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Regulatory

503A, 503B and Compounding Categories

Pharmacy compounding in the United States is not FDA approval. Category 1, 2 and 3, 503A and 503B, and a PCAC vote are different instruments.

Therapept EditorialUpdated 12 September 20268 min readReviewed by Therapept Editorial
Do not collapse these
InstrumentWhat it is
NDA/BLA approvalA specific product may be marketed for labelled uses
503A / 503BCompounding pathways for pharmacies and outsourcing facilities
Category 2Bulk substances FDA has said may present significant safety risks in compounding
PCAC recommendationAdvisory; not a listing and not an approval

In Therapept’s library, ipamorelin acetate and GHRP-2 are on FDA’s active 503B Category 2 table and Kisspeptin-10 is on the active 503A table. Several others sit on the withdrawn-nominations table. Neither position is the same thing as ‘unapproved’.

Sources

  1. FDA — Certain bulk drug substances for use in compounding may present significant safety risks
  2. FDA — Human drug compounding

This article is informational. It is not medical, legal or financial advice. Editorial policy · Report a correction