Section 503A

Section 503A of the Federal Food, Drug, and Cosmetic Act is the provision under which a licensed pharmacy may compound a drug for an individual patient who holds a valid prescription. It is the route by which a molecule with no approved product can nonetheless reach a patient lawfully, and it is the route almost every question on this index eventually turns on.

The permission is not open-ended. A pharmacy compounding from a bulk substance may draw only on substances the FDA has nominated to its interim list and sorted as compoundable while review continues, and it may not compound what is essentially a copy of a commercially available approved drug unless a prescriber documents a clinical difference for an individual patient. The FDA has rejected price as such a difference.

Compoundable in this index today

Five of the 40 molecules this index covers are filed as compoundable under section 503A: a pharmacy may prepare them for an individual patient with a valid prescription.

• SermorelinGH secretagogues · Subcutaneous injection
• NAD+Mitochondrial · Injection; IV infusion
• GlutathioneMitochondrial · Injection; IV infusion
• GHK-CuRepair peptides · Topical (cosmetic); injectable has no lawful route
• Vasoactive intestinal peptideGut peptides · Compounded preparation only; there is no approved product

Approved products are filed separately; a compounded version of an approved drug is restricted, not permitted by default.

Where this term is used