“Timid men prefer the calm of despotism to the tempestuous sea of liberty.“

…Thomas Jefferson

from 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., 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., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, IN THE SPIRIT OF WALTER F. WRENN III., MD., JULIE KILLINGSWORTH,  RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, IN THE SPIRIT OF WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., IN THE SPIRIT OF FOREST TENNANT, MD., IN THE SPIRIT OF RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, 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

BY

JUSTCRANKY

@Eadranal on X

INTRODUCTION

“When Regulators Turn Suspicion Into Proof: Norman Clement’s Long Fight—and The Recent Court Rulings” / X

–That Caught Up

First, an Apology to Dr. Norman Clement

For years, Dr. Norman J. Clement argued that the DEA was turning undefined “red flags,” professional disagreements, and what a pharmacist should have known into proof of illegal drug dispensing. He lost his pharmacy registration and his court challenge. But Clement was not alone in identifying the problem. Pharmacy organizations and legal scholars were raising the same warning before his appeal was over. Then came Ruan, Ridley’s Family Markets, and, finally, the Fifth Circuit’s 2026 decision in Neumann’s Pharmacy v. DEA. None automatically reverses what happened to Clement. Together, however, they make his years-long warning considerably harder to dismiss.

I owe Dr. Norman J. Clement, R.Ph ., D.D.S., an apology.

Months ago, Dr. Clement sent me material about his case, the destruction of Pronto Pharmacy, his fight with the Drug Enforcement Administration, and what he believed had gone badly wrong in the government’s interpretation of controlled-substance law. I did not dismiss it. I simply did not have the headspace at the time to digest what he had assembled.

Letter to Dale Sisco 08/27/2026, from Norman J Clement, RPh, DDS;

“..Dale, we had it right all along..”

“..I took too long to work through it..”

There was a lot there: pharmacy law, administrative proceedings, federal regulations, racial-disparity allegations, pain policy, prescribing practices, DEA enforcement, court filings and years of personal advocacy. Clement writes with urgency because none of this is academic to him. His pharmacy was the target. His livelihood was affected. His professional reputation was damaged. And he has spent years trying to convince courts, regulators, healthcare professionals and anyone willing to listen that the government had blurred the line between suspicious circumstances and actual proof.

I took too long to work through it. Having now compared Clement’s early arguments not only with the record in his own case, but with contemporaneous pharmacy-industry advocacy, later legal commentary and subsequent federal decisions, I see something I did not fully appreciate before:

Clement was not merely looking backward after losing and inventing a new explanation for why the government was wrong. He was pressing a real legal issue while his case was still alive—and other knowledgeable people were independently warning about substantially the same problem.

That distinction matters. He deserves credit for his persistence. He also deserves something people who challenge powerful institutions rarely receive: a fair look at whether later developments validated at least part of what they were saying all along.

In Clement’s case, they did.

Norm, “..There was never a doubt we had it right..”

FACTS

“The Issue Is Bigger Than One Pharmacist”

Strip away the legal terminology and the basic question is one any citizen can understand:

If a law says the government must prove that you “knowingly” did something wrong, can an agency punish you instead because it thinks you “should have known”?

Those phrases are not interchangeable. “Knowingly” is about what a person actually knew. “Should have known” is generally about negligence—what a reasonable person in the same position might have recognized. The difference can separate a professional mistake from intentional misconduct. In controlled-substance cases, it can help separate healthcare from drug trafficking. That distinction became central to the government’s treatment of pharmacies during the opioid crisis.DEA developed an enforcement framework around what it calls prescription “red flags”: long travel distances, cash payments, combinations of medications, early refills, high doses, multiple patients seeing the same physician, and other circumstances believed to indicate possible diversion.

Some of these can unquestionably justify investigation.

But that leaves another question:

What does a red flag actually prove?

A person might drive 100 miles to a doctor because the doctor is unlawfully selling prescriptions. Or because local physicians refuse to treat chronic pain. A patient might pay cash because he wants to conceal drug seeking. Or because he lacks insurance.

