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FDA Issues Additional Guidance For Outsourcing Facilities That Compound Sterile Human Drugs

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The U.S. Food and Drug Administration has 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:

Final guidance on registration of human drug compounding outsourcing facilities under section 503B of the FD&C Act. This final guidance assists compounding facilities that decide to register as outsourcing facilities with the logistics of registering with the FDA, and the process for registering, re-registering, and de-registering.

Final guidance on fees for human drug compounding outsourcing facilities under sections 503B and 744K of the FD&C Act. This final guidance provides information about the fees that a facility must pay to register as an outsourcing facility; how facilities can submit payment to the FDA; the consequences of failure to pay fees; and how a facility can qualify as a small business to obtain a reduction in registration fees. The guidance also provides information on fees that may be assessed for reinspection of outsourcing facilities.

Revised draft guidance on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the FD&C Act. This revised draft guidance provides information about the electronic submission of drug product reports to the FDA for registered outsourcing facilities. Upon initial registration as an outsourcing facility and twice each year, registrants must electronically submit a drug product report to the FDA. This report must identify all drugs compounded by the outsourcing facility during the previous six-month period and provide certain information for each compounded drug.

The draft guidance on electronic drug product reporting is available in the Federal Register for public comment for 60 days.