On July 23-24, 2026, the U.S. Food and Drug Administration’s (FDA’s) Pharmacy Compounding Advisory Committee (PCAC) met to consider seven peptide-related bulk drug substances for potential inclusion on the 503A Bulks List.

PCAC voted in favor of including the free-base and acetate forms of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax, while voting against inclusion of Emideltide (DSIP). Vote outcomes were the same for the free-base and acetate forms of each substance.

For each of the six peptides receiving favorable votes, PCAC’s recommendation differed from FDA’s position presented in the briefing materials. FDA had proposed that none of the fourteen peptide forms under consideration be included on the 503A Bulks List.

The votes generated significant attention across the compounding and broader peptide sectors. But regardless of one’s view of the outcome, the regulatory status of these substances did not change as a result of the advisory votes.

If ultimately reflected in FDA rulemaking, the committee’s recommendations could have significant implications for compounders, telehealth companies, prescribers, and patients.

During the meeting, several speakers and committee members raised concerns about patients obtaining peptides through online channels outside the traditional prescription drug supply chain. Some participants argued that establishing a lawful prescription pathway could shift some of that demand toward licensed providers and pharmacies while introducing additional safeguards around sourcing, quality, prescribing practices, and oversight.

Yet it is equally important not to jump ahead.

PCAC’s votes did not change the current regulatory status of these substances and do not authorize pharmacies to begin compounding them. PCAC’s recommendations are advisory and nonbinding.

Under FDA’s stated process, inclusion on the 503A Bulks List requires notice-and-comment rulemaking. FDA may propose substances for inclusion, receive and consider public comments, and ultimately issue a final rule. If FDA adds any of these substances to the 503A Bulks List, 21 CFR § 216.23 would be amended accordingly.

Until then, pharmacies should continue operating under the existing regulatory framework.

Importantly, even if all six peptides are ultimately added to the 503A Bulks List, that would not make them FDA-approved or FDA-endorsed. Nor would placement on the Bulks List, by itself, authorize every compounding or prescribing practice involving the substance. Other applicable requirements of section 503A, as well as applicable state law, would continue to apply.

We highlighted the steps that follow the PCAC meeting in this article, along with a regulatory timeline.

With peptide compounding at an important regulatory crossroads, it is worth unpacking what occurred during the July 2026 meeting, what the committee’s votes mean today, and what questions remain as FDA considers the next steps in the regulatory process.

FDA PCAC Peptide Votes Summary

The committee reviewed seven peptide-related bulk drug substances over two sessions, voting separately on the free-base and acetate forms of each. Vote outcomes were identical across both forms for each substance.

FDA PCAC Peptides Meeting July 23-24, 2026 Votes Breakdown by peptide

*All vote tallies were directly verified against FDA’s archived livestream from the first and second days of the meeting. The named vote breakdown is presented under each peptide in the detailed discussion below and was taken from the official archived livestream.

FDA Staff Position vs. Panel Outcome

An eight-member group consisting of Asare Christian, David Pope, Gabriel Alizaidy, Haleem Mohammed, Joshua Starbuck, Kris Wusterhausen, Melissa Loseke, and Sen. Bobby Harshbarger voted yes on nearly every substance, with two exceptions across the meeting: Asare Christian abstained on MOTS-c, and David Pope voted no on Emideltide. Timothy Fensky abstained on all seven substances.

FDA’s briefing materials proposed against inclusion of all seven substances under consideration. Because FDA evaluated the free-base and acetate forms separately, its materials presented fourteen individual proposals, each recommending that the applicable form not be included on the 503A Bulks List.

The committee’s recommendations therefore differed from FDA’s proposed position for six of the seven substances and aligned with FDA’s position on Emideltide.

FDA staff also identified unresolved scientific and regulatory considerations in its briefing materials, including questions related to chemical identity and characterization.

The Grey Market as a Recurring Theme

Of the issues discussed during the meeting, the peptide grey market generated substantial discussion and concern.

For purposes of this discussion, “grey market” refers generally to products obtained outside conventional licensed prescription drug channels, including products sold directly to consumers under “research use only” labeling.

Healthcare professionals, researchers, manufacturers, patient advocates, and committee members repeatedly discussed patient demand and the availability of peptide products through online vendors, including products marketed as “research use only.”

This is a topic we recently discussed on the Compounding Interest: The Business of Personalized Medicine Podcast, where we anticipated that questions surrounding patient demand and nontraditional sources of peptide products would feature prominently in the PCAC discussion.

A recurring concern raised during the meeting was that some patients may seek these products regardless of whether they are available through licensed pharmacies. Products obtained outside conventional prescription drug channels may present questions regarding identity, purity, potency, sterility, sourcing, and other quality attributes.

Available market data provide some indication of the scale of peptide demand, although they should not be interpreted as direct measures of the grey market. U.S. customs data reportedly show imports of hormone and peptide compounds from China increasing from approximately $164 million during the first three quarters of 2024 to $328 million during the same period in 2025.

Separately, analyses of cryptocurrency transactions have identified substantial and increasing payments to vendors characterized as operating in the grey-market peptide sector.

The risks associated with these channels extend beyond regulatory uncertainty. Consumers obtaining products outside the traditional prescription drug supply chain may not fully understand the differences in regulatory oversight, sourcing, testing, and quality controls applicable to those products.

A recent federal criminal case illustrates some of these concerns. In July 2026, the owner of Paradigm Peptides was sentenced to 70 months in prison after pleading guilty to introducing unapproved new drugs into interstate commerce with the intent to defraud and mislead and to illegally importing merchandise. According to the U.S. Department of Justice, the business sold products to more than 54,000 customers, imported products from China and India, and made false representations concerning its FDA status, manufacturing, testing, and product quality.

One recurring argument raised during the PCAC meeting was that a regulated prescription pathway could provide an alternative to non-pharmacy sources while introducing safeguards related to sourcing, product quality, prescribing practices, patient-provider relationships, and regulatory oversight.