September 29, 2023: Category 2
The FDA moved CJC-1295, ipamorelin acetate, and more than a dozen other peptides into Category 2 of its interim 503A compounding policy, the list of substances with significant safety concerns.
2024: the lawsuit
Evexias Medical Centers and Farmakeio sued the FDA over the lack of process behind those placements. The suit covered AOD-9604, CJC-1295, ipamorelin acetate, and thymosin alpha-1, and settled in September 2024 with the FDA agreeing to put all four through PCAC.
October 29, 2024: Ipamorelin vote
The committee voted 0 to 12, with one abstention, against ipamorelin free base, and 0 to 12 with one abstention against ipamorelin acetate. The same meeting voted 0 to 11 against MK-677.
December 4, 2024: CJC-1295 vote
The committee voted 0 to 13 against the free base and each DAC form, and 1 to 12 against the acetate. The one recorded comment was on the lack of evidence for effectiveness.
April 15, 2026: the thaw
Secretary Kennedy confirmed twelve peptides had been removed from Category 2, among them BPC-157, TB-500, MOTS-c, injectable GHK-Cu, Semax, KPV, and Epitalon. CJC-1295 and ipamorelin were not on the list.
July 23–24, 2026: PCAC meeting
Seven peptides went before PCAC, and six were recommended for the compounding list. CJC-1295 and ipamorelin were not on the agenda.
Before the end of February 2027: the remaining five
The remaining five are scheduled for a meeting before the end of February 2027. CJC-1295 and ipamorelin are not among them.
Current status
The FDA’s current 503A category document, updated May 14, 2026, lists neither compound in any category. On the 503B side, ipamorelin acetate remains in Category 2.
What that means in practice
No US pharmacy has a lawful basis to compound CJC-1295 or ipamorelin. A telehealth prescription does not create one. In sport, both are banned under WADA S2.
Conclusion
This stack is not in a gray area. Each half has been individually put before the FDA’s expert committee and rejected without a vote in favour, and the 2026 reversal that freed a dozen other peptides did not include either of them.