Compounding at the crossroads: FDA AdComm recommends adding six peptides to the 503A Bulk Drug Substances List

The Pharmacy Compounding Advisory Committee (AdComm) of the United States Food and Drug Administration (FDA) recently voted to add six peptides to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Bulks List).

DLA Piper Partner and US Lead of Life Sciences Patent Development and Strategy Raymond Miller (Philadelphia) and FDA Regulatory Partner Christopher M. Mikson, MD, JD (Philadelphia and Washington, DC), attended the AdComm meeting in person from July 23 to 24, 2026 at FDA’s White Oak Campus. The committee convened to determine whether to recommend certain bulk drug substances that are used for compounding peptides – short chains of amino acids – for inclusion on the Bulks List. 

The meeting highlighted a range of perspectives from regulators, peptide manufacturers, healthcare providers, and patients. During the discussion, FDA representatives questioned the inclusion of an active pharmaceutical ingredient (API) on a list that would permit its use in compounding without safety studies they considered sufficient. Physicians and patient advocates expressed support for access to therapies they described as well categorized and well documented. Attendees further discussed state authority to regulate pharmacies and the practice of medicine. 

Some participants noted the use of compounded peptides for health- and appearance-related purposes, often promoted through advertising and social media. Meanwhile, scientists and regulators expressed concerns regarding the availability of human clinical data supporting certain uses of these substances and discussed regulatory and enforcement approaches related to those uses.

While FDA staff recommended that all seven peptides not be added to the Bulks List, the AdComm voted to add six. As a procedural matter, committee votes are non-binding recommendations, formal rulemaking is required before any substance is added to the list, and FDA is not obligated to follow the AdComm’s recommendations. However, the vote may represent a step in the process toward the peptides’ inclusion.

In this alert, we discuss the AdComm’s composition at the meeting, its presentation of legal and regulatory issues for consideration, and potential next steps. 

Background

Section 503A of the Federal Food, Drug, and Cosmetic Act specifies that state-licensed pharmacies may compound drugs for individual patients pursuant to a valid prescription, provided the API is 1) a component of an FDA-approved drug, 2) the subject of a US Pharmacopeia (USP) monograph, or 3) included on the Bulks List. In addition, bulk drug substances must be accompanied by a valid certificate of analysis (COA) and must have been manufactured by an establishment registered with FDA.

FDA’s bulk drug substance categorization system was established under the Drug Quality and Security Act of 2013. The system includes the following three categories of bulk drug substances: 

• Category 1: Drug substances that have been evaluated by FDA and may be used in compounding subject to specific conditions
  
  
• Category 2: Drug substances that have been evaluated by FDA and found to present significant safety or quality concerns such that FDA may take enforcement action against compounding with them
  
  
• Category 3: Drug substances that have not been nominated with sufficient supporting information and are therefore prohibited from being compounded

In September 2023, FDA placed certain peptides, including those discussed in this alert, into Category 2, which limited their eligibility for compounding. That measure prompted advocacy by segments of the wellness and compounding industries, and US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. has publicly expressed support for broader access to peptides. The Secretary has independent statutory authority under Section 503A(c) to issue regulations without AdComm review.

The Federal Register published notice of this two-day meeting on April 16, 2026 to consider whether to recommend these peptides for inclusion on the Bulks List.

Committee composition

The AdComm roster was expanded for this proceeding after initially convening with three voting members. Acting Chairperson Brian Serumaga, PhD, Director of Personalized Medicines at US Pharmacopeia (USP), presided over a panel that included physicians, pharmacists, a state senator, and temporary voting members with subject-matter knowledge. Donnette D. Staas, PhD, Vice President of Regulatory Strategy at Jazz Pharmaceuticals, served as the non-voting industry representative. Matthew Lash, JD, Acting Director of the Office of Compounding Quality and Compliance, led FDA's presentations.

FDA staff position

FDA staff recommended against adding any of the seven substances and cited a variety of factors, including:

• Naming inconsistencies: The use of common names rather than US Adopted Name designations, and the conflation of free-base and acetate-salt forms, may make it more difficult to identify and track products.
  
  
• Characterization gaps: Available data regarding impurities, aggregates, bioburden, and bacterial endotoxins were described as insufficient.
  
  
• Immunogenicity risk: The risk profile for injectable, poorly characterized peptides was described as unknown.
  
  
• USP monographs: There are no USP monographs for any of the seven substances.
  
  
• FDA-approved products: There are no FDA-approved drug products containing any of the seven substances.
  
  
• COAs: The COAs presented were described as inadequate for quality-verification purposes.

Legal and regulatory considerations

The AdComm presented a variety of legal and regulatory issues for consideration, including:

• Rulemaking status: A favorable AdComm vote does not place a substance on the Bulks List. Formal rulemaking is required, and FDA has previously declined to follow AdComm recommendations. Section 503A(c) calls on the HHS Secretary to “convene and consult” an advisory committee, noting that he may issue regulations beforehand if he determines doing so is “necessary to protect the public health.”
  
  
• Supply chain and API sourcing: Section 503A requires bulk API to come from an FDA-registered establishment with a valid COA. Current COAs for these substances are incomplete, and industry representatives, including the Alliance for Pharmacy Compounding, have noted that compliant APIs are not currently available at scale for several of these substances.
  
  
• The scope of Sections 503A and 503B: The meeting only addressed Section 503A, which governs patient-specific compounding by state-licensed pharmacies. It did not address Section 503B outsourcing facilities, which compound under federal current good manufacturing practice requirements without patient-specific prescriptions.
  
  
• Enforcement posture: FDA has issued more than 80 warning letters to telehealth companies regarding glucagon-like peptide-1 marketing practices, indicating continued enforcement scrutiny of advertising and promotion in this area independent of the compounding-list outcome.
  
  
• Intellectual property: No Orange Book or Purple Book equivalent exists for compounded peptides, and there is no centralized listing of patents covering these substances, their formulations, or methods of use. There is also no dedicated patent-litigation framework analogous to the Drug Price Competition and Patent Term Restoration Act of 1984 or biosimilar litigation. As a result, freedom-to-operate analyses in this area may be conducted without a comparable regulatory framework.

Committee votes

Day 1: July 23, 2026

Substance	Proposed use	Vote	Result
BPC-157	Ulcerative colitis, tissue healing	8–6, 1 abstain	Add
KPV	Wound healing, inflammatory conditions	8–6, 1 abstain	Add
TB-500	Wound healing	8–6, 1 abstain	Add
MOTS-c	Insulin resistance, obesity, osteoporosis, longevity	8–6, 1 abstain	Add

Day 2: July 24, 2026

 

Five additional peptides – GHK-Cu, Melanotan II, Cathelicidin/LL-37, Dihexa acetate, and PEG-MGF – are scheduled for AdComm review before February 2027.

Potential next steps

1. FDA review of AdComm recommendation and public comments
   
   
2. Proposed rulemaking (if pursued)
   
   
3. Public comment period
   
   
4. Final rule
   
   
5. Supply chain development and pharmacy compliance buildout

Following discussion of the rulemaking steps, meeting participants indicated that additional regulatory action would be required before these peptides could be compounded under Section 503A, and that such process could extend beyond the committee’s recent vote.

The bottom line

The July AdComm meeting marked a significant procedural development, but the regulatory process remains ongoing. FDA’s presentations reflected questions regarding the essential characterization and safety profiles of these substances. 

Stakeholders in this space, including compounding pharmacies, telehealth platforms, and investors, are encouraged to monitor regulatory developments as the rulemaking process continues. 

For more information, please contact the authors.