RFK Jr. and the Category 2 reversal: a clear timeline of what's actually happened
TL;DR
- On September 29, 2023, the FDA placed 19 research peptides in Category 2, blocking 503A compounding pharmacies from preparing them.
- FDA removed 5 of the 19 from Category 2 on September 27, 2024, and 12 more on April 22, 2026, after their nominations were withdrawn. Only MK-677 (ibutamoren) and kisspeptin-10 remain in Category 2 as of September 14, 2026.
- In February 2026, HHS Secretary Robert F. Kennedy Jr. said in a podcast interview that FDA would soon make more peptides accessible. That was not a formal proposal; the formal step was FDA's April 2026 change to its category list.
- As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action.
- Halftime Health protocols are prescribed by licensed physicians and prepared by licensed 503A compounding pharmacies. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
What it is
This is a regulatory story about how research peptides (in plain English: lab-made short protein chains studied for healing, sleep, and metabolic effects) are categorized by the US Food and Drug Administration. The FDA sorts ingredients used by 503A compounding pharmacies (in plain English: small pharmacies that make custom prescriptions) into categories, including Category 1 (under evaluation) and Category 2 (substances FDA says raise significant safety risks). Several familiar names — including BPC-157, TB-500, thymosin alpha-1, and Selank — landed in Category 2 in 2023, which is why patients suddenly lost access. FDA removed thymosin alpha-1 and Selank from Category 2 on September 27, 2024, and removed BPC-157 and TB-500 on April 22, 2026.
How it works
Think of the FDA Categories like a kitchen pantry with two shelves. Category 1 ingredients sit on the open shelf — pharmacists can reach for them. Category 2 ingredients are behind a locked cabinet while safety and quality questions are reviewed. The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on which substances belong on the Section 503A bulk drug substances list; its votes are advisory. A change in administration, new safety data, or a public petition can prompt a fresh review.
Who asks about it
Patients who were on a peptide protocol in 2022 and lost access in 2023 want to know one thing: when can my pharmacy refill this? Physicians want to know what they can legally prescribe. Both groups follow the headlines because access has shifted twice in three years.
What the research says
The 2023 Category 2 placements were tied to gaps in US-based safety data and concerns about identity and purity. Peptide research itself is decades old, but much of the clinical literature on items like BPC-157 and Selank comes from Russian and animal studies. Since 2024, several US researchers and patient advocacy groups have pushed for a structured review rather than a blanket block. In February 2026, HHS Secretary Robert F. Kennedy Jr. said in a podcast interview that FDA would soon make more peptides accessible. That was not a formal proposal; the formal step was FDA's April 2026 change to its category list.
What to know before considering it
As of September 14, 2026, MK-677 (ibutamoren) and kisspeptin-10 remain in Category 2. FDA removed thymosin alpha-1 and Selank from Category 2 on September 27, 2024. As of September 14, 2026, they are not in any FDA 503A category and are not on the 503A bulks list. Marketplaces or websites selling them as "research only" are operating outside the licensed clinical pathway. As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action. Halftime Health protocols are prescribed by licensed physicians and prepared by licensed 503A compounding pharmacies. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety or effectiveness. For the other peptides in this article, the safest move is to follow FDA's decisions and work with a licensed physician.
The Halftime POV
Regulation moves slowly, and headlines move fast. We track the actual Federal Register entries and PCAC dockets so patients do not have to. When the reversal is real, we will say so on the same day — and not before.
Related reading:
- Category 1 vs Category 2: what the FDA labels mean
- RFK Jr. and peptide reclassification: the bigger picture
- What to watch at the July 2026 PCAC meeting
FAQ
Q: Did RFK Jr. change peptide law? A: No single person changes FDA law. His February 2026 remarks were a podcast interview, not a formal action. FDA made the formal change: it removed 12 peptides from Category 2 on April 22, 2026.
Q: Is BPC-157 legal right now? A: FDA removed BPC-157 from Category 2 on April 22, 2026, after its nomination was withdrawn. As of September 14, 2026, BPC-157 is not in any FDA 503A category and is not on the 503A bulks list. As of September 2026, FDA has not made a final decision on BPC-157. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted 8 yes, 6 no, and 1 abstention to recommend adding BPC-157 to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action. Halftime Health protocols are prescribed by licensed physicians and prepared by licensed 503A compounding pharmacies. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Q: Where can I follow the official process? A: The FDA Federal Register page and the PCAC docket are the two primary public sources.
Disclaimer
Several peptides discussed in this article — including thymosin alpha-1 and Selank — were previously in FDA's Category 2. FDA removed them from Category 2 on September 27, 2024. As of September 14, 2026, they are not in any FDA 503A category and are not on the 503A bulks list. As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action. This article is educational and is not medical advice. Halftime Health only prescribes through licensed physicians in states where our partner physicians are credentialed.
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Sources
- US Food and Drug Administration. Federal Register notices, 2023-2026. https://www.federalregister.gov/agencies/food-and-drug-administration
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee (PCAC) meeting materials. https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee-pcac
- Robert F. Kennedy Jr., HHS Secretary. Remarks on peptides, The Joe Rogan Experience podcast, February 27, 2026. HHS issued no press release or Federal Register notice.
- FDA Drug Quality and Security Act overview. https://www.fda.gov/drugs/human-drug-compounding
This article discusses compounds whose FDA compounding status has been under review (see our FDA categorization explainer). Halftime Health protocols are prescribed by licensed physicians and prepared by licensed 503A compounding pharmacies. Compounded drugs are not FDA-approved and have not been evaluated by FDA for safety or effectiveness. This article is provided for educational purposes only and does not constitute medical advice or an offer to sell.
Frequently asked questions
Are peptides legal in the US right now?
As of September 14, 2026, two of the 19 peptides FDA added to Category 2 in 2023 remain there: MK-677 (ibutamoren) and kisspeptin-10. FDA removed the other 17 on September 27, 2024 and April 22, 2026. None of the 17 removed peptides is on the 503A bulks list or in any 503A category. (Non-injectable GHK-Cu, a separate entry, is in Category 1.) FDA's interim policy of not taking action against compounding with a substance not yet on the bulks list applies only to Category 1 substances, when other conditions are met.
What did RFK Jr. say about peptides?
During and after his 2025 HHS confirmation hearings, he publicly supported revisiting peptide access. On February 27, 2026, he said on The Joe Rogan Experience podcast that FDA would act on peptides soon and that about 14 peptides would become more accessible. He also said FDA had wrongly moved 19 peptides into Category 2 in September 2023. That was an interview remark, not a formal HHS proposal. The formal step was FDA's April 2026 change to its category list.
When could the reversal be official?
FDA removed BPC-157, TB-500, and 10 other peptides from Category 2 on April 22, 2026. As of September 2026, FDA has not made a final decision on BPC-157 or TB-500. At its July 23–24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted separately on each. Both votes were 8 yes, 6 no, and 1 abstention to recommend adding the peptide to the Section 503A bulk drug substances list. The committee is advisory, and formal addition to the list requires further FDA action. At the same meeting, the committee voted to recommend KPV, MOTS-c, Semax, and Epitalon, and voted against emideltide (DSIP). As of September 14, 2026, FDA has not made a final decision on any of them.
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