Originally written and submitted August 10, 2017
republished and re-reported by youarewithinthenorms.com
NORMAN J CLEMENT, RPH, DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MDLESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
DEA’s RICHARD ALBERT FALSIFIED ORDER TO SHOW CAUSE
This online article from “youarewithinthenorms.com” was initially published and submitted to the State of Florida Board on August 10, 2017, and critically examines the bogus work and investigation of DEA diversion investigator Richard Albert “Exactly 2 years later, on August 29, 2019, DEA investigator Richard Albert issued an Falsified Order To Show Cause stating Pronto Pharmacy was an Imminent Danger to Public Health for illegally manufacturing on the very same issue which the State of Florida resolved.
The article emphasizes that compounding pharmacies are state-regulated healthcare providers, not drug manufacturers, and criticizes the Drug Enforcement Administration (DEA) for an alleged misunderstanding of compounding laws and an overzealous pursuit of an “Opioid Epidemic” agenda. It also includes an expert opinion from Jack Folson, Jr., a clinical pharmacist and owner, further distinguishing compounding from manufacturing and advocating for the importance of compounding in patient care.
This case was to proceed before a Federal District Court in Tampa, Florida. Dale Sisco Esq is the attorney, 813-224-0555; however
THE REAL PURPOSE OF THE WAR ON DRUGS
This source presents a legal argument challenging an administrative complaint filed by the State of Florida Board of Health against Pronto Pharmacy.
Written by individuals identified as Norman J. Clement, RPh.DDS, Norman L. Clement, Pharm Tech, and Jelani Z. Clement, Pharm Tech, the text asserts that the complaint is “without LEGAL MERIT” and lacks a legal foundation, particularly concerning the pharmacy’s practice of anticipatory compounding.
The authors reference federal laws, including H.R. 244 and FDA LAW 503A, to support their claim that compounding pharmacies are state-regulated healthcare providers, not drug manufacturers, and are permitted to prepare limited quantities of drugs in advance of patient-specific prescriptions.
The source also addresses specific allegations, such as the pharmacy being open without a pharmacist and offering drug form choices to customers.
Maintaining these practices aligns with Florida law and prioritizes patient empowerment. Essentially, it’s a robust defense of compounding pharmacy practices against what the authors perceive as a misunderstanding of legal definitions and an overzealous approach by regulatory bodies.
IN THIS AGE OF FAKE NEWS AND ALTERNATIVE FACTS
(BOTH OF WHICH HAVE ABSOLUTELY NO MERIT IN THE PROFESSION OF PHARMACY)
NOTES
THERE IS ONE THING I’VE LEARNED IN LIFE from a man I didn’t like nor voter for, but have come to GREATLY respect:
PRESIDENT RONALD REAGAN;
“WE MUST TRUST AND VERIFY”
PRONTO PHARMACY LEGAL TALKING POINTS
The complaint filed by the Florida Department of Health (Case Number PH201705581) is without LEGAL MERIT, lacks ANY LEGAL FOUNDATION, and lacks probable cause.
The United States Congress’s intent was to allow compounders to compound a batch of drugs in anticipation of receiving patient-specific prescription.[i]
- 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 address 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.
- The law mandates that FDA recognize that federal oversight of 503A was not the intent of Congress and that compounding pharmacies are not drug manufacturers—rather they are “state-licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within the state.”[ii]
- FDA LAW 503A (a)(2) states the following examples:[iii]
a). “A compounder regularly receives valid prescription orders from a particular prescriber or prescribers, or for a particular patient or patients, for compounded drug X. The highest number of units of drug X for which the compounder has received valid patient-specific prescriptions in a 30-day period in the last year is 500 units.
