fee – Duane Morris Life Sciences Law

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

Final Guidance on registration of human drug compounding outsourcing facilities
Final Guidance on registration fees for such outsourcing facilities
Revised Draft Guidance on electronic drug product reporting requirements for compounding outsourcing facilities

As detailed in an earlier Duane Morris Alert, the 2013 Drug Quality and Securities Act (DQSA) added Section 503B to the Food, Drug, and Cosmetic Act (FDCA), which established federal oversight for human drug compounding outsourcing pharmacies (outsourcing facilities).

To read the full text of this Alert, please visit the Duane Morris website.

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FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities