Dear Jon,
I heard that the Federal government was sending out notices regarding the new Federal Compounding Legislation that was signed into law last November. Can you tell me what they are requesting?
Jerra Banwarth, RPh
Woodland, CA
Answer
Dear Ms. Banwarth,
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. For more information on FDA's latest efforts to implement the Act, click here and here.
quoted from here
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