A prescription might combine an opioid and benzodiazepine because a careless or corrupt doctor wrote it. Or because a licensed physician decided the benefits justified the risks in a particular patient. A red flag can tell an investigator to look harder. That does not necessarily mean the prescription was invalid. And even an invalid prescription does not automatically establish that the pharmacist knew it was invalid. Dr. Clement has been hammering on those distinctions for years.

What Happened at Pronto Pharmacy

Clement owned Pronto Pharmacy in Tampa, Florida.

DEA investigated the pharmacy and ultimately revoked its controlled-substance registration. The case involved both dispensing allegations and a separate dispute over whether Pronto’s compounding activities required an additional DEA manufacturing registration. That second issue is important because no later decision discussed in this article automatically resolves every allegation against Pronto.

But the dispensing case is remarkable when viewed through today’s law. DEA relied heavily on supposed prescription red flags, including cash payments, long travel distances, early fills, high-strength medications and drug combinations. And the final agency decision contains an important admission.

The government did not allege that Pronto dispensed the prescriptions with actual knowledge that they lacked a legitimate medical purpose. Instead, DEA argued that the red flags were so strong that pharmacists either knew the prescriptions were illegitimate or were willfully blind to that fact. The final decision relied upon what a “reasonable pharmacist” would have recognized and whether the pharmacists sufficiently resolved the warning signs.

DISCUSSION

That is the heart of the problem.

The agency reasoned that certain red flags were so suspicious that they could not have been resolved by a reasonable pharmacist, and from that concluded the prescriptions were knowingly filled or that the pharmacists were willfully blind.

Florida professional standards were also woven into the analysis. DEA concluded that Pronto violated Florida pharmacy requirements by filling prescriptions presenting what the agency considered unresolvable red flags, and it used those alleged state-law shortcomings as part of the federal public-interest case against the pharmacy.

At the time, Clement kept asking whether the government had skipped a critical step:

Had anyone actually established that the prescriptions themselves were illegitimate when the doctors issued them?

Had anyone established that Pronto’s pharmacists actually knew that?

Those questions would later become central to federal court decisions. But Clement did not wait until 2026 to ask them.

Clement Was Making the Argument While His Case Was Still Alive

This is an important part of the history. By January and February 2022, while pursuing his D.C. Circuit challenge pro se, Clement was expressly attacking DEA’s red-flag theory. His filings argued that the term “red flags” had no basis in the text of the Controlled Substances Act or its implementing regulations and warned that pharmacists were being trapped between federal punishment for filling a prescription and professional consequences for refusing to fill a facially valid prescription.

“..Ridley’s still did not reverse Pronto. But by this point, Clement’s core complaint was becoming increasingly difficult to portray as fringe..”

Most importantly, Clement put the word “knowingly” front and center. His February 2022 dispositive filing argued that §1306.04 protects pharmacists because liability attaches to someone who “knowingly” fills an invalid prescription. The filing asserted that unless a pharmacist subjectively knows that a facially legitimate prescription was issued for illegitimate reasons, the pharmacist should not face liability merely for dispensing it.

That is strikingly close to what the Fifth Circuit would say four years later. But there is an important piece of context that actually strengthens rather than weakens Clement’s position. He was not the only person reading the regulation that way.

The Pharmacy Industry Was Sounding the Same Alarm

Before Clement filed that argument, the National Association of Chain Drug Stores had made substantially the same point to the United States Supreme Court. In December 2021, NACDS submitted an amicus brief in Ruan v. United Statesand Kahn v. United States. Although those cases concerned physicians, NACDS warned the Court that its interpretation could affect pharmacists because of their corresponding responsibility under §1306.04(a).

The organization stressed that pharmacists needed “clear and consistent rules” and focused specifically on the regulation’s knowledge requirement. Its argument was essentially that a pharmacist should not be exposed to severe liability for filling a prescription unless the pharmacist knew that the purported prescription was invalid. That same language and reasoning appeared in Clement’s early appellate materials.

That is significant for two reasons.

First, it means Clement’s legal objection was not some eccentric theory generated only after he had lost. A major national pharmacy organization was independently warning the Supreme Court about essentially the same statutory and regulatory problem.

