In”There is a disturbing trend within the criminal justice communities so-called “War on Drugs” whereby medical practitioners are targeted. Law enforcement agencies have raided and arrested medical personnel for filling legally prescribed medications particularly control medications of patients being treated for acute and chronic pain disease.“
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., ESTHER HYATT PHD., WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“AS THE LORD INSTRUCTED PAUL, DO NOT BE AFRAID, GO ON SPEAKING, DO NOT BE SILENT, FOR I AM WITH YOU AND NO ONE WILL ATTACK YOU TO HARM YOU, FOR I HAVE MANY IN THIS CITY WHO ARE MY PEOPLE“
“draft ONLY FOR REVIEW“
“WE ARE PHARMACISTS NOT DRUG DEALERS”
THE SO-CALLED “WAR ON DRUGS”
There is a disturbing trend within the criminal justice communities so-called WAR ON DRUGS, whereby medical practitioners are targeted. Law enforcement agencies have raided and arrested medical personnel for filling legally prescribed medications particularly control medications of patients being treated for acute and chronic pain disease.
These tribulations are no different from what our forbearers experienced, Predatory Policing that enforces Regulatory Racism. Therefore, it is not a matter of what you’re doing right, it is about putting you in your place. A place of eternal servitude, despair, and the maintenance of generational subjectivity (we are but low-hanging fruit). (15)
RAID ON PRONTO PHARMACY
On August 29, 2019, DEA agents raided Pronto Pharmacy, Tampa, Florida. They entered the premises under the authority of a search warrant based on a false narrative prescription being filled were illegal. There were numerous deficiencies in the warrant, which questions the veracity of the contents which supported or the lack of documentation to support Probable Cause.
Upon entry, the very first thing the raiding party performed was to disable building surveillance camera systems(see surveillance video 08/29/2019). (1)
“The DEA’s independent accreditation demonstrates the professionalism and dedication of the training staff. Training offered by the Academy includes both on-site and off-site training. We focus in specialized narcotics and dangerous drug law enforcement, asset forfeiture, intelligence training programs, clandestine laboratory training, pharmaceutical diversion training, and international training programs.”
Nowhere in the DEA training are instructions on disabling interior camera systems. Had these officers were properly trained, they should have known that items like an Unguanator, a machine that makes topical compounds. In other words, this machine makes topical ointment. Had probable cause was established, the agents would not have taken an academic research manual. The agents left a coffee pot because they know what it was. However, they took items which they had no concept or knowledge of what the items were. This lack of knowledge violates Pharmacist Norman J. Clement’s 4th amendment rights.
ATTORNEY GENERAL JUDGE MERRICK GARLAND AND CONGRESS MUST INVESTIGATE REGULATORY RACISM OF DOJ/DEA DRUG POLICY
GLOBAL COMMISSION ON DRUG POLICY
“We must switch from law enforcement to health”
However, according to the Global Commission on Drug Policy and the late former Secretary of State George Schultz, the DEA’s War on Drugs has been a war on civilians, an abysmal failure. (9) The purpose of The Global Commission on Drug Policy is to bring to the international level an informed, science-based discussion about humane and effective ways to reduce the harm caused by drugs and drug control policies to people and societies.
(CONGRESS MUST INVESTIGATE REGULATORY RACISM)
HOW THE DEA HAS CRIMINALIZED YOUR PERSONAL MEDICAL RECORDS BYPASSING PDMP
THE UNITED STATES HOUSE COMMITTEE ON GOVERNMENT OVERSIGHT AND SENATE JUDICIARY COMMITTEE MUST INVESTIGATE
State-run Prescription Drug Monitoring Programs (PDMPs) already track much of the information on all controlled prescriptions issued by any healthcare practitioner authorized to write for these types of medications. In a request for proposal (RFP) made in early September 2020, the DEA is seeking, software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances.
