The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: DSCSA Implementation: Product Tracing Requirements — Compliance Policy
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM427867.pdf
Content:
This guidance is intended for trading partners (manufacturers, wholesale distributors, and repackagers) who must provide and capture certain product tracing information, as required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1).
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