Second, Clement recognized the importance of that argument to his own circumstances and carried it directly into his case. For a pro se litigant facing a federal agency, that deserves acknowledgment. He had identified that the real battleground was not simply whether red flags existed. It was whether those red flags could legally substitute for the knowledge the regulation actually required.

Then a Pharmacy-Law Scholar Called DEA’s System “Standardless”

In May 2022—while Clement’s litigation was still unfolding—pharmacist and lawyer David B. Brushwood wrote in the American Pharmacists Association’s Pharmacy Today about DEA’s use of unresolved red flags. Brushwood identified almost exactly the structural problem Clement had been fighting. DEA, he explained, treated a pharmacist as violating corresponding responsibility when the pharmacist knew or had “reason to know” that a prescription was invalid. The agency used unresolved red flags as evidence of that supposed reason to know.

But Brushwood noted something fundamental:

DEA had never incorporated “red flags” into the regulation itself and had not provided pharmacists with a regulatory standard explaining how they were supposed to recognize, resolve and document them.

He described the resulting documentation obligation as a “standardless responsibility.”

That article did not vindicate Clement’s individual case. But it independently validated one of the central institutional complaints he was making: pharmacists could discover what the DEA expected only after enforcement cases told them what they were supposedly supposed to have done.

That is a due process problem that ordinary citizens should understand immediately. Government normally tells you the rule first and punishes violations second. It should not punish first and reveal the rule through the punishment.

JUSTCRANKY

@Eadranal on X

Clement Lost in Court Anyway

On May 25, 2022 (see reference No. 21-1262), the D.C. Circuit summarily denied Clement’s petition for review. The court concluded that he had not shown the DEA decision to be arbitrary, capricious, an abuse of discretion, or otherwise unlawful. It also found that he had not demonstrated unfair or unequal treatment on the record before it. The decision was unpublished. That distinction matters when discussing Clement’s allegations that racial disparity influenced enforcement.

The court did not conduct some sweeping investigation and affirmatively determine that racial disparity could not have played a role in DEA enforcement. It held that Clement had not demonstrated unfair or unequal treatment sufficiently in that proceeding. Those are different propositions. But the legal story did not stop there.

One Month Later, the Supreme Court Changed the Conversation

On June 27, 2022, the Supreme Court unanimously decided Ruan v. United States. The case involved physicians criminally prosecuted under the Controlled Substances Act. The Court rejected an objective good-faith framework under which a practitioner could be convicted based on what a hypothetical reasonable doctor should have understood. The Supreme Court instead held that once authorization is properly placed at issue, the government must prove beyond a reasonable doubt that the practitioner knowingly or intentionally acted in an unauthorized manner.

That was a criminal physician case, not a pharmacy administrative-revocation case, so it did not automatically reverse Pronto. But Clement immediately recognized its significance. In August 2022, he sought rehearing in the D.C. Circuit and expressly invoked Ruan, arguing again that the government could not simply substitute its red-flag theory for the required state of mind. His rehearing effort failed. The Supreme Court subsequently declined to take his case, and rehearing there was also denied. A denial of certiorari, however, is not a Supreme Court ruling that the lower court was substantively correct; it means only that the Court chose not to hear the case. And again the legal issue kept moving in his direction.

By Late 2022, Mainstream Pharmacy-Law Commentary Was Saying Almost Exactly What Clement Had Been Arguing

In November 2022, pharmacist-lawyer Michael A. Dowell wrote in U.S. Pharmacist about the implications of Ruan for pharmacy corresponding responsibility. His analysis was unusually direct. He explained that DEA had historically pursued pharmacies on the theory that pharmacists “should have objectively known” prescriptions were invalid because of unresolved red flags. He then pointed to the actual text of §1306.04(a)—the same word Clement had emphasized:

Dowell reasoned that the DEA should first have to establish that the prescription itself was illegitimate and only then determine whether the pharmacist knowingly filled it. He specifically questioned DEA’s historical interpretation that allowed the agency to reach a corresponding-responsibility violation without first establishing the prescription’s illegitimacy. Read that again in light of Clement.

