FDA Seeks Input on Drug Supply Chain Security Pilot Program

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By Bronwyn Mixter

Feb. 12 — The FDA will hold a public workshop in April to discuss a proposed pilot program to enhance the safety and security of the pharmaceutical distribution supply chain, according to a notice to be published Feb. 16 in the Federal Register.

The Food and Drug Administration is required under the Drug Supply Chain Security Act (DSCSA) of 2013 (Pub. L. No. 113-54) to establish one or more pilot projects, in coordination with authorized drug manufacturers, repackagers, wholesale distributors and dispensers, “to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain,” the agency said. The DSCSA establishes a federal system for tracing prescription drug products.

The FDA said the public workshop is intended to let those who are interested provide comments on and discuss design objectives of the pilot projects. The agency said it would like to get comments from interested pharmaceutical distribution supply chain members on:

  •  issues related to using the drug product identifier for product tracing,
  •  improving the technical capabilities of the drug supply chain and
  •  identifying the system attributes needed to implement the requirements established under the DSCSA.
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    The public workshop will be held April 5 from 9 a.m. to 5 p.m. and April 6 from 9 a.m. to 12:15 p.m. at the FDA's White Oak campus in Silver Spring, Md. To register for the workshop, go to http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Registration requests must be received by March 11.

    The deadline for submitting either electronic or written comments on this workshop is April 21 (Docket No. FDA-2016-N-0407).

    To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

    To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

    For More Information

    The Federal Register notice is at http://src.bna.com/cCy.