FDA Schedules PCAC Meeting on Peptide Compounding and Issues Notice of Pending 503A Bulks List Updates
The U.S. Food and Drug Administration (FDA) has taken steps that may affect the legal status of popular compounded peptides under section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). On April 15, the FDA published a notice scheduling a meeting of the Pharmacy Compounding Advisory Committee (PCAC) for July 23–24, 2026, at which the committee will consider whether to recommend certain peptide bulk drug substances for inclusion on the 503A bulks list. On the same day, the FDA also republished its interim 503A Bulks List with notable updates, announcing its intent to remove twelve peptide bulk drug substances from Category 2 (“Bulk Drug Substances that Raise Significant Safety Concerns”) within seven calendar days. Importantly, the announcement does not indicate that the peptides will be placed on the Category 1 “May Compound” list, possibly leaving those bulk drug substances in limbo unless the FDA announces enforcement discretion with regard to the substances.
These developments accompany growing interest in peptide therapies by the general public despite regulatory uncertainty surrounding their lawful compounding status. In late February 2026, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. publicly stated his expectation that the FDA would take action to make approximately 14 peptides more accessible through lawful compounding channels, arguing that their existing regulatory status has fueled a dangerous unregulated market. He also described himself as a “big fan” of peptides and was sharply critical of what he characterized as the prior administration’s mishandling of policy with respect to these substances.
During his appearance on The Joe Rogan Experience, Secretary Kennedy indicated that an agency announcement was forthcoming, and the agency’s recent PCAC meeting notice and interim bulks list updates appear to represent the first concrete steps in that direction.
The Upcoming PCAC Meeting
The FDA notice confirms that the PCAC will convene this summer to evaluate whether to recommend the following seven bulk drug substances for inclusion on the 503A bulks list:
July 23, 2026:
- BPC-157 (free base / acetate)
- KPV (free base / acetate)
- Thymosin Beta-4, Fragment (LKKTETQ) (TB-500) (free base / acetate)
- MOTs-C (free base / acetate)
July 24, 2026:
- Emideltide (DSIP) (free base / acetate)
- Semax (free base / acetate)
- Epitalon (free base / acetate)
All seven substances are of considerable interest to compounding pharmacies, prescribers, and patients. BPC-157, in particular, has been among the most publicly discussed peptides, with prominent advocates citing its potential benefits for injury recovery. Many of these substances were designated as Category 2 substances on the FDA’s interim 503A Bulks List in 2023, reflecting the FDA’s preliminary determination that they presented significant safety risks in the context of compounding. This prompted significant pushback from wellness entrepreneurs and compounding pharmacies, including litigation alleging that the agency had bypassed legally required notice-and-comment procedures in making those designations.
At the upcoming committee meeting, the PCAC, an FDA committee that provides expert advice on scientific, technical, and medical issues regarding drug compounding under sections 503A and 503B, will consider whether to recommend certain substances for inclusion in the 503A bulks list. Worth noting is that PCAC’s recommendations are not binding on the FDA, which must still undertake formal rulemaking before any substance is permanently added to the list. The real question, and the one that matters most to compounders in the near term, is whether the FDA will extend enforcement discretion to these substances, allowing them to be compounded under the interim policy while the formal rulemaking process plays out.
Additionally, the PCAC currently lists only four members. Several members of the committee were removed last year and have not yet been replaced. While there are reports of forthcoming appointments, the committee does not presently appear to have a quorum, a procedural issue that could affect its ability to act at the scheduled meeting. That said, given the lengths to which the administration appears to be going to move this agenda item forward, it seems unlikely that these vacancies will remain unfilled by summer.
Updates to the Interim 503A Bulks List
On the same day, the FDA republished its interim 503A Bulks List with updates. The principal changes are as follows:
- GHK-Cu for non-injectable routes of administration is being removed from Category 1, and GHK-Cu for injectable routes of administration is separately being removed from Category 2. Both were removed because their nominations were withdrawn by nominators, and both are slated for PCAC consultation before the end of February 2027.