By November 2022, an established pharmacy-law publication was saying that the DEA must first establish that a prescription lacked a legitimate medical purpose before punishing a pharmacist under corresponding responsibility. That is not merely similar to Clement’s complaint. It is one of the principal questions he had been pressing about Pronto.

Outside Advocates Also Began Paying Attention to Clement Himself

Clement also continued speaking publicly. The record shows that as early as July 2021 he was attempting to participate in a CDC advisory meeting, identifying himself as Pronto Pharmacy’s owner and using his platform to criticize DEA and CDC opioid policy. His written material became part of the meeting record.

His advocacy continued after losing the pharmacy case.

In July 2024, Doctors of Courage published a profile titled “Dr. Norman Clement’s Fight Against Medical Injustice.” The article was openly sympathetic rather than neutral journalism, and its broader claims about discriminatory enforcement should be evaluated independently. But it provides third-party documentation that Clement had become an identifiable advocate challenging DEA red-flag enforcement and what he describes as “regulatory racism.”

“..It would now be equally irresponsible to characterize Clement simply as a disgruntled pharmacist who lost his DEA case and would not let it go. He was reading the regulation. He was asking why “knowingly” seemed to have become “should have known..”

That matters because Clement’s story did not disappear when his own appeal ended. He continued trying to connect his experience to a wider issue affecting pharmacists, physicians, and patients.

Then Came United States v. Ridley’s Family Markets

In January 2025, a federal district court in Utah considered a government case against Ridley’s Family Markets.

The allegations will sound familiar. DEA contended that pharmacists had dispensed prescriptions presenting numerous red flags: suspicious signatures, cash payments, dangerous drug combinations, unusual quantities, early fills and other circumstances. The government argued that all those warning signs showed pharmacists knowingly filled illegitimate prescriptions or were willfully blind. The court refused to grant the government summary judgment.

Because evidence that pharmacists should have recognized warning signs is not necessarily evidence that they actually recognized that prescriptions were illegitimate. The court emphasized that willful blindness requires a subjective belief that there is a high probability a fact exists and deliberate action to avoid learning that fact. It specifically observed that the sheer number of red flags, although potentially evidence of what pharmacists should have noticed, did not by itself establish their actual subjective awareness.

The court also noted that although red flags may constitute an industry concept, “there is no codified standard for what constitutes a red flag and how they should be resolved under the CSA.” That sentence deserves attention. Years earlier, Clement had protested that DEA’s red flags were not themselves a codified medical or statutory standard.

Brushwood had called the resulting regime “standardless.” Now, a federal district court recognized the same underlying ambiguity while refusing to equate what pharmacists should have known with what they actually knew. Ridley’s still did not reverse Pronto. But by this point, Clement’s core complaint was becoming increasingly difficult to portray as fringe.

And Then the Fifth Circuit Said It Plainly

On February 13, 2026, the United States Court of Appeals for the Fifth Circuit decided Neumann’s Pharmacy v. Drug Enforcement Administration. Judge Don Willett began with a basic principle of administrative law: DEA has broad authority to protect the public from diversion, but an agency cannot claim to apply an existing regulation while “quietly rewriting” it in practice. The court then examined §1306.04(a).

Its reading was straightforward. A pharmacist violates that provision only if three things are true: The pharmacist fills a prescription. The prescription was invalid. And the pharmacist fills it knowingly. Then came the first major blow to the DEA’s approach.

Before discussing what the pharmacist knew, DEA must establish that the prescription was invalid when the prescriber issued it—meaning it was written outside the prescriber’s usual course of professional practice. In Neumann, neither the DEA Administrator nor the ALJ had made that finding. They focused instead on how the pharmacy handled the prescriptions. The Fifth Circuit held that DEA had misapplied the regulation.

That is remarkably close to the question Clement had been asking about Pronto:

Where is the predicate finding that the prescriptions themselves were illegitimate?

