PCAC recommended six peptides. What changes and what does not

On July 23 to 24, 2026, FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to recommend adding six peptides to the 503A bulk drug substances list: BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon. It voted against a seventh, DSIP. [1]

The short version: the vote is a meaningful step, but it is not a legal change. Nothing is on the bulks list until FDA finishes rulemaking, the evidence behind each peptide is exactly what it was the day before the meeting, and the WADA status of each peptide is untouched. Below is what the vote actually does, what it does not, and how to read the next steps on our regulatory tracker.

How these peptides got here

Traditional compounding pharmacies operate under section 503A of the Federal Food, Drug, and Cosmetic Act. A 503A pharmacy may compound from a bulk ingredient only if it is a component of an FDA approved drug, has a USP or NF monograph, or appears on FDA's list of bulk drug substances that can be used in compounding. [5] FDA builds that list by rulemaking; the first final rule was published in February 2019 and also described the Category 1, 2, and 3 framework FDA uses while nominated substances are evaluated. [4]

In September 2023 FDA placed a large group of nominated peptides, including all seven discussed at the July meeting, in 503A Category 2: substances that raise significant safety risks and may not be compounded while evaluation continues. [2] In April 2026 FDA revised its Category 2 page to move BPC-157 and 16 other peptides to a separate list of nominations withdrawn by their nominators. Withdrawal took them out of Category 2, but it was not an approval and did not add anything to the bulks list. [2] Seven of those peptides were then taken to the committee in July. [1]

What the vote changes

The vote gives FDA an expert recommendation to list six peptides. The committee exists to advise FDA on exactly this question, and a proposed rule is the next formal step if FDA agrees. On each affected peptide page we moved the regulatory status to "under review," which is the status we use for a substance with a pending recommendation or nomination. [1]

It also changes the practical conversation. Pharmacies and prescribers now have a public FDA record showing the committee considered these substances suitable for the list. That is not the same as permission to compound: until FDA publishes a final rule, none of the six is on the 503A bulks list, a 503A pharmacy has no federal basis to compound them from bulk, and a state board cannot authorize what federal law does not. [3] State rules still apply on top of federal ones; see the state legal guides for your pharmacy board and telehealth rules.

What the vote does not change

It does not put anything on the bulks list. Listing requires notice-and-comment rulemaking and a final rule. Until that is published, none of the six is formally listed. [3] [4]

It does not approve any drug. Bulks list eligibility means a licensed pharmacy may compound the substance for an individual patient with a prescription. It is not an FDA finding that the peptide works for any condition, and compounded products are not FDA approved.

It does not change the evidence. Our evidence grades are based on indexed studies, not votes. Five of the six recommended peptides are graded animal only, and semax is graded human observational:

• BPC-157: rodent data, including faster Achilles tendon healing in rats, mostly from one research group. A 2019 review concluded human trials are needed before clinical claims can be made. [7] [8]
• KPV: two 2008 mouse colitis studies; no indexed human trial. [9]
• TB-500: thymosin beta-4 accelerated wound closure in rats; no human trial of the injected product. [10]
• MOTS-c: mouse metabolic studies; no human interventional trial. [11]
• Semax: open-label Russian clinical studies in stroke without independent replication. [12]
• Epitalon: lifelong mouse studies and non-randomized institutional reports. [13]

If you are weighing BPC-157 against TB-500 specifically, our side-by-side comparison shows that neither has human evidence for injury healing.

It does not open 503B outsourcing. Outsourcing facilities follow a different pathway and a different list. [6]

It does not change WADA status. BPC-157, KPV, and epitalon remain prohibited for tested athletes under WADA's non-approved substances section, MOTS-c remains named under section S4.4 as a metabolic modulator, and TB-500 is named under peptide hormones and growth factors. [15]

The DSIP result is the instructive one

DSIP (delta sleep-inducing peptide) is the only peptide of the seven with randomized, placebo controlled human trials, and it was the only one the committee rejected. [1] Its trials are small, date from 1987 to 1992, and reported effects that were short-lived or inconsistent. [14] The lesson is that a randomized design alone does not carry a nomination; the committee looks at the size, consistency, and safety picture of the whole record. FDA still makes the final call by rulemaking, so we list DSIP as not eligible pending that action.

What to watch next

1. A proposed rule in the Federal Register. This would name the substances FDA intends to list and open a comment period. We will log it on the tracker the day it publishes.
2. Any FDA departure from the committee. FDA is not bound by PCAC votes and can list fewer substances, add conditions, or defer.
3. State board guidance. Some boards issue their own notices after federal changes. Our state pages track board names and rules.
4. New human data. A published trial would change a grade faster than any vote.

Until a final rule appears, treat each of these peptides as what it is today: an unapproved substance with a positive advisory recommendation and, for most, animal-only evidence.