Peptides are the product du jour and most recently top of mind at the Food & Drug Administration (“FDA” or the “Agency”). Long relegated to the corners of biohacker and body building chatrooms, peptides have rapidly entered the commercial mainstream — driven by surging consumer demand through direct-to-consumer telehealth platforms and aggressive marketing by compounding pharmacies. That commercial momentum has now drawn sustained regulatory attention. In our April article, we discussed FDA’s reported plan to reclassify more than a dozen peptides from 503A Category 2 back to 503A Category 1, designating them as “under evaluation” for inclusion on the 503A Bulks List.[1] Substances included on the 503A Bulks List are legally eligible for compounding but, importantly, so are substances “under evaluation” under Category 1, thanks to FDA’s enforcement discretion policy. This means that, if and when these substances are moved to Category 1, they may be legally compounded until FDA makes a final determination, either permitting or prohibiting continued compounding under Food, Drug, & Cosmetics Act (“FDCA”) Section 503A. For companies in the compounding, telehealth, and life sciences sectors, the regulatory pathway these peptides follow will have significant commercial and compliance implications.
Since the April article, FDA has taken a concrete step forward on this initiative — and the next formal milestone is fast approaching. FDA has now removed twelve peptides[2] from the Category 2 list, taking them out of the “significant safety risk” designation. However, with the exception of GHK-Cu, none of these peptides have been recategorized to Category 1, and they currently do not appear on any of FDA’s 503A drug substance nomination lists. The practical consequence of this interim status cannot be overstated: these substances currently exist in a regulatory gray zone. They are no longer designated as posing a “significant safety risk,” but they have not been affirmatively authorized for compounding under Section 503A or FDA guidance. Compounders who interpret removal from Category 2 as implicit permission to compound do so at considerable enforcement risk. General counsel and compliance officers should ensure that their organizations understand this distinction and refrain from compounding with these substances until they are formally placed on the Category 1 list or the 503A Bulks List. It is also worth noting that this analysis is specific to traditional compounding under Section 503A; outsourcing facilities operating under Section 503B of the FDCA face a separate regulatory framework, and the Category 2 removals do not independently authorize compounding under that provision. The next question — and it is a significant one — is whether and under what conditions these peptides will be formally permitted through placement on the 503A Bulks List.
FDA has scheduled a meeting of the Pharmacy Compounding Advisory Committee (“PCAC”) in July to discuss certain bulk drug substances being considered for inclusion on the 503A Bulks List.[3] A second PCAC meeting will be scheduled before the end of February 2027 to discuss an additional five peptides.[4] Stakeholders with a commercial or clinical interest in these substances — including compounding pharmacies, telehealth platforms, branded manufacturers, and patient advocacy groups — should strongly consider participating in the comment process. Comments received on or before July 9th will be provided to the PCAC, and comments received by July 22nd will be taken into consideration by FDA. Submissions that include robust clinical data, safety profiles, and evidence of patient need are likely to carry the most weight. Companies considering submitting comments should coordinate with regulatory counsel to ensure that submissions are strategically framed and do not inadvertently create adverse admissions.
According to Secretary Kennedy, at least, the Department of Health & Human Services (“HHS”) and FDA are giving the matter serious consideration. On the most recent episode of The Secretary Kennedy Podcast, Secretary Kennedy doubled down on his position that prohibiting these peptides from being legally compounded has not protected consumers but has instead driven them toward an unregulated market with far less oversight, and that these peptides should be made available through legitimate suppliers, properly regulated channels, and healthcare professionals operating within the bounds of the law. He suggested that “an announcement” (presumably beginning the process of restoring legally compounded status for some or all of these peptides) could occur “within weeks.”
If the PCAC recommends inclusion of one or more of the substances on the 503A Bulks List, a formal notice-and-comment rulemaking period would follow before they would actually be added to the list and eligible for compounding under 21 CFR § 216.23. Based on historical precedent, that rulemaking process could take twelve to twenty-four months or longer — meaning that even a favorable PCAC recommendation would not translate into immediate compounding authorization. Companies should plan accordingly and avoid premature commercial commitments based on anticipated regulatory outcomes. As discussed in our previous article, if these substances are ultimately added to the 503A Bulks List, permission to compound would not be unconditional — compounders would remain subject to rigorous oversight, which, based on remarks from the administration, may become increasingly restrictive. FDA's enforcement posture in the GLP-1 space offers an instructive — if not perfectly analogous — preview:[5] the Agency has issued a series of warning letters targeting compounding pharmacies and telehealth platforms for misleading advertising, unsubstantiated therapeutic claims, and failure to comply with current good manufacturing practice (“cGMP”) requirements. That enforcement approach may very well extend to other peptides, and companies should not assume that placement on the 503A Bulks List insulates them from scrutiny with respect to areas like advertising/promotion and manufacturing. Additionally, FDA regulation is only one layer of the compliance landscape. State boards of pharmacy maintain independent authority over compounding practices, and several states have adopted positions on peptide compounding that are more restrictive than the federal framework.[6] General counsel managing multi-state operations should conduct a jurisdiction-by-jurisdiction assessment of applicable state requirements. We will be covering the PCAC meetings closely and will provide updates as the regulatory landscape evolves.
FOOTNOTES
[1] See Heeding Kennedy’s Wishes, FDA Is Expected to Lift Restriction on Peptides, N.Y. Times.
[2] The peptides include: BPC-157, Cathelicidin (LL-27), GHK-Cu, Dihexa acetate, Melanotan II, Mechano Growth Factor, Pegylated (PEG-MGF), Emideltide (DSIP), Epitalon, KPV, MOTs-C, Semax (hepapeptide), Thymosin Beta-4, Fragment (LKKTETQ, also known as TB-500).
[3] The substance scheduled for review, for the uses specified on the meeting notice, include: BPC-157-related bulk drug substances (BPC-157 (free base)/ BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/ KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/ TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/ MOTs-C acetate), Emideltide (also referred to as delta sleeping inducing peptide (DSIP))-related bulk drug substances (Emideltide (free base)/ Emideltide acetate), Semax-related bulk drug substances (Semax (free base)/ Semax acetate), and Epitalon-related bulk drug substances (Epitalon (free base)/ Epitalon acetate).
[4] The substance scheduled for review include Cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II, Mechano Growth Factor, Pegylated (PEG-MGF).
[5] GLP-1 receptor agonists such as semaglutide, tirzepatide, and liraglutide were never included on the 503A Bulks List or the 503B Bulks List; rather, compounding of those substances was permitted under the drug shortage provisions of the FDCA while they appeared on the FDA Drug Shortage List. FDA removed tirzepatide from the Drug Shortage List t in 2024 and semaglutide in 2025, though liraglutide remains on the list as of this writing.
[6] E.g., Alabama, Ohio, California, and New York.