FDARegulatory IntelligenceStatuteHIGH INSPECTION RISK
FD&C Act §503A

Pharmacy Compounding — Conditions for Exemption

Exempts drugs compounded by a licensed pharmacist or physician for an identified individual patient from new-drug approval, adequate-directions-for-use labelling, and cGMP — provided a set of conditions is met. Added to the FD&C Act in its current form by the Drug Quality and Security Act of 2013.

LAST REVISED
November 2013
PRODUCT AREAS
SterileSolid Dose
SCOPE & APPLICABILITY

Compounding pharmacies and physicians preparing patient-specific preparations. A 503A compounder is regulated principally by its state board of pharmacy; FDA retains authority over adulteration and misbranding but does not apply cGMP.

KEY REQUIREMENTS
  • 01Compounding performed by a licensed pharmacist or physician, per a valid prescription for an identified patient
  • 02Bulk substances comply with the statutory sourcing conditions
  • 03Not essentially a copy of a commercially available drug product
  • 04Not a drug appearing on the FDA withdrawn/removed-for-safety list
  • 05Compliance with applicable USP compounding chapters as adopted by the state
IMPLEMENTATION TIPS
›Map every condition of the exemption to a procedure and a record — the exemption is only as good as the evidence that each condition held
›Track the 503A bulks list and the "difficult to compound" list; both change and both are enforcement triggers
›Where volume grows past patient-specific work, model the 503B path deliberately rather than drifting across the line

FD&C Act §503A: frequently asked questions

Quick answers to common questions about FD&C Act §503A.

What is FD&C Act §503A?

FD&C Act §503A — Pharmacy Compounding — Conditions for Exemption — is a statute issued by the Food and Drug Administration (United States). Exempts drugs compounded by a licensed pharmacist or physician for an identified individual patient from new-drug approval, adequate-directions-for-use labelling, and cGMP — provided a set of conditions is met. Added to the FD&C Act in its current form by the Drug Quality and Security Act of 2013.

Who does FD&C Act §503A apply to?

Compounding pharmacies and physicians preparing patient-specific preparations. A 503A compounder is regulated principally by its state board of pharmacy; FDA retains authority over adulteration and misbranding but does not apply cGMP.

What are the key requirements of FD&C Act §503A?

FDA FD&C Act §503A requires, among other things: Compounding performed by a licensed pharmacist or physician, per a valid prescription for an identified patient; Bulk substances comply with the statutory sourcing conditions; Not essentially a copy of a commercially available drug product; Not a drug appearing on the FDA withdrawn/removed-for-safety list.

When was FD&C Act §503A last updated?

The current version of FD&C Act §503A dates from November 2013.

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