Drug Supply Chain Act Readiness Prompts FDA Guidance and House Lawmaker Letter

The FDA has released a final guidance spelling out when and how drugmakers may seek a waiver, exception or exemption from its regulations as permitted by the Drug Supply Chain Security Act (DSCSA) while a bipartisan group of House lawmakers is pressing the FDA on whether the industry is prepared for the final stage of the act’s implementation.

The DSCSA mandates that by November 27 manufacturers electronically capture and share data that will track a drug at the individual package level from manufacture to sale.

Worried that not all manufacturers can comply with the fall deadline, Representatives Troy Balderson (R-Ohio) and Ann Kuster (D-N.H.) — plus more than two dozen of their fellow House lawmakers — penned an Aug. 1 letter pressing the FDA on what steps it is taking to “minimize the potential for disruptions to supply and patient care as FDA approaches the final implementation” of the DSCSA.

Changes from the May 2018 draft guidance to the final guidance published Friday “include recommendations to authorized trading partners and other stakeholders for submitting a request, and what information to include for a waiver, exception or exemption,” an FDA spokesperson told FDAnews, adding that the “guidance also outlines situations in which the recipient of a waiver, exception or exemption should notify the agency and affected entities.”

Read the FDA final guidance here.

Read the House letter here.

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