FDA’s Advisory Committee Votes on Peptides: What It Does and Doesn’t Do

A hastily reassembled Pharmacy Compounding Advisory Committee (PCAC) held meetings on July 23 and 24, 2026 to consider whether seven unapproved peptides should be included on an affirmative list of bulk ingredients that can be used by compounding pharmacies operating under the Food, Drug, & Cosmetic Act’s (FD&C Act) Section 503A (503A compounders). A second PCAC meeting to discuss an additional five peptides is expected to be scheduled in February 2027. In close votes over the course of July’s two-day meeting, the PCAC members recommended that BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax be added to the 503A affirmative list. They voted against the addition of emideltide. 

Food and Drug Administration (FDA) scientific reviewers who had assessed each of the unapproved peptides for the specific uses proposed for compounding had recommended against including all seven peptides on the 503A affirmative list due to a lack of clinical data or sufficient characterization of the drugs, among other reasons (FDA briefing documents and presentations available here). And although each compound was assessed by FDA/PCAC for one or more specific uses – for example, BPC-157 was evaluated for its utility in treating ulcerative colitis – in the wellness marketplace these peptides are promoted and sold for a wide array of diverse uses that have not been affirmed or even tested in large-scale human studies, from muscle recovery and insomnia treatment to longevity and cognitive performance. 

Putting the medical, technical, and conflict-of-interest controversies aside for the time being, what do the recent PCAC recommendations mean in practical effect? 

• Nothing has legally changed yet. As we discussed in May 2026, an advisory committee vote is not an agency action, and FDA officials will have to make an ultimate decision on whether to accept or reject those recommendations. Advisory committee recommendations are just that – advisory – and as such are not binding on FDA, but they contribute additional information to help guide official agency action. Matthew Lash, acting director of FDA’s Office of Compounding Quality and Compliance, pointed out during the meeting that some comments submitted to the docket close to the deadline were not incorporated into the briefing packages, but everything in the record would be considered during the agency’s formal decision-making process. How FDA officials decide to proceed following this momentous PCAC meeting and a more fulsome review of the entire record remains to be seen. 
• Incentives for future clinical development and FDA new drug approval for these peptides will disappear. Some committee members suggested that adding these peptides to the 503A affirmative list could create an opportunity to study the ingredients further or to develop safety profiles for the compounds. Authorizing them to be compounded and sold commercially, however, removes incentives for drug developers to formally study these peptides in clinical trials or seek FDA marketing approval for specific uses. Their commercial compounding is also unlikely to enhance the overall knowledge base because of the uncharacterized and non-standardized nature of the ingredients, which makes outcome comparisons from one setting to another extremely difficult. Notably, FDA’s briefing materials for these peptides highlighted that there are multiple forms of each substance and, in some cases, multiple published amino acid sequences. 
• Claims will still be subject to truth-in-advertising laws, constraining how these peptides can be promoted to doctors and consumers. If FDA accepts the committee’s recommendations and adds BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax to the 503A affirmative list, compounding pharmacies, telehealth platforms, med spas, wellness clinics, and other businesses advertising or promoting their use for individual diseases or conditions will have to tread carefully due to the lack of robust clinical evidence of the peptides’ safety or efficacy for any of their popular uses. Federal and state advertising and consumer protection laws generally require “competent and reliable scientific evidence” to support claims about health products, and as now documented in the public record for the PCAC meeting, there is no such evidence supporting any health-related claims for these unapproved peptides. Marketing claims therefore will need to be limited to what is actually truthful and not misleading, which could be a challenging bar for advertisers to meet. For example, “clinically proven” and even “clinically tested” would be off-limits for these experimental drugs given the dearth of well-designed clinical studies. 
• Legal challenges to any future FDA agency action may be coming. Many members who voted in favor of permitting a peptide to be used by 503A compounders stressed they were doing so to prevent consumers from solely relying on the current “gray market” of research-grade, imported synthetic ingredients and to ensure that American consumers can access unapproved peptides from legitimate sources. Such comments in the public record could form the basis of a legal challenge that any future FDA action to add these peptides to the 503A affirmative list via notice-and-comment rulemaking – or to classify them as Category 1 under agency enforcement discretion policies – is arbitrary and capricious under the Administrative Procedure Act because market and demand considerations are not an established evaluation criterion for creating the 503A affirmative list. Existing regulations state that the following criteria will be used when evaluating new substances for the 503A list:
• “The physical and chemical characterization of the substance;
• Any safety issues raised by the use of the substance in compounded drug products;
• The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and
• Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.”
• Some policy ideas are good ones but would require Congress to act. Some panelists and speakers at the PCAC meeting suggested that FDA authorize the compounding of these peptides with special “guardrails” such as a novel requirement for 503A compounders to report serious adverse events to the agency. Unfortunately, however, FDA does not have statutory authority to require state-regulated pharmacies and pharmacists to make such reports, and any attempt to impose mandatory legal requirements that fall outside of its scope of authority is likely to subject the agency to a lawsuit. Compounders and pharmacists can always submit adverse events to FDA voluntarily, absent congressional action to amend the agency’s authorizing statute to make such reporting mandatory.     

Given this complex regulatory landscape, referring to FDA’s potential future action as “legalizing” these peptides would be an oversimplification; while 503A compounders would be authorized to use these substances in the course of professional pharmacy practice, adding the peptides to the 503A affirmative list is not equivalent to an FDA new drug approval and would not include the controls common to manufactured pharmaceutical products (e.g., detailed prescribing information, limited manufacturing sites, restrictions on the promotion of unapproved uses). State boards of pharmacy are the primary regulators of 503A compounders due to FDA’s longstanding position that it does not directly oversee professional practice such as the practice of pharmacy, medicine, and nursing. And the mandates, missions, and public health concerns of state boards often differ significantly from those of FDA.    

Accordingly, future FDA action to add unapproved peptides to the 503A affirmative list may not alter the patient-first approach that some state boards of medicine and pharmacy have been taking in response to these peptides’ explosion in popularity over the past several years. For example, the statements made by the Alabama Board of Medical Examiners would not appear to be affected by any decisions to authorize peptide compounding – i.e., the substance would still be unapproved, uncharacterized, and unregulated by FDA with respect to “safety, efficacy, or manufacturing standards and consistency.”

How consumer protection efforts at the state and local level will unfold following any upcoming FDA actions to operationalize July’s PCAC votes will bear close and careful watching. 

Subscribe To Viewpoints