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Frequently Asked Questions for Pharmacists on FDA / DQSA (Drug Quality and Security Act)



FDA ISSUES FINAL GUIDANCE DOCUMENTS ON THE USE OF BULK DRUG PRODUCT FOR COMPOUNDING BY PHARMACIES AND OUTSOURCING FACILITIES.  The Food and Drug Administration has issued final guidance on the use of bulk drug product for compounding by pharmacies (under Section 503A of the Food, Drug, and Cosmetic Act) and outsourcing facilities (under Section 503B of the Food, Drug, and Cosmetic Act).  All compounders should give these documents their immediate attention:


Q: Where can I find information concerning human drug compounding?

A: The FDA's final guidance document and other information on Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities may be found here:


Q.  Does the federal Drug Quality and Security Act prohibit a pharmacy from compounding veterinary drugs for “office use”?

A.  No. The federal Drug Quality and Security Act speaks to compounding of human drug products.  The FDA’s most current statement of regulatory policy governing veterinary compounding may be found here:


Q: Has the FDA taken action against pharmacies that compound "bio-identical hormone replacement" products?

A: Yes. See


Q: What is the FDA's position on the compounding of hydroxyprogesterone caproate injection?

A: Many pharmacists are aware that the FDA approved Makena, a hydroxyprogesterone caproate injection, to be marketed by KV Pharmaceuticals. FDA has issued the following statement with respect to compounding of hydroxyprogesterone caproate injection:


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):

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.




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:




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 Q+A:

FDA Compounding Statement:



Veterinary Compounding / Compounding for Animal Patients - information here.



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