On November 27, 2013, the Drug Quality and Security Act (Act) was signed into law. This law removes the unconstitutional provisions from Section 503A and adds a new Section 503B to the Federal Food, Drug, & Cosmetic Act. The law also provides for the Food and Drug Administration (FDA) to consult with a Pharmacy Compounding Advisory Committee prior to issuing certain regulations pertaining to outsourcing facilities.
The committee will be comprised of 12 voting members including the chair, who are knowledgeable in the fields of pharmacy, pharmaceutical compounding, pharmaceutical manufacturing, medicine, and related specialties and will include representatives from NABP and the United States Pharmacopeial Convention (USP) and may include a consumer organization member. The committee may also include one or more non-voting industry interest members. The nominating process was announced in a Federal Register (PDF) notice on January 13, 2014. Members will serve on overlapping terms of up to four years. Nominations must be submitted to FDA by March 14, 2014.
Pursuant to a draft guidance, FDA is working with NABP to develop a standard memorandum of understanding (MOU) for use between FDA and the states that will address the interstate distribution of inordinate amounts of compounded products and provide for appropriate investigation by a state agency of complaints relating to compounded products distributed outside that state. NABP anticipates that this MOU will be released by the end of the first quarter of 2014. The draft guidance document is available for download from the FDA website.
NABP has received a variety of questions related to “outsourcing facilities,” as defined in the Act. Specifically, it has been asked whether or not and how the states should be licensing these types of entities even if they are solely operating as an “outsourcing facility.” This is an issue that NABP is discussing with the states and FDA, specifically as to how the “outsourcing facilities” will be licensed at the state level.
NABP will be working closely with its member boards to ensure that all resulting regulations of the Act are in the best interest of the public health.