New Draft Guidances Available for Compounders


In February 2014, we reported in Bio/Pharmaceutical Outsourcing Report on FDA’s voluntary program under which compounding pharmacies may register as outsourcing facilities and become subject to GMP requirements, and how this could open the door for some of these firms to branch into other contract services, such as analytical services or clinical drug supplies.

Over a year later, the FDA has issued three new draft guidances for pharmaceutical compounders registering under its “outsourcing facility” program:

1. The first—entitled For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act—explains what is necessary for a company to be eligible for the program, including the requirement that the company intend and be able to compound all drugs at its facility in compliance with GMP requirements.

2. A second guidance—Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities—discusses agency compliance expectations for compounders that also engage in repacking of drug products.

3. The third—Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry—details adverse event reporting expectations for compounders, including thresholds for reporting and how reports should be submitted to the FDA.

A listing of FDA registered outsourcing facilities is available at

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