DR. HELEN HANSEN “WHITE OPIOIDS: RACE IN THE WAR ON DRUGS THAT WASN’T”
“America’s War on Drugs has played a profound role in reinforcing racial hierarchies. Although Black Americans are no more likely than Whites to use illicit drugs, they are 6–10 times more likely to be incarcerated for drug offenses. Helena B. Hansen, an assistant professor in the Department of Psychiatry at New York University, examines the recent history of White opioids to show how a very different system for responding to the drug use of Whites has emerged, in which addiction is treated primarily as a biomedical disease.
Meanwhile, more punitive systems that govern the drug use of people of color have remained intact. At this seminar, Dr. Hansen argues that public concern about White opioid deaths creates an opportunity to reorient U.S. drug policy toward public health for all—and make proven harm reduction strategies widely available.”
Generally for law enforcement access to the data usually it requires an active investigation or warrant – no data mining or fishing expeditions allowed. In order to maintain patient privacy, many states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. In 2019 the DEA had to sue Colorado to get access to the state’s PDMP data. (4)
The DEA’s new plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”
Pat Anson, Editor of Pain News Network wrote November 11, 2020:
” Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.
“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. (8)
“DEA agents have no business second-guessing health care providers’ decisions on medical need and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”(8)
Richard Lawhern, BS., PhD., of the ACSH Board of Scientific Advisers, points out:
“Our problem concerning policy on opioid prescribing and imagined harms thereof is not that we lack data. It is that so many advocates so deliberately misinterpret and distort the data we already have, through an anti-opioid lens.” (10), (11)
“If you’re willing to torture the data for long enough, you can make it say anything”
Richard A “Red” Lawhern is the spouse of a chronic facial pain patient. He has advocated for pain patients and their family members for twenty years with online research, physician referrals, authoring of websites, and critical commentaries. http://www.face-facts.org/Lawhern
PRESIDENT JOE BIDEN’S EXECUTIVE ORDER PROMOTES REGULATORY RACISM, SUCH POLICIES IN THE PASS HAVE FAILED
Sadly, through Executive Order, President Joe Biden has permitted this DEA bypass medical record program to be implemented, thus every pharmacy in America is now part of law enforcement. (8) This Executive Order further gives DEA and DOJ the authority to strongarm the medical profession, Drug Manufactures, Pharmacy Drug Chains,T and the Independently own Family Pharmacies.
This is of troubling concern to Black Own Pharmacies who have found their establishments targets of both State and Federal Regulatory Racism. President Biden’s “Drug Policy” appears headed down the wrong path backward. There is time to correct his drug policy with better information with a more definitive understanding of the Pathophysiology of disease state and medicinal drug dependency. (CONGRESS MUST INVESTIGATE REGULATORY RACISM)
As reported in February 07, 2021, The Post Millennial Magazine:
Shortly after the 2020 Presidential election, Filter Magazine discovered that the DEA had put out an official notice requesting proposals for programmers to help them create a surveillance system to monitor at least 85 percent of all prescriptions nationwide. The program would also monitor patient behaviors as well as prescribers and pharmacists.(5)
To quote the DEA:
“what they hope to build is a way for their agents to get “unlimited access to patient de-identified data” on virtually everyone. It would be like Google, but for the DEA to monitor every patient and medical professional”.
Previously, the DEA and the federal government led a campaign—aided by new state laws mandating Prescription Drug Monitoring Programs (PDMPs) and Narxscores—to force pharmacies and doctors to give-up prescription information. Followed often by an informal call or letter meant to intimidate them into abandoning patients. (5), (8)
The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.” (5),(8)
CONGRESS MUST INVESTIGATE REGULATORY RACISM
Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs. For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.
“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN.
‘APPALLING FOR PEOPLE’S HEALTH’
The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine, and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts because it is a primary ingredient of Suboxone.