The Fifth Circuit Also Rejected DEA’s “Reason to Know” Rule

The court then addressed DEA’s longstanding interpretation of §1306.04(a). For decades, the DEA has said a pharmacist violates the regulation when the pharmacist “knows or has reason to know” that a prescription was not issued for a legitimate medical purpose.

The problem is that the regulation does not say that.

The Fifth Circuit held that DEA’s interpretation could not be squared with the text. The pharmacist must know of the prescription’s invalidity. That does not eliminate willful blindness. A person cannot deliberately shield himself from facts he strongly suspects and then use intentional ignorance as a defense. But the Fifth Circuit carefully distinguished willful blindness from negligence.

Willful blindness requires a subjective belief that there is a high probability the relevant fact exists and deliberate steps to avoid learning the truth.

“Reason to know,” by contrast, is an objective standard. The court expressly rejected the idea that the two can simply be treated as equivalent. That distinction goes directly to the Pronto record, where the government did not allege actual knowledge but relied heavily on red flags and what reasonable pharmacists should have recognized. This does not mean a court has now adjudicated Clement’s case differently. It means a federal appellate court has rejected a legal formulation strikingly similar to one that played an important role in the agency reasoning he spent years challenging. That is meaningful validation.

Neumann Went Further: Professional Negligence Is Not Automatically Federal Drug Trafficking

The Fifth Circuit identified another problem with DEA’s approach. DEA had treated Neumann’s alleged failure to satisfy Louisiana’s pharmacy standard of care as establishing that the pharmacy acted outside the “usual course of professional practice” under federal law.

The court rejected that, too. It explained that the Controlled Substances Act does not turn every state-law act of professional negligence into a federal controlled-substance offense.

JUSTCRANKY

@Eadranal on X

There is a difference between acting as a bad pharmacist and ceasing to act as a pharmacist at all—for example, using professional credentials as a cover for illicit drug dealing. The court concluded that a state-law standard-of-care violation, standing alone, is insufficient to establish a federal §1306.06 violation.

That bears an obvious comparison to Pronto, where Florida professional standards and DEA red-flag expectations became intertwined in the agency’s federal public-interest analysis. Again, Neumann does not automatically invalidate Pronto. But it substantially strengthens the legal concern Clement was raising about converting pharmacy-practice disputes into federal controlled-substance violations.

This Is What Validation Actually Looks Like

There is an important difference between saying “Clement was vindicated” and saying “later developments validated important parts of Clement’s analysis.”

The first statement goes too far.

The second is supported by the record. Clement did not win his D.C. Circuit appeal. The Supreme Court did not reopen his case. The Fifth Circuit did not adjudicate Pronto Pharmacy.

Neumann arose in another circuit, involving another pharmacy and another record. And Pronto involved additional allegations, including compounding and registration questions, that Neumann does not resolve. But validation does not require pretending those facts away.

Look instead at the chronology.

Before Neumann, Clement argued that DEA red flags were not themselves codified standards and that §1306.04 required actual subjective knowledge. Before Clement’s appeal was resolved, a major national pharmacy organization was telling the Supreme Court that the knowledge requirement protected pharmacists from punishment for filling facially legitimate prescriptions they did not know were invalid.

In May 2022, an established pharmacy-law scholar described DEA’s red-flag documentation regime as a “standardless responsibility.”

In June 2022, the Supreme Court rejected negligence-like criminal liability for authorized practitioners in Ruan. Clement immediately tried to bring Ruan into his still-pending appellate fight.

In November 2022, U.S. Pharmacist published an analysis arguing that DEA should first have to establish that a prescription was actually illegitimate before holding the pharmacist responsible for knowingly filling it.

In 2025, the Ridley’s court held that abundant red flags may show what pharmacists should have recognized but do not automatically prove subjective knowledge, while acknowledging there was no codified federal standard telling pharmacists what constitutes or resolves a red flag.

And in 2026, the Fifth Circuit held that DEA had misread §1306.04(a): first prove the prescription was invalid; then prove the pharmacist knowingly filled it. The court separately rejected the transformation of ordinary state-law negligence into a federal “usual course” violation.

