Compounding Route Assessment (503A or 503B)
Assessment that matches a compounding business model to section 503A or 503B of the FD&C Act: who orders and receives the drugs, a product screen against the bulk-substance, essentially-a-copy and withdrawn-drug restrictions, and the obligations each route then carries, from patient-specific prescriptions and USP chapters to FDA registration, semiannual reports, cGMP and labelling.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
An assessment that decides whether a compounding operation belongs under section 503A or section 503B of the FD&C Act, and then records how it meets that route’s obligations. The two routes carry different exemptions: 503A drugs are exempt from cGMP but must be patient-specific; 503B outsourcing facilities may supply without patient-specific prescriptions but must comply with cGMP, register, report and accept FDA inspection.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
Section 503A of the FD&C Act (21 U.S.C. 353a) exempts qualifying patient-specific compounding from sections 501(a)(2)(B), 502(f)(1) and 505, subject to its conditions on bulk substances, copies and interstate distribution. Section 503B (21 U.S.C. 353b) exempts drugs compounded by registered outsourcing facilities from sections 502(f)(1), 505 and 582, but not from cGMP, and sets registration, reporting, adverse-event, labelling and inspection requirements. USP <795> and <797> became official on 1 November 2023. The assessment structure is SPEQ practitioner synthesis.
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- FILL IT INHow to Choose Between 503A and 503B Compounding →The procedure this template records, one step at a time.
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