the CSA’s definition of “manufacturing.”
Although the CSA does not define what the term “to compound” means, it does define “manufacture.” Wedgewood Village Pharm. v. DEA, 509 F.3d 541, 543 (D.C. Cir. 2007) (noting the CSA does not define “compounding”). “[T]he term ‘manufacture’ means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container.” 21 U.S.C. § 802(15) (emphasis added). Importantly, the CSA includes compounding in its definition of manufacturing. Id. Not all compounding, however, is considered to be manufacturing. The definition of manufacturing “does not
102
include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice.” Id. Stated differently, compounding does not require a registration to manufacture so long as the compounding (1) conforms to State and local laws, and (2) is conducted “as an incident to [the] administration or dispensing” of the compounded drug.
HAVE YOU EVER HEARD OF NARC SCORES
The critical question here is whether the Respondent compounded controlled substances as an incident to dispensing them. If so, then its activity qualified for the exemption to manufacturing and the Respondent would be properly registered. If not, however, then its compounding activity would be considered manufacturing, for which it is not registered. In Wedgewood, the Agency framed this question as whether the pharmacy compounded “as an adjunct to dispensing controlled substances.” 71 Fed. Reg. at 16594. If the pharmacy compounded “as an adjunct to dispensing controlled substances to specific patients,” Wedgewood continued, then the pharmacy would be exempt from the definition of manufacturing. Id. The Agency concluded “that to be exempt from the definition of manufacturer under the CSA a DEA practitioner registrant must be engaged in compounding controlled substances on an individual patient basis. That is, a pharmacy must receive a prescription for a specific patient from a physician or other individual practitioner and must deliver or dispense that medication to the patient.” Id. at 16595. A pharmacy may avoid the regulatory requirements associated with manufacturing, including the requirement to obtain a separate registration, so long as the pharmacy compounds “for a specific patient on a patient by patient basis.” Id. at 16596.
In reaching this conclusion, the Agency turned to the traditional definition of compounding articulated by the Supreme Court in Thompson v. Western States Medical Center. 71 Fed. Reg. at 16595-96 (citing 535 U.S. 357 (2002)). In that
103
case, the Supreme Court defined compounding as “a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product.” 535 U.S. 357, 361 (2002) (emphases added). The critical element of this definition, that compounding is done on a patient-by-patient basis after having received a prescription, is also found in the Fifth Circuit’s view of compounding.45 The Agency also found support for its conclusion in the legislative history of the Food, Drug, and Cosmetic Act (FDCA).
Like the CSA, the FDCA exempts compounding pharmacies from manufacturing requirements. 71 Fed. Reg. at 16595 (citing 21 U.S.C. § 353a). Around the time Wedgewood was decided in 2006, the Food and Drug Administration (FDA) had expressed concerns, however, that some pharmacies were circumventing manufacturing requirements by mass-producing drugs in a manner that appeared at first blush to be compounding, but was in fact manufacturing. Id.; see also Wedgewood Village Pharm., 509 F.3d at 543 (noting the same concern). A House Conference Report concerning the Food and Drug Administration Modernization Act of 1997, the law which amended the FDCA at 21 U.S.C. § 353a to exempt compounding from certain requirements, states that “[i]t is the intent of the conferees to ensure continued availability of compounded drug products as a component of individualized therapy, while limiting the scope of compounding so
GERALD KILEY, FT. MTER;S FLORIDA
45 The Fifth Circuit defined compounding as “the process whereby a pharmacist combines ingredients pursuant to a physician’s prescription to create a medication for an individual patient.” Prof. & Pat. For Customized Care v. Shalala, 56 F.3d 592, 593 (5th Cir. 1995). This process, the Fifth Circuit added, is typically needed when a medication is not commercially available. Id. In another case, the Fifth Circuit stated that compounding is a process designed “to create a medication to meet the unique needs of an individual . . . patient.” Med. Ctr. Pharm. v. Mukasey, 536 F.3d 383, 387 (5th Cir. 2008). According to the American Pharmacists Association, as cited in Mukasey, pharmacists compound “patient-specific medication.” Id.
104
as to prevent manufacturing under the guise of compounding.” 71 Fed. Reg. at 16595 (quoting 1997 U.S.C.C.A.N. 2880).
By citing this portion of the FDCA’s legislative history, the Agency made clear that it shares the FDA’s concern about one of the challenges of regulating compounding and manufacturing; namely, that a pharmacy could compound on such a large scale that its operation would, in essence, be akin to that of a manufacturer. Based on this concern shared between two federal agencies charged with regulating pharmaceuticals, it is understandable why in Wedgewood the Agency chose to limit the manufacturing exemption to compounding conducted on an individual patient basis after the pharmacy receives a prescription. 71 Fed. Reg. at 16595-96.
MR. BOBBY NELSON “I DRIVE 360 MILES ROUND TRIP TO GET BECAUSE YOU TREAT ME WITH DIGNITY AND RESPECT”
The view that compounding is exempt from the definition of manufacturing only when it is conducted pursuant to a prescription for a particular patient is also consistent with the CSA’s definition of “dispense” as well as the language “incident to” in the definition of “manufacture.” Under the CSA, “dispense” means “to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery.” 21 U.S.C. § 802(10) (emphases added). The fact that the definition of “dispense” includes “compounding necessary to prepare the substance” for delivery, and the fact that compounding “incident to” dispensing exempts a pharmacy’s activity from the definition of “manufacture,” shows that the CSA drafters contemplated compounding as “an incident to” dispensing when needed to prepare a substance for delivery to a patient pursuant to the patient’s prescription. Compounding large quantities of a substance in anticipation of receiving prescriptions for that substance would not be “necessary to prepare the substance for” delivery pursuant to a patient’s prescription.
105
Furthermore, the reference to compounding as “necessary” in the definition of “dispense,” combined with the “incident to” clause in the manufacturing exemption, illustrates that the CSA drafters intended compounding to be dependent on dispensing, and for dispensing to be dependent on receipt of a valid prescription. In other words, the logical sequence of events is that (1) a pharmacy receives a prescription, (2) in some cases compounding will be “necessary” to prepare that prescription, and (3) because compounding is necessary to prepare the substance for dispensing, (4) it is viewed as incidental46 to the act of dispensing, and (5) therefore, the necessary act of compounding to fill that prescription is exempt from the definition of manufacturing. 21 U.S.C. §§ 802(10), (15). But it would only be exempt to the extent that it was necessary to prepare a substance for delivery pursuant to a prescription. Id
The thrust of the Respondent’s argument is that because the CSA does not define compounding, the appropriate question is whether the Respondent complied with Florida law and other federal laws. Resp’t PHB, at 37-38. The Respondent argues that it engaged in anticipatory compounding (i.e., compounding before receiving a prescription), which is permissible under Florida law and the FDCA. Id. at 37-41. Florida law provides that lawful compounding includes “[t]he preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.” Fla. Admin. Code r. 64B16-27.700(1)(a).
46 As pointed out by the Government, the view that the phrase “incident to” implies that compounding is dependent on dispensing is also consistent with the Black’s Law Dictionary definition of “incident to” as “dependent on, subordinate to, [or] arising out of.” Gov’t PHB, at 43. Perhaps this is the reason why the CSA drafters declined to define “compounding”: because they viewed it only as an accessory to dispensing. In other words, they viewed compounding as a necessary, but limited, means to an end, to be performed only in relation to dispensing and dependent on dispensing. Under this approach, the CSA allows pharmacies to compound on an as-needed basis in order to engage in their primary activity of dispensing, but any compounding that is not done as a means of engaging in an activity that meets the definition of “dispense” would fall under the definition of “manufacture”; thus, triggering the requirement to be registered as a manufacturer and to meet stricter standards.
106
The Respondent also argues that it complied with the anticipatory compounding provision of the FDCA. Section 353a of Title 21, United States Code, governs pharmacy compounding under the auspices of the FDA. Thompson, 535 U.S. at 362; Allergan USA v. Imprimis Pharm., Inc., No. 8:17-cv-01551-DOC-JDE, 2019 WL 4545960, at *5 (C.D. Cal. March 27, 2019). This section falls under the FDCA. Allergan USA, 2019 WL 4545960, at *5. This section of the FDCA, commonly referred to as Section 503A, exempts certain compounded drug products from the FDCA’s “new drug” approval requirements. United States v. Conigliaro, 384 F. Supp. 3d 145, 160 (2019). This provision resolves issues arising from the question of whether a compounded medication qualifies as a “new drug” requiring FDA approval. Mukasey, 536 F.3d at 389. Section 503A also establishes “safety and quality standards” for compounding ingredients (21 U.S.C. §§ 353a(b)(1)(A)- (B)); prohibits pharmacists from producing “carbon copies of commercially available drug products” (21 U.S.C. § 353a(b)(1)(D)); and prohibits pharmacists from “soliciting customers,” or advertising or promoting particular compounded drugs (21 U.S.C. § 353a(c)). Conigliaro, 384 F. Supp. 3d at 160.(SEE: CLICK ON BELOW VIDEO)
In order to receive Section 503A’s exemption from “new drug” approval requirements, the compounded drug product must meet certain criteria, the most relevant of which requires the compounding to be done “in response to a valid prescription” or that the compounding be limited to situations where a professional relationship already existed between the patient, pharmacist, and prescriber. Conigliaro, 384 F. Supp. 3d at 160 (citing 21 U.S.C. § 353a(a)). In essence, Section 503A allows compounding in only two scenarios: (1) after receiving a prescription, or (2) before receiving a prescription if the pharmacist has previously received valid prescriptions issued within the same established relationship between the pharmacist, patient, and prescriber. Allergan USA, 2019 WL 4545960, at *5. For ease of reference, the second scenario will be referred to as anticipatory
107
compounding. The fact that the Respondent may have complied with the anticipatory
compounding allowance under the FDCA, as the Respondent argues, does not mean that its conduct also complied with the CSA.47 In fact, meeting the criteria for permissible compounding under the FDCA only means that the Respondent is
DECROYO GREENSHOT GUN SHOT WOUND
47 I am not making any finding about whether the Respondent violated (or complied with) the FDCA. As the Government points out in its post-hearing brief, the FDA, the agency tasked with implementing the FDCA, is responsible for ensuring the safety and effectiveness of new drugs for their intended purposes. Gov’t PHB, at 44 (citing Am. Pharm. Ass’n v. Weinberger, 377 F. Supp. 824, 830 (D.D.C. 1974)). The DEA, in contrast, is the federal agency charged with enforcing the CSA and combatting the “unlawful diversion” of controlled substances. Id. (citing id.). By establishing the FDA and DEA, Congress manifested its intent to create two distinct institutions responsible for regulating drugs. Weinberger, 377 F. Supp. at 830. On the one hand, the FDA is responsible for “determining which new drugs should be permitted to enter the flow of commerce.” Id. On the other hand, once a drug is approved to enter the marketplace, the DEA is responsible for ensuring that a particular class of drugs, controlled substances, is not diverted outside the lawful chain of distribution from manufacturer to patient. Id.; see also Gonzales v. Raich, 545 U.S. 1, 13 (2005) (stating that in enacting the CSA, Congress created “a closed regulatory system” to curb “the diversion of drugs from legitimate to illicit channels”).