ADVISER TO CDC DR. ANDREW KOLODNY SANCTIONS PAIN PRESCRIPTION RACIAL BIAS, “RACIAL STERO-TYPING HAS HAD A PROTECTIVE EFFECT ON BLACK PATIENTS”
Listen to Below Audio link Interview Dr. Andrew Kolodny
CARL HART Ph.D. PROFESSOR COLUMBIA UNIVERSITY DEBUNKS DR. KOLODNY FALSE “OPIOID ASSERTION“
ALSO SEE NEW YORK TIMES ARTICLE: A ‘Rare Case Where Racial Biases’ Protected African-Americans, with Dr. Andrew Kolodny, NOVEMBER 25, 2019 (12) AND WHUR “Black Americans Were Prescribed Opioids Less Frequently Because Of Racial Bias, New Analysis Shows,” January 03, 2020 (13)
“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment. (2)
“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”
CONGRESS MUST INVESTIGATE REGULATORY RACISM
“This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”
EXPOSING REGULATORY RACISM IN MEDICINE TOWARD PATIENTS WITH SICKLE CELL DISEASE IN CANADA!!!
Filter Magazine discovered that the DEA had put out an official notice requesting proposals for programmers to help them create a surveillance system to monitor at least 85 percent of all prescriptions nationwide. The program would also monitor patient behaviors as well as prescribers and pharmacists. (4)
DEA AGENTS LACK OF TRAINING VIOLATES CONSTITUTIONAL RIGHTS
It becomes obvious the DEA agents lacked sufficient training that their actions violated the constitutional rights under Harris vs. Canton when the failure to train your officers amounts to a policy of no training. The actions and acts of performance displayed that the DEA agents. The inadequacy of police training may serve as the basis for liability only where the failure to train in relevant respect amounts to deliberate indifference to the constitutional rights of persons with whom the police come into contact. The elements of the DEA agents’ during the search displayed a lack of significant training.
Effective management of chronic pain, however, frequently requires the coordinated efforts of the pain management team. Effective pain management does not mean total eradication of all pain. Medical professional operating in the field of pain management knows this to be true.
However, the matter of search warrant at Pronto Pharmacy, DEA Registration number FP2302076, the DEA agents do not know. The complexities of pain management they wrote the DEA’s investigation determined the Pronto Pharmacy was engaged in the “manufacture” of controlled substances, as that term is defined in the Controlled Substances Act, despite not being registered with the DEA as a manufacturer.
By their own training the DEA should have known that Pronto Pharmacy was not a manufacture” of controlled substances. The DEA knows Pronto Pharmacy compound medication under the state and federal laws. In as such, the DEA should have known that, pain management of often a troubling aspect by medical practitioners. The DEA agents therefore criminalized a legitimate medical procedural practice. Whereby they DEA agents listed that Pronto Pharmacy refilled prescriptions. (3)
Therefore had the DEA Agents followed or either were properly trained. They should have known that manufacturing is not a tacit event. When class 2 drugs are manufactured the DEA would have known this to be true by their internal automatic electronic reporting systems that are controlled and monitored by the United States Justice Department. If the DEA agents did not know this the agency clearly failed to train or the officers failed to retain the knowledge. Thus, the lead supervisor should have known and reinstruct the officers. However, they lacked sufficient training that their actions violated the constitutional rights under Harris vs. Canton when the failure to train your officers amounts to a policy of no training.
ATTORNEY GENERAL JUDGE MERRICK GARLAND AND CONGRESS MUST INVESTIGATE REGULATORY RACISM OF DOJ/DEA DRUG POLICY
Moreover, the police have little knowledge of therapeutic medical procedures to control or subside the pain. A DEA agent functioning in the area of raiding medical professional offices certainly lacks sufficient knowledge of therapeutic medical pain procedures.
Therefore, the raiding DEA agents lacked the medical know-how and the knowledge of what is and are needed for pain control management. Their lack of knowledge supports the agency’s policy of no medical training or medical certification for a DEA agent to properly understand what right or wrong within a practicing medical facility.
Therefore, under Harris vs. Canton when the failure to train your officers amounts to a policy of no training. The lack of training is so reckless or gross negligent that depravation of the citizenry constitutional rights was substantially certain to result U.S. Supreme Court (1989).
Medical pain controls, is a branch of medicine employing an interdisciplinary approach for easing the suffering and improving the quality of life of those living with chronic pain the typical pain management team includes medical practitioners, pharmacists, clinical psychologists, physiotherapists, occupational therapists, physician assistants and nurses. The team may also include other mental health specialists and massage therapists.
