FDA on Peptides: A New Landscape for Compounders

In early 2026, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. publicly spoke of his long-standing belief in the therapeutic potential of peptidesSee The Joe Rogan Experience, Ep. #2461 – Robert F. Kennedy Jr. (February 2026),https://www.youtube.com/watch?=wk7DQom821s. and shared his goal of making 14 specific peptides more accessible to consumers, in line with previous Congressional requests to ease the regulatory burdens on providing peptides to patients and their prescribers by the Food and Drug Administration (FDA or the Agency).See, e.g., Letter to Robert F. Kennedy Jr. from Rep. Diana Harshbarger (Nov. 10, 2025), https://a4pc.org/hubfs/PDFs/2025-11-10_Harshbarger-Letter-to-HHS-Peptides.pdf?_hsenc=p2ANqtz-_3R54SQGxT4AdM5xpAaFxX_VsOD3T1oqWILTAAUJ_sTLc0ciFo2g4KTTwfUS61dzq7HO7b. FDA subsequently announced a meeting of the Pharmacy Compounding Advisory Committee (PCAC or the Committee) to assess whether these peptides should be made available for compounding as bulk drug substances. In advance of this meeting, Secretary Kennedy also named several new members to the PCAC, including several well-known peptide promoters. Despite FDA’s recommendation against the use of the peptides on safety grounds, the Committee ultimately voted to recommend all but one of the proposed peptides for use in compounding.

The recommendations are, by definition, advisory, and FDA is the final decisionmaker on whether any of the Committee’s recommendations will actually be implemented. But the prospect of the Committee openly rejecting FDA’s recommendations against use highlights a brewing showdown on these issues. These recent developments, viewed against the backdrop of evolving consumer interest, raise questions about FDA’s scientific concerns and how the Agency will proceed as the PCAC moves to consider more peptides in the near term.

Peptides at a Glance

Peptides are short chains of amino acids that can have multiple effects on the body. They are believed to help orchestrate hormone activity, manage inflammation, and impact immune defenses.See Harvard Health Online, Marygrace Taylor, Peptides: What they are, potential benefits, and safety concerns (July 7, 2026), https://www.health.harvard.edu/medications-and-treatments/peptides-what-they-are-potential-benefits-and-safety-concerns. They are used today in a broad swath of therapeutic and non-therapeutic products, including dietary supplements (e.g., creatine peptides),To the extent that peptides are sold as dietary supplements, these products commonly have some history of use as a food, such as collagen peptides derived from animal proteins, or casein (or whey) derived peptides in commercially available protein mixes. cosmetics (e.g., collagen peptides), and drug products (e.g., GLP-1 products and insulin). For any peptide product, the regulatory authority asserted by FDA depends on the associated claims and other materials used to establish a peptide’s intended use.See, e.g., 21 U.S.C. § 321(i), (g)(1), (ff); 21 C.F.R. §§ 101.93, 210.128; 801.4.

With the advent of the second Trump administration’s Make America Healthy Again agenda and the proliferation of online health information content available to consumers, there is a renewed wellspring of interest in peptides, especially with respect to injectable products that are thought to help bodily recovery from injuries or are promoted to otherwise improve health and appearance,American Medical Association, What Doctors Want Patients to Know About Injectable Peptides (Apr. 29, 2026), https://www.ama-assn.org/public-health/prevention-wellness/what-doctors-want-patients-know-about-injectable-peptides. such as BPC-157, thymosin beta-4, and glycyl-l-histidyl-l-lysine. Secretary Kennedy, in a February appearance on The Joe Rogan Experience, further cemented the administration’s desire to increase peptide availability to consumers and ease regulatory burdens on industry.See supra, note 1. As discussed below, this increased availability in the near term may ultimately depend on FDA’s approach to its drug compounding authority, given the lack of clarity on whether such peptides may be lawfully considered supplements under current US lawThis is because the Federal Food, Drug, and Cosmetic Act generally prohibits the marketing of a dietary ingredient that has been approved as a new drug or that is the subject of substantial public clinical investigations and was not previously marketed as a supplement or food. See 21 U.S.C. § 321(ff)(3)(B). and the costs and time associated with bringing a drug to market through the new drug approval process.

At a high level, drug compounding is a process by which certain types of bulk drug substances (i.e., active pharmaceutical ingredients or APIs) can be combined, mixed, or altered to create a prescription medication for use by an individual patient. FDA broadly categorizes compounded drugs into statutory categories based in part on who is compounding a drug, whether it is a bespoke product compounded to meet the unique needs of an individual patient, and for whom a drug is compounded.

Most relevant for peptides, Section 503A of the Federal Food, Drug, and Cosmetic Act establishes the conditions by which certain drugs may be compounded in certain situations for patients without the need for FDA approval or adherence to certain manufacturing and labeling requirements. In the case of 503A compounding, a licensed pharmacist or physician can compound a patient-specific drug with either (1) a bulk drug substance that complies with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, or (2) any API that is a component of an FDA-approved drug. FDA can also sanction the use of other APIs that do not meet those criteria by including them on a Bulks List it promulgates through rulemaking. While these compounded drugs are subject to fewer FDA regulatory requirements, 503A compounders are still prohibited from compounding products that are essentially copies of commercially available products, and are subject to state pharmacy practice laws.See FDA, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act – Guidance (June 2016), at 3-4.

