DSCSA Resources

Manufacturers, Wholesale Distributors, Dispensers, and Pharmacies on 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

Trust.Med's DSCSA Solutions allow all trading partners to communicate and meet federal requirements.

DSCSA Final Guidance

Drug Product Tracing: The Effect of Section 585 of the FD&C Act

Date Published: 02/04/2022

Product Identifiers Under the Drug Supply Chain Security Act

Date Published: 06/03/21

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

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DSCSA Public Meetings

DSCSA Enhanced Drug Distribution Security Public Meeting - Part 1 of 3

DSCSA Enhanced Drug Security Public Meeting Part 1 Cover Image
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DSCSA Enhanced Drug Distribution Security Public Meeting - Part 2 of 3

DSCSA Enhanced Drug Security Public Meeting Part 1 Cover Image
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DSCSA Enhanced Drug Distribution Security Public Meeting - Part 3 of 3

DSCSA Enhanced Drug Security Public Meeting Part 1 Cover Image
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DSCSA Enhanced Drug Distribution Public Meeting Associated Materials

Drug Supply Chain Security Act pilot project program and enhanced drug distribution security

Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act

February 28 meeting recordings

December 5 meeting recordings

Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act

December 6 meeting recordings

August 23 meeting recordings

Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act

Proposed Pilot Project(s) Under the Drug Supply Chain Security Act - Day 1

Proposed Pilot Project(s) Under the Drug Supply Chain Security Act - Day 2

Standards for the interoperable exchange of tracing information for finished, human, prescription drugs - Day 1

Standards for the interoperable exchange of tracing information for finished, human, prescription drugs - Day 2

DSCSA Draft Guidances

Verification Systems Under DSCSA for Certain Prescrption Drugs

Date Published: 03/10/2022

DSCSA Standards for the Interoperable Exchange of Information for Tracing

Date Published: 07/05/2022

Definitions of Suspect Product and Illegitimate Product for Verification

Date Published: 06/03/2021

Enhanced Drug Distribution Security at the Package Level Under DSCSA

Date Published: 06/03/2021

Identifying Trading Partners Under the Drug Supply Chain Security Act

Updated: 07/05/2022

Drug Supply Chain Final Guidance Explination Table
Final Guidance Date Published Description Original Source
Drug Product Tracing: The Effect of Section 585 of the FD&C Act
02/04/2022
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.
FDA
Product Identifiers Under the Drug Supply Chain Security Act
06/03/2021
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.
FDA
Drug Supply Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry
06/03/21
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.
FDA
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect of Illegitimate Product - Compliance Policies
10/22/20
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.
FDA

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