Pain sometimes resolves promptly once the underlying trauma or pathology has healed, and is treated by a practitioner, with drugs such as analgesics and anxiolytics. Effective management of chronic pain, however, frequently requires the coordinated efforts of the pain management team. Effective pain management does not mean total eradication of all pain.
The troubling aspect of the search is more befitting as an act of an improperly trained or non-trained office acting under the guidelines that a crime was taking place. These acts display an insufficient level of training, management and supervision of the complexities of therapeutic medical procedures. Furthermore, in compliance of the law, Pronto Pharmacy maintained dispensing records of all controlled substances.
PRONTO PHARMACY UNDER ATTACK BY TRUMP’S DEA
Pronto Pharmacy, Is a small family-run business often times we are excluded from many insurance plans who contract with large chain pharmacies. Many insurances simply don’t pay their bills to the small family-owned pharmacy. Simply put they cheat us on extraordinary fee attachments.
Most noticeable, the chain pharmacies (CVS, Walgreens) are now owners of the drug insurance companies. So they now own the Market, the Pricing and who plays and who is excluded. The problem is so extensive, Walmart had to lay-off 40% of their pharmacy staff around the country in part because of a dispute with CVS CAREMARK over reimbursements.
Today, when a family’s own pharmacy takes insurance approximately 7 additional fees are attached to their reimbursement every quarter. For example, a pharmacy receives a total quarterly reimbursement by the insurance company for $50,000.00 the insurance companies will then sent a bill to the pharmacy at the end of each quarter for as much a $15k each on fees. If a pharmacy bills 3 or 4 insurances, then they will receive 3 or 4 different large bills. FAMILY OWN PHARMACIES ARE BEING CHASED OUT OF BUSINESS. As a result, small pharmacies like Pronto Pharmacy take cash and are red-flagged by the DEA as criminals, while our patients are considered junkies.
The warrant issued identified items that are evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.
The intent of this law implies that it shall be unlawful for any person knowingly or intentionally— to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.
This law identified the individual(s) as a person which stands for a reasonable officer that a human being regarded as an individual.
Wherefore on August 29, 2019, In the city of Tampa Florida, Pronto Pharmacy was raided by reasonable and competent officers. Whereby the execution of Warrant 8:19MJ2143AEP implies that a person was in violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.
However, Norman J. Clement was acting in the capacity of a licensed pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drugs. This definition and is a statute within the Florida Admirative Code & Florida Administrative Register. The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. The intent that a person and not a licenses Pharmacist committed a crime.
The removal of files is an act of searching to discover items to suggest a criminal act took place or is taking place. This is not implied within the warrant and the act of looking to find a criminal act is not supported by probable cause. Such act to find is an investigative function that violates the premise of a search warrant is a basis of reasonable suspicion. The search conducted was not specific in nature whereby the agents confiscated a black three-ring binder that was located on top of a desk.
Therefore, the removal of such documents serves the purpose of developing a case beyond the scope and statutes of the search when the ordering and dispensing ‘Approved Medicinal Drug Products’ created tacit reasons to search.
CONGRESS MUST INVESTIGATE REGULATORY RACISM
The Fourth Amendment was intended to create a constitutional buffer between U.S. citizens and the intimidating power of law enforcement. The officers failed to indicate within their search warrant the components of what to be seized. Therefore, the officers exercised undue discretion when they choose to search and seize. Therefore, the interest of the defendant was violated when the search and seizures became “unreasonable” and not authorized by the warrant based upon probable cause, to remove personal artifacts such as documents of academic research. This binder contained copyrighted academic research.
Therefore, such actions are on the facts that a reasonable officer would know what a pharmacist’s duty and functions are, and to oath and act upon what is believed but not know is in its self a violation of the law and a mistrust of the duty to protect and serve. The officers did not know that a pharmacist is not just a person but a licensed individual to create, distribute, or dispense, or possess with a controlled substance. The act to remove all electronic devices is an act to suspend the income and eliminate the practice of filling legal prescriptions.