- Twelve peptide bulk drug substances in total are being removed from Category 2 within seven calendar days of the notice, as their nominations have been withdrawn by the respective nominators.
The complete list of substances being removed from Category 2 is as follows:
- BPC-157
- Cathelicidin LL-37
- Dihexa Acetate
- Emideltide (DSIP)
- Epitalon
- GHK-Cu (for injectable routes of administration)
- KPV
- Mechano Growth Factor, Pegylated (PEG-MGF)
- Melanotan II
- MOTs-C
- Semax (heptapeptide)
- Thymosin Beta-4, Fragment (LKKTETQ) (TB-500)
Of these, the substances not scheduled for consideration at the upcoming meeting in July (Cathelicidin LL-37, Dihexa Acetate, GHK-Cu (injectable routes of administration), Mechano Growth Factor Pegylated (PEG-MGF), and Melanotan II) are slated for separate PCAC consultation before the end of February 2027.
Practical Implications
As a practical matter, these changes to the interim list are of limited immediate consequence. Removal from Category 2 does not render these bulk drug substances eligible for compounding under section 503A. They also remain outside the scope of the FDA’s interim enforcement discretion policy, which currently extends only to substances in Category 1.
The real question, and the one that matters most to compounders in the near term, is whether the FDA will extend enforcement discretion to these substances, allowing them to be compounded under the interim policy while the formal rulemaking process plays out. Under the FDA’s Interim Policy on Compounding Using Bulk Drug Substances, the agency has stated that it does not intend to take enforcement action against pharmacies that compound with bulk drug substances listed in Category 1, provided the pharmacy otherwise complies with the conditions of section 503A. This includes the critical requirement that compounding be pursuant to a valid prescription for an individually identified patient.
If the FDA were to reclassify any of the removed Category 2 substances into Category 1, compounding pharmacies would be able to resume lawful use of those substances under the interim policy without waiting for completion of the formal rulemaking process. This would also enable prescribers to lawfully prescribe these substances consistent with their prescribing authority under applicable state law and the broad discretion afforded to physicians under the practice of medicine.
API Supply Chain Considerations
If the FDA ultimately moves these substances into Category 1, there may be supply chain obstacles that could delay their practical availability. At present, active pharmaceutical ingredients (API) available for many of these peptides exist only as research-grade, which cannot lawfully be used in compounded drug products dispensed to patients. Under current Good Manufacturing Practice (cGMP) requirements, compounding pharmacies must source pharmaceutical-grade API from FDA-registered facilities that comply with applicable quality standards. Pharmaceutical-grade API for some of these peptides do not yet exist at commercial scale, in large part because these substances have not been authorized for human use.
That said, there are early indications that certain API manufacturers and compounding industry participants are already positioning themselves to meet anticipated demand should the FDA authorize their lawful compounding. If the PCAC issues favorable recommendations and the FDA subsequently reclassifies any of these peptides into Category 1, the availability of pharmaceutical-grade API will likely become the principal bottleneck governing how quickly compounding pharmacies can bring compliant products to market.
While the public advisory committee meetings convened in 2024 resulted in the PCAC voting against inclusion of all previous peptides under review, finding that they posed unacceptable safety risks for compounding, whether the current regulatory and political environment will produce a different outcome at the July meeting remains to be seen. Stakeholders in the compounding supply chain should monitor these developments closely and consider proactive engagement with API suppliers to ensure readiness.
How Frier Levitt Can Help
Frier Levitt attorneys with experience in both pharmacy and FDA regulatory law advise pharmacies, telehealth platforms, clinics, and investors on peptide-related compliance, enforcement defense, and regulatory strategy as regulations in the peptide sector continue to evolve. Our team routinely counsels clients on compounding compliance under Sections 503A and 503B, FDA enforcement trends, and risk mitigation strategies related to bulk drug substances and evolving agency guidance. We also assist clients in responding to regulatory inquiries, preparing for inspections, and structuring compliant operational models in a rapidly changing legal landscape.
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