FDA's Peptide "Interim Access Policy" Is Not Amnesty: The Federal Criminal Exposure Florida Compounders, Clinics and Peptide Sellers Still Face

On October 14, 2026, the FDA sent the White House a document titled "Interim Access Policy for Compounding Using Certain Peptides." The OMB regulatory review listing (RIN 0910-ZD94) calls it a notice, not a rule, and says nothing about what it contains. Press reports, citing unnamed sources, say it would let pharmacies temporarily compound popular peptides, BPC-157 among them. If you compound, prescribe, inject or sell peptides in Florida, that headline is already being read as permission. It is not. The distance between what this policy can do and what the market thinks it does is where the next round of federal peptide cases will come from.

A notice under White House review is not a rule. The statutes that govern peptide compounding and sales have not moved.

Key Takeaways

• The FDA peptide interim access policy, RIN 0910-ZD94, is a notice under White House review, not a rule, and its text is unpublished.
• Enforcement discretion leaves the statutes intact; 21 U.S.C. § 331 and 21 U.S.C. § 333 still criminalize distributing misbranded and unapproved drugs.
• FDA's existing 503A bulk-substance policy shields licensed pharmacies and physicians only, not research use only sellers or online peptide distributors.
• Past sales are not forgiven, and wire fraud and conspiracy charges under 18 U.S.C. §§ 1343 and 1349 sit entirely outside FDA's discretion.
• Florida compounders, telehealth prescribers and Southern District of Florida med spas should audit sourcing and marketing now, before the policy's conditions are published.

What the FDA Sent the White House on October 14

The primary source is thin, and that matters. The OIRA entry lists HHS and FDA as the agency, RIN 0910-ZD94, stage "Notice," received October 14, 2026, not economically significant, no legal deadline. That is the whole public record. According to Reuters, the filing gives no details, and the Associated Press, citing two people familiar with the plan, reported that it would allow some popular peptides, including BPC-157, to be compounded.

The backdrop is the FDA's July 23 and 24 Pharmacy Compounding Advisory Committee meeting, which took up seven peptides as candidates for the 503A Bulks List: BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and epitalon. FDA's own reviewers recommended against all seven. Published reports say the committee recommended easing restrictions on six. Formally adding a substance to the bulks list under 21 U.S.C. § 353a takes notice-and-comment rulemaking. An interim access notice is the shortcut: the agency tells pharmacies what it will not pursue while the rule, if it ever comes, works its way through.

FDA's existing interim policy turns on four conditions, including registered manufacturers and a valid certificate of analysis. Miss one and the product is outside the policy.

What Enforcement Discretion Is, and What It Is Not

FDA already runs this kind of program, and its structure tells you what to expect. Under its January 2025 Interim Policy on Compounding Using Bulk Drug Substances, FDA says it does not intend to take action against a State-licensed pharmacy, a Federal facility or a licensed physician compounding with a Category 1 substance when four conditions are met: the substance appears in Category 1 on FDA's website, every manufacturer in the chain is registered under section 510, the substance comes with a valid certificate of analysis, and the product is compounded in compliance with all other conditions of section 503A.

Miss one condition and the product is outside the policy. A footnote in the same guidance states that drug products distributed in violation of these or other provisions of the Act remain subject to enforcement action. Expect the peptide notice to be drafted the same way. The conditions are the whole game.

Three limits follow. First, enforcement discretion is a statement about where FDA will spend its resources. It does not amend the Federal Food, Drug, and Cosmetic Act, it can be narrowed or withdrawn, and it does not bind a federal grand jury. Second, it reaches only the people it names. FDA's existing policy covers licensed pharmacies, Federal facilities and physicians. A research use only website, a gym selling vials, or a med spa reselling product it bought from an unregistered source is not a pharmacy compounding under 503A. Third, it is not retroactive. Peptides sold last year were sold while FDA's own scientists were telling the compounding committee these substances should not be compounded.

The Charges That Remain on the Table

The core statute is 21 U.S.C. § 331. Section 331(a) prohibits introducing a misbranded or adulterated drug into interstate commerce, and section 331(d) reaches introduction of an unapproved new drug under 21 U.S.C. § 355. Misbranding is defined in 21 U.S.C. § 352. Penalties sit in 21 U.S.C. § 333: a misdemeanor of up to one year that requires no proof of intent, and a felony of up to three years per count when the government proves intent to defraud or mislead.

Compounding protection under section 503A is conditional. The statute requires, among other things, a valid prescription for an identified individual patient, limits on anticipatory compounding, and bulk drug substances from registered establishments with a valid certificate of analysis. A product that fails those conditions loses the exemptions from the new drug approval and labeling requirements, and the case becomes a straightforward introduction of unapproved new drug prosecution.

