January 18, 2018

Dear Colleagues,

The U.S. Food and Drug Administration (FDA) today issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of the law relevant to compounders. DQSA put in place more robust oversight of compounders and enabled closer federal and state collaboration. It also established a clear legal framework that provides for compounding to meet patients’ medical needs, while also giving the FDA tools to promote the quality of compounded products – which have not undergone FDA premarket review for safety, efficacy and manufacturing controls – and address unlawful compounding practices that threaten public health. Significantly, the law created a new category of compounders, called outsourcing facilities, which may engage in larger-scale, nationwide distribution under additional FDA oversight.

The 2018 Compounding Policy Priorities Plan specifically details how the FDA will:

· address manufacturing standards for outsourcing facilities;

· regulate compounding from bulk drug substances;

· restrict compounding of drugs that are essentially copies of FDA-approved drugs;

· solidify the FDA’s partnership with state regulatory authorities; and

· provide guidance on other activities that compounders undertake.

As part of its implementation of the plan, the FDA today issued two final guidance documents explaining the agency’s policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. For example, the guidance documents describe the characteristics of drugs that may be considered “essentially a copy” and the FDA’s policies regarding prescriber review of changes between compounded drugs and commercially available or approved drugs to determine whether they produce a significant or clinical difference for individual patients.

The FDA today also issued a final guidance on mixing, diluting, or repackaging biological products, which describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. These policies are intended to minimize public health risks, while preserving access to these products for patients who have a medical need for them.

For more information:

2018 Compounding Policy Priority Plan

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This message is being broadcast by the Division of Communications in FDA’s Office of Regulatory Affairs (ORA).

Thank you,

FDA/ORA

Office of Communications and Project Management

Division of Communications

Mailbox: DivComm-ORA@fda.hhs.gov

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