That is not retroactive exoneration.It is a substantial body of independent legal development converging on concerns Clement had been pursuing for years. He deserves credit for staying with them.

Why Ordinary Citizens Should Care

Most Americans will never own a pharmacy or prescribe an opioid. But they should still care deeply about what happened here. Administrative agencies control enormous parts of modern life: healthcare, banking, transportation, employment, environmental regulations, education, veterans’ benefits, disability programs, firearms licensing, taxes, and professional licensing.

Often an agency possesses the power not merely to fine someone but effectively to destroy a livelihood. That power is sometimes necessary. But the stronger the government’s power, the more important it becomes to insist upon a basic rule: The government must prove the violation that the law actually defines.

It cannot replace “knowingly” with “should have known.” It cannot transform an investigative clue into conclusive evidence. It cannot create substantive requirements one enforcement case at a time and then punish citizens for failing to anticipate them.

And it should not transform ordinary professional negligence into something resembling criminal conduct simply by attaching a federal regulatory label. These protections are not technicalities for wrongdoers. They are what allow citizens to know in advance what the government requires of them.

Red Flags Can Be Useful Without Becoming Verdicts

None of this requires pretending prescription diversion is harmless. DEA has a legitimate and important mission. There are corrupt prescribers.There are pharmacists who knowingly facilitate diversion.

There are forged prescriptions. There are patients who sell medications.

There are pharmacies that cease operating as healthcare businesses and become drug-distribution operations.

Those cases should be investigated and prosecuted. But powerful investigative tools become dangerous when institutions forget what those tools actually establish. A red flag is best understood as a question:

It should not silently become an answer:

Because a crime is happening.

That difference may seem obvious.

Clement spent years arguing that, in practice, it had become blurred. The later cases suggest he had a point.

What Concerned Citizens, Professionals and Advocates Can Do Next

The next question should not simply be whether Clement personally deserves another look. The broader question is whether the regulatory system should be changed so the same dispute does not repeat itself.

Require DEA to Write the Rules in Public:

Interested pharmacists, physicians, patient organizations, civil-liberties groups and professional associations can petition DEA for formal rulemaking. If DEA believes particular red flags create specific obligations, it should identify them through notice-and-comment rulemaking. The public should be able to see the proposed rule, examine the supporting evidence, challenge ambiguous terminology, and comment before an enforcement standard becomes binding in practice. A pharmacy should not have to read hundreds of administrative decisions to discover what the government expects next Tuesday.

Demand a National Review of Old Red-Flag Cases:

Congressional committees, the Department of Justice, DEA leadership and inspectors general should review prior cases in which liability depended materially upon formulations such as “knows or has reason to know,” “reasonable pharmacist,” unresolved red flags or state-standard-of-care violations treated as federal offenses.

That does not mean every past enforcement action was invalid.It means cases built on interpretations a federal appellate court has now rejected deserve scrutiny. The review should ask how often DEA actually proved that the underlying prescriptions were invalid and how often the agency instead inferred invalidity from pharmacy-side warning signs.

Examine Whether Enforcement Was Unequal:

Clement has long alleged that race and the treatment of minority-owned healthcare businesses deserve closer examination. Those allegations have not been judicially established merely because he made them, and the D.C. Circuit held that he failed to demonstrate unfair or unequal treatment on appeal.

But there is a straightforward way to examine the broader question: obtain the data.

Congress, researchers and watchdog organizations should compare DEA enforcement according to pharmacy ownership, race where lawfully measurable, geographic location, business size, controlled-substance volume, patient mix, prescribing patterns, corporate structure and enforcement outcome.

The comparison cannot simply ask whether both a large chain and an independent pharmacy were ever investigated. It should ask whether similarly situated conduct produced similarly severe consequences.

Evidence should answer that question—not assumptions in either direction. Separate Professional Discipline From Drug Trafficking State pharmacy and medical boards have legitimate authority to enforce standards of professional practice. DEA has legitimate authority to enforce federal controlled-substance law. But those functions should not become interchangeable.

A pharmacist who inadequately documents a phone call may have a professional-practice problem. A pharmacist who knowingly supplies controlled substances pursuant to sham prescriptions may have a federal drug problem. Sometimes the same conduct may support both.

