US status

Compoundable

By Peptide America · Publisher · Reviewed September 2026

Section 503A lets a licensed pharmacy compound a drug for an individual patient with a valid prescription, drawing on bulk substances the FDA has nominated for its interim list. Category 1 of that list holds substances under review without identified safety concerns; pharmacies may compound them while the review continues.

Category 1 is a permission during review, not an approval, and it can end. The molecules below hold that position today, each verified on the date shown; sermorelin adds a stronger foundation, since it was itself an approved drug withdrawn for commercial rather than safety reasons.

Molecules holding this status

MoleculeClassUS statusPosition
SermorelinGHRH(1–29); formerly GerefGH secretagoguesCompoundable (503A)Previously approved (Geref), discontinued in 2008 for business reasons; compounded today under 503A. Verified August 2026.
NAD+Nicotinamide adenine dinucleotideMitochondrialCompoundable (503A)Category 1 of the interim 503A bulks list; compoundable with a valid prescription while FDA evaluates. Verified August 2026.
GlutathioneMitochondrialCompoundable (503A)Category 1 of the interim 503A bulks list; compoundable with a valid prescription. Verified August 2026.
GHK-CuCopper tripeptide-1Repair peptidesCompoundable (503A)Nominations withdrawn April 2026; the non-injectable route was restored to Category 1 in May, the injectable route was not and has no lawful route. Verified August 2026.
Vasoactive intestinal peptideVIP; aviptadilGut peptidesCompoundable (503A)Category 1 of the interim 503A bulks list; a pharmacy may compound it while FDA review continues. No approved product containing it exists.

The pending page tracks six peptides that a July 2026 advisory vote recommended adding to this list; none has crossed yet.

Elsewhere in this index

Evidence reviews

Reference tables

Definitions

  • Section 503AThe provision under which a licensed pharmacy compounds a drug for an individual patient with a valid prescription.
  • The interim 503A bulks listThe FDA's interim list of bulk drug substances nominated for use in 503A compounding, sorted into categories.
  • Category 1Substances under FDA review without identified safety concerns; pharmacies may compound them while review continues.
  • Compounded drugA drug prepared by a pharmacy rather than manufactured under an approval. FDA does not approve it or review it for safety, effectiveness, or quality.
  • All glossary terms