FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know (Post 1 of 2)

The peptide compounding landscape shifted last week, and if you are interested or involved in the peptide industry, compounding pharmacies, telehealth, or the broader market for injectable wellness products, you’ll want to understand what happened—and perhaps more importantly, what hasn’t happened yet.

FDA’s PCAC Meeting Announcement

We have been waiting for some type of “peptide announcement” from FDA/HHS—at least since HHS Secretary Robert F. Kennedy Jr.’s  appearance on the Joe Rogan podcast. (Yes…the senior blogger on this post now gets her breaking FDA/HHS news from her 28 year-old son and a Rogan podcast regular listener).

Then, on April 16, 2026, FDA published a Federal Register notice announcing a Pharmacy Compounding Advisory Committee (PCAC) meeting scheduled for July 23-24, 2026, at FDA’s White Oak Campus in Silver Spring, Maryland.  The PCAC will consider seven peptides for potential inclusion on the Section 503A Bulk Drug Substances List:

• On July 23^rd: BPC-157, KPV, TB-500, and MOTs-C
• On July 24^th: Emideltide (DSIP), Semax, and Epitalon

The specific indications under review range from ulcerative colitis and wound healing to opioid withdrawal, cerebral ischemia, and insomnia.  FDA also announced the PCAC will convene again before the end of February 2027 to review five additional peptides for the 503A Bulks Drug Substances List, including GHK-Cu, Melanotan II, Cathelicidin (LL-37), Dihexa acetate, and Mechano Growth Factor, Pegylated (PEG-MGF).

In parallel, FDA updated its 503A bulk substance categories to reflect that the peptides under consideration would be removed from Category 2 within seven calendar days.  Taken together, these moves signal that the 19 peptides that were moved to Category 2 in 2023 during the Biden administration’s “are potentially moving to some form of regulated access—though the road from here to there is longer than some headlines may suggest.

And, please don’t forget, lest you are as confused as we were by Secretary Kennedy’s recent testimony here (starting around the 2:16:32ish mark), these peptides to be considered by the PCAC, were never on “Category 1,”  which of course is the list of substances that may legally be used in Section 503A compounding if they are not a component of an FDA-approved drug or the subject of a USP/NF monograph.  Of note, FDA has also been interestingly silent concerning Section 503B outsourcing facilities’ ability to compound using peptides—FDA has not indicated that these 12 peptides will be reviewed for or otherwise moved to the Agency’s separate 503B Category 1 list.

How’d we get here?

To understand where we are, it helps to recall where we’ve been.  In September 2023, FDA moved over a dozen peptides into Category 2 of the 503A bulks list:  a designation that effectively prohibited their use in compounding.  But note again, these peptides were never listed in Category 1 and thus could not be legally used in compounding.

The Agency cited “significant safety concerns” for these popular peptides, including risks related to immunogenicity, impurities, and availability of only limited human clinical data.  That decision did not eliminate demand for these products—it likely just redirected it.  Next, FDA was sued by Evexias and Farmakeio down in Texas under the Administrative Procedure Act, citing a lack of transparency concerning the placement of certain peptides in Category 2.  That lawsuit dealt specifically with four peptides:  AOD-9604, CJC-1295, Ipamorelin acetate, and Thymosin Alpha-1 (“Ta1”).

Tweeting since 2024, Secretary Kennedy has made reversing this “policy” a public priority, citing the “black market” prior restrictions and framing the current shift as an effort to “restore” regulated access for patients and providers.  For a third time, they were never legally permitted under 503A.  Secretary Kennedy has discussed the issue extensively in public media appearances, and his interest in the issue—and a history-remaking advisory committee process—has not gone unnoticed by stakeholders closely watching the PCAC’s composition.  The committee currently sports a roster of only three voting members, one industry liaison, and no chair, against an authorized slate of up to twelve voting members.  Some observers have noted concerns that the PCAC’s makeup could be shaped by political appointments before the July meetings, though there is no indication that has occurred.

See our long and winding coverage of the rollercoaster ride that has been the 503A bulks list here, here, here, here, here, here, here, here, and here.

Why the PCAC Meetings Matter—and What It Doesn’t Do

Let’s be clear:  The July 2026 meeting is likely a necessary procedural step, not the finish line.  Under FDA’s typical process, changes to the 503A Bulk Drug Substances List are routed through the PCAC; without such a review, any modification would likely face a legal challenge.  Notably, PCAC’s recommendation is non-binding, and formal rulemaking is what comes next.  Even if PCAC recommends adding these peptides to 503A’s “Category 1” list, and even if FDA agrees, notice-and-comment rulemaking is still required—a process that, under standard timelines, can take more than a year.  Given the bulks list final rulemaking that has not yet occurred under Section 503A, other than for about ten substances, the process could take a very long time.  For industry participants planning product or service launches around peptide compounding, that timeline is important to internalize.  If indeed FDA decides to place these peptides in Category 1, then the Agency should include them in Category 1 on an interim basis, as that has been FDA’s policy since the passage of Section 503A in 1997 and the Drug Quality and Security Act in 2013.

And, Secretary Kennedy, with the stroke of the pen, arguably could determine to place the referenced peptides in Category 1, and permit immediate legal access, given that Section 503A(c) states, “the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health.” (Emphasis added.)  While one could consider that such a provision would only be invoked to remove unsafe substances, Secretary Kennedy arguably could use this provision to place these peptide substances in Category 1 in the “interest of public health,” or more specifically, to shut down the fast-growing gray/black peptide market.

Notwithstanding, moving peptides to Category 1 poses other issues and questions.  We will discuss those in our post tomorrow, so stay tuned.