Three New FDA Draft Guidance Documents for Drug Compounders

Regulatory NewsRegulatory News | 15 April 2016 |  By 

On Friday, the US Food and Drug Administration (FDA) released three draft guidance documents for drug compounders.

The guidance describes FDA’s interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act (FD&C Act), how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the definition of the term “facility," in reference to section 503B of the FD&C Act.

The draft guidance documents include:

  • Draft Guidance: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act, which describes FDA’s proposed policies on prescription requirements for compounding human drugs for identified individual patients under section 503A. 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.
  • Draft Guidance: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act, which offers recommendations to pharmacies located within a hospital or standalone pharmacies that are part of a health system and which frequently provide compounded drugs for administration within the hospital or health system. Some of these compounders have registered 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 This draft guidance describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded in state-licensed hospital or health system pharmacies for use within the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  • Draft Guidance: Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Section 503B defines an outsourcing facility, in part, as “a facility at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 on the meaning of the term “facility,” such as whether multiple suites used for compounding human drugs at a single address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be divided into separate operations compounding under different standards.

Each draft guidance document is available for public comment for 90 days.

Office Use Compounding

Lee Rosebush, a partner with the FDA practice the law firm BakerHostetler, told Focus that the guidance “is going to hurt traditional compounding pharmacies, as it is clear they are not going to be able to do office use compounding.”

FDA has also expanded the role of a 503B facility, particularly into the hospital market, he said.

The draft guidance on prescription requirements notes: “Hospitals, clinics, and health care practitioners can obtain non-patient-specific compounded drug products from outsourcing facilities registered under section 503B. Outsourcing facilities, which are subject to CGMP requirements, FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that provide greater assurance of the quality of their compounded drug products, may, but need not, obtain prescriptions for identified individual patients prior to distribution of compounded drug products.”

Rosebush noted the push to get compounders to register as 503B facilities: ”With the increase in compounding, there has been an increase in office use compounding (otherwise known as compounding for use in a prescriber's office). With the passage of the DQSA [Drug Quality Security Act], there has been a push to move office use compounding to 503B facilities (as they follow cGMP [current good manufacturing practices] and are FDA regulated) from the traditional 503A pharmacies.”

He also explained part of the impact on hospital pharmacies as “a pharmacy in a hospital cannot compound medication and send to another hospital in the same system unless the hospital pharmacy is registered as a 503B facility with the FDA.”  

New Draft Guidance on Drug Compounders


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