THE DEA’S ORDER TO SHOW CAUSE AND IMMEDIATE SUSPENSION OF REGISTRATION AND THE ABUSE OF PHARMACISTS, PHYSICIANS, AND PATIENTS CONSTITUTIONAL RIGHTS
The acts of the DEA were based on information that a crime was committed. ORDER TO SHOW CAUSE AND IMMEDIATE SUSPENSION OF REGISTRATION indicated that “Patients Travelling Long Distances to Fill Prescriptions at Pronto Pharmacy”: DEA’s expert opined that it can be a red flag of abuse and diversion if a patient travels a significant distance to a specific pharmacy, especially if the patient also travels a significant distance to a particular prescriber.
In 2017 Former Utah Senator
This video is the game-changer that exposes the nature of DEA/DOJ abuses in targeting BLACK OWN PHARMACIES: Senator Hatch on DEA and Opioid Crisis and Abuse| C-SPAN.org
The facts to support parable cause cannot be justified by mere suspicion, “DEA’s expert opined that it can be a red flag of abuse” this cannot support an express intent that a crime was afoot. Thus, it cannot establish probable cause.
ATTORNEY GENERAL MERRICK GARLAND AND CONGRESS MUST INVESTIGATE REGULATORY RACISM OF DOJ/DEA DRUG POLICY
The show cause to support suspension lacks sufficient evidence to support that a criminal act was afoot. The facts one traveled a significant distance to obtain and fill prescriptions are a legal action under the law. Assuming the doctor is licensed to practice in his/her or her state and also has a valid DEA number, does not constitute a crime? The controlled substance prescription written can be filled in any state. In this matter, the knowledge that a crime was committed was based on DEA’s expert opined that it can be a red flag of abuse and diversion. Whereby no statutory elements support any police actions to make an arrest or to secure a warrant.
As Walmart pointed out when they sued the Department of Justice and the DEA:
”We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact, expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs.” (5)
According to Michael Kraus, a law professor at George Mason University wrote in The Wall Street Journal, December 27., 2020 Opinion Page “Case Against Walmart Mocks Justice”
“Alcohol sales to adults are legal in all 50 states, and some substantial percentage of legally purchased alcohol is consumed by alcoholics, to their and society’s detriment. Imagine a federal lawsuit against a grocery chain for selling beer to adults without protecting alcoholics from buying it. Such a case would be groundless: No federal law limits beer sales to adults in this way.
The Justice Department last week announced a similarly groundless civil suit against Walmart. The complaint alleges that the chain’s 5,000-plus pharmacies fueled the opioid crisis by “unlawfully” filling prescriptions.
Like the hypothetical beer case, this case against Walmart mocks the rule of law. State laws require pharmacists to fill prescriptions that have been validly written by qualified medical practitioners. Pharmacists lack the expertise to second-guess doctors’ judgments about the appropriate necessity of a medication and the proper dosing for a particular patient. To write a prescription for a controlled substance—which includes all opioids—a physician must be qualified by the Drug Enforcement Administration, and Walmart complies with that federal rule.
Under the Constitution’s Supremacy Clause, when there’s a contradiction between valid federal and state law, the former prevails. But there’s no federal law requiring that Walmart pharmacists refuse to fill prescriptions that state law requires them to fill. The Controlled Substances Act creates only two circumstances in which pharmacists commit a federal crime by filling facially valid prescriptions for controlled substances.”
First, if they “knowingly fill” a prescription that wasn’t issued by a doctor “in the usual course of professional treatment”—for instance, if a doctor hands out his entire Rx pad without examining any patient. Second, if they fill a prescription outside the “usual course of” pharmacy practice—for instance, if a “pill mill” dispenses opioids without checking the DEA number of the prescribing doctor. Not only isn’t Walmart being sued for such infractions; it has adopted innovative opioid-stewardship programs and worked with law enforcement agencies including the DEA to root out corrupt doctors.
