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News & Press: Legislative & Regulatory

Update on the Implementation of the Drug Quality and Security Act

Thursday, January 9, 2014   (0 Comments)
Posted by: Crystal Carter
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The President signed the Drug Quality and Security Act (DQSA) into law on November 27, 2013. Title I of DQSA, the Compounding Quality Act, includes important provisions relating to the oversight of compounding of human drugs. Today, Commissioner Hamburg sent letters encouraging purchasers to consider requiring compounders from which they purchase compounded sterile drugs to meet the medical needs of patients that cannot be met by FDA-approved products to register with the Food and Drug Administration (FDA) as outsourcing facilities. The Commissioner also sent letters to State Governors, State Boards of Pharmacies, and State Boards of Health asking them to consider how they could encourage compounding pharmacies located outside of their States that ship compounded sterile drugs into their States to register with FDA as outsourcing facilities under Section 503B of the Federal, Food Drug and Cosmetic Act.

FDA also published on its web site a list of firms currently registered as Human Drug Compounding Outsourcing Facilities, as well as additional information about the firms and what it means to be a registered outsourcing facility. FDA will update the list of firms registered as outsourcing facilities weekly.

Please see the following links for more information about FDA’s latest efforts to implement the Act:  ·         http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm380596.htm 

**As shared by the U.S. Food and Drug Administration**


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