There is, undoubtedly, overlap between the scope of FDA’s and DEA’s authority. Weinberger, 377 F. Supp. at 831. In a broad sense, both agencies are responsible for protecting the public from unsafe or dangerous drugs. Weinberger, 377 F. Supp. at 831. These are similar regulatory missions. And yet, it is important to keep in mind, as the D.C. District Court explained in Weinberger, that the FDA ensures a drug is safe before entering the market, while the DEA protects the public from the diversion of controlled substances after entering the stream of commerce. 377 F. Supp. at 830-31.
NOT YET
Given this distinction, it is understandable why the Agency has stopped short when it comes to interpreting the FDCA or holding respondents accountable for violating the FDCA. For example, in Wedgewood, the Agency stressed that it did “not rely on FDA’s position” when applying the CSA’s “compounding” provisions, even though its interpretation happened to be consistent with FDA guidelines and statutes. 71 Fed. Reg. at 16596. In two other DEA cases, the Agency explicitly stated that it lacked the authority to interpret the FDCA or to declare violations of the FDCA. Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44368 n.27 (2011); Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49989 (2010). First in Bui, then reinforced in Battershell, the Agency emphasized that the “DEA is not charged with administering the [FDCA]”; therefore, any attempt to “definitively interpret” the FDCA would be outside the scope of its delegated authority. Id. Similarly, this lack of authority to interpret the FDCA “bars the Agency from deciding whether Respondent violated the statute.” Battershell, 76 Fed. Reg. at 44368 n.27. Simply put, the issue of whether a registrant violated the FDCA is “outside of the Agency’s authority to adjudicate.” Bui, 75 Fed. Reg. at 49989.
RODNEY PEETE “I HAVE TO TRAVEL MILES TO GET MY PAIN MEDICATIONS”
Although the Agency has stated that interpreting or declaring violations of the FDCA is outside its authority, the extent to which violating the FDCA may be considered under Factor Five is another matter. In Battershell, the Agency noted that the respondent’s plea agreement established that he violated the FDCA and that evidence of such violation could “be considered under factor five” for the “purpose of assessing the likelihood of Respondent’s future compliance with the CSA.” 76 Fed. Reg. at 44368 n.27 (citing Wonderyears, Inc., 74 Fed. Reg. 457, 458 n.2 (2009) (stating unlawful conduct related to non-controlled drugs is relevant in determining whether the respondent can be trusted to comply with the CSA)). Although a violation of the FDCA adjudicated in another forum could be analyzed under Factor Five to evaluate the Respondent’s likelihood of following the CSA, the Government has not advanced any such theory in this case. In fact, the Government’s only Factor Five allegation is that the Respondent’s business consisted almost exclusively of dispensing controlled substances to patients presenting numerous red flags. Gov’t PHB, at 39- 40. Because the Government has not argued that the Respondent’s compounding should be assessed under the FDCA in a Factor Five analysis, I will not consider whether the Respondent violated or complied with the FDCA under Factor Five. David W. Bailey, M.D., 81 Fed. Reg. 6045, 6046 n.2 (2016) (stating no findings may be made under Factor Five unless the Government specifically advances a theory under that factor).
108
exempt from satisfying the FDA’s “new drug” approval process. It does not mean that the Respondent is exempt from the CSA’s definition of manufacturer.
The same is true with respect to Florida law. Although the Respondent’s practice of anticipatory compounding may have been permissible under Florida law, that fact alone does not automatically render the practice in accord with the CSA’s definitions. While I agree with the Respondent that part of the CSA’s manufacturing exemption includes “conformity with applicable State or local law,” the CSA also requires that compounding be done “as an incident to . . . dispensing” in order to be exempt from the definition of manufacturer. 21 U.S.C. § 802(15). And as already shown, anticipatory compounding is inconsistent with the phrase “as an incident to . . . dispensing.” Id. It is also inconsistent with the Agency’s view of permissible compounding articulated in Wedgewood. 71 Fed. Reg. at 16595.
JOHN CONYERS
The Respondent’s post-hearing arguments address neither Wedgewood nor the “incident to” language in the CSA’s definition of manufacture. The Respondent’s primary argument is that both Florida law and the FDCA allow anticipatory compounding, and that “the evidence appears to suggest that the Respondent engaged in permissible anticipatory compounding in compliance with applicable federal and state law.” Resp’t PHB, at 41. I reject the Respondent’s argument that it can seek refuge under Florida’s anticipatory compounding allowance for three reasons. First, I recognize that consistent with Gonzales v. Oregon, the Agency typically looks to the standards of practice in the registrant’s state of registration as the appropriate benchmark against which to evaluate the registrant’s conduct. See 546 U.S. 243, 270 (2006) (noting the CSA “manifests no intent to regulate the practice of medicine generally” and that the CSA rests “upon a functioning medical profession regulated under the States’ police powers”); Joseph Gaudio, M.D., 74 Fed. Reg. 10083, 10090 (2009) (explaining the DEA looks to state standards to evaluate whether a bonafide doctor-patient relationship was formed).
109
Deference to state standards of medicine is based, in part, on the Supreme Court’s finding that the CSA “conveys unwillingness to cede medical judgments to an executive official,” such as the U.S. Attorney General, “who lacks medical expertise.” Oregon, 546 U.S. at 266. Deciding to limit compounding to an activity dependent on dispensing, as the CSA does, is not, however, a medical judgment that requires medical expertise, in the same way that determining proper medical treatment is a medical judgment requiring medical expertise. Defining what is and is not manufacturing is wholly different than interfering with a state’s police power to regulate the practice of medicine.
Second, while compounding is generally a matter left to state regulators, drug manufacturing remains subject to federal authority. Prof. & Pat. For Customized Care, 56 F.3d at 593. Accordingly, the CSA views anticipatory compounding as a form of manufacturing. And while registrants are obligated to follow state law, they are also obligated to follow the CSA, which includes its registration requirements. Nothing in the Florida law cited by the Respondent exempts the Respondent from the CSA’s requirement to obtain appropriate DEA registration before engaging in certain regulated activities as the CSA defines them. And as already discussed, the CSA considers compounding (even if conducted in compliance with state law) to be manufacturing unless it is an incident to dispensing.
Third, federal law typically trumps state law. “The Supremacy Clause unambiguously provides that if there is any conflict between federal and state law, federal law shall prevail.” Gonzalez v. Raich, 545 U.S. 1, 29 (2005). I view the conflict here as analogous to the conflict between state and federal regulation of marijuana. While many states have relaxed their restrictions around the cultivation, use, and sale of marijuana, that drug remains a schedule I controlled substance under the CSA. While Florida law may permit anticipatory compounding, that conduct meets the definition of manufacturing under the CSA, and therefore, triggers federal
110
obligations on top of state obligations, such as obtaining the proper federal registration.
The Respondent also argues that the evidence fails to show that the Respondent sold any of the drugs it compounded to a distributor or reseller, “as would be expected in the case of a traditional drug manufacturer.” Id. The CSA’s definition of manufacture, however, does not depend on to whom the drugs are sold after being created. 21 U.S.C. § 802(15). The CSA’s definition of manufacture focuses on how the drug is created, not the manufacturer’s business model for selling it. Id. Consequently, the Respondent can still be held accountable for manufacturing controlled substances without the proper registration regardless of the fact that it sold its compounded drugs directly to patients rather than to distributors or wholesalers.
This brings us to the evidence of record. The clearest evidence that the Respondent manufactured, rather than compounded for individual patients, comes from the closing inventory conducted by DI Albert and Mr. Clement, Sr., in September 2018. Tr. 52, 54, 56, 165-66; GX 7. The closing inventory documented the number of controlled substances the Respondent had on hand at the time. Id. DI Albert observed Mr. Clement, Sr., conduct the inventory and Mr. Clement, Sr., signed off on it. Tr. 56, 166.
The closing inventory shows that on September 10, 2018, the Respondent had 3,546 compounded capsules of hydromorphone 8 mg on hand and 574 compounded capsules of oxycodone 30 mg on hand. GX 7, p. 1. These capsules were sitting in a safe when they were counted. Tr. 56. Several thousand capsules sitting in a safe is not consistent with compounding for an individual patient’s therapeutic needs as an incident to dispensing. It is consistent with manufacturing capsules in bulk and storing them until a prescription is presented.
The Respondent argues that no evidence of record proves that it “produced significantly large quantities of any drug.” Resp’t PHB, at 41. Whether the 4,120
111
capsules stored in the Respondent’s safe on September 10, 2018, constitutes a “significantly large” quantity is beside the point. Whether the Respondent produced a large or small amount of compounded capsules, however, is relative, and my finding on this allegation has nothing to do with the amount of capsules produced. In fact, the Agency has instructed that “volume alone does not show that [a registrant’s] activity is manufacturing rather than compounding.” Wedgewood, 71 Fed. Reg. at 16597. While volume can be one relevant factor to consider,48 the distinguishing factor is whether the pharmacy compounded “on an individual patient basis” as an adjunct to dispensing. Id. at 16594-95, 16597. And as already noted, storing over four thousand compounded capsules in a safe is not consistent with compounding “on an individual patient basis” as an adjunct to dispensing. Id. It is, in effect, manufacturing.
