US status
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today, each verified on the date shown; sermorelin adds a stronger foundation, since it was itself an approved drug withdrawn for commercial rather than safety reasons.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
| Molecule | Class | US status | Position |
|---|---|---|---|
| SermorelinGHRH(1–29); formerly Geref | GH secretagogues | Compoundable (503A) | Previously approved (Geref), discontinued in 2008 for business reasons; compounded today under 503A. Verified August 2026. |
| NAD+Nicotinamide adenine dinucleotide | Mitochondrial | Compoundable (503A) | Category 1 of the interim 503A bulks list; compoundable with a valid prescription while FDA evaluates. Verified August 2026. |
| Glutathione | Mitochondrial | Compoundable (503A) | Category 1 of the interim 503A bulks list; compoundable with a valid prescription. Verified August 2026. |
| GHK-CuCopper tripeptide-1 | Repair peptides | Compoundable (503A) | Nominations withdrawn April 2026; the non-injectable route was restored to Category 1 in May, the injectable route was not and has no lawful route.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; aviptadil | Gut peptides | Compoundable (503A) | Category 1 of the interim 503A bulks list; a pharmacy may compound it while FDA review continues. No approved product containing it exists. |
GHRH(1–29); formerly Geref
Previously approved (Geref), discontinued in 2008 for business reasons; compounded today under 503A. Verified August 2026.
Nicotinamide adenine dinucleotide
Category 1 of the interim 503A bulks list; compoundable with a valid prescription while FDA evaluates. Verified August 2026.
Category 1 of the interim 503A bulks list; compoundable with a valid prescription. Verified August 2026.
Copper tripeptide-1
Nominations withdrawn April 2026; the non-injectable route was restored to Category 1 in May, the injectable route was not and has no lawful route.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.
VIP; aviptadil
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.
Evidence reviews
Reference tables
Definitions