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FDA News Release

FDA issues additional guidance for outsourcing facilities that compound sterile human drugs

Agency outlines details on registration, fees, and drug product reporting for outsourcing facilities

For Immediate Release

November 21, 2014

Release

Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.

The DQSA added section 503B to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 503B, a compounder can elect to register with the FDA as an outsourcing facility.  Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the FD&C Act, including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and increased federal oversight. Some health care providers purchase compounded sterile drugs to treat patients whose medical needs cannot be met by FDA-approved drugs. In such cases, the FDA encourages health care providers to purchase from compounders that register as outsourcing facilities. 

“As an agency committed to protecting public health, it’s important to the FDA that outsourcing facilities fully understand how to comply with the new law,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These policy documents clarify the process for outsourcing facilities to register, pay fees, and report the drugs compounded by the facility.”

The new guidance documents are:

The draft guidance on electronic drug product reporting is available in the Federal Register for public comment for 60 days.

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.

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Page Last Updated: 11/21/2014
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