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Advisory panel votes pressure FDA to allow access to compounded peptides

Members of the Pharmacy Compounding Advisory Committee narrowly voted in support of including six unapproved peptides on the FDA’s so-called 503A bulks list, overriding agency staff’s many concerns. The FDA’s decision will shape how consumers access these in-demand compounds, but could also implicate its overall drug regulation system.

By Ned Pagliarulo | Jul 27, 2026 6:15 PM EDT

Drug compounding: A quick primer

  • Compounded drugs are generally intended for patients whose medical needs are not otherwise met by an approved drug product. A compounding facility can combine, mix, dilute, pool, reconstitute or otherwise modify a drug or bulk drug substance to create an individualized product. For example, a patient with an allergy might require a specific medication without a certain dye, while a patient with trouble swallowing might need a liquid formulation of a drug only manufactured as a tablet. Compounded drugs are not subject to the premarket review set out in Section 505 of the Food, Drug, and Cosmetic Act – so are therefore considered unapproved – nor do they come with labeling describing directions for use. Historically, compounded drugs have represented a small slice of overall drug prescriptions in the U.S., although estimates are imprecise. Recently, however, compounding facilities helped fuel a boom in telehealth prescriptions for the in-demand obesity drugs Wegovy (semaglutide) and Zepbound (tirzepatide) while those drugs were in shortage.
  • Compounded drugs can be made in two different types of facilities, called 503A and 503B for the relevant sections of the FDCA. 503A compounding covers human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician. These state-regulated operations are typically small, and are not required to meet the FDA’s current good manufacturing practice requirements. 503B, or outsourcing, facilities can produce at a larger scale, as they’re not required to have obtained prescriptions for identified individual patients. However, they are subject to FDA inspections, must register with the FDA annually and meet quality standards. There are also no explicit limits on their shipping product across state lines.
  • Compounding facilities are restricted in how they can prepare products from “bulk drug substance,” or active pharmaceutical ingredients. A 503A facility may compound only if the bulk drug substance either 1) complies with an applicable United States Pharmacopeia or National Formulary monograph if one exists, 2) are components of FDA-approved drug products if a USP or NF monograph does not exist, or 3) appear on an FDA list of bulk drug substances that can be used in compounding if the first two circumstances don’t apply. Outsourcing facilities, meanwhile, may only compound using a bulk drug substance if the drug product is listed in short supply by the FDA or appears on a list of bulk drug substances for which there is a clinical need. The two lists are known as the 503A bulks list and 503B bulks list, respectively.
  • The FDA has listed few drugs on either the 503A or 503B bulks lists. Six are included on the 503A list and five are on the 503B list. The agency has solicited nominations for both lists several times, most recently in 2015. The FDA adds to the former via rulemaking and to the latter via notice and comment in the Federal Register, according to interim policies the FDA finalized in separate 2025 guidance documents. Nominations are evaluated against different criteria, however. When considering a substance for the 503A bulks list, the FDA considers its physical and chemical characterization, any safety issues raised by use in compounded products, history of compounding and available evidence of effectiveness, if it exists. The FDA’s process for considering 503B nominations is different, although it involves these criteria in part.
  • The interim policies, which were initially published in 2017 and later updated, set out a process by which the FDA could categorize nominations while it evaluated them for inclusion on the bulks lists. The agency indicated it would not take any enforcement action against facilities producing substances it placed in Category 1, allowing compounding from bulk drug substance to continue as the FDA’s formal evaluation proceeded. This enforcement discretion would not apply to any substances placed in Category 2, which indicates the FDA identified significant safety risks relating to their compounding. Category 3, meanwhile, refers to substances that may be eligible for inclusion on either bulks list, but weren’t nominated with enough supporting evidence. (In finalizing the interim policy guidances in 2025, the FDA said it would no longer categorize newly nominated substances.)

