Frequently Asked Questions for Pharmacists on the Federal Drug Quality and Security Act of 2013
GUIDANCE ON THE FEDERAL DRUG QUALITY AND SECURITY ACT. North Carolina pharmacists are aware that in November 2013, federal Drug Quality and Security Act became effective. Board staff periodically receive questions about DQSA’s operation and have created this guidance document (last updated March 6, 2015): http://www.ncbop.org/faqs/FAQsDQSA030615.pdf.
More reading -
August 2014: "The Drug Quality and Security Act: What Does It Mean for Compounding Pharmacies?" by Jay Campbell, Executive Director, North Carolina Board of Pharmacy
And a follow-up article, September 2014.
THURSDAY, JULY 3, 2014
FOOD AND DRUG ADMINISTRATION RELEASES ADDITIONAL GUIDANCE CONCERNING IMPLEMENTATION OF THE DRUG QUALITY AND SECURITY ACT. On Tuesday, July 1, 2014, the federal Food and Drug Administration released additional guidance concerning implementation of the Drug Quality and Security Act, including: (1) draft interim guidance concerning CGMP compliance for Section 503B outsourcing facilities; (2) a proposed rule revising FDA’s list of drug products that may not be compounded because they have been withdrawn or removed from the market for lack of safety or efficacy; (3) final guidance to compounding pharmacies on Section 503A; and (4) notice of reopening the nomination process for lists of bulk drug substances that may be used to compound drug products. More information, including links to the various documents, may be found here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564681.htm.
FRIDAY, DECEMBER 6, 2013
FEDERAL DRUG QUALITY AND SECURITY ACT BRINGING CHANGES TO COMPOUNDING PHARMACY REGULATION. On November 27, 2013, the President signed into law the Drug Quality and Security Act (DQSA). DQSA focuses on two broad issues: (1) further refinement of the state and federal roles in regulating compounding pharmacy practices; and (2) creation and implementation of a national “track and trace” program intended to ensure integrity of the prescription drug supply chain. Compounding pharmacists undoubtedly have questions about the impact of this statute on their practices. Board staff will continue to provide information as available. Earlier this week, FDA issued guidance on the new statute. Compounding pharmacists are strongly advised to read FDA guidance. It may be found here:
FDA Compounding Statement: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm