FDA guidances provide clarity on compounding exceptions

FDA released two draft guidance documents that provide clarity on the agency's thinking on sections 503A and 503B of the Food, Drug & Cosmetics Act, which restrict compounding of drugs that are essentially a copy of a commercially available or FDA-approved drug. The documents detail the criteria to qualify for an exception to these restrictions.

One draft guidance covers section 503A, which covers compounding by licensed pharmacists in a state-licensed pharmacy or federal facility or by a licensed physician. The document outlines a two-step process for determining whether a compounded drug meets the exception criteria. FDA said it will first determine whether the compounded drug is essentially a copy of a commercially available drug; if it is, the agency will then determine whether the compounded version "was compounded regularly or in inordinate amounts," which is prohibited. ...