THE TRIUMPHOF APARTHIED APARTHIED MUSEUM JOHANNESBURG
This is especially true when the Respondent typically filled only two to four prescriptions per day. Tr. 508. The rough math shows that four thousand compounded capsules could be enough for two weeks of dispensing. Considering that a month’s supply of oxycodone would be roughly 112 tablets (GX 18, p. 6) and a month’s supply of hydromorphone would be roughly 120 tablets (GX 44, p. 6), the Respondent had enough oxycodone capsules on hand to fill approximately 5 prescriptions and enough hydromorphone capsules on hand to fill about 29 prescriptions. Together, this would approximate the number of prescriptions the Respondent typically saw over the course of two
THE SPIRIT OF NELSON R. MANDELA THE MADIBA, GAZES DOWN UPON THIS TRIBUNAL AND GIVES ME THE POWER AND THE STRENGTH TO FIGHT ON AGAINST THIS INJUSTICE.
weeks. This lends further support to my conclusion that the amount of compounded capsules the Respondent had on
BASED ON DR. DON SULLIVAN THE DEA ARGUED
48 Based on Dr.Sullivan’testimony,theGovernmentarguedthat“theextremevolumeofRespondent’scompounding indicated that it was not being done in response to the individualized patient needs.” Gov’t PHB, at 47. Compounding only 30 capsules would still be manufacturing if not done for an individual patient. Four thousand capsules, however, raises far more suspicions than 30 would. Thus, I have considered the amount of compounded capsules, and I find that it further supports my conclusion that the Respondent was manufacturing rather than compounding on a patient-by-patient basis. Per Wedgewood, however, the volume of compounding alone is not outcome determinative. 71 Fed. Reg. at 16597.
112
hand on September 10, 2018, is not consistent with compounding for individual patients as an incident to dispensing. Rather, it is consistent with manufacturing.
In addition to the closing inventory, the Government also points to statements made by Mr. Clement, Sr., in 2012. Gov’t PHB, at 46. In May 2012, during execution of an administrative inspection warrant (AIW) at the Respondent pharmacy, TFO Shearer interviewed Mr. Clement, Sr., the Respondent’s owner. Tr. 183. Mr. Clement, Sr., was not in custody at the time and was free to leave. Id. In the interview, Mr.Clement, Sr., told TFO Shearer about his process for manufacturing oxycodone and hydromorphone in capsules. Tr.183-84. Mr. Clement, Sr., told TFO Shearer that he could buy a 100 gram bottle of oxycodone powder for $1,100, enough to manufacture about 6,000 dosage units. Tr. 185. Tablets of oxycodone purchased from commercial distributors cost roughly $2-$10 per pill. Id. In other words, $1,100 worth of powder could produce at least $12,000 worth of dosage units. Mr. Clement, Sr., told TFO Shearer that he manufactured thousands of capsules per batch because it was cost effective. Tr. 184- 85. The batch records that TFO Shearer reviewed in 2012 documented that Mr. Clement, Sr., produced thousands of pills in each batch. Id. Mr. Clement, Sr., also told TFO Shearer that he persuaded patients to take capsules even if they did not want them because capsules have the same effect as tablets.49 Tr. 185-86.
Although these statements were made in 2012, they demonstrate that the Respondent had a system in place to compound thousands of capsules at a time. Tr. 184-85. These statements also demonstrate that the Respondent’s motive for mass-compounding thousands of capsules per batch was cost effectiveness, rather than patients’ unique therapeutic needs. Tr. 184-86. These statements provide
49 While reliable hearsay statements may be admissible in these administrative proceedings, Mr. Clement, Sr.’s, statements to TFO Shearer in 2012 are not hearsay. They enjoy enhanced credibility as they would qualify as statements by a party opponent and would, therefore, be excluded from the definition of hearsay. Fed. R. Evid. 801(d)(2).
113
additional support to the conclusion that the Respondent’s compounding was cost- driven rather than patient-driven, and that the Respondent was, therefore, manufacturing and not compounding as the CSA understands those terms.
The Government also points to the batch records obtained pursuant to the 2017 subpoena. Gov’t PHB, at 46; Tr. 27. A batch record documents the production of a controlled substance and lists the ingredients in the controlled substance. Tr. 33. The batch record is created by the person who makes the substance. Id. The batch records indicate how many capsules were used in the production of each batch. Tr. 38, 40-41. The batch records in Government Exhibit 5 document the production of hydromorphone 8 mg. The batch records in Government Exhibit 6 document the production of oxycodone 30 mg. The hydromorphone batch records show that the Respondent “compounded” from 600 to 2,400 capsules per batch, with 1,200 capsules being the most frequently occurring quantity. See generally GX 5. The oxycodone batch records show that the Respondent “compounded” from 600 to 1,800 capsules per batch, with 1,200 capsules being the most frequently occurring quantity. See generally GX 6. These numbers are consistent with the number of compounded capsules found during the 2018 closing inventory and with Mr. Clement, Sr.’s, statements to TFO Shearer in 2012. These numbers are also consistent with manufacturing rather than compounding on an individualized patient basis.
APARTHIED MUSEUM JOHANNESBURG
Furthermore, the Respondent’s dispensing records also demonstrate that the patients for whom the Respondent compounded oxycodone and hydromorphone did not have valid therapeutic needs for compounded medication. Dr. Sullivan explained that compounding is only done when necessary “to meet the individual, unique therapeutic needs of a patient.” Tr. 231. Compounding would be necessary, he continued, if the patient had an allergy to the commercially available version or if the patient needed a unique dose or strength that was not available in the mass-
114
produced product. Tr. 230-31. Dr. Sullivan’s testimony on this topic is consistent with case law. As already noted, the Fifth Circuit described compounding as a process designed “to create a medication to meet the unique needs of an individual . . . patient.” Mukasey, 536 F.3d at 387. The Fifth Circuit further noted that compounding is necessary to create “patient-specific medication.” Id. The Supreme Court has observed that one reason why a pharmacist would need to compound patient-specific medication is if the patient is allergic to an ingredient in the commercially manufactured drug. Thompson, 535 U.S. at 361. Other reasons, the Fifth Circuit has also recognized, include “diluted doses for children and altered forms of medications for easier consumption.” Prof. & Pat. For Customized Care, 56 F.3d at 593.
REBECA “I’M PROFILED BY MOST PHARMACIES”
Dispensing records, however, show that the Respondent dispensed both commercially manufactured tablets and compounded capsules to the same patient. The fact that the Respondent dispensed both commercially available tablets and compounded capsules of the same controlled substances to the same patients indicates that the patients lacked “unique therapeutic needs” for the compounded version. Tr. 231, 256. For example, the Respondent dispensed seven prescriptions of oxycodone 30 mg tablets to patient A.G. from June 2017 to August 2018. ALJ Ex. 42, p. 11. During that same time period, the Respondent also dispensed to A.G. three prescriptions of oxycodone 30 mg compounded capsules. Id. A note dated March 13, 2017, in A.G.’s profile states that a doctor approved dispensing medication to A.G. in compounded capsules. GX 15, p. 1; ALJ Ex. 42, p. 13. After March 2017, however, the Respondent continued dispensing both tablets and compounded capsules to A.G. ALJ Ex. 42, p. 11. Thus, even if a doctor approved of A.G. taking compounded capsules, it was not for a therapeutic or medical reason since he continued to alternate between capsules and tablets.
115
In another example, the Respondent dispensed both tablets and compounded capsules to patient R.G. to fill the same oxycodone prescription. GX 49; Tr. 325- 26. Dr. Sullivan opined that R.G. clearly had no valid therapeutic need for compounded capsules since he also took the tablet form of the same drug. Tr. 326. Patient R.G. also received oxycodone in capsules on 15 occasions from June 2017 to September 2018, and in tablets on 2 occasions during the same time period. ALJ Ex. 42, p. 45. As Dr. Sullivan observed, the fact that the Respondent dispensed oxycodone to R.G. in both capsule and tablet forms, and dispensed capsules and tablets together on one occasion, demonstrates that the Respondent was not compounding for R.G. in response to a unique therapeutic need for compounded capsules. Tr. 325-26. Furthermore, no profile for any of the patients documents an allergy that would have necessitated compounded capsules. Tr. 339; GX 15, 20, 23, 26, 29, 32, 35, 38, 41, 47, 51.
GO BLUE
DR. DON SULLIVAN “PATIENTS LACKED LEGITIMATE THERAPEUTIC JUSTIFICATION“
Dr. Sullivan pointed out numerous other instances where the Respondent’s dispensing history demonstrated that patients lacked legitimate therapeutic justification for compounded capsules.
DR. DON SULLIVAN “LACKING LEGITAMATE JUSTIFICATION”
From January 2018 to December 2018, the Respondent dispensed compounded capsules of hydromorphone 8 mg to A.H. on eight occasions: January 4; February 15; March 5; April 3; May 2; August 16; September 11; and December 5. ALJ Ex. 42, pp. 15-16; GX 19; GX 21. The Respondent then dispensed tablets of hydromorphone 8 mg to A.H. on the following five occasions in 2019: January 22; February 15; February 27; March 14; and April 18. Id. The fact that the Respondent dispensed capsules of hydromorphone to A.H. on eight occasions in 2018 and then tablets of hydromorphone on five occasions in 2019 demonstrates that A.H. had no unique therapeutic justification that required the Respondent to compound hydromorphone capsules for him. Tr. 255- 56, 258-59, 269.
116
I NEED A KNEE REPLACEMENT I’M IN CONSTANT PAIN
Dr. Sullivan noted a lack of therapeutic justification to compound hydromorphone for B.S. since he received hydromorphone in both tablets and capsules. Tr. 274. From August 2017 to August 2018, the Respondent filled 12 hydromorphone prescriptions with compounded capsules for B.S.: August 22, 2017; September 27, 2017; October 18, 2017; November 15, 2017; December 12, 2017; January 4, 2018; January 29, 2018; February 28, 2018; March 26, 2018; April 23, 2018; May 22, 2018; and August 24, 2018. ALJ Ex. 42, p. 19; GX 24. On February 5, 2019, the Respondent filled a hydromorphone prescription for B.S. with tablets. ALJ Ex. 42, p. 20; GX 22. The fact that the Respondent dispensed hydromorphone tablets to B.S. in 2019 shows that B.S. had no unique therapeutic justification that required the Respondent to compound hydromorphone capsules for him on 12 occasions in 2017 and 2018. Tr. 255-56, 258-59, 269, 274.
