As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year - Pink Sheet

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Read the full text of the source article, so you can be sure about what is included and excluded from the one year delay in enforcement action.

According to the article:

"The US Food and Drug Administration has given pharmaceutical distribution trading partners an extra year to comply with package-level Drug Supply Chain Security Act product tracing requirements that take effect 27 November [2023] before it starts enforcing them."

Source Article:  As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year -  Pink Sheet

Go to the FDA Guidance:  Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies - FDA.gov

Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

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According to the article:

"With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations."

... "she noted. “That outbound scanning is expected to increase labor by a minimum of 12 to 15% based on recent time studies. As an example, a distribution center with a 50-person night crew will need to hire six additional people just to support the outbound scanning.”"

Read the full source article:  Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

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The Latest Activities Related To The DSCSA - FDA Website

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Latest Activity - Drug Supply Chain Security Act (DSCSA)

I like how the FDA is listing and reporting activity related to the DSCSA. They're now providing links to pertinent activities in a section called "Latest Activity."

According to the referenced FDA webpage:

"The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually."

Go to:  Drug Supply Chain Security Act (DSCSA) - FDA.gov

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FDA overdue on guidance as DSCSA deadline looms - RAPS.org

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According to the article:

"Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place for tracking  products through the supply chain under the Drug Supply Chain Security Act (DSCSA).

Food and drug law attorneys outlined ways the industry can meet these requirements at a 15 April traceability forum on DSCSA implementation sponsored by the Healthcare Distributors Association (HDA)."

Read the full source article:  FDA overdue on guidance as DSCSA deadline looms - RAPS.org

You might also be interested in:  Drug Supply Chain Security Act Law and Policies - FDA.gov

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6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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According to the article:

"The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023."

"The discussions and perspectives in the meeting were often conflicting and sometimes seemed to ignore insights developed over the past years by several industry workgroups. We would like to suggest some concrete actions the FDA can take now to help bring together a complex and diverse number of sectors in advance of 2023 enforcement:"

Read the full source article:  6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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The DSCSA Standards Guidance is here! « Ag/FDA Blog

Updated June 30, 2025

The link to the full article broke.

---  the original post follows below  ---

Read the full article: The DSCSA Standards Guidance is here! « Ag/FDA Blog:

"With trading partners required on January 1, 2015, to begin exchanging transaction data when covered pharmaceuticals change owners, guidance from the agency was imperative. FDA specifically recognizes that, although the guidance is a “draft,” “the DSCSA clearly intends for stakeholders to rely upon this draft guidance document before finalization.”  As such, FDA is immediately implementing the Draft Guidance."

'via Blog this'

Read the draft guidance:
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (PDF - 85KB)

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