Key takeaways:
The FDA is reviewing whether several experimental peptides should become eligible for pharmacy compounding. But it doesn’t mean that these peptides or products will become FDA approved.
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) has recommended adding six peptides to the 503A Bulks List. This list identifies bulk drug substances that pharmacies can use to compound medications. The FDA’s PCAC is scheduled to meet again in February 2027 to vote on whether to add five additional peptides to the 503A Bulks List.
In late October, the U.S. Department of Health and Human Services released an interim policy that provides a temporary pathway for six peptides to be compounded under specific conditions.
The final decision on the 503A Bulks List will be made by the FDA, which isn't required to follow PCAC recommendations. The agency will publish a proposed rule that indicates which peptides it plans to add (or not add). The public will have an opportunity to provide comments before the FDA issues a final rule.
Experimental peptides have received growing attention in recent years, especially across social media. Interest in using them for muscle recovery, longevity, and other promoted uses, has driven this surge in awareness. At the same time, the FDA is evaluating whether certain peptides should become eligible for compounding, a process in which pharmacies prepare customized medications.
It’s important to remember that becoming eligible for compounding isn’t the same as FDA approval. It also doesn’t mean the FDA has determined that a peptide is safe and effective for its promoted uses. These decisions simply determine whether pharmacies may legally compound these substances under specific circumstances.
Because the regulatory process continues to evolve, we’re tracking the latest FDA announcements, advisory committee meetings, and other significant developments here.
HHS releases interim policy for compounding six peptides
October 28, 2026
The U.S. Department of Health and Human Services (HHS) has released an interim enforcement discretion policy for compounding six peptides. Under the policy, HHS generally won't take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound these peptides under specific conditions:
BPC-157 acetate: subcutaneous (under-the-skin) or intramuscular injections, oral forms, or topical forms
Epitalon acetate: subcutaneous or intramuscular injections dispensed in intermittent courses
KPV acetate: oral and topical forms
MOTS-c acetate: subcutaneous or intramuscular injections
Semax free base: intranasal forms
TB-500 acetate: subcutaneous or intramuscular injections
To qualify, the medication must be prescribed for a specific person, contain only one listed peptide, and meet sourcing, quality, labeling, and reporting requirements. For oral forms, compounders must have documentation showing that the specific formulation can be adequately absorbed when taken by mouth.
This policy doesn't add the peptides to the 503A Bulks List or make them FDA approved. The temporary policy may also change if safety or quality concerns arise. It's also important to note that state-level rules may differ from this policy.
FDA submits proposed interim access policy for compounding certain peptides
October 16, 2026
The FDA and HHS have submitted an "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget (OMB) for review. The policy was received on October 14 and remains under review.
The full policy hasn't been made public. But it's expected to outline circumstances in which the FDA would temporarily allow certain peptides to be compounded while the agency completes the formal process for deciding whether to add them to the 503A Bulks List.
This development doesn't change the current status of these peptides or make them FDA approved. It also doesn't mean pharmacies can begin compounding them immediately. More details, including which peptides would qualify and the requirements compounding pharmacies would need to follow, should become available if the policy clears OMB review.
FDA compounding advisory committee to review 5 additional peptides during February 2027 meeting
July 24, 2026
The FDA’s Pharmacy Compounding Advisory Committee (PCAC) plans to review another group of experimental peptides during its February 2027 meeting.
The committee is expected to discuss whether the following peptides should be added to the 503A Bulks List, which identifies bulk drug substances that may be used in compounded medications.
Cathelicidin
GHK-Cu
Dihexa acetate
Melanotan II
PEG-MGF
As with previous meetings, FDA staff will first present their scientific review of each peptide. After that, PCAC will vote on whether to recommend adding each peptide to the list. The final decision will be from the FDA, which may or may not match the committee’s vote.
FDA compounding advisory committee votes to recommend 6 peptides to be added to the bulks list
July 24, 2026
During a two-day public meeting, the FDA’s PCAC reviewed seven experimental peptides that were previously nominated for inclusion on the 503A Bulks List. The nominations had been withdrawn, but the FDA decided to move forward with the review.
FDA reviewers recommend against adding all seven peptides to the Bulks List
Before the committee meeting, FDA reviewers concluded that none of the seven peptides met the criteria for inclusion on the Bulks List, including:
BPC-157
KPV
TB-500
MOTS-c
Emideltide
Semax
Epitalon
Across the review, FDA reviewers cited several recurring concerns, including:
Limited human clinical evidence
Uncertainty about safety and effectiveness
Questions about product characterization (such as composition, structure, and stability)
Insufficient information to support the proposed medical uses
PCAC votes to recommend adding 6 peptides to the Bulks List
After reviewing the available evidence and hearing public comments, PCAC voted to recommend adding 6 of the 7 peptides to the Bulks List. With the exception of emideltide, the committee voted in favor of recommending these peptides:
BPC-157
KPV
TB-500
MOTS-c
Semax
Epitalon
Several committee members acknowledged that the evidence supporting many of these peptides was limited. However, others cited existing demand and the opportunity to move use from the gray market into regulated pharmacies.
FDA will continue reviewing information before issuing a proposed rule
The PCAC’s vote doesn’t automatically change which peptides can be compounded. Before deciding whether to add any peptides to the 503A Bulks List, the FDA will continue reviewing:
Comments and documentation submitted to the public docket
Additional scientific and regulatory information
The agency will then publish a proposed rule describing which peptides it plans to add (or not add) to the list. After another public comment period, the FDA will issue a final rule.
References
Choi, J. (2026). FDA panel votes to add peptides to permitted compounding list despite opposition from agency scientists. The Hill.
U.S. Food and Drug Administration. (2024). FDA rules and regulations.
U.S. Food and Drug Administration. (2026). Bulk drug substances used in compounding under Section 503A of the FD&C Act.
U.S. Food and Drug Administration. (2026). FDA briefing document: Pharmacy compounding advisory committee (PCAC) meeting.
U.S. Food and Drug Administration. (2026). July 23-24, 2026: Meeting of the pharmacy compounding advisory committee.
U.S. Food and Drug Administration. (2026). Meeting of the pharmacy compounding advisory committee.
U.S. Food and Drug Administration. (2026). Pharmacy compounding advisory committee meeting July 23, 2026.
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