FDA Advisory Committee Endorses Compounding of Certain Peptides

The U.S. Food and Drug Administration's (FDA) Pharmacy Compounding Advisory Committee (PCAC) voted at its July 23-24, 2026, meeting to recommend adding certain peptides to the 503A compounding bulk substance list (503A Bulks List), a step toward making them eligible for lawful compounding.

The seven peptides up for discussion, which cannot legally be compounded currently, were 1) BPC-157-related bulk drug substances, 2) KPV-related bulk drug substances, 3) TB-500-related bulk drug substances, 4) MOTs-C-related bulk drug substances, 5) Emideltide (also referred to as delta sleep-inducing peptide (DSIP)-related bulk drug substances), 6) Semax-related bulk drug substances and 7) Epitalon-related bulk drug substances. Consumers are still accessing these peptides even though compounding pharmacies are not legally permitted to compound and sell them, as none is on the 503A Bulks List or in an approved drug.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a strong supporter of peptides, has endorsed the notion that peptides should be more available – and the PCAC was FDA's first step in accomplishing that goal. FDA scientists, however, previously found that these seven peptides pose potentially significant safety risks – with some of them reiterating their beliefs at the PCAC meeting.

The PCAC is designed to provide independent expert advice and make nonbinding recommendations to FDA regarding human drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA is not obligated to follow the PCAC recommendations but often does. Once the PCAC process is complete, FDA must use a notice-and-comment rulemaking process to effectuate a change.

The PCAC heard presentations and debated the merits of the seven popular peptides purported to treat ulcerative colitis, wound healing and other conditions. Though the PCAC votes were split, the meeting resulted in the committee's recommendation to add six of the seven reviewed peptides to the 503A bulk drug compounding list. Emideltide was the only one of the seven not recommended. Moving these peptides onto the 503A bulk drug compounding list would make them eligible and, thereby, legal for compounding.

Secretary Kennedy and peptide supporters argue that adding these peptides to the list would move consumers away from a "gray market" where, for example, people purchase what they perceive to be high-quality or "research grade" products but actually are contaminated.

The PCAC's recommendations, including those of members who were named to the PCAC by Secretary Kennedy, are contrary to the views of many FDA scientists who, based on safety and efficacy concerns, have historically argued against adding these peptides to the list. In the preparatory documents for the meeting, FDA reviewers wrote that there is a lack of evidence to evaluate the effectiveness and safety of the specific peptides being reviewed. This is consistent with FDA's long-standing position that many peptides lack such evidence and pose significant safety concerns. Some FDA scientists, along with opponents of adding the peptides to the compounding list, echoed these views during the meeting.

Next Steps

Notably, because the committee's recommendations are nonbinding, they did not result in any change in law. Thus, as of this writing, these peptides still cannot be lawfully compounded, and FDA can continue to take enforcement action against compounding pharmacies that make these peptides.

The only mechanisms to change that rule and include the peptides on the 503A Bulks List are for 1) formal notice-and-comment rulemaking to occur or 2) the U.S. Congress to amend the FDCA.

Holland & Knight's FDA Team will continue to monitor these developments.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.