The peptide compounding market is at an inflection point. Recent comments from U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. suggest that the regulatory window for properly licensed and compliant compounding pharmacies to re-enter the peptide market could open sooner than many industry stakeholders expected.
What Just Happened
During an appearance on The Joe Rogan Experience on February 27, 2026,[1] HHS Secretary Robert F. Kennedy Jr. signaled that a significant shift in the administration’s approach to peptide regulation. According to Kennedy, the U.S. Food and Drug Administration (FDA) is expected to take action that could make approximately14 peptides more accessible.
On the podcast, Kennedy stated that he expects an announcement “within a couple of weeks,” expressing hope that these substances will “end up with . . . a place where people have access from ethical suppliers.” He also described himself as a “big fan” of peptides and cast the prior administration’s handling of these substances in adversarial terms, asserting that the FDA, during the Biden era, “illegally” reclassified 19 peptides to a category of substances considered potentially unsafe on the agency’s interim bulks drug substance list.
Kennedy appeared to be referencing the 17 peptides that the FDA designated as Category 2 substances in September 2023.[2] While the specifics of any forthcoming FDA action remain unclear—HHS has not responded to press inquiries, and at least one agency employee whose portfolio includes compounded drugs reported no internal communication about what is coming[3]—near-term action could include:
- A leadership-driven agency push to reclassify certain Category 2 peptides;
- Increased enforcement action against unregulated sellers.
Additionally, court filings in a related lawsuit challenging the FDA’s Category 2 designation of Ipamorelin, CJC-1295, AOD-9604, and Thymosin Alpha-1 reflect the FDA’s own representation that a final rule on these substances is expected, with the case administratively closed pending its anticipated publication no later than March 14, 2027.[4]
Understanding the Federal Regulatory Framework
To appreciate the significance of Kennedy’s comments, one must understand the basic legal architecture governing compounded peptides in the United States. Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), state-licensed pharmacies and physicians may compound drug products for identified individual patients pursuant to valid prescriptions, provided they meet certain statutory conditions.[5] A critical condition is that compounded drugs must be prepared using bulk drug substances that either:
- comply with United States Pharmacopeia (“USP”) or National Formulary (“NF”) standards,
- are components of FDA-approved drugs, or
- appear on FDA’s official Section 503A Bulks List.[6]
Bulk drug substances that do not satisfy one of these criteria may not be used in compounding under Section 503A.
Because the FDA has been developing the 503A Bulks List for years now, through an ongoing, substance-by-substance review process, the agency has established an interim policy to avoid disrupting patient care during what has become a prolonged period of evaluation.[7] Under this framework, the FDA categorized nominated bulk drug substances into distinct categories.
Category 1 includes substances under evaluation that have not been identified as presenting significant safety risks. For Category 1 substances, the agency has exercised enforcement discretion to temporarily permit compounding, provided that manufacturers are registered, valid certificates of analysis are obtained, and all other 503A conditions are met.[8] Peptides such as GHK-Cu (except for injectable routes of administration), and vasoactive intestinal peptide (VIP), for example, may currently be compounded under this policy.
Category 2 substances, by contrast, are those for which the FDA has identified potential significant safety risks. The agency’s enforcement discretion does not extend to Category 2 substances, meaning they cannot be lawfully compounded under its interim policy.[9] Many of the peptides that have become popular in biohacking and longevity circles, including BPC-157, GHK-Cu Injectable, CJC-1295, Ipamorelin, Epithalon, Melanotan II, Semax, fall in this category.[10] As a practical matter, this means that despite broad availability in the open market through unregulated channels, it is unlawful for 503A pharmacies to presently compound any of these peptides for human use.
Kennedy’s assertion that the Biden-era FDA “illegally” reclassified 19 peptides[11] is worth contextualizing against the applicable legal framework. Under FDA’s interim policy, Category 2 designations are not formal rulemakings but rather interim categorizations applied broadly across many categories of bulk drug substances, reflecting a preliminary determination that a substance may present significant safety risks related to its use in compounding pending further evaluation.[12]
For many peptides in Category 2, the FDA has cited concerns that include immunogenicity for certain routes of administration, peptide-related impurities, API characterization complexities, and limited human safety data.[13]
It is also worth noting that several substances initially placed in Category 2, including AOD-9604, CJC-1295, Ipamorelin acetate, Thymosin alpha-1, and Selank acetate, were subsequently removed because nominations for inclusion in the interim list were withdrawn by the nominators. After the nominations were withdrawn, FDA consulted with the Pharmacy Compounding Advisory Committee (PCAC), an independent advisory body, on the potential inclusion of several of these substances on the 503A bulks list. In each case, FDA recommended against inclusion, and the PCAC voted against their inclusion.[14] These peptides are now listed by the FDA under “Other Bulk Drug Substances That May Present Significant Safety Risks,”[15] and four of them are the subject of a lawsuit referenced by Secretary Kennedy during the Joe Rogan interview.
Why This Matters Now
If the FDA acts on Kennedy’s signal and moves a significant number of peptides out of Category 2—or otherwise opens a pathway for their lawful compounding—it would represent a substantial shift in the peptide market, which has been primarily dominated by sellers operating in violation of the FDCA.