DR. DONALD SULLIVAN OF THE OHIO STATE UNIVERSITY “NOTED A LACK OF THERAPEUTIC JUSTIFICATION”
The Respondent dispensed oxycodone capsules and tablets to C.R., indicating that there was no valid therapeutic reason for the Respondent to compound oxycodone capsules for her. Tr. 255-56, 258-59, 269, 274, 279-80. On July 19, 2017, and October 26, 2017, the Respondent filled oxycodone prescriptions for C.R. with compounded capsules. ALJ Ex. 42, p. 23; GX 27. The Respondent then filled four oxycodone prescriptions for C.R. with tablets: March 6, 2018; April 19, 2018; July 12, 2018; and August 28, 2018. Id.
DEA”S DR. DON SULLIVAN “NO VALID THERAPEUTIC NEED”
Dr. Sullivan observed that J.M. alternated between tablets and capsules of oxycodone, demonstrating that there was no valid therapeutic need for the Respondent to compound oxycodone capsules for her. Tr. 290. First, the Respondent dispensed oxycodone tablets to J.M. on January 25, 2018, and then filled J.M.’s next oxycodone prescription with compounded capsules on March 1, 2018. ALJ Ex. 42, p. 30; GX 33; Tr. 290. The next month the Respondent switched back to oxycodone tablets on April 4, 2018, followed by oxycodone capsules on April 19, 2018, and then switched back again to tablets on May 16, 2018. Id. The fact that
FLYOD WILLIAMS IM TOO DARK AND MY TEETH TOO SHINY
117
the Respondent alternated between dispensing oxycodone tablets and capsules to J.M. demonstrates that there was no valid therapeutic reason for the Respondent to compound oxycodone capsules for her. Tr. 255-56, 258-59, 269, 274, 279-80, 290.
DR SULLIVAN “OBSERVED”
Dr. Sullivan observed that the Respondent dispensed oxycodone tablets and compounded capsules to M.M. Tr. 295, 297. From June 2017 to August 2018, the Respondent filled 14 oxycodone prescriptions for M.M. with compounded capsules. Tr. 295, 297; ALJ Ex. 42, pp. 33-34; GX 34; GX 36. From January 2019 to April 2019, the Respondent filled five oxycodone prescriptions for M.M. with tablets. Id. The fact that the Respondent dispensed compounded oxycodone capsules to M.M. for over a year and then switched to dispensing oxycodone tablets to her for several months demonstrates that there was no valid medical reason for the Respondent to have compounded oxycodone for her. Tr. 255-56, 258-59, 269, 274, 279-80, 290, 295, 297.
DR. SULLIVAN “WITHOUT ANY THERAPEUTIC JUSTIFICATION”
Dr. Sullivan observed that the Respondent compounded hydromorphone capsules for N.B. without any apparent therapeutic justification. Tr. 302. From June 2017 to August 2018, the Respondent filled twelve hydromorphone prescriptions for N.B. with compounded capsules. ALJ Ex. 42, p. 37; GX 39.
UNTIL IT IS DONE
Dr. Sullivan pointed out that the Respondent compounded hydromorphone capsules for R.B. without any apparent medical justification. Tr. 311, 319-20. From June 2017 to January 2019, the Respondent filled 14 hydromorphone prescriptions for R.B. with compounded capsules. GX 40; GX 43; ALJ Ex. 42, pp. 41-42. At least three of those prescriptions were originally written for tablets and were substituted for capsules by the Respondent. Tr. 319-20; GX 44, pp. 6-7. The Respondent then dispensed hydromorphone tablets to R.B. on three occasions from February to April 2019. ALJ Ex. 42, p. 42; GX 40. The fact that the Respondent dispensed tablets and capsules of hydromorphone to R.B., switching prescribed
I AM DENTIST SO I SHOULD KNOW SOMETHING ABOUT PAIN “BUT IN THE COURTROOM YOU CAN’T WIN AGAINST PRIVILEGE”
118
tablets to capsules, demonstrates that there was no valid therapeutic reason for the Respondent to compound hydromorphone for R.B. Tr. 311, 319-21.
DR DONALD SULLIVAN “EVIDENCE PAINTS A PICTURE OF MASS- COMPOUNDING BULK QUANTITIES OF OXYCODONE AND HYDROMORPHONE”
Lastly, Dr. Sullivan noted that the Respondent compounded capsules of hydromorphone for R.L. without any apparent medical justification. Tr. 331; ALJ Ex. 42, p. 49; GX 52. From June 2017 to September 2018, the Respondent filled 14 hydromorphone prescriptions for R.L. with compounded capsules. Id.
In sum, the evidence paints a picture of a pharmacy mass-compounding bulk quantities of oxycodone and hydromorphone in thousands of capsules per batch. The evidence further reveals the Respondent’s motive for doing so: profit rather than patient need.
MANDIBULAR MXYOMA “WHAT I SEE AS A DENTIST” THIS IS FROM DENTAL TRAINING” WE TREAT THOSE WHO ARE AFFLICTED WITH DIGNITY AND RESPECT
The evidence shows that the Respondent’s “compounding” was not incidental to the act of dispensing. Because the Respondent’s “compounding” was not conducted “on an individual patient basis” after having received a prescription, it is not exempt from the CSA’s definition of “manufacture.” Wedgewood, 71 Fed. Reg. at 16595. This is true regardless of whether the Respondent complied with Florida law and the FDCA, since it must also comply with the CSA’s registration requirements. Thus, the Respondent engaged in manufacturing thousands of controlled substance dosages over a period of several years without the proper registration. For these reasons, the Government’s allegation that the Respondent illegally manufactured controlled substances is SUSTAINED. ALJ Ex. 1, pp. 8-10, ¶ 20-28.
REBECA “WALK AT DAY IN MY SHOES”
Government’s Burden of Proof and Establishment of a Prima Facie Case Based upon my review of each of the allegations by the Government, it is necessary to determine if it has met its prima facie burden of proving the requirements for a sanction pursuant to 21 U.S.C. § 824(a). At the outset, I find that the Government has demonstrated and met its burden of proof in support of revocation through its case that the Respondent has failed to resolve red flags of
119
diversion and to document the resolution of red flags of diversion in accordance with Florida law and the usual course of professional practice in Florida. Furthermore, the Government has additionally demonstrated that the Respondent unlawfully manufactured controlled substances without the proper registration. Inasmuch as the Government has established by a preponderance of the evidence that the Respondent violated state and federal laws relating to controlled substances on numerous occasions and committed such other conduct which may threaten the public health and safety, it has met its prima facie burden of proving that the requirements for a sanction pursuant to 21 U.S.C. § 824(a) are satisfied.
PATIENT APPEARS NORMAL BUT STATES HE WAS SHOT 9 TIMES
PUBLIC INTEREST DETERMINATION: THE STANDARD Pursuant to 21 U.S.C. § 823(f) (2006 & Supp. III 2010), the Acting Administrator50 may revoke a DEA Certificate of Registration if persuaded that
maintaining such registration would be inconsistent with the public interest. Evaluation of the following factors have been mandated by Congress in determining whether maintaining such registration would be inconsistent with “the public interest”:
(1)The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2)The [registrant’s] experience in dispensing, or conducting research with respect to controlled substances.
(3)The [registrant’s] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety. 21 U.S.C. § 823(f).
“These factors are . . . considered in the disjunctive.” Robert A. Leslie, M.D.,
50 This authority has been delegated pursuant to 28 C.F.R. §§ 0.100(b) and 0.104 (2008). 120
68 Fed. Reg. 15227, 15230 (2003). Any one or a combination of factors may be relied upon, and when exercising authority as an impartial adjudicator, the Agency may properly give each factor whatever weight it deems appropriate in determining whether a registrant’s registration should be revoked. Id. (citation omitted); David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 16422, 16424 (1989). Moreover, the Agency is “not required to make findings as to all of the factors,” Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall, 412 F.3d at 173, and is not required to discuss consideration of each factor in equal detail, or even every factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988) (holding that the Administrator’s obligation to explain the decision rationale may be satisfied even if only minimal consideration is given to the relevant factors, and that remand is required only when it is unclear whether the relevant factors were considered at all). The balancing of the public interest factors “is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest.”Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 462 (2009).
GUN SHOT WOUND
Factors Two and Four: Experience in Dispensing, and Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances
The Government seeks the revocation of the Respondent’s COR based primarily on conduct most appropriately considered under Public Interest Factors Two and Four.51 The Government has also raised one allegation under Factor Five.
51 21 U.S.C. § 823(f)(2), (4). There is nothing in the record to suggest that a state licensing board made any recommendation regarding the disposition of the Respondent’s DEA COR (Factor One). Likewise, the record contains no evidence that the Respondent has been convicted of (or charged with) a crime related to controlled substances (Factor Three).
121
Factor Two: Experience in Dispensing Controlled Substances
Factor Two requires consideration of the Respondent’s experience in dispensing controlled substances. The plain language of Factor Two dictates that a registrant’s prior experience in the regulated activity must be considered. The Agency has acknowledged that even a considerable level of benign or even commendable experience could be easily outweighed by evidence demonstrating that continued registration was inconsistent with the public interest.52
The Respondent did not offer specific direct evidence, either documentary or testimonial, relating to experience in dispensing. Although the Government has proved misconduct which could be considered under Factor Two and Factor Four, I will only weigh that misconduct under Factor Four to avoid double-counting the same violations under multiple factors.
Factor Four: Compliance with Applicable Federal, State, or Local Laws Relating to Controlled Substances
Evidence is considered under Factor Four when it reflects a respondent’s compliance (or non-compliance) with laws related to controlled substances. Established violations of the CSA, DEA regulations, or other laws regulating controlled substances at the state or local level are cognizable under Factor Four. As DEA has held in the past, a registrant’s “ignorance of the law is no excuse” for actions that are inconsistent with responsibilities attendant upon a registration. Daniel A. Glick, D.D.S., 80 Fed. Reg. 74800, 74809 (2015) (quoting Sigrid Sanchez, M.D., 78 Fed. Reg. 39331, 39336 (2013) (citing Patrick W. Stodola, 74 Fed. Reg. 20727, 20735 (2009) and Hageseth v. Superior Ct., 59 Cal. Rptr. 3d 385, 403 (Ct.
