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FDA announces enforcement discretion and 3-year delay in DSCSA Requirements for Wholesale Distributors and Dispensers

This week, the Food and Drug Administration (FDA) announced release of a new guidance for immediate implementation that extends for another 3 years, until November 27, 2023, its enforcement discretion regarding verification of a prescription drug returns prior to resale.  FDA also announced that it is delaying until November 27, 2023, its requirement that pharmacies and other dispensers begin verifying product identifiers in suspect and illegitimate product investigations.  FDA’s grant of enforcement discretion represents an additional 3-year delay from the delay the agency previously granted in 2019 and eases requirements that were very burdensome for the pharmaceutical industry to meet by November 27, 2020. 

On November 27, 2019, wholesale distributors were required under the Drug Supply Chain Security Act (DSCSA) to verify a returned product’s identifier before it could resell the return.  On September 24, 2019, FDA stated it would exercise discretion and not enforce this requirement to verify saleable returns until November 27, 2020.  This week, FDA extended its enforcement discretion until November 27, 2023.  Consequently, wholesale distributors do not have to verify a return’s identifier with the product’s manufacturer prior to resale until 2023, though, if a manufacturer receives a verification request, it must continue to meet its DSCSA obligations and respond.   FDA also states that a product  should  be handled  as suspect product  if  the product  identifier is  not  successfully  verified  

In addition, FDA announced that it does not intend to take action against pharmacies and other dispensers who do not verify the statutorily-designated portion of product identifiers of suspect or illegitimate product before November 27, 2023.  This policy is also a 3-year delay in enforcement of the requirements for dispensers to verify the product identifier when investigating suspect or illegitimate product.

Tish Eggleston Pahl, Principal at Olsson Weeda Frank Terman Matz PC, will be reviewing these and other efforts to meet applicable and upcoming DSCSA requirements at the Health Distribution Alliance’s annual Traceability Seminar, November 2-4.  Tish will be examining the DSCSA’s requirements, recent FDA  actions, and the impact of importation initiatives on supply chain security. 

Tish Pahl is highly experienced in working with pharmaceutical supply chain stakeholders, including manufacturers, wholesale distributors, repackagers, dispensers and their respective trade associations on implementation of the DSCSA.

For more information about HDA’s Traceability Seminar, including registration and the daily schedule, please visit their website here.

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