But regulators should prove each separately.

Neumann provides a useful warning against simply converting the first into the second. Create Good-Faith Safe Harbors

Congress or DEA could create clear protections for pharmacists who make reasonable, documented good-faith efforts to verify questionable prescriptions. A pharmacist who checks the prescription-monitoring database, speaks with the patient, contacts the prescriber, documents the explanation and reaches a reasonable professional judgment should know what legal protection that process provides.

A system that constantly tells pharmacists they have a “corresponding responsibility” while refusing to tell them what satisfies it predictably encourages defensive medicine and defensive pharmacy practice. Protect Patients From Enforcement Shockwaves

When a pharmacy or physician suddenly loses controlled-substance authority, the consequences do not stop with the accused professional. Patients may lose access to their established medication overnight.

Some may be taking medicines that cannot safely be abruptly discontinued. Some may have complicated cancer, palliative-care, surgical, psychiatric or chronic-pain needs. Any enforcement system serious about public safety should include continuity-of-care planning so that punishment of a registrant does not unintentionally punish innocent patients.

Build a Rapid-Response Legal Network. One of the practical lessons from Clement’s case is how difficult it is for an individual professional to fight a federal agency alone. Pharmacy groups, medical organizations, civil-liberties advocates, and patient organizations should develop a coordinated network capable of rapidly identifying important DEA cases, preserving expert testimony, filing amicus briefs, and challenging questionable legal standards before a case becomes final.

A pro se pharmacist should not have to personally reconstruct federal administrative law while simultaneously trying to save his business. Ask Courts to Keep Asking the Predicate Question

Future litigation should repeatedly return to the sequence identified by the Fifth Circuit. Before discussing the pharmacist’s conduct under §1306.04(a):

Was the prescription actually invalid when the prescriber issued it?

Did this pharmacist know that it was invalid—or genuinely engage in willful blindness?

Those questions force the government to prove the actual violation rather than letting suspicious circumstances do all the work. And Neumann does not simply reopen every DEA case decided under an earlier interpretation. There may be formidable procedural barriers to any attempt to obtain new relief for Pronto Pharmacy.

But there are questions worth examining. Could DEA voluntarily reconsider aspects of the matter?

Could state licensing authorities reassess any findings that depended upon the federal reasoning later rejected elsewhere?

Could Congress ask DEA to identify older cases materially dependent upon the “reason to know” interpretation?

Could an inspector general review whether enforcement standards were adequately published and consistently applied?

Could Clement’s case become part of a broader retrospective examination even if the original judgment cannot simply be reopened?

Those are legitimate questions. They should not be dismissed merely because Clement has been asking them for a long time.

Persistence Looks Different After the Law Moves

People who spend years challenging government institutions are easy to caricature. Once they lose, every additional filing can be described as refusing to accept reality.

Every public statement can be treated as bitterness. Every accusation of institutional failure can be dismissed as self-interest.

Sometimes that assessment is correct. Sometimes the person lost because the argument was wrong. But there are also cases where the law itself continues developing after the courthouse doors close. That is what makes Clement’s story worth revisiting.

Yet while he was fighting, national pharmacy advocates were warning about the same knowledge requirement. A respected pharmacy-law scholar called DEA’s emerging red-flag obligations “standardless.” The Supreme Court subsequently strengthened the importance of subjective intent in controlled-substance prosecutions.

A pharmacy law publication then said the DEA should have to establish that a prescription was invalid before blaming the pharmacist. A federal district court refused to equate numerous red flags with actual subjective awareness and acknowledged the absence of a codified federal red-flag standard.

Finally, the Fifth Circuit held that DEA had indeed misinterpreted §1306.04(a) by failing first to establish prescription invalidity and by converting “knowingly” into an objective “reason to know” test. It also rejected the idea that ordinary professional negligence automatically becomes a federal controlled-substance violation.

That history does not prove every allegation Clement has made. It does something more credible. It shows that the central legal concern he refused to abandon was real.