Compounding up to 500 units of drug X in advance of receiving prescriptions for the drug, and holding no more than that amount to fill new, valid patient-specific prescriptions as the compounders receive them, would be consistent with this policy. [iv]
b). “ A compounder regularly receives valid prescription orders from a particular prescriber or prescribers, or for a particular patient or patients, for compounder drug” {FURTHER REVIEW PG 6,7,8,9 FDA GUIDELINES}
The complaint further alleges that, upon a routine inspection on 03/03/2017, the pharmacy was opened without a pharmacist. On March 3, 2017, the pharmacy was open with a pharmacist. March 3rd was Norman J Clement’s 66th birthday.
IN THIS ERA OF ALTERNATIVE NEWS AND FACTS, WE LEARN that THAT CONCEPT HAS ABSOLUTELY NO basis in pharmacy. OUR ATTITUDE IS BASED ON PRESIDENT RONALD REAGAN’S “TRUST AND VERIFY”
- The Pharmacy was not opened for dispensing, on 3/30/2017. The pharmacy was locked and secured no medications were being dispensed and the pharmacy being monitored through our security system by a Florida Licensed Pharmacist. The Pharmacy waiting room was open for guests to sit and watch television until the pharmacist arrived on-premises, more importantly, the woman observed in the window is the pharmacist’s wife and an owner the window is not in the filling area. The licensed technician is the pharmacist’s son and was not dispensing, filing medications until his father arrived.
- “THE MISSION OF THE DEPARTMENT OF HEALTH IS TO PROTECT, PROMOTE & IMPROVE THE HEALTH OF ALL PEOPLE IN FLORIDA THROUGH INTREGRATED STATE, COUNTY AND COMMUNITY EFFORTS” therefore Pronto Pharmacy LLC can fill and dispense prescription from anywhere in the State of Florida.
The complaint is that the Pharmacist, Clement, advised that he give customers a choice between capsules and tablets, and that capsules are cheaper than tablets.
- Florida laws differs to and empower the patients IN THE STATE OF FLORIDA, All Pharmacy are required to post by law visible to the public “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW
- Cocktail: Drug Optimization, CML: Gleeves, Cytarbine, Doxirubecine, Vincristine, Chlorambucil, Use in “cocktails”. Cocktail is prosecutorial slang, just like pill mills, in order to secure convictions by juries and fail to inform juries of drug optimization, mechanism of action, and pathophysiology.
A) If such a combination weren’t being used, a larger amount of the Opiate would be required.
B) Such so-called prosecutorial expert testimonies are seriously flawed and go unchallenged. Ref: Edward Imwinkelreid, When Science Takes the Stand.
10. RED FLAG IN LIFE ARE NOT LIKES STOP SIGNS IN TRAFFIC…document, evaluate, access every case individually, (don’t lie to us), distant documented same reason I go to the Henry Ford Hospital Center in Detroit (HFH) for colon cancer treatment, local pharmacy areas does not fill my prescriptions,” rejected 25 times particularly minorities,” statement of a patient coming to pronto.. may set us up for discrimination and/or profiling. We simply treat people with dignity and respect.
11. DX Codes: Question: What Purpose: we are here to render a second opinion, eg, dental ridge augmentation, sinus lift, dentist complaint patient unable to get medication filled.
A)Concern: Flip-flopping if we consult with the provider charged with conspiracy, conclusion, so we avoid or limit our contact.
B)Moving the Goal Post backward and forward.
12. Insurance: Critical discussion most insurances aren’t avail to small pharmacy establishment rules for eligibility change all the time.
13. CHINESE DISSIDENT: ARTIST AL WEIWEI, I cannot live in fear, we must live by the law. Where is the law DEA: put it in writing , miles, diagnostic codes( Costco’s, Sam’s, CVS, Walgreens, anticipatory compounding, cocktails, pill mills, insurance, cash payment.
COMPOUNDING VS MANUFACTURING
According to Jack Folson, Jr, Clinical Pharmacist, Owner of THE CALYX GROUP, Expert in Pharmacy Practice, “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, according to two economists, was the first change in patent terms since 1861. One of the pillars of the generic drug push by Congress was to ensure that patients had affordable alternatives to brand-name drugs.