Peptide Compounding Developments

Following Secretary Kennedy’s public statements on increasing the availability of peptides for consumers, FDA announced in April 2026 the removal of 12 peptides from its 503A Category 2 list, which is a list of bulk drug substances pending review that FDA believes pose safety risks and thus may not be used for compounding a human drug product. FDA cited the withdrawal of these peptides by their initial nominators as the reason for removal.See FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (last updated April 22, 2026), https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks?srsltid=AfmBOopPzlmY31V9wzil11eNELeutovf8fm8jFG2BLs0uAiv9ascX6PX&remove_item=62db9e3397c76207a687c360e0243317&_wpnonce=77031f4f16#table-2. That same month, FDA announced a series of meetings of the PCACSee 91 Fed. Reg. 20465 (Apr. 16, 2026). beginning in July 2026 to evaluate several peptide bulk drug substances and their proposed uses over the course of three meetings:

In May 2026, FDA updated its list of 503A-nominated bulk drug substances to include GHK-Cu on its 503A Category 1 list,See FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (last updated May 14, 2026), https://www.fda.gov/media/94155/download. which denotes bulk drug substances that may be used to compound human drug products pursuant to an in effect enforcement discretion policy.See FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry (Jan. 2025), at 12-13. Then, in June 2026, Secretary Kennedy announced the appointment of several new members to the PCAC, including prominent backers of peptides.For example, at least three members named to the PCAC own compounding pharmacies. See FDA, Pharmacy Compounding Advisory Committee (PCAC) Meeting July 23-24, 2026 – Meeting Roster, https://www.fda.gov/media/193772/download.

Over the course of the two-day PCAC meeting, the Committee was tasked with evaluating 14 specific peptides (i.e., the free base and acetate salt iterations of seven distinct peptides). FDA presented extensive information regarding the physical and chemical characterization, safety issues, available evidence of effectiveness, and historical use for each of the seven distinct peptides, and it recommended to the Committee that none should be included in the Agency’s 503A bulk drug list.See, e.g., FDA, Introductory Remarks (July 23, 2026), https://www.fda.gov/media/193773/download; FDA, Introductory Remarks (July 24, 2026), https://www.fda.gov/media/193774/download; FDA, Briefing Document Introduction, https://www.fda.gov/media/193342/download. In particular, FDA cited a variety of issues affecting each of these peptides, including minimal evidence of safety or effectivenessSee, e.g., FDA, Briefing Document (BPC-157), at 27, https://www.fda.gov/media/193343/download. (and in some cases no human effectiveness or even toxicological data)See, e.g., FDA, Briefing Document (KPV), at 21, 23, 27, https://www.fda.gov/media/193346/download; FDA, Briefing Document (MOTS-C), at 33, https://www.fda.gov/media/193347/download. and increased risks of developing other health conditions, such as cancer or bleeding.See, e.g., FDA, Briefing Document (Epitalon), at 35, https://www.fda.gov/media/193345/download; FDA, Briefing Document, Semax, at 41, https://www.fda.gov/media/193348/download. Despite FDA’s presentation, the Committee ultimately voted to recommend six of the seven proposed peptides for inclusion on FDA’s 503A bulk drug list. The Committee narrowly excluded emideltide on a 6-7 vote, with two Committee members stating during the meeting that the lack of quality evidence was enough to vote against inclusion.See Joanne S. Eglovitch, FDA Advisory Committee Backs Two More Peptides, Rejects One for Compounding List, Regulatory News (July 24, 2026), https://www.raps.org/resource/fda-advisory-committee-backs-two-more-peptides-rejects-one-for-compounding-list.html. As of this writing, FDA is now reviewing the six PCAC recommendations and has not made a final decision on whether they should be authorized for use in 503A compounding.The July 2026 PCAC meeting was focused on FDA’s 503A bulks list and not the Agency’s 503B bulks list. We note that future advisory committee meetings may choose to incorporate discussion of FDA’s 503B authorities. The PCAC plans to meet again before February 2027 to review additional peptides, including GHK-Cu.

Takeaways

It is important to understand amid these developments that peptides are not a novel category of substances. Certain types of peptides with longstanding clinical uses — like insulin, certain types of cancer drugs, and synthetic versions of human hormones such as oxytocin and vasopressin — are all currently marketed in the US with the benefit of FDA approval. Further, despite the PCAC’s recommendations, none of the other proposed peptides have been authorized for use in compounding. For APIs that are not in FDA-approved products and that must otherwise be authorized for use (e.g., by way of recognition on an applicable USP or NF monograph, or inclusion on a published bulk drug substance list), FDA retains the sole authority to make this determination and is not bound by the PCAC’s recommendations. Indeed, it may decide to reject these recommendations, especially in light of the safety risks the Agency flagged for each of the six peptides under consideration.

However, while the mechanisms of FDA’s regulatory oversight of 503A drug compounding in this context are well-established, it is less clear how the internal deliberations in FDA will evolve given Secretary Kennedy’s public statements, the recent PCAC appointments, and the Administration’s interest in the potential therapeutic benefits of certain peptides even in the face of potential risks. Given the groundswell of interest in these products and the prospect of additional PCAC meetings on the topic, drug compounders and brand-name producers of peptide products should continue to monitor the progress of FDA’s deliberations.