In 2023 a batch of the most popular peptides landed on a list most buyers have never heard of. It is the clearest signal the agency has published.
the compounding context
Licensed 503A pharmacies can compound medications from bulk substances, but only from substances the FDA has evaluated. Nominated substances get sorted into categories while under review. Category 1 covers those that may be used during evaluation. Category 2 covers those that raise significant safety risks — and Category 2 placement means a licensed pharmacy cannot compound with them.
what happened
In 2023 the agency placed a group of well-known peptides into Category 2, among them BPC-157, ipamorelin, CJC-1295, epitalon and kisspeptin. The stated reasons varied by substance and included immunogenicity concerns, insufficient safety characterisation, and inadequate information to evaluate risk. This was a considered regulatory assessment, not an oversight.
In 2023 a batch of the most popular peptides landed on a list most buyers have never heard of.
what it changes and what it doesn't
It closed the compounding pharmacy route. It did not ban possession, and it had no direct effect on research-chemical vendors, who were never operating through that channel. So the practical outcome was that the regulated, licensed, quality-controlled path shut while the unregulated one continued unaffected — which is close to the opposite of what you would want.
why it's worth knowing
This is the most explicit public statement the FDA has made about these specific compounds. When a compounding pharmacy declines a request that a research vendor fills the same afternoon, this list is why. Anyone weighing these compounds should know that a regulator looked at the available safety data and concluded there was not enough of it.