FDA Sends Peptide ‘Interim Access Policy’ to White House for Review

Proposed policy could temporarily allow compounding pharmacies to make certain peptides, including BPC-157, while permanent rules are considered.

The U.S. Department of Health and Human Services and the Food and Drug Administration submitted an “interim access policy for compounding using certain peptides” to the White House on Thursday.

The policy is reportedly intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157.

How the Policy Would Work

The policy would essentially assure compounding pharmacies that they won’t be targeted for producing certain peptides. That approach, known as enforcement discretion, allows the FDA to selectively choose not to enforce some of its own regulations.

That is distinct from formally adding peptides to the 503A Bulks List. Formally adding the peptides to the FDA’s list of drugs that are safe for compounding would require federal rulemaking, a process that could take years and involves multiple rounds of public comment.

Such a move would let these peptides reach the market while the FDA develops permanent rules, despite a lack of evidence supporting their purported benefits.

Background

The FDA previously placed BPC-157 and more than a dozen other injectable peptides on its list of substances considered too risky to be compounded by pharmacies, citing possible risks including contamination, allergic reactions and tumor growth. Earlier this year, Health and Human Services Secretary Robert F. Kennedy Jr. directed the agency to reconsider a short list of these substances.

In July, the FDA’s Pharmacy Compounding Advisory Committee voted to recommend adding six of seven peptides to the list of bulk drug substances 503A compounding pharmacies may use: BPC-157, KPV, TB-500, MOTS-C, Epitalon and Semax. The panel declined to recommend emideltide. FDA staff scientists reiterated that the peptides lack sufficient clinical studies to establish their safety and effectiveness.

What Med Spa Professionals Should Know

• Nothing has changed yet. The policy is under White House review, and its terms, including which peptides it covers and what conditions apply, have not been made public.
• Enforcement discretion is not approval. Even under an interim policy, these peptides would remain unapproved drugs. The FDA would only be signaling that it does not intend to take action against qualifying compounders.
• State law still applies. Rules on prescribing authority, delegation, supervision and administration of compounded medications would continue to govern med spa practice.
• Vet your sources. Practices should work only with properly licensed compounding pharmacies. See AmSpa’s supplier verification checklist.
• Keep marketing claims in check. Most evidence on these peptides comes from animal studies, and claims about recovery, anti-aging or performance have not been established in robust clinical trials.

AmSpa will continue to monitor the FDA’s next steps and share updates as details of the policy are released. Get med spa law alerts sent straight to your inbox >>