FDA Announces Availability of Draft Guidance Regarding Licensure Standards Under Title II of the DQSA

Food and Drug Administration (FDA) has issued a question-and-answer draft guidance document to assist industry and state governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug and Cosmetic Act added by Title II of the Drug Quality and Security Act (DQSA). FDA is issuing this document, “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers,” (PDF) to help stakeholders understand the immediate effects of the law and to clarify section 585’s effect on state product tracing requirements, and on standards, requirements, and regulations related to licensing wholesale distributors and/or third-party logistics providers (3PLs).

Signed into law on November 27, 2013, Title II of the DQSA, also known as the Drug Supply Chain Security Act (DSCSA), “establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain and requires trading partners to provide, receive, and maintain certain product and distribution information. The DSCSA also requires FDA to establish Federal standards for licensing of wholesale drug distributors and 3PLs.”

FDA is seeking public comment on the draft guidelines by December 8, 2014. Comments received by this deadline will be considered before the agency begins work on the final guidance, notes FDA. Additional information and instructions for submitting comments are available in the Federal Register notice.