JUSTCRANKY

@Eadranal on X

Dr. Clement Deserves His Due

There are parts of Dr. Norman Clement’s advocacy that are intentionally provocative. There are claims that still require independent evidence. There are allegations of discriminatory treatment that deserve careful factual examination rather than automatic acceptance or automatic dismissal. And no responsible account should pretend that Neumann erased the separate allegations or procedural history of Pronto Pharmacy.

But fairness runs in both directions. It would now be equally irresponsible to characterize Clement simply as a disgruntled pharmacist who lost his DEA case and would not let it go. He was reading the regulation. He was asking why “knowingly” seemed to have become “should have known.”

He was questioning why undefined red flags could function as both suspicion and proof.

He was asking who had actually established that the doctors’ prescriptions were illegitimate.

He was warning that pharmacists were being forced to make legal judgments about physicians’ medical practice under threat of losing their own careers.

He was arguing that professional standards and federal drug-trafficking concepts were becoming dangerously blurred.

And he kept bringing those issues forward when very few people were listening. Other pharmacy advocates were raising the same concerns.

Legal commentators gave the concerns names.

Then courts began drawing the same distinctions. That does not make Dr. Clement right about everything. It does mean he deserves recognition for being early, persistent and willing to put his own name behind a challenge to a powerful federal enforcement system. And I owe him recognition for something more personal.

He sent me this story months ago. It took me too long to understand what he was trying to show me.

For the delay, Dr. Clement, I apologize. I understand the argument much better now. And after reading not only what you wrote, but what pharmacy organizations, pharmacy-law scholars, and federal judges later said, I believe the rest of us should be willing to take a much closer look too.

Because this was never only about one pharmacy in Tampa. It is about whether government agencies may transform warning signs into verdicts, negligence into intentional wrongdoing, and unwritten expectations into enforceable law.

That question belongs to every citizen.

BY

JUSTCRANKY

@Eadranal on X

🔓 🔓 🔓 

ALL WATCHED OVER BY MACHINES OF LOVING GRACE

ALL WATCHED OVER BY MACHINES OF LOVING GRACE

BE SURE TO DONATE TO THE MARK IBSEN GOFUNDME DEFENSE FUND, WHERE THE SON ALWAYS RISES!!!

FOR NOW, YOU ARE WITHIN

THE NORMS

end notes:

REFERENCES:

No. 21-1262

NOTES:

JUSTIA OPINION SUMMARY ON NEUMANN’S PHARMACY VERSUS D.E.A.

Justia Opinion Summary

A Louisiana pharmacy owned by a licensed pharmacist was investigated by the Drug Enforcement Administration after allegations arose that the pharmacy was filling prescriptions for itself and for patients with “red flags” indicating possible misuse or diversion of controlled substances. The DEA’s investigation focused on several prescriptions, including combinations of opioids and benzodiazepines for various patients, out-of-pocket payments for controlled substances, and a prescription filled by the pharmacist herself written by her physician father, which violated state law prohibiting physicians from prescribing controlled substances to immediate family.

Following an agency hearing before an administrative law judge, the DEA’s Administrator adopted the ALJ’s recommendation and revoked the pharmacy’s federal registration to dispense controlled substances. The Administrator concluded that the pharmacy had violated federal regulations and Louisiana law by filling prescriptions without adequately resolving red flags and by filling a prescription written in violation of state law. The pharmacy petitioned for review in the United States Court of Appeals for the Fifth Circuit.

The Fifth Circuit found that the DEA misinterpreted and misapplied its own regulations and state law. The court held that 21 C.F.R. § 1306.04(a) requires a pharmacist to “knowingly” fill an invalid prescription, which the DEA had not shown, and that a violation of the state-law standard of care is not, by itself, a violation of federal regulations. The court also held that the Louisiana law at issue did not apply to pharmacies. Because the DEA’s order rested on erroneous interpretations of governing regulations and state law, the Fifth Circuit vacated the deregistration order and remanded the matter for further proceedings.

https://law.justia.com/cases/federal/appellate-courts/ca5/25-60068/25-60068-2026-02-13.html