The US Food and Drug Administration (FDA) is issuing draft guidance, The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third- Party Logistics Provider Licensing Standards and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,
to assist industry and state and local governments in understanding the effects of Section 585 (Uniform 22 National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of 23 the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013. Title II, which is also referred to 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 pass, receive, and maintain certain product and distribution information. The DSCSA also requires the FDA to establish federal standards for licensing of wholesale drug distributors and third-party logistics providers; the FDA is currently drafting these regulations. Section 585 sets forth a uniform national policy preempting states from establishing or continuing in effect certain standards and requirements. The FDA is issuing this guidance to help industry and states understand the immediate effects of the law and clarify section 585’s effect on state product-tracing and standards and requirements for wholesale distributor and third-party logistics provider licensing.
Beginning on November 27, 2013, the date of enactment of the DSCSA, states were preempted from establishing or continuing in effect any requirements for tracing prescription drugs through the pharmaceutical distribution supply chain that are inconsistent with, more stringent than, or in addition to any requirements applicable under section 503(e) of the FD&C Act (21 U.S.C. 353(e) (as amended by the DSCSA)) or Subchapter H (added by the DSCSA) or regulations issued thereunder. Section 585 enumerates the types of requirements that states are preempted from establishing or continuing in effect in any manner that is inconsistent with, more stringent than, or in addition to federal law, including: statements of distribution history, transaction history, transaction information, or transaction statement of a product as the product changes ownership in the supply chain, verification, investigation, disposition, notification, or recordkeeping relating to the distribution systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system
Prior to January 1, 2015, the federal pedigree requirements of section 503(e)(1) of the FD&C 108 Act, remain in effect. Therefore, until January 1, 2015, states may not regulate tracing in any way that is inconsistent with, more stringent than, or in addition to the requirements of section 110 503(e)(1) of the FD&C Act. Beginning January 1, 2015, the federal tracing requirements of Section 582 of the FD&C Act established under the DSCSA, go into effect. After that date, states may not regulate tracing in any way that is inconsistent with, more stringent than, or in addition to those requirements.