US FDA extends track-and-trace deadline for pharmacies

By Dan Stanton contact

- Last updated on GMT

Dispensers must comply with product-tracking requirements set out in Section 582 of the Food, Drug, and Cosmetic Act, as made law in 2013's DSCSA
Dispensers must comply with product-tracking requirements set out in Section 582 of the Food, Drug, and Cosmetic Act, as made law in 2013's DSCSA

Related tags: Drug supply chain, Food and drug administration, Pharmaceutical drug

The US FDA says has granted a four month amnesty to pharmacies which do not comply with new track-and-trace regulations that come into force today.

The Drug Supply Chain Security Act (DSCSA) of November 2013​ set into motion a number of actions to guard against contaminated or counterfeit drug products.

Under the Act, pharmaceutical dispensers would have been required as of today to capture and maintain product-tracing information before accepting pharmaceutical products from their trading partners, namely wholesalers, but the US Food and Drug Administration (FDA) has said it will not enforce this until November.

Some dispensers have expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date [July 1]​,” the agency said in guidance issued yesterday.

FDA understands that many dispensers intend to utilize electronic systems to capture and maintain product tracing information. Thus, FDA recognizes that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by section 582 [of the Food, Drug, and Cosmetic Act] is captured and maintained by dispensers​.”

Therefore, the agency continued, “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving product tracing information, prior to or at the time of a transaction… or do not capture and maintain the product tracing information​.”

The guidance was commended by industry group the National Community Pharmacists Association (NCPA) which, alongside the American Pharmacists Association, wrote to the FDA​ last week citing its concerns that the majority of its members were unprepared for the July 1 deadline and immediate enforcement would run the risk of product shortages or disrupt patient access to prescription drugs.

Due to circumstances beyond their control, many pharmacies would have had difficulty complying with the July 1 statutory deadline,​” said NCPA CEO Douglas Hoey.

The FDA's latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the US pharmaceutical system​.”

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