What FDA’s July 2026 PCAC Meeting Actually Decided — and What It Did Not

FDA’s Pharmacy Compounding Advisory Committee met at White Oak on 23 and 24 July 2026 to discuss bulk drug substances nominated for the 503A Bulks List. The docket is FDA-2025-N-6895. The meeting page, current as of 6 August 2026, is the primary record for the agenda, the uses FDA evaluated, and the briefing files.

An advisory committee gives FDA non-binding advice. FDA’s own explainer on that page says the agency generally follows the recommendations but is not legally bound to do so. The briefing-document introduction is more specific still: FDA does not intend to issue a final determination until input from the advisory-committee process has been considered and all reviews have been finalized. A vote, a staff proposal, and a listing are three different acts. This file records the first two from documents a reader can open. It does not invent the third.

What was on the table

The substances were considered as free-base and acetate pairs. The uses in the table are the uses FDA says it evaluated — they are not approved indications, and they are not instructions.

Nominations were withdrawn. FDA went ahead anyway.

The briefing-document introduction records that the nominations FDA lists for these substances had been withdrawn — LDT Health Solutions on behalf of the International Peptide Society, and Wells Pharmacy Network, under docket FDA-2015-N-3534. In each case the introduction states that FDA is electing to proceed with the presentation to PCAC.

Withdrawal of a nomination is not a finding that the substance is safe, and it is not a finding that it is unsafe. It is a procedural fact: the nominator stepped back, and the agency chose to keep the file in front of the committee. Several of the same names already appear on FDA’s separate table of bulk substances nominated for compounding and subsequently withdrawn, where the published safety concerns remain.

What staff proposed

The same introduction, under “Points to Consider,” states a proposal for every salt and free-base form on the agenda. The wording is uniform: FDA is proposing that the substance NOT be included on the 503A Bulks List. That covers BPC-157, KPV, TB-500 and MOTS-c on 23 July, and emideltide, Epitalon and Semax on 24 July — fourteen proposals, all against inclusion.

A staff proposal is the agency’s starting position for the committee’s discussion. It is not a regulation, not a Category 2 listing, and not a determination that a particular research-use lot is adulterated. Compounding under section 503A from a bulk substance that is not on the bulks list, is not a component of an approved drug, and has no applicable USP or NF monograph is a separate legal question from whether PCAC was asked for advice.

How to read this against the rest of the library

• Chemical identity is still a PubChem / CAS / sequence question. A compounding-list proposal does not identify the vial in hand.
• WADA status is a different system. BPC-157, TB-500 and AOD-9604 are named on the 2026 Prohibited List; most of the July PCAC substances are not.
• Evidence files on Therapept classify papers. They do not score effectiveness, and they do not convert a briefing proposal into a clinical conclusion.
• AOD-9604 and retatrutide were not on this agenda. AOD-9604 is on the withdrawn-nominations table and the WADA list. Retatrutide is an investigational drug substance with published Phase 2 data and sponsor Phase 3 toplines — not a compounded bulk under discussion here.

What this file is not

It is not legal advice, not a prediction of FDA’s final rule, and not a claim that any of these substances is or is not being compounded. It is a map of what the primary meeting record contained as of the review date, written so that a later listing decision can be added without rewriting the history of the meeting.