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Drug Information Update - FDA Issues the Drug Supply Chain Security Act (DSCSA) Implementation: Product Tracing Requirements for Dispensers-Compliance Policy Guidance

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. Today FDA issued the DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy Guidance. This document announces that FDA does not intend to take enforcement action against dispensers who, prior to November 1, 2015:

1. accept ownership of certain human, finished prescription drugs without receiving the transaction information, transaction history, and a transaction statement (product tracing information) prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); or

2. do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.

 

Under the DSCSA, a dispenser cannot accept ownership of certain human, finished prescription drugs unless the previous trading partner provides specific information (product tracing information) about those drugs. Additionally, dispensers must provide, capture and maintain the product tracing information associated with such drugs for all qualifying transactions they engage in.

However, FDA recognizes that some dispensers may need more time beyond the July 1st deadline to work with trading partners, to ensure they can properly receive, capture and maintain the product-tracing information required by law.

FDA posted a supporting webinar, “DSCSA Updates and Readiness Check: DSCSA  Requirements for Dispensers and other Trading Partners,” and plans to host a series of stakeholder calls in the coming weeks.

Please check http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm to find the latest activities on the DSCSA.


This is an automated message delivery system.  Replying to this message will not reach DDI staff.  If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm ET Monday - Friday.  You can also email us at druginfo@fda.hhs.gov.


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