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    An overview of FDA’s 503B outsourcing facility requirements


    Ned MilenkovichThe 2013 Compounding Quality Act passed by Congress provides a pathway for a pharmacy acting as a Section 503B “outsourcing facility” to register as such with the FDA. Once registered, an outsourcing facility must meet specific conditions to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval requirements and product labeling requirements.

    The law requires that drugs be compounded in compliance with CGMPs either by or under the direct supervision of a licensed pharmacist in a registered facility. Information on the products compounded at the facility must be reported, to include a list of all products compounded during the previous six months and details about the compounded products, such as source of ingredients used. Other conditions must also be met under the law including reporting adverse events and labeling products with prescribed information.

    An outsourcing facility will not be considered registered until it has paid its annual registration fee. In addition, the law requires that outsourcing facilities register and report their products to FDA electronically.

    Traditional pharmacy compounding

    Drugs produced by pharmacy compounders that are not registered as outsourcing facilities must meet the conditions of section 503A to qualify for the specified exemptions. Except for the limited exemptions, all other applicable provisions of the FDCA remain in effect for compounded drugs, even if the conditions in section 503A are met.

    FDA’s intention with regard to FDCA Section 503a is described in a draft guidance document issued by the agency. Also described in this draft guidance are the provisions of the law that can be applied to compounded drugs that do not qualify for exemptions, and the other provisions of the FDCA applicable to compounded drugs whether or not they qualify for the exemptions under Section 503A. FDA also withdrew CPG 460.200 Pharmacy Compounding, issued in 2002, and the guidance Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act, published in November 1998.

       Board of Pharmacy Interface

    The Compounding Quality Act requires FDA to obtain submissions from state boards of pharmacy concerning certain actions taken against compounding pharmacies or expressing concerns that a facility may be acting contrary to Section 503A. State boards of pharmacy also must be notified when FDA receives certain submissions from the state or makes a determination that a compounding pharmacy is acting contrary to section 503A.


    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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