FDA Issues Three New Compounding Guidance Documents

On April 15, 2016, FDA issued three draft guidance documents related to compounding of human drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance documents describe FDA’s policies on the prescription requirement in section 503A of the FD&C Act and the definition of “facility”.

In order for drug products compounded by a state-licensed or federal facility to be exempt from provisions of the FD&C Act, they must be compounded for an identified individual patient, after the receipt of a valid prescription order or in limited quantities before receipt of a valid prescription order for the patient. Also, a compounder can register with FDA as an outsourcing facility, which also is entitled to exemptions from provisions of the FD&C Act. The new draft guidance documents provide FDA’s proposed policies concerning these exemptions qualifications.

Draft Guidance: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Actdescribes FDA’s proposed policies concerning requirements for compounding human drug products. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use (or “office stock”).

The second draft guidance, Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act, describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded in a state-licensed hospital or health system pharmacies for use within the hospital or health system.

The third guidance answers questions about the meaning of the term “facility” as it applies to Section 503B of the FD&C Act’s definition of an outsourcing facility. It addresses questions such as whether multiple suites used for compounding drugs at a single street address are considered one or multiple facilities.

Source: FDA