| 6/12/2024 | Notice | Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period | |
| 12/6/2023 | Final Guidance | Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs | Notice of Availability |
| 11/20/2023 | Notice | Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements; Request for Information and Comments | |
| 9/6/2023 | Final Guidance | DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry | Notice of Availability |
| 9/1/2023 | Final Guidance Compliance Policy | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies | Notice of Availability FDA Statement: DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems |
| 8/31/2023 | Final Guidance | Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act | Notice of Availability |
| 8/28/2023 | Final Guidance Compliance Policy | Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies | Notice of Availability FDA Statement: DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems |
| 8/4/2023 | Final Guidance | Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act | Notice of Availability |
| 3/16/2023 | Final Guidance | Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry | Notice of Availability |
| 9/23/2022 | Final Guidance | 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 Guidance for Industry | Notice of Availability |
| 7/06/2022 | Draft Guidance | Identifying Trading Partners Under the Drug Supply Chain Security Act | Notice of Availability |
| 3/10/2022 | Draft Guidance | Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs | Notice of Availability |
| 2/4/2022 | Proposed Rule | National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers | Notice of Availability Announcement Extension of Comment Period |
| 2/4/2022 | Proposed Rule | Certain Requirements Regarding Prescription Drug Marketing | Notice of Availability Announcement |
| 2/4/2022 | Proposed Rule; Withdrawal | Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Withdrawal | Notice of Availability Announcement |
| 2/4/2022 | Final Guidance | Guidance: Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers | Notice of Availability Announcement |
| 6/3/2021 | Final guidance | Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability | Notice of Availability
FDA in Brief |
| 6/3/2021 | Final guidance | Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification | Notice of Availability
FDA in Brief |
| 10/22/2020 | Final Guidance | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies | Notice of Availability |
| 4/30/2020 | Final Guidance | Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency | |
| 9/23/2019 | Final Guidance | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry | Notice of Availability |
| 7/3/2019 | Notice | Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information | |
| 9/19/2018 | Final Guidance | Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF - 254 KB) | Notice of Availability FDA In Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain |
| 9/19/2018 | Final Guidance | Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF - 319 KB) | Notice of Availability FDA in Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain |
| 2/28/2018 | Draft Guidance | Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170 KB) | Notice of Availability |
| 7/20/2017 | Notice | Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments | |
| 4/28/2017 | Notice | Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information | |
| 2/16/2017 | Final Guidance | Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy Guidance for Industry | Notice of Availability |
| 1/9/2017 | Draft Guidance | Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers: Guidance for Industry | Notice of Availability |
| 10/28/2015 | Final Guidance | DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance for Industry (Revised) | Notice of Availability |
| 12/23/2014 | Final Guidance | DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry | Notice of Availability |
| 12/8/2014 | Draft Guidance | Drug Supply Chain Security Act Implementation--Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers | Notice of Availability
Webinar |