For 503A compounding pharmacies, a reclassification would unlock the ability to prepare patient-specific formulations of peptides that are currently prohibited. It would also create significant commercial opportunities across both the supply chain and patient services delivery, from API suppliers to prescribing physicians, wellness clinics, and telehealth platforms. The market opportunity is substantial as consumer demand is already robust, driven largely by unlawful sourcing that a regulated market would displace.
Under FDA’s interim policy, lawful compounding of a Category 1 bulk drug substance requires more than list placement alone. The substance must also be manufactured by a registered establishment under Section 510 of the FDCA and accompanied by a valid certificate of analysis.[16] This means that even if a substance is moved to Category 1, compounders cannot simply source from unregulated sources which are sometimes food-grade chemicals or chemicals that have not been produced in an FDA-registered facility under GMP; they will need pharmaceutical-grade active pharmaceutical ingredients (API) from registered manufacturers, with proper documentation.
Additionally, federal requirements exist concurrently with state-specific requirements governing the practice of pharmacy, including sterile compounding standards under USP <797>, which many states have independently adopted as enforceable requirements, and state board of pharmacy licensure requirements for sterile compounding, which vary by jurisdiction.
From a broader market perspective, there is also the question of what happens to the present unregulated ecosystem of peptide suppliers and distributors unlawfully operating without FDCA approval. The extent to which reclassification displaces the existing unregulated market remains to be seen. As with other markets where regulated and unregulated channels have coexisted, we predict that the degree of displacement will largely be driven by price dynamics, consumer demand, product quality and availability, supply chain readiness, and perhaps most importantly, the pace of enforcement.
A Possible Uptick in Enforcement?
During the Joe Rogan interview, Secretary Kennedy also called attention to what he described as the dangers of the unregulated peptide market, characterizing it as “very, very substandard” while noting that consumers “have no idea” whether what they are obtaining is legitimate.
Kennedy contrasted the current marketplace with the prior regime where peptides were sourced from FDA-inspected facilities producing the same API used by the pharmaceutical industry, while expressing urgency about moving approximately 14 peptides back to a status where they can be lawfully compounded. Significantly, the Secretary framed the solution in terms of access through legitimate pharmaceutical channels, what he called “ethical suppliers,” indicating that the administration’s priority is expanding lawful access while hinting at a potential crackdown on unregulated peptides.
The market may already be responding to these signals. In a notable development, Peptide Sciences, one of the largest and most well-known online sellers of research-use-only peptides, recently announced that it is voluntarily shutting down operations and will discontinue the sale of research peptides.[17] This move could be interpreted as a sign that the era of unregulated peptide sales may be drawing to a close as the regulatory landscape shifts toward lawful compounding channels.
For 503A compounding pharmacies with proper licensing, registered ingredient suppliers, and compliant operational infrastructure—this represents a potentially transformative commercial opportunity. The pharmacies that are already gearing up to produce peptides in the United States stand to be among the first movers in a market that is expected to grow substantially. For the unregulated market, this may signal a narrowing window before regulatory and enforcement pressure intensifies.
How Frier Levitt Can Help
For pharmacies, clinics, and investors evaluating peptide-related activity, the key risk is not merely theoretical legality but practical exposure—inspection risk, forced cessation of operations, reputational harm, and collateral scrutiny of broader business activities. As demand for peptides continues to grow, regulatory scrutiny will follow, and stakeholders across the supply chain should plan accordingly.
Frier Levitt attorneys with experience in both pharmacy and FDA law advise pharmacies, telehealth platforms, clinics and investors on peptide-related compliance, enforcement defense and regulatory strategy as this rapidly evolving sector continues to develop.
[1] The Joe Rogan Experience, Episode #2461, RFK Jr., YouTube (Feb. 27, 2026),
[2] U.S. Food & Drug Admin., Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, (last updated July 8, 2025).
[3] Lauren Gardner, A Peptide in FDA’s Step, Politico: Prescription Pulse (Mar. 3, 2026, 12:00 PM EST),
[4] See Order of Administrative Closure, Evexias Med. Ctrs., PLLC v. U.S. Food & Drug Admin., No. 4:24-cv-00293 (N.D. Tex. Aug. 18, 2025) (O’Connor, C.J.) (ECF No. 47); see also Gardner, supra note 1.
[5] 21 U.S.C. § 353a (Section 503A of the Federal Food, Drug, and Cosmetic Act).
[6] Id. § 353a(b)(1)(A)(i)–(iii).
[7] U.S. Food & Drug Admin., Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (January 2025).
[8] Id at 11-12.
[9] Category 3 substances are bulk drug substances that were nominated for inclusion on the 503A bulks list but whose nominations were not supported by sufficient information for the FDA to evaluate them.
[10] U.S. Food & Drug Admin., Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (updated Sept. 27, 2024),
[11] The agency’s own records reflect 17 such designations.
[12] Id at 6.
[13] U.S. Food & Drug Admin., Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, (last updated July 8, 2025), generally.
[14] The PCAC voted against Ipamorelin-related substances on October 29, 2024, and voted against CJC-1295, AOD-9604, and Thymosin alpha-1 on December 4, 2024.
[15] U.S. Food & Drug Admin., Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, (last updated July 8, 2025).
[16] Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FDCA at 10-11 (Jan. 2025).
[17]https://www.peptidesciences.com/
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