Date Published |
Type |
Title |
Additional Information |
---|
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Draft Guidance |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
|
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
|
6/3/21 |
Final guidance |
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability |
Notice of Availability FDA in Brief |
6/3/21 |
Final guidance |
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification |
Notice of Availability FDA in Brief |
6/3/21 |
Draft guidance |
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry |
Notice of Availability FDA in Brief |
6/3/21 |
Draft guidance |
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act |
Notice of Availability 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 |
|
10/24/2018 |
Draft Guidance |
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs |
Notice of Availability |
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
|
9/19/2018 |
Draft Guidance |
Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers (PDF - 363 KB) |
Notice of Availability |
5/8/2018 |
Draft Guidance |
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 117 KB) |
Notice of Availability |
2/28/2018 |
Draft Guidance |
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF - 170 KB) |
Notice of Availability |
8/18/2017 |
Draft Guidance |
Identifying Trading Partners Under the Drug Supply Chain Security Act, Guidance for Industry |
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 |
12/8/2016 |
Guidance |
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry |
Notice of Availability
Webinar |
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 |
11/26/2014 |
Draft Guidance |
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information |
Notice of Availability
Public Workshop
|
10/7/2014 |
Draft Guidance |
The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers |
Notice of Availability |