Wire fraud under 18 U.S.C. § 1343 and conspiracy under 18 U.S.C. § 1349 each carry up to 20 years. None of those statutes is subject to FDA's enforcement discretion.

The heavier exposure comes from Title 18. When a peptide business sells with health claims while disclaiming human use, prosecutors charge the marketing as a scheme to defraud. Wire fraud under 18 U.S.C. § 1343 and conspiracy under 18 U.S.C. § 1349 each carry up to 20 years. Conspiracy to defraud the United States under 18 U.S.C. § 371 carries five and is used to describe schemes that evade FDA oversight. None of those statutes is subject to FDA's enforcement discretion. Once fraud is charged, the guideline range under USSG § 2B1.1 tracks gross revenue, and forfeiture follows the money.

Mistakes Florida Operators Are Making Right Now

Treating a press report as the policy. No one outside the government has seen the text. Restocking BPC-157 on the strength of an anonymous-source story is a decision a prosecutor will describe later, in detail.

Changing the marketing. Website copy announcing that a peptide is "now legal" or "FDA cleared" is a fresh misbranding problem and, if false, a fraud problem. FDA reads websites, and the government treats marketing copy as evidence of intended use.

Assuming a research use only peptide business is covered. Nothing in FDA's existing framework protects a non-pharmacy seller. The RUO peptide label has never been a defense; in charged cases it has been offered as proof that the seller knew human use was the point.

Ignoring the supply chain. If the active ingredient came from an unregistered foreign manufacturer without a valid certificate of analysis, the product falls outside the current policy, and nothing suggests the new one will be looser on sourcing.

Talking without counsel. An FDA inspection, an agent visit, or a warning letter response is the moment the record gets made. A careless answer about sourcing or marketing can supply the intent element that turns a misdemeanor into a felony.

"Restocking BPC-157 on the strength of an anonymous-source story is a decision a prosecutor will describe later, in detail."— Aaron M. Cohen, AMC Defense Law

How These Matters Get Defended

The work that changes outcomes is done before anyone is charged. For a 503A compounding pharmacy, that means auditing every peptide against the four conditions FDA already uses, documenting sourcing and certificates of analysis, and confirming that each preparation traces to a patient-specific prescription. For prescribers and med spas, it means knowing exactly where product comes from and what the clinic's own website says about it. A peptide attorney who handles federal investigation defense can run that review under privilege.

It does not erase past conduct, and it will not help a seller whose case is built on misrepresentation. Whether to engage the assigned prosecutor, whether to proffer, and how to respond to a federal grand jury subpoena are decisions for a federal criminal defense attorney or white collar defense attorney with experience in FDA OCI investigations, made before the government finishes building its file.

Why the Next 90 Days Matter

Executive Order 12866 sets a 90-day target for OIRA review, which can be extended. When the notice is published, its conditions will define who is inside and who is outside, and the gap between those groups will be enforced. In the meantime the statutes have not moved, and FDA's warning letter program against online peptide sellers has not paused. Anyone who has received a warning letter, a subpoena, or a federal target letter should treat this period as the window to act, not a reason to wait.

Common Questions

Facing a Peptide or Compounding Investigation in Florida?

AMC Defense Law represents compounding pharmacies, prescribers, med spa operators and peptide businesses in federal investigations and prosecutions, from its Boca Raton office and in federal districts nationwide. If you have received an FDA warning letter, a federal grand jury subpoena, or a letter from the U.S. Attorney's Office, or if agents have contacted you or your staff, contact the firm for a confidential consultation before you respond to the government.

Aaron M. Cohen, AMC Defense Law, Boca Raton.

If you or your loved ones have been arrested or are under federal investigation in a peptide or compounding matter, call Aaron M. Cohen, 24 hours a day to get help.

About the author: Aaron M. Cohen is the founder and principal attorney of AMC Defense Law, a criminal defense firm in Boca Raton, Florida, with more than 30 years of experience in state and federal courts. He is admitted to practice in Florida, New York, New Jersey, and the District of Columbia, and before the United States District Courts for the Southern and Middle Districts of Florida, the Southern, Eastern, and Western Districts of New York, the District of New Jersey, and the Northern District of Texas. He appears pro hac vice in other federal districts nationwide. The firm represents clients in federal investigations and prosecutions involving healthcare fraud, Anti-Kickback Statute matters, DME and telemedicine fraud, peptide and compounded-drug enforcement, controlled-substance and drug conspiracy cases, financial crimes, and complex federal litigation, in Florida and nationwide.

This article is provided for general informational purposes only. It is not legal advice, and it does not create an attorney-client relationship. Every case is different, and outcomes depend on the specific facts and law involved. The FDA policy discussed here had not been published when this article was written; its final terms may differ from press reports. If you are facing an investigation or charges, consult a qualified attorney about your specific situation.