52 See,e.g.,PaulJ.Caragine,Jr.,63Fed.Reg.51592,51560(1998)(“[E]venthoughthepatientsatissueareonlya small portion of Respondent Pharmacy’s patient population, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future.”); Med. Shoppe-Jonesborough, 73 Fed. Reg. at 386 (finding that the misconduct outweighed the fact that only a relatively small portion of the respondent’s patient population was involved).
122
App. 2007) (a “licensed health care provider cannot ‘reasonably claim ignorance’ of state provisions regulating medical practice”))). Under Agency precedent, “[a]ll registrants are charged with knowledge of the CSA, its implementing regulations, as well as applicable state laws and rules.” Id. at 74809 (internal citations omitted). Standard of Care as to Charged Violations
Prescriptions for controlled substances may only be “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). Although “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner . . . a corresponding responsibility rests with the pharmacist who fills the prescription.” Id. This “prohibits[s] a pharmacist from filling a prescription for a controlled substance when she either knows or has reason to know that the prescription was not written for a legitimate medical purpose.” Wheatland Pharm., 78 Fed. Reg. 69441, 69445 (2013) (internal quotations, alterations omitted). This “standard of care refers to that generally recognized and accepted in the medical community rather than a standard unique to the practitioner.” Rene Casanova, M.D., 77 Fed. Reg. 58150, 58161 (2012) (citing Robert L. Dougherty, M.D., 76 Fed. Reg. 16823, 16832 n.11 (2011) (internal citations omitted)). While “state law is a relevant factor in determining whether a practitioner is acting in the ‘usual course of professional practice,’ it is appropriate in the context of an inquiry under federal law to also consider ‘generally recognized and accepted medical practices’ in the United States.” Id. (citing Bienvenido Tan, M.D., 76 Fed. Reg. 17673, 17681 (2011)).
A pharmacy’s standard of care for dispensing controlled substances is governed by federal and state law, as well as standards of practice accepted within the state. “A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice.” 21 C.F.R. § 1306.06. Under Florida law, a pharmacy is required to conduct a prospective drug
123
DEA’S DR. DON SULLIVAN “RELEVANT TO RESOLVING RED FLAGS”
use review before filling or refilling any prescription for controlled substances. Fla. Admin. Code r. 64B16-27.810. Florida law also requires pharmacies to question suspicious prescriptions and to only fill a prescription if the pharmacy can validate the prescription’s medical legitimacy. Fla. Admin. Code r. 64B16-27.831. Florida law also requires pharmacies to maintain a patient record system. Fla. Admin. Code r. 64B16-27.800. Dr. Sullivan explained that under Florida law, pharmacies must document information relevant to resolving red flags in the patient record system. Tr. 209, 453-55, 489. He further noted that a patient record system is synonymous with a patient profile. Tr. 209. The Agency has previously interpreted Florida law as requiring pharmacies to document information in the patient profile that they would need to resolve red flags. Trinity II, 83 Fed. Reg. at 7330. Failure to document information pertinent to red flag resolution in the patient profile would violate Florida law and, therefore, be outside the usual course of professional practice in Florida.
IT LEAVES ME WONDERING
While violations of state law are cognizable under Factor Four, Agency precedent provides that “the mere fact that a violation of a state rule occurs in the context of the dispensing of controlled substances does not necessarily mean that the violation has a sufficient nexus to the CSA’s core purpose of preventing the diversion and abuse of controlled substances.” Fred Samimi, M.D., 79 Fed. Reg. 18698, 18710 (2014). There must be a nexus between the state law that has been violated and the CSA’s purpose of preventing drug abuse and diversion. Id. Therefore, the inquiry is twofold: it must be determined whether the Respondent’s conduct violated the particular state law alleged and whether that state law has a nexus with the CSA’s purpose of preventing drug abuse and diversion. See Judulang v. Holder, 565 U.S. 42 (2011) (actions of a regulatory agency must bear a rational relationship to the purposes of the statute it is charged with enforcing); Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49989 (2010) (holding that in order for a registrant’s
124
“conduct to be actionable, there must be a substantial relationship between the conduct and the CSA’s purposes of preventing drug abuse and diversion, and that the conduct may constitute a threat to public health and safety”); see also Paul Weir Battershell, N.P., 76 Fed. Reg. 44359 n.27 (2011) (to same effect).
JOHN CONYERS
This condition is met here. The Florida laws that the Respondent violated share the CSA’s purpose of combatting the diversion of controlled substances. Similar to DEA regulations, Florida law defines a valid prescription as one “based on a practitioner-patient relationship” and “issued for a legitimate medical purpose.” Compare Fla. Admin. Code r. 64B16-27.831(1)(a), with 21 C.F.R. § 1306.04(a). Furthermore, Florida law places a priority on the medical legitimacy of controlled substance prescriptions. Florida pharmacies are required to confirm the medical legitimacy of a controlled substance prescription before filling it. Fla. Admin. Code r. 64B16-27.831(2)-(3). Florida law even provides steps the pharmacy should take in its process to validate the prescription. Id. If a pharmacy is unable to resolve the concerns raised by a controlled substance prescription, the pharmacy should refuse to fill it. Id. at 64B16-27.831(2)(c). The same regulation also requires Florida pharmacies to report prescribers suspected of diversion to the Florida Department of Health. Id. at 64B16-27.831(4).
Florida law also specifies that before dispensing medication, pharmacies should be on the lookout for signs of clinical abuse or misuse of prescriptions drugs. Fla. Admin. Code r. 64B16-27.810(1)(g). In addition to looking out for signs of abuse, Florida pharmacies are also required to maintain a patient record system for the purpose of documenting information relevant to resolving red flags of diversion or abuse. Id. at 64B16-27.800; Tr. 209, 453-55, 489.
The objectives of these Florida laws are to ensure prescriptions for controlled substances are issued for legitimate medical purposes; to impose on pharmacies a process to confirm the medical legitimacy of controlled substances before dispensing
125
them; to be on guard for evidence that drugs are being abused or misused; and to memorialize findings relevant to red flag investigation in the patient’s records. These objectives demonstrate the same fundamental purpose of the CSA to ensure controlled substances remain within legitimate channels.
The Government has also raised allegations involving a pharmacy’s corresponding responsibility under 21 C.F.R. § 1306.04(a). The DEA has consistently interpreted a pharmacist’s corresponding responsibility “as prohibiting a pharmacist from filling a prescription for a controlled substance when he either ‘knows or has reason to know that the prescription was not written for a legitimate medical purpose.’” Medicine Shoppe—Jonesborough, 73 Fed. Reg. 364, 381 (2008) (quoting Medic-Aid Pharmacy, 55 Fed. Reg. 30043, 30044 (1990)). In short, a pharmacist has a “corresponding responsibility under Federal law” to dispense only lawful prescriptions. Liddy’s Pharmacy, L.L.C., 76 Fed. Reg. 48887, 48895 (2011) (citation omitted). The regulation does not require the pharmacist to practice medicine, but instead, imposes a responsibility upon the pharmacist “not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows [or has reason to know] that the issuing practitioner issued it outside the scope of medical practice.” E. Main St. Pharmacy, 75 Fed. Reg. 66149, 66157 (2010) (quoting United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979)).
MR. GREEN WAS SHOT EIGHT TIMES IN 2 ATTEMPTED ROBBERIES ON HIM
Providing further guidance concerning a pharmacist’s corresponding responsibility the DEA has held:
[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a “reasonable professional,” there is a duty to “question the prescription[].” Ralph J. Bertolino, d/b/a/Ralph J. Bertolino Pharmacy, 55 Fed. Reg. 4729, 4730 (1990). Though initially framed as a “reasonable professional” standard, the Agency has considered the duty to discharge the corresponding responsibility by evaluating the circumstances in light of what would
126
be considered suspicious by a “reasonable pharmacist.” East Main Street Pharmacy, 75 Fed. Reg. 66149, 66165; see also Winn’s Pharmacy, 56 Fed. Reg. 52559, 52561 (1991). Accordingly, a pharmacist or pharmacy may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid. Id. Because Agency precedent limits the corresponding responsibility to circumstances which are known or should have been known,
DIAGNOSIS AND PAYMENT METHOD IS GENERALLY LISTED ON MOST PRESCRIPTIONS
Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24523, 24530 (2011), it follows that, to show a violation of a corresponding responsibility, the Government must establish that: (1) the Respondent dispensed a controlled substance; (2) a red flag was or should have been recognized at or before the time the controlled substance was dispensed; and (3) the question created by the red flag was not resolved conclusively prior to the dispensing of the controlled substance. See Sun & Lake Pharmacy, 76 Fed. Reg. at 24532 (Finding that pharmacy violated corresponding responsibility where it took no steps to resolve red flags prior to dispensing controlled substances.). The steps necessary to resolve the red flag conclusively will perforce be influenced by the nature of the circumstances giving rise to the red flag.
Further, to establish a violation of a pharmacist’s corresponding responsibility, the Government must establish the requisite degree of scienter. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49835 (2016) (citing JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 Fed. Reg. 28667, 28669 (2015)). To establish scienter, the Government can show that a pharmacist violated his or her “corresponding responsibility” by filling a prescription while knowing that it lacked a legitimate medical purpose. Hills Pharmacy, L.L.C., 81 Fed. Reg. at 49835. In the case before me, however, the Government presented no evidence that one of the Respondent’s pharmacists filled a prescription with actual knowledge that the prescription was not legitimate. Absent actual knowledge, the Government can
I CAN’T GET MY MEDICATIONS FILLED
127
establish scienter by showing that a pharmacist was “willfully blind (or deliberately ignorant) to the fact that the prescription lacked a legitimate medical purpose.” Id. To establish willful blindness, it is necessary to show that a pharmacist subjectively believed that there was a high probability that the prescription lacked a legitimate medical purpose and that the pharmacist deliberately avoided learning the truth. Id. Here, the Government argues that the Respondent’s failure to document the resolution of numerous red flags when it filled many prescriptions establishes that the Respondent was willfully blind as to the medical legitimacy of those prescriptions. Gov’t PHB, pp. 34-35.
MY SON AARON JONES JR WAS MURDERED BY A DRUNK DRIVER AND THERE HAS BEEN NO JUSTICE
The Government has introduced a preponderance of evidence to prove that the Respondent dispensed numerous controlled substance prescriptions for at least eleven patients. Those prescriptions raised classic red flags of drug abuse and/or diversion, to include early fills, travelling long distances, paying in cash, dangerous drug cocktails, and highest strength of the medication, among others. The Government also introduced the patient profiles for each of these eleven patients, as well as twelve hardcopy prescriptions for two of the patients. The profiles contain insufficient information, and in some cases no information, that would have enabled the Respondent to sufficiently resolve the suspicion raised by the prescriptions.
