Grey
Grey: conditional, contested, or unfinished
Compounded peptides, shortage-era GLP-1 copies, favorable PCAC recommendations without final FDA rulemaking, and state overlays that change what a pharmacy will put in writing. Not automatically illegal. Not automatically clear.
Means
- · You need a pharmacy that will state, in writing, the authority it is relying on for that compound today.
- · Consent language must say the product is compounded and not FDA-approved as a finished drug.
- · Federal Category 1 / PCAC-recommendation headlines are not the same thing as a final bulks-list decision.
Does not mean
- · Counsel said you can skip documentation because a committee voted.
- · A research-use-only vendor became a pharmacy.
- · Every state treats interim Category 1 the same way.
Clinic test
Can you produce one sentence of regulatory status per menu item, plus a pharmacy letter that matches that sentence?
Examples
Patient-specific 503A compounding (selected peptides)
Depends on bulks-list status, pharmacy policy, and state board posture.
July 2026 PCAC recommendations (e.g. BPC-157, TB-500, MOTS-c)
Committee recommended inclusion on the 503A bulks list; FDA still controls the next step.
Compounded GLP-1s after shortage relief
FDA has published concerns about unapproved GLP-1 products and salt forms; treat as high-documentation.