[Drug Compounding Final Guidance]: Prescription requirement under section 503A

Today the U.S. Food and Drug Administration (FDA) issued final guidance titled Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.

Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) describes the conditions under which drug products compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, are exempt from certain requirements of the FD&C Act. One of the conditions is that the drug product must be compounded for an identified individual patient based on the receipt of a valid prescription order for the patient or in limited quantities before receipt of a valid prescription order for an identified individual patient.

The guidance issued today addresses the prescription requirement in section 503A, including FDA’s policies regarding compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of such a prescription (“anticipatory compounding”), and compounding for office use (or “office stock”).

The FDA published a notice of availability for this guidance in the Federal Register.

See FDA’s website for more information on compounding.