FDA DSCSA Resources:
Note: All links in the table below are directed to the FDA website.
| Date | Title | Link |
|---|---|---|
| 12/06/2023 | Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs | Download |
| 11/20/2023 | Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements; Request for Information and Comments | Download |
| 09/06/2023 | DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry | Download |
| 09/01/2023 | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies | Download |
| 08/31/2023 | Enhanced Drug Distribution Security at the Package-Level Under the Drug Supply Chain Security Act | Download |
| 08/28/2023 | Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug and Cosmetic Act – Compliance Policies | Download |
| 08/04/2023 | Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act | Download |
| 03/16/2023 | Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry | Download |
| 09/23/2022 | Exemption 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 |
| 02/04/2022 | Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers | Download |
| 06/03/2021 | Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability | Download |
| 06/03/2021 | Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification | Download |
| 10/22/2020 | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product | Download |
| 04/30/2020 | Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency | Download |
| 09/23/2019 | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product Compliance Policy Guidance for Industry | Download |
| 09/19/2018 | Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry | Download |
| 09/19/2018 | Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier | Download |
| 02/16/2017 | Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy Guidance for Industry | Download |
| 10/28/2015 | DSCSA Implementation: Product Tracing Requirements for Dispensers Compliance Policy Guidance for Industry (Revised) | Download |
| 12/23/2014 | DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry | Download |
