This is the service line where we most often tell people no, so it is worth setting out the reasoning rather than the sales pitch.
Where peptides actually stand
BPC-157 was placed in Category 2 — substances with safety concerns — in late 2023, which prohibits compounding it. In 2026 the FDA signalled an intention to remove twelve peptides including BPC-157 from that category, and the Pharmacy Compounding Advisory Committee narrowly recommended BPC-157 for the 503A bulks list at its July 2026 meeting.
Both of those are movement. Neither is permission. Removal from a do-not-compound list is not the same as addition to the list you may compound from, and listing runs through rulemaking. Regulatory limbo is not a green light, and absence from a prohibited list is not authorization.
The harder cases
- Retatrutide is investigational and not approved for any indication. It is not a component of an approved drug, has no USP monograph, and is not on the 503A or 503B bulks lists — so there is no lawful compounding pathway at all. Product in circulation appears to use research-grade API, which is not permitted in human drugs. Our providers do not prescribe it and our protocols do not permit it.
- “Research use only” supply is not a workaround. Labelling does not change what the substance is or who may lawfully receive it.
- Exosomes and stem cell products are a separate category with its own problem — generally unapproved biologics, and the marketing is what draws enforcement.
What we will do
- Tell you, per molecule, whether a lawful pathway exists before a protocol is written.
- Build programs around what can actually be sourced, with the basis documented.
- Provide licensed providers, good faith exams and monitoring labs for the ones that can.
- Review your marketing, because in this category the copy is usually further ahead than the pharmacology.
Frequently asked questions
Can we offer BPC-157?
Not on the basis that the FDA has signalled movement. Category 2 placement prohibits compounding, and the proposed changes run through rulemaking that has not concluded.
Our pharmacy says they can make it. Is that enough?
No. Willingness is not authority. Not everything a pharmacy is prepared to compound is something it may lawfully compound, and the prescriber carries their own exposure.
What about peptides sold as research chemicals?
Research-grade API is not permitted in drugs administered to humans. The label does not create a separate legal category for the same substance.
Will you take us on if peptides are our main offering?
Usually not as it stands, and we will say so at the first call rather than after an invoice.
General information, not legal or medical advice. Requirements differ by state and change often. Confirm your obligations with counsel licensed where you operate.