GUN SHOT WOUND DECOROYO WILLIAMS
The evidence reveals a concerning pattern of a pharmacy that repeatedly ignored its state-mandated obligation to document information needed to resolve red flags in a patient record system. This concerning pattern demonstrates that regardless of the obvious signs of drug abuse and diversion that are well-known to the pharmacy community, and firmly-established in DEA precedent, the Respondent repeatedly dispensed controlled substances and rarely, if ever, documented any information in response to those red flags in the patient record. And when the Respondent documented information, it was always insufficient to resolve all the concerns raised by the prescription.
128
With respect to the twelve prescriptions in evidence, the Government has further demonstrated a violation of the Respondent’s corresponding responsibility under 21 C.F.R. § 1306.04(a). While I declined to sustain the Government’s allegation that the Respondent violated its corresponding responsibility with respect to prescriptions not in evidence, the other sustained violations are more than enough for the Government to establish its prima facie burden justifying sanction. The Government has proven this violation through documentary evidence and testimony from its expert witness.
Furthermore, the Respondent failed to rebut or discredit the Government’s case. The Respondent did not introduce any documentary evidence and it only offered the testimony of a single witness, who failed to convincingly rebut the Government’s evidence. In light of the record as to this factor, I find that the Government has overwhelmingly proven that the Respondent failed to comply with federal and state law with respect to resolving and documenting resolution of red flags of drug abuse and/or diversion, and with respect to its corresponding responsibility for the prescriptions in evidence.
Furthermore, I find that the Government has sponsored a preponderance of evidence to show that the Respondent engaged in unlawful manufacturing of controlled substances without the proper DEA registration, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). Thus, the Government has introduced evidence against the Respondent with respect to two aspects of the controlled drug supply chain, dispensing and manufacturing. The totality of this evidence demonstrates a concerning lack of compliance with applicable federal and state law that poses a significant risk of diversion and threatens public health and safety. This evidence further demonstrates a lack of commitment on the Respondent’s part with respect to its federal and state controlled substance obligations. Therefore, I find that this factor significantly favors revoking the Respondent’s registration.
129
Factor Five: Such Other Conduct Which May Threaten the Public Health and Safety
The Government argues that in addition to weighing the misconduct committed on a patient-by-patient basis, the Tribunal should also consider that the “Respondent’s business consisted almost entirely of dispensing controlled substances to customers who exhibited one or more significant red flags.” Gov’t PHB, p. 39 (emphasis in original). To support this allegation, the Government contends that nearly all of the Respondent’s customers paid cash and nearly all of them lived over 100 miles from the pharmacy. Id., pp. 39-40. The Government adds that controlled substances, specifically schedule II narcotics, constituted a grossly disproportionate percentage of the Respondent’s overall dispensing. Id., p. 40. Thus, the Government urges that in addition to the “specific violations relating to specific patients” under Factors Two and Four, it is appropriate to “consider the pervasiveness of Respondent’s misconduct” under Factor Five. Id., p. 39. This is the only misconduct the Government has alleged under Factor Five.
DEA’S DR DON SULLIVAN “PROOF POSITIVE”
As I announced at the hearing, however, I will not sustain any allegations based solely on statistical grounds.53 Tr. 18, 218. Although Dr. Sullivan suggested that the high number of patients provided compounded medication alone was proof positive that the subject compounding could not have been legitimate, Tr. 336-37, I don’t accept that the law of averages alone may sustain the Government’s burden of proving Respondent’s subject alleged failures. Even if the Respondent’s business consisted entirely of dispensing controlled substances to cash-paying patients who
53 Due Process notice concerns may be implicated in allegations of “guilt” by statistical analysis. The essential requirements of due process “are notice and an opportunity to respond” before a person is deprived of a protectable property interest. Cleveland Bd. of Educ. v. Loudermill, 470 U.S. 532, 542, 546 (1985). Where a single misfeasance can justify sanction, does the allegation on the basis of a statistical overview provide the respondent with sufficient notice of charges in which to defend? See Pope v. U.S. Postal Service, 114 F.3d 1144, 1148-49 (1997) (concluding an employee’s due process right to notice was not violated where, among other things, “the administrative judge required the Postal Service to break down the charges into multiple specifications, each directed to a specific act of misconduct, which helped alleviate due process notice concerns”).
130
lived over 100 miles from the pharmacy, that fact alone would only be grounds for sanction if the Government proved Respondent violated its corresponding responsibility or dispensed controlled substances outside the usual course of professional practice by failing to resolve and document red flags. This Tribunal believes these evaluations must necessarily be individualized to specific prescriptions. Statistical analysis may be an important tool in focusing attention on particular practitioners warranting further investigation, and it may be evidence in support of an ultimate conclusion that an individual prescription was improperly compounded or dispensed, but it does not, in itself, constitute proof positive of any violations.54 Accordingly, this Tribunal is not convinced that evidence of statistical probability constitutes proof positive of actionable misconduct, even under the catch-all provision of Factor Five.
In the alternative, the Government has introduced evidence pertaining to eleven patients, sustaining its burden with respect to those patients by focusing on each dispensing event individually. That evidence has been evaluated under Factor Four. For these reasons, I decline to consider any conduct under Factor Five.
Acceptance of Responsibility
With the Government’s prima facie burden having been met as to violations of the corresponding responsibility under 21 C.F.R. § 1306.04(a) with respect to twelve prescriptions; dispensing controlled substances outside the usual course of professional practice in violation of 21 C.F.R. § 1306.06 for failing to document red flag resolution in compliance with state law; and unlawfully manufacturing controlled substances without the proper DEA registration in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e), an unequivocal acceptance of responsibility
54 What would such a finding look like, “on average, the evidence proves that the Respondent must have prescribed at least a single compounded medication improperly”?
131
stands as a condition precedent for the Respondent to prevail. George Mathew, M.D., 75 Fed. Reg. 66138, 66148 (2010).
This feature of the Agency’s interpretation of its discretionary authority under the CSA has been sustained on review. MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 2011). Accordingly, the Respondent must present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility incumbent with such registration. Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (2008); Samuel S. Jackson, 72 Fed. Reg. 23848, 23853 (2007). As past performance is the best predictor of future performance, DEA has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for its actions and demonstrate that it will not engage in future misconduct. ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995); Medicine Shoppe, 73 Fed. Reg. at 387; see also Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) (reasoning that “admitting fault” is “properly consider[ed]” by DEA to be an “important factor[]” in the public interest determination). Likewise, in making the public interest determination, “this Agency places great weight on a registrant’s candor, both during an investigation and in [a] subsequent proceeding.” Robert F. Hunt, 75 Fed. Reg. 49995, 50004 (2010); Hoxie, 419 F.3d at 483.
Although correcting improper behavior and practices is very important to establish acceptance of responsibility, conceding wrongdoing is critical to reestablishing trust with the Agency. Holiday CVS, L.L.C., 77 Fed. Reg. 62316, 62346 (2012); Daniel A. Glick, D.D.S., 80 Fed. Reg. 74800, 74801 (2015).
DECROYO GREEN WAS SHOT IN A CARJACKING AND A ROBBERY HAS DIFFICULTY GET HIS PAIN MEDICATIONS
The Respondent has not unequivocally accepted responsibility for the proven violations. In fact, the Respondent has not tendered any acceptance of responsibility at all, whether equivocal or unequivocal. The Respondent’s owner and pharmacist-in-charge never testified at the hearing in order to accept responsibility. Instead, the Respondent’s sole witness, a pharmacy tech, never admitted that the Respondent. (SEE: CLICK ON BELOW VIDEO)
committed any wrongdoing. The Respondent’s post-hearing brief is silent on this issue. Resp’t PHB, p. 29, ¶ (i); p. 32, ¶ (ii); p. 36, ¶ (iii).
The Respondent took the similar approach in its opening statement, arguing that the Government has failed to satisfy its burden; accusing the DEA of never intending to clearly or objectively evaluate the evidence; attacking the credentials of the Government’s expert; claiming that the Respondent exercised appropriate judgment when dispensing the relevant controlled substance prescriptions in compliance with Florida law; and complaining about the so-called “ivory tower aspirational” standard the DEA is imposing on its conduct. Tr. 503-05. In other words, the message from the Respondent’s post-hearing brief and its opening statement is that it has done nothing wrong. These sentiments are inconsistent with a registrant that is remorseful for misconduct and determined to regain the Agency’s trust. By failing to accept responsibility, the Respondent has failed to overcome the Government’s prima facie case. In addition to failing to accept responsibility, the Respondent has also failed to offer any evidence of remediation.
Egregiousness and Deterrence
While a registrant must accept responsibility and demonstrate that it will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 Fed. Reg. 10083, 10094 (2009); Southwood Pharm., Inc., 72 Fed. Reg. 36487, 36504 (2007). The egregiousness and extent of an applicant’s misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 Fed. Reg. 19386, 19387-88 (2011) (explaining that a respondent can “argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation”); Paul H. Volkman, 73 Fed. Reg. 30630,
133
30644 (2008); see also Gregory D. Owens, 74 Fed. Reg. 36751, 36757 n.22 (2009). I find that the proven misconduct is egregious and that deterrence considerations weigh in favor of revocation. The proven misconduct involves repeated instances of dispensing high-strength schedule II controlled substances despite the presence of well-known signs of drug abuse and diversion. The proven misconduct also involves repeat instances of failing to follow state law and state standards of practice with respect to documenting red flag resolution in the patient profile. Continuously dispensing high-strength schedule II opioids, sometimes dangerously combined with high-strength benzodiazepines, to patients who raised multiple red flags of diversion, and failing to document any investigation into those red flags in the patient profiles, constitutes egregious misconduct because it allowed for the potential of unchecked diversion of controlled substances into illegitimate channels. Finding that the Respondent’s proven misconduct is egregious is warranted
despite the fact that I only weighed the Government’s evidence under Factor Four. The public interest factors are considered separately and any one or combination of factors may be considered when weighing the evidence. Robert A. Leslie, M.D., 68 Fed. Reg. at 15230 (citation omitted). It is not necessary that a sanction be supported by findings under each factor. Hoxie v. DEA, 419 F.3d at 482; Morall, 412 F.3d at 173. It is also not required to discuss consideration of each factor in equal detail, or even every factor in any given level of detail. Trawick v. DEA, 861 F.2d at 76. The balancing of the public interest factors “is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest.” Jayam Krishna-Iyer, M.D., 74 Fed. Reg. at 462. Thus, I find that sanction is justified and that the Respondent’s conduct was egregious even though the evidence was only weighed under a single
134
factor. In addition to the severity of the Respondent’s dispensing misconduct, the
Respondent also unlawfully manufactured thousands of capsules of schedule II controlled substances without being registered with the DEA as a manufacturer. As noted earlier, registered manufacturers of controlled substances are held to higher standards than practitioners with respect to recordkeeping, reporting, security, and frequency of renewing registration. Thus, manufacturing controlled substances without the DEA’s blessing enabled the Respondent to produce thousands of dosage units of controlled substances over several years in the absence of regulatory monitoring. As with unlawful dispensing, unlawful manufacturing is an egregious violation and warrants the revocation of registration.
