November 27, 2013

The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that differ from commercially available drugs according to individual needs. If a pharmacy chooses to register as an OF, it will be exempt from the new drug application, labeling, and track and trace requirements imposed on pharmaceutical manufacturers. In addition, the OF will be permitted to dispense drugs without an individual patient prescription.

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