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    An overview of FDA’s 503B outsourcing facility requirements


    Nominations for Lists

    In sections 503A and 503B are included various requirements for FDA to develop lists of drugs that may or may not be compounded and lists of bulk drug substances that may be used in compounding. Section 503A specifies that to qualify for the exemptions under section 503A, a compounder may only use bulk drug substances to compound if:

    • The bulk drug substances comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if one exists;

    • If such a monograph does not exist, the drug substance(s) is a component of an FDA-approved human drug product; or

    • If such a monograph does not exist and the drug substance is not a component of an FDA-approved human drug product, it appears on a list of bulk drug substances for use in compounding developed by FDA.

    Under section 503B, a registered outsourcing facility may only use for compounding a bulk drug substance that is included on an FDA-established list of bulk drug substances for which there is a clinical need or which are on FDA’s drug shortage list. Prohibited under sections 503A and 503B is the compounding of drugs that are on a list of drugs that present difficulties for compounding.

    Inspections and Enforcement

    FDA has stated that it intends to continue inspections of compounding pharmacies, and has taken aggressive action, including enforcement actions, as appropriate to protect the public health. In many cases, Form FDA-483’s were issued accompanied by recalls of sterile products.

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...


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