“WE ARE PHARMACISTS NOT DRUG DEALERS”
“When Walmart pharmacists have hesitated to fill legally written opioid prescriptions, they have often been subjected to state sanctions. The president of the Texas Medical Board threatened to issue “cease and desist orders” against pharmacists who “change amounts of opioids prescribed” or “override” a physician’s judgment, on grounds that doing so constitutes practicing medicine without a license. Wisconsin’s Board of Pharmacy threatened disciplinary action against a Walmart pharmacy because it “informed a local clinic that the Pharmacy would no longer fill controlled substance prescriptions from that clinic due to concerns of overprescribing.” Complaints against Walmart and its pharmacists for refusing to fill opioid prescriptions have been filed with or pursued by pharmacy boards in Alaska, Arkansas, Colorado, Idaho, Kansas, Maryland, Missouri, New Hampshire, Ohio, Oregon, Pennsylvania, Tennessee, and West Virginia.”
“The Justice Department alleges Walmart isn’t rigorous enough in checking facially valid opioid prescriptions written by DEA-authorized physicians. If this is a problem, let the DEA propose specific regulations requiring pharmacies to conduct increased diligence before filling any opioid prescription. Before being adopted, costs and benefits of such regulations would be subjected to public scrutiny. These rules would require pharmacies to violate state law, and if adopted they would be enforceable under the Supremacy Clause. Until this happens, it’s a travesty to blame Walmart for complying with state law.” (1),(6)
The DEA must acknowledge that it is not a crime to drive a significant distance for cancer treatment. In this matter, the DEA expressed their own idea, feelings, opinions about what is a criminal act. With argumentation, they can present their own points of view based on their individual reasons as well as from their individual experiences. Yet in this agency there were no medical examinations of any member of the public that drives many miles to seek treatment, to support a criminal act being a red flag is police cultured terminology. This act must fear us all that to drive many miles to seek care can give the government grounds to suspend the basic fundamental rights of freedom of movement.
Again, the DEA expressed that numerous red flags that were highly indicative of abuse and diversion. What elements of a red flag support the statutory elements of probable cause? An opinion act that ‘red flags’ result in pharmacists acting in the usual course of professional practice is more of an abstract of the laws than the actual practice of the law.
DOJ CRIMINALIZATION OF VALID PAIN PRESCRIPTIONS
The Editorial Board of the Wall Street Journal pointed out in their December 29, 2020 article The Scapegoat of Walmart, “THE FEDS SEEKS BILLIONS IN PENALTIES FOR FILLING VALID OPOID PRESCRIPTION:
“The DOJ complaint against Walmart Pharmacy also includes more than 190 mentions of “red flags” about suspicious opioid prescriptions. It claims Walmart often didn’t adequately resolve them and sometimes knowingly filled illegitimate prescriptions despite the warnings. But Walmart notes in its lawsuit that the Controlled Substances Act “and its implementing regulations do not include the concept of red flags, let alone identify any particular factors as a red flag.”
The feds try to side-step this problem by claiming that, under the Controlled Substances Act and regulations, “the pharmacist’s conduct must adhere to the usual course of his or her professional practice as a pharmacist.” The complaint argues that catching and resolving “red flags” for opioid prescriptions is “a well-recognized responsibility of a pharmacist in the professional practice of pharmacy,” so “failing to fulfill this responsibility” is a violation of the federal law.
All of this raises constitutional issues based on a lack of legal standing. A negligence claim like the one alleged here is supposed to have a specific party claiming a specific injury caused by someone specific. Those are typically claims by one private party against another. The government can sue for violations of law, not because someone was negligent. The government’s claims of Controlled Substances Act violations are so general that they seem contrived to add some violation of the law.
In effect, DOJ is asking the federal court to overrule state law in favor of informal federal guidance and a vague notion of pharmaceutical best practices.” (7) Such actions by DOJ represent pure unadulterated, prosecutorial abuse.
PETER PISCHKE PRINCIPLES
Writer, Peter Pischke, reported in his February, 07, 2021, article The Post Millennial,
“ At heart the opioid crisis is a black swan of interconnecting unholy incentives to screw American patients over. The crisis was born from the multi-billion-dollar effort by “big litigation” and its allies; to find a new milk cow after the easy cash in big tobacco went dry. In turn, “big lawyer” pays the media for coverage, who are all too happy to gorge themselves on the drama.
