[4/15/16] The U.S. Food and Drug Administration (FDA) issued three draft guidance documents related to human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by Title I of the Drug Quality and Security Act (DQSA) in November 2013, that apply to both outsourcing facilities and compounders seeking to operate under section 503A.
The draft guidance documents describe FDA’s proposed policies concerning: the prescription requirement in section 503A of the FD&C Act, how the agency intends to apply the prescription requirement in section 503A to compounding in a hospital or health system pharmacy, and the definition of the term “facility” in section 503B of the FD&C Act.
The draft guidance documents are:
Draft Guidance: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
This draft guidance describes FDA’s proposed policies concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the FD&C Act. 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”).Draft Guidance: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act
Pharmacies located within a hospital or standalone pharmacies that are part of a health system frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders have registered with the FDA as outsourcing facilities under section 503B of the FD&C Act and others are state-licensed pharmacies subject to section 503A. This draft guidance describes how the FDA intends to apply section 503A of the FD&C Act to drugs compounded in state-licensed hospital or health system pharmacies for use within the hospital or health system.Draft Guidance: Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” This guidance seeks to answer questions received from outsourcing facilities and other stakeholders about the meaning of the term “facility,” such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards.
Each draft guidance document is available for public comment for 90 days.
Section 503A of the FD&C Act describes the conditions under which drug products compounded by a State-licensed pharmacy or Federal facility, or by a licensed physician, are entitled to exemptions from provisions of the FD&C Act concerning new drug approval, labeling with adequate directions for use, and current good manufacturing practice (CGMP) requirements. One of the conditions that must be met for a compounded drug product to qualify for exemptions from these requirements is that it must be compounded for an identified individual patient, after the receipt of a valid prescription order for the patient or in limited quantities before receipt of a valid prescription order for the patient.
Under section 503B of the FD&C Act, a compounder can elect to register with the FDA as an outsourcing facility. Drugs compounded by an outsourcing facility as defined in section 503B are entitled to exemptions from provisions of the FD&C Act concerning new drug approval, labeling with adequate directions for use, and drug supply chain security. Outsourcing facilities may or may not receive prescriptions for identified individual patients for their compounded drug products, but they are subject to CGMP requirements, FDA inspections according to a risk-based schedule, and other conditions that provide greater assurance of the quality of their compounded drugs.