“Wellness” peptides in focus

  • HHS Secretary ROBERT F. KENNEDY JR has repeatedly advocated for looser regulation of peptides, a term that refers to short amino acid chains but has more recently become a catch-all description of a wide array of approved and unapproved compounds. A self-described “big fan” of peptides, Kennedy arrived at HHS pledging to end the FDA’s “aggressive suppression” of peptides. More recently, Kennedy zeroed in on compounding restrictions that the FDA had previously put in place for a handful of peptides popular among wellness influencers, longevity clinics and biohacking communities. In a February appearance on JOE ROGAN’s podcast, he claimed the agency had “illegally” moved those peptides to Category 2 of its enforcement discretion policy during the Biden administration. The FDA did this in response to safety concerns they had identified while reviewing them for inclusion on the 503A bulks list. In Kennedy’s view, however, their placement on Category 2 pushed demand to what he termed a black market of online suppliers. He indicated to Rogan, and one month later to podcasters LAURYN and MICHAEL BOSSTICK, that he wanted the FDA to act. “My hope is that they’re going to get moved to a place where people have access from ethical suppliers,” he told Rogan.
  • The FDA in April removed 12 peptides from Category 2, announcing plans to hold advisory committee meetings in July to discuss adding seven of them to the 503A bulks list and again in February to discuss the remaining five. The peptides included BPC-157, which has been touted as a general-purpose healing compound, as well as others that have recently gained online notoriety, such as KPV, TB-500 and MOTS-c. These compounds had been nominated for inclusion on the bulks list but their sponsors – LDT Health Solutions and Wells Pharmacy Network – withdrew the nominations in April. The FDA moved forward with evaluating the case for their inclusion on its own initiative, according to briefing documents released ahead of the July 23-24 meeting of the Pharmacy Compounding Advisory Committee, or PCAC. The panel was recently recast to include several physicians and pharmacists who have promoted peptides. One, ROBERT HARSHBARGER, is the son of Rep. DIANA HARSHBARGER (R-Tenn.), who in November urged Kennedy to convene the PCAC.
  • FDA staff recommended against inclusion on the 503A bulks list of all seven peptides slated for PCAC discussion in July, the briefing documents showed. FDA scientists evaluated each peptide against the four evaluation criteria outlined in guidance and determined that publicly available data “weigh against” their inclusion on the list. For all seven, agency reviewers wrote nominated peptides were not well characterized on a physiochemical basis. In its briefing document for BPC-157, for example, the FDA noted that it found multiple salts and derivatives, including different active moieties, that were marketed under the same name. Their reviews generally turned up scant published information on the compounds’ safety profile, including their immunogenicity risk, and effectiveness. In some cases, such as with MOTS-c, FDA staff couldn’t identify any human data from clinical testing. In all cases, reviewers noted the existence of FDA-approved therapies for the conditions that the nominated peptides are meant to treat.

