What "FDA Category 1" actually means for the peptides you're asking about.
The peptide conversation online is noisier than it needs to be. The FDA sorts bulk substances into three categories that decide whether a pharmacy can compound them. Here's the plain version, and why "Category 1" is not the same as "FDA-approved."
The three tiers
Category
What it means
Compoundable?
Category 1
Sufficient safety information to compound under interim policy.
Yes, with a patient-specific prescription and clinical oversight.
Category 2
Significant safety risk identified.
No, not compoundable.
Category 3
Insufficient data to evaluate.
No, not compoundable.
Category 1 ≠ FDA approval
Category 1 means a substance can be compounded under interim policy with clinical oversight. It does not mean the substance went through FDA drug approval. Compounded medications are not FDA-evaluated for safety, efficacy, or quality.
What's compoundable now
Sermorelin, 503A eligible (Category 1), available today under clinician supervision.
Gonadorelin, 503A eligible (Category 1), available as a hormone-support adjunct.
GLP-1 (semaglutide / tirzepatide), a separate 503A / shortage-exception pathway, distinct from Category 1. Confirm current eligibility with the pharmacy.
The federal requirements
A patient-specific prescription from a licensed clinician of record.
503A or 503B sourcing, a licensed compounding pharmacy, not a research-chemical vendor.
USP 797 sterile-compounding standards.
FDA-registered API with a valid Certificate of Analysis (COA).
Questions, answered
The honest answers.
Yes. Sermorelin is 503A eligible (Category 1) and can be compounded today with a patient-specific prescription under clinician supervision. It was FDA-approved in 1997 and withdrawn in 2008 for commercial reasons, not safety or effectiveness.
Most compounded peptides are not FDA-approved. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality. A few molecules have an approved branded form for a specific use; we label which is which plainly.
No. BPC-157 is one of seven peptides under FDA review (PCAC, July 23–24, 2026) and has not been reclassified. It is not available to compound today, being under review is not the same as being legal to compound or available.
Medically reviewed by the Peptós.LIFE clinical team · Last reviewed Jun 2026 · Sources on file. Educational content, not medical advice. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality. Reclassification is not the same as FDA approval.