Compounding has been a primary facet of pharmacy practice since the profession’s inception. 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 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 refers to the process of creating or modifying drug products to be tailored to the individual patient, regardless of whether this is done at a factory or 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 I do.
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. However, I maintain that my interpretation of all these sometimes seemingly conflicting laws and regulations is understandable to me.
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 the Administrative trial, held in late January 2020, Mr. Sullivan expressed his opinion that compounding should be narrowly defined. This flies in the face of 200 years of Pharmacy Practice standards. 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 suboptimal. 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 (e.g., Cimetidine), but small-batch compounding can only affect a few people and is 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 a stronger hold on the government through their bribes and corruption, the compounding in the Pharmacy began to diminish. We found that as insurance penetration into the profession increased, the reimbursement for compounding decreased.
However, Congress and the State Boards of Pharmacy have not entirely abandoned the profession, and compounding still holds 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 necessary components for compounding are present, rather than those required for manufacturing. 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 show up in reasonable time frames. All over the country, anticipatory compounding is done, and a typical limit is about 3 weeks , but it may last as long 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. DEA’s Diversion Expert Investigator Richard J. Albert admitted at trial that he has 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—
(1)to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense a controlled substance
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 independent activities; 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 of 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 activities
As can be seen, when the DEA contended that Pronto Pharmacy needed to be registered as a manufacturer, the law states otherwise. Compounding of controlled substances has been taking place in every state of the union since its inception. If the prohibition is against a certain substance, the law could be changed, 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, which 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 define the issue too broadly by piercing anticipatory compounding would be counterproductive.
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 doubtful that the Legislature would have intended 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 responsible for administering and enforcing the Controlled Substances Act.
The State Boards of Pharmacy regulate the practice of 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 available in the public space to help figure these things out. However, they did not focus their gaze on the possible treatment of patients but instead on suspicion and innuendo.
A reasonable and prudent individual might conclude that discovering the truth was not the goal in this investigation.”
Living in the Spirit of Sankofa
For Now You’re Within
The Norms
[i] http://www.pharmacist.com/article/federal-funding-law-includes-compounding-language-apha-win
[ii] https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm496286.pdf
[iii] In this example, it would be consistent with FDA’s policy if, after distributing 200 units of drug X pursuant to valid patient-specific prescriptions, the compounder produces up to 200 additional units of drug X so that the total number of units that the compounder is holding for distribution returns to 500 units.
- [iv] The limited quantities policy, which relates to the amount of inventory held by the compounder, does not alter the product’s BUD. For example, if the BUD for the product is 9 days, the compounder should not produce more units than can be distributed pursuant to valid prescriptions and used within 9 days.
_______________________________________________________
REFERENCES:
Detailed Briefing Document: Pronto Pharmacy Legal Challenge
Overview
This briefing document summarizes the key arguments and facts presented in “Pronto Pharmacy: Challenging the Florida Board of Health Complaint,” an article from youarewithinthenorms.com, originally published August 10, 2017, and updated regarding a subsequent DEA “Order To Show Cause” on August 29, 2019. The article, authored primarily by Norman J. Clement, RPh, DDS, Norman L. Clement, Pharm Tech, and Jelani Z. Clement, Pharm Tech, presents a robust legal defense of Pronto Pharmacy against administrative and federal allegations, particularly concerning anticipatory compounding and the distinction between compounding and manufacturing.
Main Themes and Most Important Ideas/Facts
The central contention of the document is that the administrative complaint filed by the State of Florida Board of Health (Case Number PH201705581) and subsequent DEA actions against Pronto Pharmacy are “without LEGAL MERIT, lacks ANY LEGAL FOUNDATION, and lacks probable cause.” The authors emphasize a need for “TRUST AND VERIFY,” attributing this ethos to President Ronald Reagan.
1. Distinction Between Compounding and Manufacturing: The Core Legal Argument
- Federal and State Law Support Anticipatory Compounding: The document asserts that both federal and Florida state law explicitly permit licensed pharmacists to compound “in limited quantities before the receipt of a valid prescription order for such individual patient.” This is a crucial point, directly countering the state’s implicit (and the DEA’s explicit, later) accusation of illegal manufacturing.