I further find that deterrence considerations weigh in favor of revocation. Allowing the Respondent to retain its COR despite the proven misconduct would send the wrong message to the regulated community. Imposing a sanction less than revocation would create the impression that registrants can maintain DEA registration despite repeatedly failing to resolve and document the resolution of red flags in accordance with state law, and despite engaging in a regulated activity without obtaining approval from the DEA to engage in that activity. Revoking the Respondent’s COR communicates to registrants that the DEA takes all failings under the CSA seriously and that severe violations will result in severe sanctions.
Advice of Counsel
When the DEA executed an AIW at the Respondent in September 2018, the Respondent’s owner and pharmacist-in-charge, Mr. Clement, Sr., refused to speak to DI Albert upon advice of counsel to not answer any questions. Tr. 168, 173, 177. The Respondent has an absolute right to seek advice of counsel, and no adverse inference from obtaining advice of counsel may be drawn. It does not provide,
135
however, any defense to actions taken, including failing to eventually respond to DEA inquiries following consultation with counsel, or lack of cooperation with the DEA’s investigation.
Loss of Trust
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Acting Administrator that he can be entrusted with the responsibility commensurate with such a registration. Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (2008).
There is no evidence that suggests the Respondent has learned any lessons from its misconduct. As just discussed, the Respondent does not appear to believe it has done anything wrong. And the Government’s evidence proves violations that occurred within the past few years, allowing a significant lapse of time for the Respondent to reform its ways.
These actions do not engender trust. The Respondent’s failure to accept responsibility and present remediation evidence has convinced this Tribunal that the DEA cannot trust Respondent with the obligations of a DEA registration. Furthermore, on two occasions the Respondent exhibited a lack of trustworthiness. First, in May 2017, the Respondent’s owner directed his wife to ask a DEA Diversion Investigator to leave the pharmacy during an inspection. Tr. 27. Secondly, during execution of an AIW in September 2018, the Respondent’s owner refused to answer the same Diversion Investigator’s questions upon advice of counsel. Tr. 168, 173, 177. As just noted, the Respondent is entitled to rely upon the advice of counsel; however, relying on advice of counsel cannot serve as a defense to actions taken, such as refusing to cooperate with the DEA’s investigation. Both of these instances demonstrate a concerning reluctance on the Respondent’s
136
part to work with the DEA in correcting its transgressions. If the DEA cannot trust the Respondent to cooperate with its investigators, it is hard to trust that it will take its duties under the CSA seriously. See Satinder Dang, M.D., 76 Fed. Reg. 51424, 51425 (2011) (noting the ALJ determined a respondent’s lack of cooperation with DEA investigators weighed against the respondent); Kimberly Maloney, N.P., 76 Fed. Reg. 60922, 60929 n.25 (2011) (noting respondent’s cooperation with investigators weighed in her favor). Thus, I find that the Respondent has lost a significant amount of trust and has failed to overcome that loss of trust by demonstrating to the Agency that it can be relied upon to lawfully discharge it’s COR obligations.
DR. DON SULLIVAN “EXAMINE ANY PATIENT, SAW NO PATIENTS RADIOGRAPH (XRAYS) SPOKE WITH NO PHYSICIAN AND HAD NEVER MET RICHARD ALBERT UNTIL JANUARY 28, 2020 THIS IS ACADEMIC FRAUD ON BEHALF OF THE OHIO STATE UNIVERSITY AND SHOULD BE TERMINATED BY THE OSU”,
RECOMMENDATION
Considering the entire record before me, the conduct of the hearing, and observation of the testimony of the witnesses presented, I find that the Government has met its burden of proof and has established a prima facie case for revocation. Furthermore, I find that the Respondent has not accepted responsibility, or presented sufficient evidence demonstrating that the Agency can entrust it with a COR.
GERALD KILEY “IS THERE ANY PLACE ELSE I CAN GO TO GET MY SCRIPTS FILLED”
Therefore, I recommend that the Respondent’s DEA COR No. FP2302076 should be REVOKED, and that any pending applications for modification or renewal of the existing registration, and any applications for additional registrations, be DENIED.
Signed: May 5, 2020
Mark M. Dowd
MARK M. DOWD U.S. Administrative Law Judge
137
Certificate of Service
This is to certify that the undersigned, on May 5, 2020, caused a copy of the foregoing to be delivered to the following recipients: (1) John Beerbower, Esq., Counsel for the Government, via email to the DEA Government Mailbox at dea.registration.litigation@usdoj.gov; and (2) Dale R. Sisco, Esq., Sisco-Law, Counsel for the Respondent, via email at dsisco@sisco-law.com.
Bella A. Mapeso
Bella Mapeso, Secretary Office of Administrative Law Judges
Judge Mark D. Dowd may be in legal circles a great juris in the field of medicine and pharmacy he is but a fool and needs to step down immediately and earn a living as an Uber Driver.
PHARMACY COMPOUNDING WHILE BLACK!!!
The DEA investigation was an act of brazen misconduct against a licensed retail pharmacy that is licensed by law to compound medications. These cases are not only about bad science but bad law and poor training. Diversion Investigator Richard Albert prepared a warrant that was “opinion based on a red flag,” that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy, wherein a licensed pharmaceutical company by law, that can compound medication. Diversion Investigator wrote,
ILLEGAL MANUFACTURING :
Between January 2018 and May 2019, the Respondent was engaged in manufacturing controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing it tomanufacture controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28.
“In addition, the Government previewed that its evidence will show that the Respondent unlawfully manufactured controlled substances, specifically oxycodone and hydromorphone, without a manufacturer’s registration.”
To support this allegation, the Government intended to show that in May 2012 the Respondent’s owner, Mr. Norman J. Clement, Sr., told DEA investigators that he compounded oxycodone and hydromorphone because it was cheaper than obtaining them from distributors.
THE MANUFACTURING OF OXYCODONE
Pronto Pharmacy does not manufacture Oxycodone nor Hydromorphone, which is a far more complex process. Pronto would have to:
Acquire large tons of harvested opium paste from Tasmania, India, or Afghanistan, transporting these volumes to Tampa, Fl., for processing.
Process the opium paste, large volumes of agents, reagents, equipment, and space would be needed, notwithstanding the fact that to bring the product Oxycodone and Hydromorphone to a pharmaceutical-grade that meets FDA purity standards.
The water bill and electrical bill at Pronto Pharmacy would be enormous.
The manufacturing of Oxycodone into a bulk product is an extremely complex procedure and would involve: (see google scholar manufacture Oxycodone footnote 4)
Oxycodone is manufactured in high yields and with high purity using codeine or salt of codeine as the starting material. The manufacturing process involves the following steps:
(a) codeine or a codeine salt (e.g., codeine phosphate) is converted into the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine,
(b) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine resulting from step (a) is oxidized to yield the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone;
(c) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone resulting from step (b) is enolized with a base and the resultant enolate is thereafter methylated to yield the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine;
(d) the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine resulting from step (c) is reduce to yield thebaine;
(e) the thebaine resulting from step (d) is oxidized to yield the intermediate 14-hydroxycodeinone; and
(f) the intermediate 14-hydroxycodeinone resulting from step (e) is hydrogenated to yield oxycodone.
THERE WAS NOT ONE SINGLE CAPSULE EVER MANUFACTURED AT PRONTO PHARMACY
1. There is not one piece of equipment that the DEA seized from Pronto that was used in manufacturing. All equipment taken was for compounding 2. All medications compounded was purchase from two wholesalers (Fagron and B&B)
3. There is not a single controlled substance compounded for encapsulation at Pronto Pharmacy which was manufactured at the pharmacy or by a Pronto pharmacist and/or their technicians. Here are the containers. ( see below) 4. The containers of powders were obtained from B&B Pharmaceutical and were recorded into the CSOS system which reported back to the DEA and wholesalers. Therefore, Richard James Albert should have known this but chose to falsify his warrant in order to put Pronto out of business and its owners in prison.
DEA MOVING THE GOAL POST BACKWARD AND FORWARD AND SETTING QUOTAS
We see this early in the case of Pronto Pharmacy when Diversion Investigator Richard James Albert (DI Albert) came upon compounding, and when he could not repeatedly find anything wrong with the pharmacy’s records His handlers instructed him to redefine this long-standing pharmaceutical methodology as manufacturing.
It is more than clear that the DEA Diversion Investigators were operating in absent the law based on mis-facts, lies, distortions. DEA has learned well. When there is no evidence of wrongdoing, DI Richard James Albert’s handlers cleverly instructed him to redefine the meaning of pharmaceutical procedures to accomplish their goals. The Diversion Investigator’s charges and findings were easily scientifically debunked.
It became clear from his court testimony he did not understand compounding or its procedures. But likely learned from his handlers like Amy Hickerson, who was guiding him on how to divert both meanings to convince a Federal Administrative Judge to secure a warrant to shut Pronto Pharmacy LLC down. Additionally, he testified that he did not “know or understand the law(s) or how any law applies to the practice of Pharmacy. Florida Statue 499.1.2 states the wholesaler must assess the purchases of control medication by an individual pharmacy.
