On July 7, 2016, FDA released two draft guidance documents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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