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FDA DSCSA Resources

DateTitleLink
09/06/2023DSCSA Standards for the Interoperable Exchange of Information for Tracing
of Certain Human, Finished, Prescription Drugs Guidance for Industry
Download
09/01/2023Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance PoliciesDownload
08/31/2023Enhanced Drug Distribution Security at the Package-Level Under the Drug Supply Chain Security ActDownload
08/28/2023Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the
Federal Food, Drug and Cosmetic Act – Compliance Policies
Download
08/04/2023Waivers, Exceptions, and Exemptions from the Requirements of
Section 582 of the Federal Food, Drug and Cosmetic Act 
Download
03/16/2023Definitions of Suspect Product and Illegitimate Product for Verification Obligations
Under the Drug Supply Chain Security Act Guidance for Industry
Download
09/23/2022Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Download
02/04/2022Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act,
Questions and Answers
Download
06/03/2021Product Identifiers Under the Drug Supply Chain Security Act:
Questions and Answers; Guidance for Industry; Availability
Download
06/03/2021Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification
Download
10/22/2020Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and
Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product
Download
04/30/2020Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act
During the COVID-19 Public Health Emergency
Download
09/23/2019Wholesale Distributor Verification Requirement for Saleable Returned Drug Product
Compliance Policy Guidance for Industry
Download
09/19/2018Product Identifier Requirements Under the Drug Supply Chain Security Act –
Compliance Policy Guidance for Industry
Download
09/19/2018Grandfathering Policy for Packages and Homogenous Cases of Product
Without a Product Identifier
Download
02/16/2017Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy Guidance for IndustryDownload
10/28/2015DSCSA Implementation: Product Tracing Requirements for Dispensers
Compliance Policy Guidance for Industry (Revised)
Download
12/23/2014DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for IndustryDownload

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