FOR NOW
REV AL SHARPTON, CANDIDATE FOR STATE REP. FL/32 SOUTH LAKE COUNTY STEPHANIE DUKES, NORMAN J CLEMENT RPH., DDS
YOU’RE WITHIN THE NORMS
1) Joseph Madison “The Black Eagle” XM 126, THE URBAN VIEW, Thank you Joe, if i’m a celebrity then let it be for Obamacare which saved my life from Invasive Early Stage Colon Cancer through an eye exam 2016.
2) Good compounding practice applicable to state-licensed pharmacies. In: Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Park Ridge, Ill: National Association of Boards of Pharmacy; 1993;C-1-C-5.
WALTER R, CLEMENT, BS., MS., MBA,* NORMAN L. CLEMENT JR., PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA, AARON HOWARD, PHARMD., VICTOR OBI, RPH, JACK FOLSON, RPH., RICARDO FERTIL, PHARMD., BERES MUSCHETT BS., STRATEGIC ANALYSIS, MARTIN NDJOU, RPH.
CHINESE DISSIDENT: ARTIST AL WEIWEI
“I cannot live in fear, we must live by the law,”
THE MANIFESTO OF THE NORTH STAR PROJECT
When you see THROUGHOUT LIFE most of your friends, colleagues, and classmates who are of degree being defiled, sanctioned, terminated, harassed, arrested, jailed, and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do Then at some point, you are compelled to ask yourself when
ENOUGH IS ENOUGH.
At some point in your life, you have to say and proclaim enough is enough and what are you going to do about it. Then we must stand and fight as soldiers together or die like mice.
ENOUGH IS ENOUGH.
THIS PRESENTATION CONTAINS MUST SEE VIDEOS WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE
INTRODUCTION
THE DEA HAS BEEN GIVEN PERMISSION TO INVESTIGATE PEOPLE PROTESTING GEORGE FLOYD’S DEATH
The DEA has acted as an unregulated medical agency policing medical facilities and medical practices without legal standards and grounds and the DEA Administration Court System body, which operates within the Department of Justice (DOJ), like a runaway unconstitutionally entity, and immune to all laws of governance to all courts within the Justice System.
THE CIVIL RIGHTS BILL OF 1964 STARTED HERE IN ST. AUGUSTINE WITH THE PROTEST BY CHILDREN
As reported by Buzz Feed News “The justice Department gave the agency the temporary power to enforce any federal crime committed as a result of the protests over the death of George Floyd”
According to Frank Figliuzzi, former Assistant Director for Counterintelligence at the Federal Bureau of Investigation states ” We are in trouble the DEA has been given permission investigate people protesting George Floyd’s death”
DEA’s mission is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations involved in the growing,
THE STRUGGLE OF ALL COURAGEOUS INDIVIDUALS/GROUPS
manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.
THE POOL ON THIS SITE LEAD TO THE US CIVIL RIGHTS ACT JEWISH RABBIS CAME FROM ACROSS THIS COUNTRY TO SUPPORT THIS PROTEST
FOR NOW
REMEMBER ST. AUGUSTINE 1964
YOU ARE WITHIN THE NORMS
35 YEARS LAW ENFORCEMENT DETROIT POLICE DEPARTMENT , TRAINER, INSTRUCTOR, ADJUNCT PROFESSOR
“THIS LETTER FROM DR. ANTHONY MOYNHAM, FORENSIC PATHOLOGIST FROM AU WHO I HAD THE PLEASURE TO MEET AND BEFRIEND AT PADDINGTON SQUARE HILTON HOTEL, LONDON ENGLAND WHEN I WAS ON HOLIDAY WITH MY FAMILY 2018. WE HAD BEEN DISCUSSING OF BOTH OUR INTEREST IN FORENSIC DENTISTRY AND HUMAN REMAINS IDENTIFICATION DURING MASS CASUALTY EVENTS…HE ADDRESSES HIS OUTRAGE ON THE DEATH OF MR. GEORGE FLOYD”
Dear Norman,
As I see the media reports I have to let you know of how apprehensive I am of events in your part of the world. In Australia, we have managed to keep the number of deaths from Covid-19 down to 103 so far with the number of positive diagnoses being 7202. These figures are sound and are not massaged. Being an island it is much easier for this country to isolate itself. Our government also acted quite early when a pandemic looked to be heading our way. There is also much cooperation between our six states and two territories together with the federal government. We have a much smaller population than the USA (about 26 million) and our states and territories are not quite as diverse in culture as in your part of the world. In many ways, they are almost clones of one another. The various governments are spending big in their budgets to assist the unemployed however it is expected that there will be at least about 10% unemployment nationally from all of this which will still need to be addressed.
WINDSOR CASTLE WIDSOR ENGLAND
As I see the daily news I know that the figures for this COVID disease are not so good in your part of the world. As with any infectious disease of this type, people must be separated from one another where possible. It will often involve changes to the workplace and even a temporary shutting down of some businesses. It will also stop travel in many situations too. The financial burden upon some people can be severe when this occurs. The choice between being without finance or being affected by the disease (and possibly losing your life) can be difficult when people are under this type of pressure.
FROM JOURNEY THROUGH MEDICINE HENERY WELLCOME’S LEGACY LONDON MUSEUM OF SCIENCE
I have to admit to being outraged with what has occurred in your part of the world with the way that the police are treating Afro-American people. I am not too surprised as I know that there has been a culture of prejudice in this way for many decades in the USA. I know that I am not the only person who feels this way. I have great sympathy for the families and loved ones of those persons. These events should never happen. If these events do occur then they must be addressed by the rule of law which must apply equally to all of us without exception.
The present situation is not being assisted by a leadership which deals with it combatively instead of diplomatically. Leadership should not in any way endorse activities which promote division on racial, religious or ethnic lines – unfortunately leadership is not following this approach in your part of the world. I trust that things will settle and that there will be some progress towards harmony as the future unfolds.
LONDON, ENGLAND 2018 MY DAUGHTER AC ADAMS PHARMD, HER HUSBAND ANTHONY “SPICE” ADAMS AND NORMAN J CLEMENT RPH., DDS
For this to occur a number of events have to take place. A change of attitude is not enough. It is not just a matter of changing entrenched prejudices in a number of people it must also include a vision where equality of opportunity is established throughout the community. It has to address issues such as chronic poverty, poor housing, universal access to medical care and employment opportunities unencumbered by prejudice.
I hope that you do not mind me showing my concern for people in your part of the world and having a few views. Public opinion in Australia is dismayed by the events which have caused the problems in many of your cities and also by the lack of a conciliatory tone coming from Washington.
DR. ANTHONY MOYNHAM FORENSIC PATHOLOGIST FROM AUSTRALIA IN LONDON ENGLAND 2018
As you have probably heard the International Association of Forensic Scientists has postponed its conference in Sydney until 17 – 21 May, 2021. I hope that you will be able to attend this conference.
If you are at the conference I hope that it will be possible for us to catch up and have a meal and a chat together. Perhaps I can point out a few spots of interest in Sydney as well. The venue for a meal may be a bit different from the executive lounge at the Paddington Hilton in the UK during breakfast time.
May I wish you well and hope that you are safe. Take care.
I first met Henry Gremillion as a instructor at the University of Florida School of Dentistry while working on my Masters in General Dentistry CDP-29 program. He was active and supportive in the National Dental Association Convention especially with Black students in promoting research. I can’t begin to tell anyone what tremendous influence Dr. Gremillion’s research, and teaching had on me, especially in the areas of pain control, periodontics and occlusion. The field of Dentistry around the world has lost a very great one.
THIS IS DEVASTATING NOT HENERY GREMILLION DDS MAGD:
Florida AGD
Henry Gremillion, DDS, MAGD LSU Health School of Dentistry Dean October 15, 1951 – May 17, 2020
It is with tremendous sadness that we inform you of the sudden passing of Henry Gremillion, DDS, MAGD, Dean of our School of Dentistry. Henry, a Louisiana native and 1977 graduate of the LSU Health New Orleans School of Dentistry, came home to lead his alma mater in 2008. He was the sixth dean since the founding of the dental school and the only LSU Health New Orleans School of Dentistry alumnus who held the position.
Henry was a visionary leader on the local, state and national levels. He shepherded to completion the first new permanent building on the Dental School campus since the school was originally constructed. The $31 million, 64,899 square foot structure now named the Allen A. Copping, DDS Advanced Clinical Care and Research Building opened in 2018. Thanks to Henry’s leadership guiding their extensive renovation, students now hone their skills in some the most advanced preclinical labs in the country.
HENRY GREMILLION DDS, MAGD MEETING NATIONAL DENTAL ASSOCIATION 2018
Henry led the state’s only School of Dentistry and the only one in the country with degree programs in dentistry, dental hygiene and dental laboratory technology.
His many honors include LSU Health New Orleans School of Dentistry Alumnus of Year in 2001, the school’s highest alumnus award, and the University of Florida College of Dentistry Teacher of the Year in 2002 and 2007. A beloved educator, the Florida Dental Association honored him as the Florida Dental Educator of the Year in 2002 and 2006. Henry received the Louisiana Academy of General Dentistry Career Service Award in 2003. He was selected as a 2007 Distinguished Professor by the University of Florida Blue Key Society. In 2008, the American Academy of General Dentistry honored Dr. Gremillion with the prestigious Theodore V. Weclew award for contributions to the education of general dentists. In 2009, the Dawson Academy honored him with its Career Service Award. In 2010, he received the American Academy of Orofacial Pain Service Award, and in 2015, the Pierre Fauchard Gold Medal. He was a member of the American Dental Association, Louisiana Dental Association, Academy of General Dentistry, Omicron Kappa Upsilon Honorary Dental Fraternity, American Academy of Orofacial Pain, American Pain Society, International Association for the Study of Pain, American Equilibration Society, American Association for Dental Research and International Association for Dental Research.
You can read more about Henry in this story written when he was elected Chair of the Board of Directors of the American Dental Education Association — the sole national organization representing academic dentistry.
Despite his national stature, Henry easily related to people from all walks of life. Students, faculty, patients, members of the community, elected officials, local, state and national leaders all found him approachable, respectful, caring, engaged and down to earth.
Arrangements are incomplete at this time.
Please keep his family, as well as his Dental School and Health Sciences Center colleagues in your thoughts and prayers as they cope with this inestimable loss.
Condolences can be sent to:
Mackey Gremillion and Family 226 Rue Saint Peter Metairie, LA 70005