- H.R. 244 and FDA LAW 503A: The authors cite specific legislation to support their claims:
- H.R. 244, signed into law by President Donald J. Trump, clarifies that Congress did not intend for the FDA to regulate “dispensing” but rather “distribution,” and that compounding pharmacies are not drug manufacturers. Instead, they are “state-licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within the state.”
- FDA LAW 503A (a)(2) provides examples of permissible anticipatory compounding, illustrating that a pharmacy can compound quantities based on a history of receiving valid patient-specific prescriptions. For instance, if a compounder regularly receives 500 units of a drug in a 30-day period, compounding up to 500 units in advance is consistent with policy.
- Definition of Manufacturing vs. Compounding: The document meticulously quotes federal statutes (21 U.S. Code § 802 for manufacturing and Section 503A of the Federal Food, Drug, and Cosmetic Act for compounding). The critical exception in the manufacturing definition is that it “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.” This directly supports Pronto Pharmacy’s activities as compounding, not manufacturing.
- Expert Opinion on Compounding: Jack Folson, Jr., Clinical Pharmacist Owner of THE CALYX GROUP, an expert in pharmacy practice, states that compounding has been a primary facet of pharmacy practice since its inception. He criticizes the narrow interpretation of compounding by opposing “experts” (Mr. Sullivan, Mr. Alpert), stating it “flies in the face of 200 years of Pharmacy Practice standards.”
- Safety and Cost-Effectiveness: The document argues that small-batch compounding is safer than manufacturing errors leading to nationwide recalls and allows pharmacies to offer more affordable alternatives, aligning with the spirit of the Hatch-Waxman Act which promotes generic drugs. “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.”
2. Allegations and Rebuttals Regarding Pharmacy Operations
- Pharmacy Open Without a Pharmacist: The complaint alleged the pharmacy was open without a pharmacist on March 3, 2017. The authors refute this, stating a pharmacist (Norman J. Clement) was present, noting it was his 66th birthday. For March 30, 2017, they clarify the pharmacy was “not opened for dispensing” but the “waiting room was open for guests to sit and watch television until the pharmacist arrived.” They explicitly state the woman observed was the pharmacist’s wife and owner, and the licensed technician (the pharmacist’s son) was not dispensing until his father arrived.
- Customer Choice on Drug Forms (Capsules vs. Tablets): The complaint cited the pharmacist advising customers of choices (e.g., capsules being cheaper). The authors argue this is compliant with Florida law, which “empower[s] the patients IN THE STATE OF FLORIDA” by requiring pharmacies to post information advising customers to “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG.”
3. Challenges to Prosecutorial Practices and Expert Testimony
- “Cocktail” as Prosecutorial Slang: The document criticizes the use of terms like “Cocktail” (referring to drug combinations) and “pill mills” as “prosecutorial slang” designed to secure convictions by juries without informing them of “drug optimization, mechanism of action, and pathophysiology.” They argue that such combinations might require a smaller amount of opiates.
- Flawed Expert Testimonies: The authors assert that prosecutorial expert testimonies are “seriously flawed and go unchallenged,” referencing Edward Imwinkelreid’s “When Science Takes the Stand.” They specifically highlight DEA Diversion Expert Richard Alpert’s admission at trial that he had “no understanding of compounding.”
- DEA Lack of Understanding/Evidence: The document repeatedly claims the DEA lacks mastery of compounding laws and did not produce evidence demonstrating such understanding.
4. Anticipatory Compounding of Controlled Substances
- Legality Under DEA Regulations: Despite the DEA’s contention of “illegally manufactured controlled substances,” the authors cite 21 USC § 1301.13, which explicitly allows a pharmacist to “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.” This falls under “Dispensing or Instructing” business activity, including retail pharmacies, and is permitted without requiring a separate manufacturer registration.
- Historical Precedent: They argue that “Compounding of controlled substances has been taking place in every state of the union since its inception.”
