FDA: DSCSA Standards for the Exchange of Information for Tracing of Certain Drugs Guidance for Industry

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

III. TO WHOM DOES THIS GUIDANCE APPLY?

This guidance applies to manufacturers, wholesale distributors, dispensers, and repackagers11 who engage in  transactions of “products” as defined in section 581(13) of the FD&C Act. Whether an entity meets the DSCSA  definition of a particular type of trading partner depends on the activities engaged in by such entity. If an entity  meets the definition of more than one type of trading partner, the entity must comply with all applicable  requirements under section 582(a)(1) of the FD&C Act. However, trading partners are not required to duplicate  requirements. The DSCSA requires that manufacturers, wholesale distributors, dispensers, and repackagers who  engage in transactions of products meet the applicable requirements for being authorized13 trading partners.

IV. WHAT PRODUCTS DOES THIS GUIDANCE ADDRESS?

This guidance applies to transactions involving products as defined in section 581(13) of the FD&C Act. In general,  a product is a prescription drug in a finished dosage form for administration to a patient without requiring substantial  further manufacturing, such as capsules, tablets, and lyophilized products before reconstitution. See section 581(13)  of the FD&C Act for specific exclusions from the definition of product. Stakeholders should review these exclusions  to determine whether a specific prescription drug is excluded from the DSCSA definition of product and is thus  excluded from the product tracing requirements of section 582 of the FD&C Act.

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