FDA Extends Compliance Dates for Drug Dispensers

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-11-04-2015, Volume 11, Issue 11

Citing compliance issues, FDA extends deadline for product tracing information requirements for dispensers to March 1, 2016.

FDA has issued a revised guidance document that extends a previously issued Compliance Policy for the Drug Supply Chain Security Act (DSCSA) from Nov. 1, 2015 to March 1, 2016 because some drug dispensers-primarily smaller, independent pharmacies and health systems-have expressed that they need additional time to work with partners on compliance issues.  

The DSCSA requires dispensers, primarily pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. In a Compliance Policy published on July 6, 2015, FDA stated that the agency did not intend to take action until Nov. 1, 2015 against dispensers that accepted ownership of product without receiving the product tracing information or who did not capture and maintain the product tracing information as required by the law. 

The most recent FDA guidance document, DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised), issued on Oct. 28, 2015, extends this compliance date to March 1, 2016. FDA notes that the compliance policy does not extend to other requirements of the Federal Food, Drug, and Cosmetic Act, including those in section 582, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.


The guidance document is available on the FDA website.

Source:  US Food and Drug Administration