Panel backs peptides’ inclusion on 503A bulks list

  • PCAC members narrowly voted in favor of adding six of the seven peptides to the 503A bulks list at the July 23-24 meeting, splitting along generally consistent lines on questions of the compound’s characterization, safety and supporting data. They supported inclusion of BPC-157, KPV, TB-500, MOTS-c, epitalon and semax, but did not endorse the addition of emideltide. (AgencyIQ has compiled all votes in the table below.) Before each vote, panelists heard from the public and from FDA staff, who outlined their evaluation and recommendation against inclusion. While some speakers in the open public hearing sessions urged the committee to recommend against addition, many were supportive and audibly cheered following the first positive vote.
  • Panelists wrestled with whether the available evidence for the nominated peptides was sufficient for inclusion. Those voting yes acknowledged the limited supporting data but generally believed it was enough to meet the FDA’s criteria for 503A. Some also felt the agency did not adequately substantiate the safety risks that it raised. “The thing that I kept coming back to was the 503A standards are not the same as a new drug approval standard,” said Robert Harshbarger, who is a Tennessee state senator as well as a pharmacist. Panelists in favor of inclusion also raised concerns about perpetuating a “gray market” of research-use only peptides sold online with little transparency into their provenance. “It’s a real-world thing that is happening,” said HALEEM MOHAMMED, chief medical officer of Gameday Health. “There’s stuff happening out there that we need to try and control and make sure that we keep patients as safe as possible and that’s why I voted yes.”
  • Committee members who voted no often cited concerns about the lack of clinical data, leaving them unsure about the compounds’ safety and efficacy. “I voted no because there’s just too much unknown about this product, said WILLIAM ZAMBONI, a director of cancer pharmacokinetics and pharmacodynamics at the University of Pittsburgh Medical Center, after a vote on BPC-157. Some expressed hesitancy about recommending an action that consumers may interpret as FDA endorsement of compounds that remain unapproved. “I’m concerned that we’re responding to a market-induced demand rather than a decision based in solid science,” said ELIZABETH REBELLO, executive director of anesthesiology, critical care and pain medicine at the University of Texas MD Anderson Cancer Center.
  • FDA officials repeatedly emphasized that they lacked critical information to characterize the nominated peptides, so much so they said they were unsure what exactly they were being asked to add to the bulks list. “We say something like BPC-157 is ‘reported to be’ because we don’t actually know with any certainty what it is,” said RUSSELL WESDYK, an associate director for regulatory affairs within the Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality. “This isn’t a criticism of industry or anything else. It’s foundational with these common name substances that are in early-stage research. You will see many, many different forms.” In opening presentations on July 23 and 24, Wesdyk emphasized how the common names for the nominated peptides often conflated distinct bulk drug substances, while the nominations didn’t clearly identify the peptides’ forms, such as free base or acetate. This uncertainty has regulatory implications, as only the bulks list must specify a single active moiety – any other related forms that are compounded would be adulterated and subject to enforcement. But it also implicates manufacturing and clinical performance: “Different forms have different chemical structures and different physical, chemical, and [pharmacokinetics/pharmacodynamics] characteristics,” Wesdyk noted. “This impacts patient safety and product efficacy.”
  • Some panelists, in voting for inclusion, suggested the FDA place some boundaries on use, require safety monitoring or enforce quality standards, prompting agency officials to note on several occasions the limits of their 503A authority. For instance, MELISSA LOESKE, chief medical officer of the Re-New Institute, described her vote to include BPC-157 on the bulks list as conditional. “I would like to see some tighter restrictions with APIs from U.S.-based pharmacies only, patient registries, mandatory side effects reporting,” she said. FDA officials pushed back several times on those calls. “I don’t have a lot of regulatory authority,” Wesdyk said during a discussion of the peptide KPV. “Once I put [a peptide] on a list, any bulk drug manufacturer can make it any way they want and test it to any standard they want, and that’s where you may still have concern even with a smaller peptide.” MATTHEW LASH, acting director of the FDA’s Office of Compounding Quality and Compliance, noted that the FDA can’t require state-licensed pharmacies to report adverse events or register with the FDA, nor can it conduct surveillance inspections of 503A pharmacies or require they only use certain API.
  • FDA officials suggested at several points that questions on the nominated peptides’ safety and efficacy could be best answered through clinical study under an Investigational New Drug application. Wesdyk opened the meeting urging industry to consider this approach, as did Office of New Drugs Director MARY THANH HAI in brief introductory comments on July 24. Opening an IND to study a peptide could also help address some of the questions of identity that have frustrated FDA reviewers. Speakers during the open public hearing took issue with this, suggesting the FDA was improperly applying new drug approval standards upon the compounding framework. “How many times have you heard IND today?” said LEE ROSEBUSH, chair of the American Academy of Peptide Medicine. “That’s a 505 requirement for the new drug application approval process. There’s nothing in 503 that requires an IND. So even if they don’t say they’re using 505 new drug approval standards, they obviously are.” In addition to INDs, FDA officials also suggested the peptide industry consider advancing the nominated compounds through the U.S. Adopted Names Council process to obtain consistent scientific names.

Pharmacy Compounding Advisory Committee votes in July 23-24, 2026, meeting:

Peptide Uses evaluated Vote on base form (yes/no/abstain)* Vote on acetate form (yes/no/abstain)*
BPC-157 Ulcerative colitis 8-6-1 8-6-1
KPV Wound healing, inflammatory conditions 8-6-1 8-6-1
TB-500 Wound healing 8-6-1 8-6-1
MOTS-c Obesity, osteoporosis 7-5-2 7-5-2
Emideltide Opioid withdrawal, chronic insomnia, narcolepsy 6-7-1 6-7-1
Epitalon Insomnia 7-4-1 7-4-1
Semax Cerebral ischemia, migraine, trigeminal neuralgia 8-5-1 8-5-1

*Note: 11 PCAC members voted on all questions. Seven others voted only on questions involving specific peptides, while another participated in all but the last vote on semax. Timothy Fensky, a representative from the National Association of Boards of Pharmacy, abstained on all votes in accordance with his organization’s policy.

