Peptide consultation
Peptide therapy sits in an unusual regulatory position. In April 2026 several peptides including BPC-157 and TB-500 were removed from 503A Category 2, so compounding them is no longer prohibited — but they were not added to the 503A positive list either. In July 2026 an FDA advisory committee recommended adding six of them, a recommendation the agency has not yet acted on and which would require formal rulemaking. They remain without FDA approval, without an approved indication, and without a USP monograph.
What a provider evaluates
- Your goals, and whether an approved therapy addresses them
- Full medical history, including any history of malignancy
- Current medications and supplements
- Baseline laboratory work relevant to the protocol under discussion
- Your understanding that these are not approved therapies
What treatment may involve
- A provider-directed protocol using a compounded peptide preparation
- Baseline and follow-up laboratory monitoring
- A recommendation against peptide therapy where an approved option is more appropriate
Whether any of these is appropriate is determined by a licensed provider after reviewing your history and laboratory results.
Medications a provider may consider
BPC-157
BPC-157 is a synthetic peptide with no FDA approval and no approved indication. Learn its current regulatory status and what a provider considers.
Sermorelin
Sermorelin is a growth hormone-releasing hormone analogue. Learn what it is, how it is administered, and what a provider evaluates first.
CJC-1295 / Ipamorelin
CJC-1295 and ipamorelin are peptides sometimes prescribed together. Learn their regulatory status and what evaluation precedes any prescription.
Questions about peptide consultation
Are peptides FDA-approved?
The peptides discussed in this category are not FDA-approved and have no approved indication. They are compounded preparations prescribed at the discretion of a licensed provider. There is no USP monograph for them, human clinical evidence is limited, and dosing protocols are not standardised between prescribers. Anyone presenting them as proven therapies is overstating what is known.
What is the current regulatory status of BPC-157?
In late 2023 the FDA placed BPC-157 into 503A Category 2, which effectively prohibited compounding it. In April 2026 it was removed from Category 2, but it was not added to the 503A positive list — the list of substances affirmatively permitted — so it became neither prohibited nor authorised. In July 2026 the Pharmacy Compounding Advisory Committee voted 8–6 to recommend adding it to that list. That vote is a recommendation rather than a rule: the FDA has not acted on it, and doing so requires formal rulemaking that ordinarily takes a year or more. As things stand it remains without FDA approval and without an approved indication.