- Consequences of Prohibition: Prohibiting anticipatory compounding would lead to “many far-reaching negative consequences for patient care and an exponential increase in unnecessary waste.” It would affect a vast array of dosage forms and drugs, posing an “egregious threat to public safety” and “burdensome costs.”
5. Criticisms of the Investigation and Broader Context
- Lack of Truth-Seeking: The authors conclude that “the search for truth was not existent in this procedure,” citing the DEA’s failure to interview prescribers, analyze PDMP data, or understand patient needs and pain management therapies.
- “Prosecutorial Myopathy” and “Witch Hunt”: The document suggests the DEA’s actions were driven by an “agenda which is based upon incomplete information and a desire to combat the so called ‘Opioid Epidemic’,” leading to “overzealous” focus on diversion and making individual practitioners a “scapegoat.”
- Distinction Between Suspicion and Actual Diversion: A key point is that “suspicion of diversion is not necessarily actual diversion.”
- Overlapping Jurisdictions: The authors acknowledge that pharmacists must navigate “sometimes overlapping jurisdictions and subsequently possibly contradictory information” from the FDA (regulating compounding and manufacturing), DEA (enforcing Controlled Substances Act), and State Boards of Pharmacy (regulating practice of compounding).
Timeline of Main Events
- 1861: First change in patent terms for drugs since this year, preceding the Hatch-Waxman Act.
- 1984: The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) is legislatively negotiated and signed into law, aiming to balance drug development with generic drug availability.
- March 3, 2017: Pronto Pharmacy undergoes a routine inspection. The Florida Department of Health’s administrative complaint later alleges the pharmacy was open without a pharmacist on this date. The authors of the source clarify that Norman J. Clement was present (it was his 66th birthday), and the pharmacy was not open for dispensing, but the waiting room was accessible, with monitoring by a licensed pharmacist.
- March 30, 2017: The Florida Department of Health’s administrative complaint alleges the pharmacy was open for dispensing without a pharmacist. The authors of the source state the pharmacy was locked and secured, not dispensing medications, and monitored by a licensed pharmacist. The woman observed in the window was the pharmacist’s wife and owner, and the licensed technician (the pharmacist’s son) was not dispensing until his father arrived.
- August 10, 2017: The administrative complaint (File Number PH201705581) is filed by the State of Florida Board of Health against Pronto Pharmacy. This is also the initial publication date of the “youarewithinthenorms.com” article challenging the complaint.
- 2019 (likely early): The Office of the Inspector General (OIG) issues a report on the DEA (referenced by the authors as E1905.pdf), criticizing the DEA’s focus on diversion, which the authors suggest contributed to an “overzealous” approach leading to cases like Pronto Pharmacy’s.
- August 29, 2019: DEA Investigator Richard Albert issues a “Falsified Order To Show Cause” stating Pronto Pharmacy was an “Imminent Danger to Public Health” for illegally manufacturing, on the same issue previously addressed by the State of Florida.
- Unknown Date (Pre-publication): President Donald J. Trump signs H.R. 244 into law, clarifying compounding regulations implemented in the Drug Quality and Security Act (DQSA 2013). This law clarifies that Congress did not intend for the FDA to redefine “distribution” to include “dispensing” across state lines, and that compounding pharmacies are state-licensed healthcare providers, not drug manufacturers.
- Trial (Date not specified): A trial related to the DEA’s allegations against Pronto Pharmacy takes place. Key participants include Administrative Law Judge Mr. Dowd, Diversion Expert Mr. Alpert, Prosecutor Mr. Beerbower, and Expert Witness Mr. Sullivan. During this trial, Mr. Sullivan expresses an opinion that compounding should be narrowly defined, and Mr. Alpert admits he has no understanding of compounding. The case was set to proceed before a Federal District Court in Tampa, Florida.
