Bulk-list bound? PCAC backs majority of peptides in two-day public meeting

On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee (PCAC) recommended the addition of BPC-157, KPV, TB-500, MOTs-c, Epitalon, and Semax, each in free base and acetate formulations, to the US Food and Drug Administration (FDA) 503A Bulk Drugs List. The PCAC voted to not recommend one of the proposed peptide compounds, Emideltide. These recommendations, if adopted by the FDA, would permit compounding pharmacies to use the added peptides in compounded preparations, which would provide a pathway under the Federal Food, Drug, and Cosmetic Act (FDCA) §503A for access to individual patients who receive a valid prescription. FDA will initiate notice-and-comment rulemaking to consider the formal addition of the recommended peptides to the 503A Bulk Drugs List; however, FDA is expected to exercise some form of informal enforcement discretion in the interim, at least for those peptides recommended for addition to the 503A Bulk Drugs List by the PCAC.

Below we describe the most important and practical considerations for peptide compounders, prescribers, and marketers.

Background

Bulk drug lists and compounding

FDA promulgates bulk drugs lists for Section 503A and Section 503B compounding, which include various peptides, for the purpose of assessing the safety of products used in compounding. Historically, nominated products were divided into three categories: Category 1 (adequate support for inclusion; FDA received sufficient information and has not identified significant safety concerns); Category 2 (significant safety risks; FDA received sufficient information but has identified significant safety concerns); and Category 3 (inadequate information; FDA has not received adequate information to assess the product).

Products listed in Category 1 are subject to FDA enforcement discretion and may be utilized in compounding although not technically part of the official bulk drugs lists. Products listed in Categories 2 and 3 were not afforded this discretion and could not be utilized in compounding without fear of reprisal by the FDA. However, in 2025, the FDA promulgated guidance announcing that it would no longer categorize nominated products, though Category 1-listed products would remain subject to enforcement discretion. Although the bulk drugs lists are for compounding and not a direct FDA determination of safety or efficacy, the FDA’s statements can provide insight into safety risks and considerations of nominated products.

Peptide categorization

In September 2023, under the prior administration, the FDA categorized more than a dozen peptides into Category 2 of the Section 503A Bulk Drugs List, a designation that effectively prohibited their use in compounding. The agency cited “significant safety concerns” for these peptides, including risks related to immunogenicity, impurities, and availability of only limited human clinical data.

On February 27, 2026, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that many of the peptides on the FDA’s Category 2 restricted list would be considered for reclassification to Category 1 and, on April 15, 2026, Secretary Kennedy confirmed the removal of 12 peptides from Category 2 due to withdrawal of nominations by the nominators. These peptides include BPC-157, TB-500, MOTs-c, GHK-Cu (injectable), Melanotan II, Semax, PEG-MGF, Emideltide (DSIP), Epitalon, KPV, Cathelicidin LL-37, and Dihexa acetate. Importantly, removal from Category 2 does not automatically confer Category 1 status.

Pharmacy Compounding Advisory Committee

PCAC is an advisory body to the FDA; PCAC reviews scientific evidence and provides recommendations to the FDA on questions related to drug compounding. Critically, the committee does not make law and does not issue approvals. When PCAC votes on a substance, the FDA receives that vote as a recommendation it can accept, reject, or sit on for years. However, as noted by the FDA during the July 23, 2026, PCAC meeting, the agency rarely diverges from the PCAC recommendations.

July PCAC meetings

On July 23 and 24, 2026, PCAC convened a vote on recommendations for the inclusion of BPC-157, KPV, TB-500, MOTs-c, Emideltide, Epitalon, and Semax, on the 503A Bulk Drugs List. The PCAC voting members included representatives from industry, academia, state government, the National Association of Boards of Pharmacy, the United States Pharmacopeia, and various clinical entities. Each peptide discussion included an open public speaking session, a presentation and recommendation by FDA scientists, and a question-and-answer session between the PCAC members and the FDA.

During the open public speaking session, opponents of the peptides voiced concerns that the peptides are not sufficiently categorizable given the variation of formulations utilized in the industry. Opponents further noted the lack of substantial clinical safety and efficacy data along with insufficient adverse event reporting information. Inclusion, the opponents argued, could be interpreted as FDA approval or endorsement of the peptides; therefore, proponents of the peptides should instead seek formal FDA approval through the established drug approval process.

Conversely, supporters argued that the peptides’ long histories of use by licensed practitioners and the need for patient access to fulfill unmet needs weighed in favor of inclusion. Supporters noted that the lack of moiety complexity and usage histories increase the difficulties of seeking intellectual property protections, which normally incentivize manufacturers to undertake the burden of formal FDA drug approvals. Supporters further argued that inclusion on the bulk drugs list would enable greater regulatory scrutiny and standards to minimize the risks associated with the current gray market.

In each instance, FDA scientists recommended against inclusion of the peptides, citing concerns of insufficient safety, efficacy, and moiety characterization information.

Ultimately, on July 23, 2026, PCAC recommended the addition of BPC-157, KPV, TB-500, and MOTs-c, each in free base and acetate formulations, to the FDA 503A Bulk Drugs List. PCAC votes were split, with eight votes for “yes,” six votes for “no,” and one vote in abstention for each of BPC-157, KPV, and TB-500. MOTs-c was recommended with seven votes for “yes,” five votes for “no,” and two votes in abstention.