For law enforcement: the crisis represents a chance to fill their coffers (the DEA is dependent on asset forfeiture), hoping to prove to the politicians and the public their usefulness in a world that is more accommodating to drug use and much harder to catch drug dealers.
Opioids have become, for our elite members, a way to prove their righteousness and make a name for themselves. And the system is willing to oblige, regardless of whatever the law says.”
It is a fact. Every autopsy analysis, yearly drug review, and substance abuse study confirms it. Drug use in the US did not significantly increase in the last decade, as much as the substances they were taking got more lethal. A massive change caused unintentionally by the geniuses at the FDA.
Pronto Pharmacy routinely dispensed high doses of oxycodone along with high doses of benzodiazepines to the same patient. There is no criminal element to fill a legitimate prescription prepared by the patient’s doctor. This matter what the number of contacts constitutes a crime. What constitutional elements supported actions were, in fact, the DEA clearly stated this was an opinion which is known to the agency but not supported by law.
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 AS FOLLOWS:
“Pharmacists may compound, in reasonable quantities, drug preparations the are commercially available in the mar place if a pharmacist-patient-prescriber relationship exists and a valid prescription is presented.
Pharmacists 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.”
Furthermore, the DEA knows and understands the processes and order to be a manufacturer. If Pronto Pharmacy engaged in manufacturing the requesting company must forward a 222 form. “Investigation concluded that Pronto Pharmacy is engaged in “manufacturing”
DEA’S ACTIONS AGAINST PRONTO PHARMACY ARE CONTRARY TO THEIR OWN WEBSITE
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’s 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 manufacturing. The chart of guidelines more than contradicts all DEA assertions made by both DI Albert and his handlers against Pronto Pharmacy.
VIDEO THE DEA IS COMING AFTER PHARMACIST
Yet, what is more, troublesome is 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.|
CONGRESS MUST INVESTIGATE REGULATORY RACISM
Rather than “compounding” controlled substances, as those terms are used in the CSA The DEA clearly knows and understands this practice. Therefore, the suggested manufacturing that occurred is negligent. Furthermore, to suggest through an opinion based on a red flag that Proto Pharmacy engaged in manufacturing and compounding-controlled substances on an individual patient basis are a far reach into the laws, and therefore, each prescription was filled outside the standard of care in Florida. This is an assumption that a crime was committed within the Pronto Pharmacy. This facility is a licensed pharmaceutical company. Which in fact, according to the law, compound oxycodone/ hydromorphone.
FLORIDA 64B16-27.700 Definition of Compounding.
“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S.
The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.
(1) Compounding includes:
(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis, and the patient has been made aware that the compounded product will be prepared by the pharmacist. The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible without notice to the practitioner.
If the officers were asked the difference between compounding and manufacturing, they must know what they are being asked. A reasonable officer could not support or testify to the facts of any item or file that was within the seized computer or secondary storage systems.
In an attempt to justify their law enforcement actions, law enforcement identified a Patient as the name A.H.: The agency indicated that on January 22, 2019, Pronto Pharmacy filled a 30-day prescription hydromorphone eight mg tablets for Patient A.H. The law enforcement agency indicated Pronto Pharmacy filled additional prescriptions for Patient A.H. for 30 days.
Supplies of hydromorphone eight mg tablets on February 15, 2019 (six days early).
What stands out within this warrant is the lacking of probable cause to support a search. Companies typically refilling prescriptions on or before seven days of a 30-day supply. What is most disturbing is the DEA has on its own criminalized medical therapeutic procedures. They further indicated that on February 27, 2019 (18 days early); and March 14, 2019 (15 days early) the prescriptions were refilled. This civilization of such procedures failed to indicate if the prescriptions refill, on February 27, and March 14, 2019, were partial refills. Whereby the officer’s affidavit to secure a search is tarnished whereby the testimony to secure the warrant is absent to indicating that prescription refills were acts of criminal conduct.
