PCAC Recommends BPC-157, KPV, TB-500, and MOTS-c for 503A Compounding

The FDA Pharmacy Compounding Advisory Committee, or PCAC, met on July 23, 2026. The committee reviewed four peptide-related bulk drug substances.

The committee voted in favor of all four substances:

• BPC-157
• KPV
• TB-500
• MOTS-c

Each vote was 8 in favor, 6 against, and 1 abstention. The committee reviewed the free-base and acetate forms of each substance.

This result is important. It is also limited. The votes are advisory. They do not approve these substances as drugs. They do not create an immediate general right to compound them.

What did the committee recommend?

PCAC recommended that FDA add the reviewed forms to the list of bulk drug substances that can be used for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act.

Substance	Forms reviewed	Use that FDA evaluated	PCAC vote
BPC-157	Free base and acetate	Ulcerative colitis	8 yes, 6 no, 1 abstention
KPV	Free base and acetate	Wound healing and inflammatory conditions	8 yes, 6 no, 1 abstention
TB-500	Free base and acetate	Wound healing	8 yes, 6 no, 1 abstention
MOTS-c	Free base and acetate	Obesity and osteoporosis	8 yes, 6 no, 1 abstention

The FDA meeting page gives the official agenda, forms, and reviewed uses. The Associated Press report gives the vote result and the main points from the meeting.

What is the 503A Bulks List?

Section 503A applies to traditional pharmacy compounding under specified conditions. A compounder can use a bulk drug substance if one of these conditions applies:

1. The substance has an applicable USP or NF monograph.
2. The substance is a component of an FDA-approved drug.
3. The substance appears on the 503A Bulks List.

FDA explains these conditions in its 503A bulk drug substance guide.

The list process uses a balancing test. FDA considers the identity and chemical properties of the substance. FDA also considers safety, evidence of effectiveness, and historical use.

This process is not the FDA drug-approval process.

What did not change?

The July 23 votes did not do these things:

• They did not make BPC-157, KPV, TB-500, or MOTS-c FDA-approved drugs.
• They did not prove that these substances are safe or effective.
• They did not approve a dose, route, product, or medical claim.
• They did not approve products from online research vendors.
• They did not remove the need for a valid patient-specific prescription when section 503A requires one.
• They did not cancel state pharmacy law or other federal requirements.

FDA states that compounded drugs are not FDA-approved. FDA does not verify the safety, effectiveness, or quality of a compounded drug before it reaches a patient. The FDA compounding policy page explains this limit.

Why did FDA staff oppose inclusion?

FDA staff proposed that the reviewed forms should not go on the list. The four briefing documents give the reasons.

BPC-157

FDA found a small human evidence file. The reviewed studies were short and had small sample sizes. FDA also found problems with substance identity, characterization, safety information, and the ability to interpret the results.

Read the FDA BPC-157 briefing document.

KPV

FDA did not identify adequate human clinical evidence for the reviewed uses. The agency also described gaps in characterization and human safety information.

Read the FDA KPV briefing document.

TB-500

FDA did not find human clinical studies of the nominated TB-500 substance for wound healing. The agency also raised identity, quality, and immunogenicity questions.

Read the FDA TB-500 briefing document.

MOTS-c

FDA did not find adequate public human evidence for the reviewed obesity and osteoporosis uses. The agency also described substance-characterization and safety gaps.

Read the FDA MOTS-c briefing document.

These findings did not stop the favorable votes. Some committee members gave more weight to clinician oversight and access through regulated pharmacies. Other members gave more weight to the missing human evidence and uncertain substance identity.

Why can PCAC disagree with FDA staff?

PCAC gives independent expert advice. FDA staff prepare the scientific review. Committee members then discuss the same evidence and apply the statutory factors.

The committee can reach a different balance. FDA is not legally required to follow the committee vote. The FDA meeting notice states that advisory committee recommendations are non-binding.

What happens next?

FDA will review the votes, the discussion, and the public comments. A formal addition to the 503A Bulks List normally requires agency action through the applicable regulatory process. FDA can also issue an interim enforcement policy while that process continues.

The timing is not fixed. A favorable vote can affect FDA policy, but it does not replace the final agency step.

The committee completed the second day of votes on July 24:

• PCAC did not recommend Emideltide, also called DSIP. The vote was 6 yes, 7 no, and 1 abstention.
• PCAC recommended Epitalon. The vote was 7 yes, 4 no, and 1 abstention.
• PCAC recommended Semax. The vote was 8 yes, 5 no, and 1 abstention.

Read our DSIP vote report for the evidence behind the negative recommendation. These votes were advisory. They did not approve any substance as a drug.

What should readers verify?

Use precise language when you read or share this news.

Correct: PCAC recommended inclusion on the 503A Bulks List.

Incorrect: FDA approved the peptides.

Also separate a pharmacy-compounding decision from an online vendor claim. A research vendor's product, label, or COA is not covered by a pharmacy's section 503A status.

For a source-linked view of FDA enforcement against that separate online market, see the 13-storefront warning-letter census.

For compound-specific evidence, read our research pages for BPC-157, KPV, TB-500, and MOTS-c.

Sources

1. FDA: July 23-24, 2026 PCAC meeting, agenda, and materials
2. FDA: Introduction to the PCAC briefing documents and the 503A test
3. FDA: BPC-157 briefing document
4. FDA: KPV briefing document
5. FDA: TB-500 briefing document
6. FDA: MOTS-c briefing document
7. FDA: Bulk drug substances used in compounding under section 503A
8. FDA: Compounding laws and policies
9. Associated Press: Report on the July 23 PCAC votes

This article is for education. It is not medical advice. It does not give dose, injection, or treatment instructions.