DSCSA Resources
Draft Guidances, Final Guidances, Public Meetings, and more...
Manufacturers, Distributors, Repackagers, and Dispenserson the United States Drug Supply Chain must comply with the Drug Supply Chain Security Act (DSCSA). This DSCSA resource provides FDA issued materials to promote DSCSA compliance. All requirements, terms, definitions, documents, videos, and materials are sourced directly from: FDA.gov DSCSA Resources
DSCSA Final Guidance
Drug Product Tracing: The Effect of Section 585 of the FD&C Act
Date Published: 02/04/2022
Drug Supply Chain Act Implementation: Identification of Suspect Product and Notification Guidance for Industry
Date Published: 06/03/2021
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements
Date Published: 10/22/20
View Comments
DSCSA Public Meetings
DSCSA Enhanced Drug Distribution Security Public Meeting - Part 1 of 3
DSCSA Enhanced Drug Distribution Security Public Meeting - Part 2 of 3
DSCSA Enhanced Drug Distribution Security Public Meeting - Part 3 of 3
DSCSA Enhanced Drug Distribution Public Meeting Associated Materials
Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA)
Meeting Recordings: February 28, 2018
Meeting Recordings: December 5, 2017
Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA)
Meeting Recordings: December 6, 2017
Meeting Recordings: August 23, 2017
Proposed Pilot Project(s) Under the Drug Supply Chain Security Act:
Standards for the interoperable exchange of tracing information for finished, human, prescription drugs:
Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act
Drug Supply Chain Security Act pilot project program and enhanced drug distribution security
DSCSA Draft Guidances
Verification Systems Under DSCSA for Certain Prescrption Drugs
Date Published: 03/10/2022
Identifying Trading Partners Under the Drug Supply Chain Security Act
Updated: 07/05/2022
Enhanced Drug Distribution Security at the Package Level Under DSCSA
Date Published: 06/03/2021
Definitions of Suspect Product and Illegitimate Product for Verification
Date Published: 06/03/2021
DSCSA Standards for the Interoperable Exchange of Information for Tracing
Date Published: 07/05/2022
Drug Supply Chain Final Guidance Explanation Table
| Final Guidance | Date Published | Description | Original Source |
|---|---|---|---|
| Drug Product Tracing: The Effect of Section 585 of the FD&C Act | The Food and Drug Administration (FDA) is issuing these questions and answers to assist industry and State and local governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee- 4), added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on drug product tracing. | ||
| Product Identifiers Under the Drug Supply Chain Security Act | This guidance is intended to address anticipated questions regarding product identifiers that are required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), for packages and homogenous cases of certain drug products. | ||
| Drug Supply Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry | This guidance is intended to aid trading partners3,4 (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined at section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and terminating notifications. | ||
| Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect of Illegitimate Product - Compliance Policies | On September 24, 2019, FDA published the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy guidance (the 2019 Compliance Policy), where FDA announced a 1-year delay in enforcement of the requirement for wholesale distributors to verify saleable returned product as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(c)(4)(D)). The 2019 Compliance Policy explained that the Agency intended to delay enforcement of this requirement until November 27, 2020. This guidance announces FDA’s extension of such delay in enforcement. It also sets forth the Agency’s enforcement policy with respect to section 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the FD&C Act (21 U.S.C. 360eee-1(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)), which generally provide that, beginning November 27, 2020, a dispenser must verify the product identifier of suspect or illegitimate product in the dispenser’s possession or control. |
Got Questions? We've got answers...
Complete the form and we will connect you with a member of our team.
/drop_ship
We've got it covered!
The information provided on this website does not, and is not intended to, constitute legal advice; instead, all information, content, and materials available on this site are for general informational purposes only. Information on this website may not constitute the most up-to-date legal or other information. This website contains links to other third-party websites. Such links are only for the convenience of the reader, user or browser; .Med does not recommend or endorse the contents of the third-party sites.
Readers of this website should contact their attorney to obtain advice with respect to any particular legal matter. No reader, user, or browser of this site should act or refrain from acting on the basis of information on this site without first seeking legal advice from counsel in the relevant jurisdiction. Only your individual attorney can provide assurances that the information contained herein – and your interpretation of it – is applicable or appropriate to your particular situation.
All liability with respect to actions taken or not taken based on the contents of this site are hereby expressly disclaimed. The content on this posting is provided "as is;" no representations are made that the content is error-free.