On July 7, 2016, FDA released two draft guidance documents setting forth the Agency's policies for applying the "essentially a copy" provisions of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act ("FDCA"). Under Section 503A, a drug product may be exempt from the FDCA's manufacturing, labeling, and new drug application requirements if, among other things, the pharmacist or physician "does not compound regularly or in inordinate amounts ... any drug products that are essentially copies of a commercially available drug product." 21 U.S.C. § 353a(b)(1)(D). The 503A guidance outlines FDA's proposed approach to applying this provision, including the Agency's interpretation of the terms commercially available, essentially a copy of a commercially available product, and regularly or in inordinate amounts. Under Section 503B, a drug compounded by a registered outsourcing facility may be exempt from the FDCA's labeling, new drug application, and distribution requirements if, among other things, the drug "is not essentially a copy of one or more approved drugs." 21 U.S.C. § 353b(a)(5). The 503B guidance explains how FDA plans to apply the statutory definition of the term essentially a copy of an approved drug, id. § 353a(d)(2), when comparing a compounded drug to an approved drug or, alternatively, a covered over-the-counter ("OTC") drug. We previously discussed other guidance documents related to Sections 503A and 503B here.

In addition, in response to feedback from stakeholders, FDA is changing its inspection procedure for drug compounders that are not registered as outsourcing facilities under Section 503B of the FDCA. Before closing the inspection, FDA investigators will now make a preliminary assessment of whether the entities are compounding in accordance with certain conditions of Section503A. An inspector will include observations representing deviations arising solely from current good manufacturing practice ("CGMP") requirements—which do not apply to a drug if the conditions of Section 503A are satisfied—only if the inspector's preliminary assessment reveals that the firm compounds drugs that do not qualify for exemption under Section 503A.

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