Cast of Characters
- Norman J. Clement, RPh, DDS: One of the primary authors and challengers of the Florida Board of Health complaint against Pronto Pharmacy. He is identified as a pharmacist and owner of Pronto Pharmacy. It was his 66th birthday on March 3, 2017, the date of a pharmacy inspection. He is also mentioned as having given customers choices between capsules and tablets, noting capsules are cheaper.
- Norman L. Clement, Pharm Tech: An author of the article challenging the complaint, identified as a Pharm Tech. He is also the son of Norman J. Clement and a licensed technician at Pronto Pharmacy.
- Jelani Zimbabwe Clement, BS, MBA: An author of the article challenging the complaint, identified with a BS and MBA.
- Richard James Alpert (Richard Albert): A DEA investigator who issued a “Falsified Order To Show Cause” against Pronto Pharmacy on August 29, 2019. He is referred to as a “Diversion Expert” in the trial, but admitted at trial that he had no understanding of compounding.
- Dale Sisco Esq: The attorney for Pronto Pharmacy in the Federal District Court case in Tampa, Florida.
- Jack Folson, Jr.: Clinical Pharmacist Owner of THE CALYX GROUP, an expert in Pharmacy Practice, Compounding vs. Manufacturing. He provides extensive expert opinion and background on compounding and manufacturing, including his own experience in both. He asserts that he could be considered an “authority” on the subjects due to his varied experience.
- Mr. Dowd: The Administrative Law Judge in the trial related to Pronto Pharmacy.
- Mr. Beerbower: The Prosecutor in the trial related to Pronto Pharmacy.
- Mr. Sullivan: An Expert Witness in the trial related to Pronto Pharmacy. His opinion that compounding should be “narrowly drawn” is critically challenged by the authors.
- Walter F. Wrenn III., MD., Julie Killingsworth, Renee Blare, RPh, Dr. Terence Sasaki, MDLesly Pompy MD., Christopher Russo, MD., Nancy Seefeldt, Willie Guinyard BS., Joseph Webster MD., MBA, Beverly C. Prince MD., FACS., Neil Arnand, MD., Richard Kaul, MD., Leroy Baylor, Jay K. Joshi MD., MBA, Adrienne Edmundson, Ester Hyatt Ph.D., Walter L. Smith BS., Michele Alexander MD., Cudjoe Wilding BS, Martin Njoku, BS., RPh., Beres E. Muschett: Individuals listed under the author’s names, identified as “Strategic Advisors” or associated with the “In the Spirit of…” acknowledgments, suggesting their influence, inspiration, or support for the authors’ work, though their direct roles in the events are not detailed.
- Belinda Brown-Parker: Listed with the authors’ names and “Strategic Advisors.”
- Harvey Jenkins MD, Ph.D.: Listed with the authors’ names and “Strategic Advisors.”
- The Pharmacist’s Wife (Pronto Pharmacy Owner): An unnamed individual, identified as an owner of Pronto Pharmacy and the wife of Norman J. Clement. She was observed in the pharmacy window on March 30, 2017, but not in the filling area.
- President Ronald Reagan: Referenced for his quote, “WE MUST TRUST AND VERIFY,” used by the authors to underpin their approach to the allegations.
- President Donald J. Trump: Signed H.R. 244 into law, which clarified compounding regulations and affirmed that compounding pharmacies are state-regulated healthcare providers, not drug manufacturers.
- Al Weiwei: Chinese dissident artist, quoted by the authors for his statement, “I cannot live in fear; we must live by the law.”
Conclusion
The “Pronto Pharmacy” document presents a comprehensive challenge to the legal and factual basis of the complaints against the pharmacy. Its core arguments hinge on a detailed interpretation of federal and state laws regarding compounding, particularly anticipatory compounding, and a strong assertion that Pronto Pharmacy’s practices align with established pharmacy standards and patient care principles, rather than constituting illegal manufacturing or other violations. The authors portray the actions against Pronto Pharmacy as misguided and based on a fundamental misunderstanding of pharmacy practice and relevant regulations, driven by an “overzealous” pursuit of an anti-opioid agenda.
