DQSA — Drug Quality and Security Act (HR 3204)

A dosage form is a pharmaceutical preparation consisting of drug substance(s) and/or excipient(s) to facilitate dosing, administration, and delivery of the content of the drug product or placebo to the patient.

Enacted by Congress on November 27, 2013, DQSA amends the Federal Food, Drug and Cosmetics Act (FDC&A or FDCA), allowing federal oversight of compounding facilities and supply-chain distribution.

Title I of DQSA, referred to as the Quality Compounding Act (QCA), creates a federal framework for compounding of human drugs.

Title II, referred to as the Drug Supply Chain Security Act (DSCSA), establishes regulations to facilitate the interoperable tracing of manufactured prescription drug products throughout national pharmaceutical supply-chains and distributors.

Section 503A: applies to human drug compounding performed by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician.

Section 503B: applies to human drug compounding conducted in an outsourcing facility.