The draft Guidance addresses three issues: product tracing, wholesale drug distribution and third-party logistics.
First, FDA discussed the electronic, interoperable system to identify and trace prescription drugs that are distributed in the United States. Specific concerns addressed by the draft Guidance included the preemption of State drug tracing requirements that are inconsistent or less stringent than, or in addition to, federal requirements. Such preempted requirements include:
- 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.
Next, FDA discussed the future preemption – upon adoption of FDA rules – of State wholesale drug distribution standards and licensing.
Finally, FDA discussed third-party logistics (3PL) standards and licensing and what will be allowed prior to adoption of FDA federal licensing regulations.
(Title & date of draft Guidance: The Effect of Section 585 of the FD&C Act [Federal Food, Drug, and Cosmetic Act] on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers, dated October 2014).
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