Analysis

  • The compounding and drug approval processes are distinct and designed to serve different medical purposes. Yet the tension between them ran throughout the meeting proceedings on both days. Both the FDA and the panelists who voted no struggled with the paucity of data supporting use of the seven peptides for specific clinical purposes. Agency officials and some committee members proposed the IND process as a means of addressing these unknowns. “This is a drug I think that you could actually get an IND on and actually have real evidence,” said JOSH MAILMAN, the committee’s patient representative and president of the NorCal CarciNET Community, after a no vote on KPV. The panelists who voted yes – and many of the open public speakers – argued that efficacy questions were not material to the committee’s votes and resisted holding the peptides to standards they associated with drug approval. The committee was similarly divided over whether inclusion on the 503A bulks list would send a signal equivalent to FDA approval or, conversely, protect consumers from a more dangerous gray market outside of any regulated setting. (This gray market argument is one advanced by HHS Secretary Kennedy.)
  • The committee consistently divided along generally the same lines across all votes, possibly reflecting the panelists’ backgrounds and business ties. Five panelists – Harshbarger, Loseke, JOSHUA STARBUCK, KRIS WUSTERHAUSEN and GABRIEL ALIZAIDY – voted to include all seven peptides on the bulks list. Harshbarger oversees operations at a compounding pharmacy, while Starbuck, Wusterhausen, Alizaidy and Loseke are involved with clinics that promote peptide therapy. ASARE CHRISTIAN, who voted in favor of including six peptides and abstained on a vote for the seventh, founded a longevity clinic that offers peptides. The only peptide that failed to secure the panel’s support was emideltide; DAVID POPE, chief pharmacy officer at a XiFin Pharmacy Solutions, who voted in favor of including the six other peptides, cited the compound’s “complex regimen” and “potentially dangerous downstream consequences.”
  • While the FDA is weighing whether to allow compounding of the seven nominated peptides, it’s simultaneously seeking to restrict compounding of peptides approved for weight loss. In April, the agency proposed to exclude the glucagon-like peptide-1 drugs semaglutide, tirzepatide and liraglutide from the 503B bulks list. Outsourcing facilities can compound from bulk drug substance the active pharmaceutical ingredients that are included on this list, which differs slightly from the 503A version by identifying substances for which there is a clinical need or that have been identified as being in shortage. The drugs are not currently on the list, but inclusion would keep open a window for large-scale production of compounded GLP-1 drugs – production that took off during since-resolved shortages of tirzepatide and semaglutide. “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” former FDA Commissioner MARTIN MAKARY said in a statement on the agency’s proposal, which has drawn nearly 4,000 comments to date.
  • The FDA’s proposal on compounded GLP-1 drugs involves different facilities, products and legal statute. Yet it still provides a contrast to its deliberations on the 503A front, especially as the telehealth boom that popularized compounded peptides for weight loss is the same that’s boosting compounded peptides for wellness. In essence, the agency is considering opening a legal pathway to compounding unapproved peptides with scarce safety and efficacy data at the same time as it seeks to shutter compounding of approved peptides with extensive safety and efficacy data. The former pathway would ostensibly be for individualized prescribing, while the latter more clearly raises concerns of whether telehealth firms are mass marketing essentially a copy of an approved drug. But it’s worth asking whether consumers would notice a difference, if the firms that provide access to both are the same. In public testimony, for example, Hims & Hers Chief Medical Officer ANANT VINJAMOORI indicated his company plans to provide peptides like BPC-157 if compounding is permitted. While Hims now offers telehealth access to branded GLP-1s, its previous wide promotion of compounded versions made it synonymous with the trend and earned it the ire of the FDA. An executive for Noom, another telehealth firm that does offer compounded GLP-1s, indicated they also plan to offer BPC-157 if permitted.
  • What’s next? The advisory panel vote is only one input in the FDA’s consideration of the seven peptides for bulks list inclusion, although the agency does tend to follow its panels’ advice. FDA staff will also review materials submitted to the FDA’s docket for the hearing before initiating a rulemaking process to either include or exclude the compounds on the bulks list. “We’ll consider the rationale that the panel members provided, and then we’ll draft a proposed rule with our proposal,” said KEMI ASANTE, an acting branch chief in OCQC. The FDA would then collect comments on the proposed rule before finalizing it. Rulemaking is a long process, but the FDA could possibly put the peptides supported by the committee on Category 1 for enforcement discretion while it proceeds. That approach could be complicated by the nominations’ withdrawal, however, as Category 1 substances are defined as having been nominated with sufficient supporting information. The peptides could be re-nominated, but the agency previously indicated in guidance that it would not categorize any nominations received after January 2025.

To contact the author of this item, please email Ned Pagliarulo ( npagliarulo@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com) and Holland Johnson ( hjohnson@agencyiq.com).

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