Peptide Regulatory Tracker — US & EU
A running log of FDA and EU regulatory developments relevant to research peptides. Educational, not legal or medical advice. Last updated: 4 July 2026.
- 23 Jul 2026 US Upcoming
FDA advisory committee (PCAC) to review 7 peptides for the 503A bulks list
The Pharmacy Compounding Advisory Committee is scheduled (Jul 23–24) to review BPC-157, KPV, TB-500, MOTS-C, DSIP (Emideltide), Semax and Epitalon. FDA’s pre-meeting briefing documents proposed NOT adding any of them to the 503A bulks list. Outcome pending — check back after the meeting.
- 23 Apr 2026 US
FDA removed 12 peptides from the Category 2 restricted-compounding list
Effective 23 April 2026, easing one restriction pathway. None of these peptides is FDA-approved as a drug; this concerns compounding categories, not marketing authorisation.
- Feb 2025 EU
ePrivacy Regulation withdrawn
The proposed ePrivacy Regulation was withdrawn; the 2002/58/EC ePrivacy Directive still governs email/cookies, with member-state variation. Relevant to newsletter consent and analytics.
- Ongoing EU
REACH R&D exemptions frame research peptides as reagents
Peptides sold strictly for research (no therapeutic claims, RUO labeling) are generally chemical reagents under REACH — but national medicines law (e.g. Germany’s AMG) applies once a product is presented for therapeutic use. See the legal-status table.
How we track this
We monitor FDA (compounding lists, advisory-committee dockets) and EU/EMA developments and update this page when something materially changes — bumping the "last updated" date only on genuine changes. For country-level rules, see the legal-status table; for our sourcing standards, the methodology. Everything here is research use only.