Update on FDA’s Implementation of the Drug Supply Chain Security Act

clock lowThe U.S. Food and Drug Administration (FDA) is sticking to its timeline for implementation of the Drug Quality and Security Act (DQSA). According to IWLA Washington Representative Pat O’Connor:

  • The FDA expects to meet the Nov. 27, 2014, deadline for issuing guidance for the interoperable exchange of transaction information/history/statement in paper or electronic form. Note: Third-party logistics customers must be in compliance with this guidance effective Jan. 1, 2015. It is unclear what FDA’s position will be if a manufacturer or wholesaler does not have compliant IT systems in place by the first of the year.
  • Beginning Nov. 27, 2014, 3PLs are required to report “on an annual basis pursuant to a schedule determined by the secretary (FDA). However, the FDA has not issued guidance on when, where, or how to report.
  • Beginning Jan. 1, 2015, supply chain partners are required to do business only with “authorized trading partners.”  A 3PL is an authorized trading partner if licensed. Until FDA issues the national licensing standards, the Drug Supply Chain Security Act (DSCS) deems a 3PL to be licensed unless the FDA makes a finding that the 3PL does not use good handling and distribution practices. Please contact Pat O’Connor  if you are getting inquiries from your customers asking if you meet the requirement as an “authorized trading partner.”

IWLA will continue to update members on the unknowns of compliance and date changes during the coming months. We will also continue the dialogue with the FDA to bring clarity to guidance as it is issued. Stay tuned.

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