Drug Quality and Security Act: Title I – Compounding


On November 23, 2013, the President signed the Drug Quality and Security Act (DQSA) into law. As discussed previously on the Baer Law Blog, the legislation was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system.

The goal of Title I of the DQSA is to clarify the FDA’s authority over drug compounding by removing any uncertainty over the applicability of federal law and to create a new entity, the outsourcing facility. Title I of the DQSA:

  1. Amends Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and re-establishes Section 503A as the applicable law;
  2. Requires the FDA and States to ensure the safety of compounded drugs; and
  3. Differentiates traditional compounders that compound medications in response to patient specific prescriptions from outsourcing facilities who make large volumes of compounded sterile medications.

Under the DQSA, traditional compounding pharmacies will continue to be regulated by State Boards of Pharmacy, while those companies who are engaged in large-scale compounding can voluntarily register as outsourcing facilities. However, the compounding companies that choose to register as outsourcing facilities will be subject to federal registration, fees and strict reporting requirements

Even though over thirty companies have voluntarily registered as outsourcing facilities, Title I of the DQSA remains a hot topic for debate.