Shortly after President Barack Obama signed the Drug Quality and Security Act (H.R. 3204) into law, the U.S. Food and Drug Administration (FDA) issued draft guidances for industry to provide direction on its imple- mentation: (i) “Interim Product Reporting for Human Drug Compounding Outsourcing Facilities,” (ii) “Registration for Human Drug Compounding Outsourcing Facilities,” and (iii) “Pharmacy Compounding of Human Drug Products.”
Comments on each are requested by February 3, 2014. Additional infor- mation about the legislation appears in Issue 68 of this Bulletin.
The agency also issued requests for nominations of “bulk drug substances that may be used to compound drug products” and “specific drug products or categories of drug products” presenting “demonstrable difficulties for compounding.”
Nominations for each list are requested by March 4, 2014. These requests relate to outsourcing-facility exemption provisions requiring FDA to estab- lish such lists. See Federal Register, December 4, 2013.