FDA's 'Interim Access Policy' for compounded peptides: what is known and what it could mean

What the public record shows

OMB’s regulatory review dashboard lists an HHS/FDA item titled “Interim Access Policy for Compounding Using Certain Peptides,” RIN 0910-ZD94, received October 14, 2026, at the “Notice” stage. OIRA’s meetings page lists an Executive Order 12866 meeting on the item for October 21, 2026, requested by the American Academy of Peptide Medicine. That is all of the primary record. The document itself is not public.

Our news report has the reporting from POLITICO, the Associated Press and Reuters, and will be updated when FDA publishes.

Three different routes to “access”

The policy’s name invites confusion. There are three distinct legal routes for a peptide to reach patients, and they are not equal:

Route	What it is	How durable	Peptides using it today
FDA approval	A manufacturer proves safety and effectiveness for a use	Permanent unless withdrawn	Semaglutide, tirzepatide and other branded drugs
503A bulks list	FDA adds the ingredient by notice-and-comment rule (21 CFR 216.23)	Permanent unless changed by rule	None
Enforcement discretion	FDA says it will not act against certain compounding, under conditions	Can be revised or withdrawn without rulemaking	Category 1 substances such as glutathione and non-injectable GHK-Cu

Press reports describe the interim access policy as the third route. AP reported it is meant to let pharmacies temporarily compound some popular peptides, including BPC-157, using enforcement discretion.

FDA has used this tool before

FDA’s existing interim policy for 503A bulk substances works the same way. For Category 1 substances, FDA says it “does not intend to take action against a compounder” while it evaluates the nomination, if conditions in its guidance are met (Category 1 explainer). FDA stopped placing new nominations into those categories for substances nominated on or after January 7, 2025. A peptide-specific policy would be a new use of the same approach.

Open questions

Until the text is published, these are unknown:

• Which peptides. Whether it follows the July 2026 advisory votes (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon), goes wider or narrower.
• Conditions. Whether it requires 503A pharmacies only, specific quality testing, prescriptions, routes of administration or adverse-event reporting.
• 503B. Whether outsourcing facilities are included.
• Duration. “Interim” suggests a bridge until rulemaking, but no end point has been reported.
• Relationship to safety findings. FDA’s Category 2 page still carries its safety concerns for these peptides (Category 2). The CSPI letter of October 14 asks FDA to side with its staff (report).

What it would not change

Based on everything reported, the policy concerns compounding by licensed pharmacies on prescription. It would not:

• approve any peptide as a drug;
• make “research use only” products lawful to sell for human use (why);
• change anti-doping rules. WADA’s 2026 list still bans BPC-157, TB-500 and MOTS-c (sport);
• override state law. Louisiana’s Act 374 already stops boards there from blocking federally compliant compounding (state laws).