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FDA Guidance for Industry: DSCSA Implementation: Product Tracing Requirements for Dispensers - Compliance Policy (Revised)

Origin/Publisher:

FDA

Content:
This guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(d)(1)) related to the exchange of transaction information, transaction history, and transaction statements (product tracing information).

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