Magazine article Drug Topics

FDA Offers More Guidance for "Outsourcing Facilities"

Magazine article Drug Topics

FDA Offers More Guidance for "Outsourcing Facilities"

Article excerpt


In mid-November, FDA provided additional assistance to help compounders of sterile human dmgs that have registered with the agency as "outsourcing facilities" under the Dmg Quality and Security Act (DQSA),which was enacted in November 2013. The DQSA added Section 503B to the Federal Food, Dmg, and Cosmetic Act. It is this section that the additional guidance addresses.

Dmgs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the FDC Act, including the new dmg approval requirements and the requirement to label dmg products with adequate directions for use. Outsourcing facilities are subject to increased federal oversight.

The three policy documents produced by the agency outline in greater detail the registration process, the specific fees to be paid for registration, and the requirements for electronics submission of dmg product reports.

"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, MD, director of the FDA's Center for Dmg Evaluation and Research.


The documents that concern registration and fees for registration have been finalized. …

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