January 27, 2014 FDA Three Draft Guidances To Regulate Compound Pharmacies – Registration, Reporting and Enforcement

In November of 2013, President Obama signed into law the Drug Quality and Security Act. Recently, with the agency's clarified powers over compound pharmacies, the FDA issued three draft guidances. The first states prohibitions in previous FDA guidances, while the second guidance instructs compounders how they can register as "outsourcing facilities," the new "voluntary" category for certain compounding pharmacies. The third guidance explains how outsourcing facilities should report the drugs they compound. Comments and suggestions regarding these draft documents should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. The first guidance is titled: "Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act". This guidance document describes the process for registering as an outsourcing facility under section 503B of the FD&C Act. A separate guidance provides instruction on how outsourcing facilities should report to FDA the products they compound. This guidance reflects current thinking in light of data standards, information technology, and information management resources. - See more here