MOLRECORD
NEWS BRIEF REGULATION Regulation and policy

From Category 2 to review: how twelve peptides came off the restricted list

A three-year sequence from restriction to re-examination, with the final decision still open.

Published 5 Oct 2026 Event 15 Apr 2026 Sources 4 REGULATORY · CATEGORY 2 SINCE SEP 202312 REMOVED · APR 2026PCAC · JUL 2026 AND FEB 2027

In September 2023 the FDA added nineteen peptides, among them BPC-157, TB-500, CJC-1295, ipamorelin, MOTS-c and injectable GHK-Cu, to Category 2 of its list of bulk drug substances nominated for compounding. Category 2 is reserved for substances the agency considers to raise significant safety concerns, and placement discourages pharmacies from compounding with them. [1][2]

On 27 February 2026 the Secretary of Health and Human Services said publicly that roughly fourteen of the nineteen would be moved toward compounding-eligible status. On 15 April 2026 the agency gave notice that twelve peptide substances would be removed from Category 2 because their nominations had been withdrawn, and published a Federal Register notice convening the Pharmacy Compounding Advisory Committee on 23–24 July 2026 and again before the end of February 2027. [1][3]

Removal from Category 2 is not approval and not a listing; the substances returned to an unresolved status pending committee review. The April removals did not include CJC-1295 or ipamorelin acetate, whose 503A nominations had already been withdrawn in September 2024; ipamorelin acetate remains in Category 2 for 503B outsourcing facilities. Removal from a category is not eligibility: a withdrawn substance stays outside the 503A bulks list until a rule adds it. [1][2][4]

SOURCES

  1. Orrick. FDA announces removal of 12 peptides from Category 2 and schedules PCAC meetings. 16 Apr 2026. Legal analysis. https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings
  2. FDA. Certain bulk drug substances for use in compounding that may present significant safety risks. Updated 22 Apr 2026. Regulatory document.
  3. Goodwin. FDA signals potentially evolving stance toward compounding of certain peptides. May 2026. Legal analysis. https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides
  4. AJMC. Peptide regulation debate intensifies after FDA advisory panel's controversial vote. 25 Sep 2026. News feature. https://www.ajmc.com/view/peptide-regulation-debate-intensifies-after-fda-advisory-panel-s-controversial-vote

CHANGELOG · 5 Oct 2026 FIRST PUBLISHED · CORRECTIONS ARE ADDED HERE, NEVER HIDDEN