United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2018_register executive 2018-10-25 article Notices D09002ee1c7df72f1 D09002ee1c7df744d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." The draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food,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 Specifically, this draft guidance covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect and quarantine and disposition of a product determined to be illegitimate. The draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale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 after a suspect product investigation because it is determined that the product is not an illegitimate product. 83 FR 53880 https://www.govinfo.gov/app/details/FR-2018-10-25/2018-23306 2018-23306 fr25oc18-57 4164-01-P Docket No. FDA-2018-D-3462 https://www.govinfo.gov/app/details/FR-2018-10-25/2018-23306 https://www.govinfo.gov/content/pkg/FR-2018-10-25/html/2018-23306.htm https://www.govinfo.gov/content/pkg/FR-2018-10-25/pdf/2018-23306.pdf 3 p. 53880 53882 83 FR 53880 Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability; Federal Register Vol. 83, Issue NOTICE 2018-23306 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-12-24 Docket No. FDA-2018-D-3462 4164-01-P 2018-23306 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." The 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 draft guidance covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect and quarantine and disposition of a product determined to be illegitimate. The 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 after a suspect product investigation because it is determined that the product is not an illegitimate product.

Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Sarah Venti, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, drugtrackandtrace@fda.hhs.gov. Guidance: Verification Systems under Drug Supply Chain Security Act for Certain Prescription Drugs , drugtrackandtrace@fda.hhs.gov https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 207 Office of the Federal Register, National Archives and Records Administration 2018-10-25 continuing daily deposited born digital 174 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-10-25 P0b002ee19d79f27a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25oc18 https://www.govinfo.gov/app/details/FR-2018-10-25 https://www.govinfo.gov/content/pkg/FR-2018-10-25/pdf/FR-2018-10-25.pdf https://www.govinfo.gov/content/pkg/FR-2018-10-25/xml/FR-2018-10-25.xml fdlp 53801 53963 DGPO 2018-10-25 2024-06-01 FR-2018-10-25 machine generated eng FR FR-2018-10-25 83 207