FDA Removes 12 Peptides from Category 2, Schedules PCAC Review Meetings

April 17, 2026

FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List

Shari Esfahani, Thora Johnson, Amy Joseph, Georgia Ravitz, Jeremy Sherer Orrick, Herrington & Sutcliffe LLP + Follow Contact LinkedIn Facebook X ;) Embed

On April 15, 2026, the U.S. Food and Drug Administration ("FDA") announced a major shift in the regulatory landscape for compounded peptides.  FDA updated its Bulk Drug Substances Nominated for Use in Compounding Under Section 503A list, providing notice that after 7 days, it will remove 12 peptide bulk drug substances from Category 2 of its Section 503A bulk drug substances list— the category reserved for substances the agency has determined raise significant safety concerns — due to their nominations being withdrawn by the nominators.  The "significant safety risks" designation had previously formed the basis for FDA enforcement action against compounders distributing these peptides. FDA simultaneously published a Federal Register Notice announcing it will convene the Pharmacy Compounding Advisory Committee ("PCAC") at public meetings on July 23–24, 2026, and before the end of February 2027 to discuss whether these peptides should be added to the 503A bulks list, which would formally authorize their use in compounding.  Additionally, the FDA is removing one peptide, GHK-Cu, from Category 1 (substances under evaluation that have not been identified as presenting significant safety risks and as to which FDA is exercising enforcement discretion) for the same reason — withdrawal of the nomination — with PCAC consultation planned before the end of February 2027.

This action follows weeks of anticipation after HHS Secretary Robert F. Kennedy Jr. signaled during an appearance on The Joe Rogan Experience on February 27, 2026, that the administration would take steps to make approximately 14 peptides more accessible through lawful compounding channels.

Secretary Kennedy's Joe Rogan Announcement

On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. appeared on The Joe Rogan Experience and announced that the FDA was expected to take action imminently regarding peptides that had been restricted under the Biden administration. Secretary Kennedy stated he expected an announcement "within a couple of weeks," expressing hope that these substances would "end up with . . . a place where people have access from ethical suppliers." He described himself as a "big fan" of peptides, noted he had personally used them "with really good effect on a couple of injuries," asserted that the agency under the Biden administration had "illegally" reclassified 19 peptides into Category 2 in September 2023.

Secretary Kennedy also drew attention to the dangers of the unregulated peptide market, characterizing it as "very, very substandard" and warning that consumers in the gray market "have no idea" whether they are getting a legitimate product. He contrasted this with the prior regime where peptides could be sourced from FDA-inspected facilities and framed the administration's solution in terms of expanding access through "ethical suppliers" — i.e., legitimate, regulated pharmaceutical channels.

Regulatory Framework and Prior PCAC Precedent

Section 503A of the FD&C Act exempts compounded drugs from cGMP, labeling, and new drug approval requirements, provided the conditions of section 503A are met, including that bulk drug substances used either comply with USP/NF monograph standards, are components of FDA-approved drugs, or appear on the 503A bulks list.  Under the FDA's interim policy, nominated substances are placed into Category 1 (no significant safety risks identified; enforcement discretion permits compounding), Category 2 (significant safety risks identified; compounding not permitted), or Category 3 (inadequate supporting information).

There is prior precedent from the Biden administration when several peptides previously on the Category 2 list were similarly withdrawn by nominators and removed from the list and were then brought before the PCAC, which recommended against inclusion on the 503 bulks list in each case. However, the current environment is materially different: many prior FDA staff have departed, the PCAC has significant vacancies that Secretary Kennedy could fill before the July meeting, and the administration has publicly signaled support for broader peptide access.

Implications for Industry Stakeholders

Compounding Pharmacies

Once these peptides are formally removed from Category 2 (approximately by April 22, 2026), they will no longer carry the "significant safety risks" designation. However, removal from Category 2 does not, by itself, place these substances on the 503A bulks list or into Category 1 for which FDA is exercising enforcement discretion. The peptides will exist in a regulatory gray area until the PCAC meets and the FDA takes final action. Compounding pharmacies should still exercise caution regarding these peptides until their status is determined by FDA.

If the PCAC recommends inclusion and the FDA includes the peptides on the 503A bulks list, pharmacies holding state licenses and meeting all other 503A conditions would be authorized to prepare patient-specific formulations of the included peptides — a substantial commercial opportunity. To comply with section 503A, pharmacies will need to source pharmaceutical-grade API from FDA-registered manufacturers, accompanied by valid certificates of analysis; sourcing from unregulated suppliers is not permissible.

Conversely, if the PCAC votes against inclusion — as it did previously regarding peptides withdrawn from the Category 2 list under the Biden administration — the substances could be placed in the "Other Bulk Drug Substances That May Present Significant Safety Risks" category. That said, the PCAC's recommendations are advisory, and the FDA retains authority to accept, modify, or reject them. Given the current administration's stated priorities, the ultimate outcome may not mirror the prior precedent.

API Manufacturers and Distributors

This development represents a significant potential market opening. Manufacturers should ensure their peptide APIs are produced in FDA-registered facilities under cGMP conditions with valid certificates of analysis, and should assess capacity to supply both free base and acetate salt forms. The administration's focus on "ethical suppliers" suggests that enforcement actions against unregulated sellers may intensify even as lawful compounding channels open.

Takeaways

Stakeholders should consider engaging in the PCAC public comment process. Written comments submitted by July 9, 2026 will be provided directly to the Committee, and requests to make oral presentations must be submitted by June 30, 2026.

The regulatory landscape remains fluid. There is no guarantee the peptides removed from Category 2 will be added to the 503A bulks list, though the current administration's posture suggests a more favorable environment than in prior proceedings. The composition of the reconstituted PCAC — including any new appointments by Secretary Kennedy — will be a significant factor to watch.  Stakeholders should closely monitor this process but should not begin compounding with any of the 12 peptides solely on the basis of their removal from Category 2. Until the FDA affirmatively places these substances on the 503A bulks list or into Category 1 with enforcement discretion, compounding these substances carries regulatory risk.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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