NORMAN J. CLEMENT RPH., DDS.,
WITH CONTRIBUTION FROM
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 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
DIVERSION INVESTIGATOR RICHARD JAMES ALBERT AND HIS HANDLERS
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.
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.
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:
BlACK DEA AGENTS STATES AGENCY IS BIAS
” 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 AS FOLLOWS:
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.
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.
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.
Other examples include persons who have survived traumatic accidents such as automobile accidents, gunshot wounds (civilian and military), notwithstanding leukemia and other cancers.
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.
(SEE VIDEO BELOW “IT SOUNDS LIKE PROFILING)0d863f86-04ce-4209-9a81-da19a64c8e0bMR. KILEY “IT SOUNDS LIKE PROFILING TO ME”
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).
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.
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
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.
YOU ARE WITHIN THE NORMS