In the second session, on July 24, 2026, PCAC recommended against the addition of Emideltide, with six votes for “yes,” seven votes for “no,” and one vote in abstention. PCAC also recommended the addition of Epitalon and Semax, each in free base and acetate, with margins similar to the first day. PCAC will further consider the additions of GHK-Cu, Dihexa acetate, Cathelicidin LL-37, PEG-MGF, and Melanotan II in a meeting to be held before the end of February 2027.

Following the PCAC meetings, the FDA will initiate notice-and-comment rulemaking to officially add the peptides to the 503A Bulk Drug List, which could occur in 2027 or extend into a multi-year process. It is possible that Secretary Kennedy will add the peptides to Category 1 on an interim basis or otherwise promulgate statements signaling enforcement discretion pending final rulemaking.

Until a rule is finalized, peptide marketers must be especially prudent in how any peptides are advertised, as violative promotion can, among other things, trigger liability from the FDA, the Federal Trade Commission, litigants under the Lanham Act, and states (the latter discussed further, below).

Compounding of recommended peptides

Products compounded under Section 503A must meet one of three categories: (1) have an applicable United States Pharmacopeia – National Formulary (USP/NF) drug monograph, (2) be a component of an FDA-approved drug product, or (3) appear on the 503A Bulk Drugs List. Until the FDA completes its notice-and-comment rulemaking process to formally add the peptides to the 503A Bulk Drugs List, the peptides do not technically meet any of the three categories of permissible compounding. However, as noted above, peptides listed in Category 1 are subject to FDA enforcement discretion. Importantly, Category 1 status and formal inclusion on the 503A Bulk Drugs List are distinct: Category 1 reflects an interim enforcement posture, whereas formal listing provides a definitive legal basis for compounding.

In the event that the FDA lists the peptides on Category 1 on an interim basis or otherwise signals enforcement discretion extension to the peptides recommended for inclusion on the 503A Bulk Drugs List, compounding of such peptides may be permissible.

Importantly, addition to the 503A Bulk Drugs List is not equivalent to FDA approval. Unlike the FDA drug approval process, which requires demonstration of safety and efficacy through clinical trials, the bulk drugs list evaluation focuses on whether a substance can be adequately characterized for identity, purity, and potency, whether the substance presents significant safety risks in compounded preparations, and whether there is adequate published literature to inform safe compounding practices. As such, inclusion on the bulk drugs list reflects a determination that the substance can be safely used in compounding under appropriate conditions, rather than a finding of therapeutic efficacy for any particular indication.

State regulatory oversight

On the state level, state boards of pharmacy possess broad authority to regulate compounding activities within their jurisdictions, and compounding pharmacies that compound peptides face a range of state-level enforcement risks, which may arise from state pharmacy practice acts, board rules and guidance, or general consumer protection statutes. These risks are not wholly independent of federal law; state pharmacy regimes often directly reference or incorporate federal compounding requirements.

In fact, certain states have taken a more active approach to the oversight of peptide compounding. In Ohio, for instance, the Board of Pharmacy has issued guidance on common prescriber-clinic and medical-spa violations, explicitly stating that peptides categorized as Category 2 or Category 3 on the Section 503A Bulk Drugs List cannot be compounded, and that doing so would constitute a violation of state law. This guidance reflects consistent enforcement actions (including, in certain cases, summary suspension) the Ohio Board of Pharmacy has taken against pharmacies compounding peptides that are not yet explicitly authorized for compounding under federal standards, such as BPC-157, CJC/Ipamorelin, and Kisspeptin. Other states and their professional boards may take similar or divergent approaches.

State boards of medicine and other professional boards similarly possess broad authority to regulate licensed professionals in their jurisdictions and to enact statutes, regulations, and guidance that impose a more-restrictive standard on their licensees. Accordingly, prescribers should consult with counsel regarding the specific requirements and professional standards applicable to their practices, in each jurisdiction where they operate, including considerations such as monitoring patient outcomes and documenting appropriate informed consent prior to engaging in peptide therapy treatment offerings, among other clinical considerations. How the PCAC recommendations impact state enforcement approaches remains uncertain.

Next steps

Stakeholders should remain vigilant of FDA notice-and-comment rulemaking and submit comments as desired. The FDA noted during the PCAC meetings that it will consider any and all information received, even following the PCAC meeting submission deadlines. Comments addressing safety data, adverse event reporting, and characterization of peptide identity and purity may be particularly persuasive given the concerns raised by FDA scientists. Note, certain PCAC voting members conditioned their recommendations for addition on various safeguard implementations, including requirements for authorized active pharmaceutical ingredient sourcing, adverse-event reporting, and formulations. Stakeholders should monitor the Federal Register for the publication of proposed rules, which may occur in late 2026 or 2027.

In the coming months, stakeholders should continue to monitor the FDA’s statements and enforcement actions, along with state board of pharmacy and state professional board guidance, for compliance requirements.

We will continue to monitor FDA actions and signals for updates on regulatory enforcement status and agency perspectives on peptide compounding.