On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of the Food, Drug and Cosmetic Act (“FD&C Act”) when a 503A state-licensed nuclear pharmacy that is not a 503B outsourcing facility compounds or repackages radiopharmaceuticals for human use. Although the guidance will need some tweaking and it fails to acknowledge ongoing distribution problems in the radiopharmacy supply chain, it is a very welcome development given that the most recent official Agency guidance on this topic was issued in 1984.
Yes – 1984. For this reason alone, please join us and many others across the country as we ring in the New Year with a toast to FDA. Cheers!
As a threshold issue, the guidance acknowledges that although radiopharmaceuticals are generally not eligible for the 503A exemptions, there are certain circumstances under which the FDA will not take action for violations of the FD&C Act. Specifically, the guidance sets forth two major categories of these circumstances: (1) “minor deviations” and repackaging; and (2) compounding other than minor deviations.