The members of the DEA and the Affiant, having subscribed and sworn to an affidavit for a search warrant, knew that while under oath deceived the judge by misrepresenting the facts to satisfied that probable cause exists. The officer should know that failing to express the facts that no C2 medication such as in the class of hydromorphone, and oxycodone cannot refill without a new prescription. When, in fact, a patient returns for medication that individual must present a new prescription.
The act in this matter violates the sanctity of law and the duty to protect and serve. The seizure of items just to discover what is believed to be a crime has no standings within the constitution and is a direct violation of the law and police conduct. This clearly supports the misconduct and the act of Giglio.
PETER PISCHKE ORWELL’S GENIE
FROM TRUMP TO BIDEN
” In the Trump era, things got bad enough. Recent studies examining Medicare found many patients had been abruptly discontinued. Another study found that nearly half of general practices now outright refuse to take on the care of a pain patient. The power of decision-making regarding prescribing got removed from your doctor and given to the state.
But under the leadership of the Biden administration, what was unofficial playing at the margins, is becoming law. The DEA is planning to create a program that entirely ignores everyone’s HIPPA privacy protections. In the face of evidence that proves prohibition doesn’t work (shocker), politicians like Sen. Elizabeth Warren are demanding even more regulation, and President Joe Biden, the genie for the far left, is likely to obey.
The last time I checked, we all supported HIPPA. We know that if people knew cancer patients and dying children get denied treatment, there would be hell to pay in Washington, DC. But as you see with the lockdown, the pain is hidden behind quiet walls; and America has become deaf to those cries that somehow breakthrough.
The DEA is acting in a way that will harm the vulnerable and the healthy as well. It is an open question as to how far Biden will let them push him. Americans should say something before we are left in a fatal, painful position and find out for ourselves.”
FOR NOW, YOU ARE WITHIN THE NORMS
- Mr. Krauss is a professor emeritus at George Mason’s Scalia Law School.
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, including 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, 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 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).”
4. https://thepostmillennial.com/joe-bidens-new-eo-that-denies-patients-in-pain-the-medication-they-need, 02/07/21, The Post Millennial, by Peter Pischke
5. https://thepostmillennial.com/joe-bidens-new-eo-that-denies-patients-in-pain-the-medication-they-need, 02/07/21, The Post Millennial, by Peter Pischke
11. https://www.acsh.org/news/2021/02/21/if-you-torture-data-long-enough-you-can-make-it-say-anything-15359, Richard “Red” Lawhern is a technically trained non-physician who advocates on behalf of patients who are now being widely denied safe and effective opioid therapy for their pain. I’ve been active in this field for 25 years, communicating with tens of thousands of patients, caregivers, and medical professionals.
14. ” America’s War on Drugs has played a profound role in reinforcing racial hierarchies. Although Black Americans are no more likely than Whites to use illicit drugs, they are 6–10 times more likely to be incarcerated for drug offenses. Helena B. Hansen, an assistant professor in the Department of Psychiatry at New York University, examines the recent history of White opioids to show how a very different system for responding to the drug use of Whites has emerged, in which addiction is treated primarily as a biomedical disease. Meanwhile, more punitive systems that govern the drug use of people of color have remained intact. At this seminar, Dr. Hansen argues that public concern about White opioid deaths creates an opportunity to reorient U.S. drug policy toward public health for all—and make proven harm reduction strategies widely available.”
15. We are especially grateful for the work of Belinda Brown Parker and her work on Predatory Policing by the Louisiana United International, Inc. There is a nexus and “We are united together to combat corruption including unlawful discrimination in the State of Louisiana Slidell, Lousiana,” the State of Florida, Michigan, Texas, and anywhere or form Predatory Policing exist, which is especially true in professional licensing and regulation.
Louisiana United International, Inc. Louisiana United International, Inc. (LUI) is an all-volunteer, nonprofit organization that is supported by people like you, who believe in the organization’s social justice work. LUI works diligently to combat and expose public sector corruption within the state. A part of this work calls for in-depth research and investigations.