federal_register: 2022-05018
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-05018 | Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this revised draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The revised draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as "trading partners") after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the revised draft guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns. | 2022-03-10 | 2022 | 3 | https://www.federalregister.gov/documents/2022/03/10/2022-05018/verification-systems-under-the-drug-supply-chain-security-act-for-certain-prescription-drugs-draft | https://www.govinfo.gov/content/pkg/FR-2022-03-10/pdf/2022-05018.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." This revised draft guidance addresses... |