Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete. The FDA recognizes that there may be situations where there is a clerical error or discrepancy in the product tracing information that may not be indicative of a suspect product. As a result, the FDA stipulated that if a dispenser or other trading partner purchases a product and identifies a potential clerical error or other discrepancy in the product tracing information received, it should resolve the error or discrepancy within 10 business days. (Dispensers must respond within 2 business days to a request from the Secretary of HHS or other appropriate Federal or State official in the event of a recall or for the purpose of investigating a suspect product or illegitimate product, or in such other reasonable time as determined by FDA based on the circumstances of the request.)
The second piece of guidance is a revised final compliance policy guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies. In this guidance, FDA stated it does not intend to take action before Nov. 27, 2024, against dispensers who do not 1) verify the product identifier of the statutorily designated proportion of suspect product as required by the DSCSA; and 2) verify, as required by the DSCSA, the product identifier of the statutorily designated proportion of product that is the subject of an illegitimate product notification by FDA or a trading partner. This represents a one-year extension of the 2020 Compliance Policies, from Nov. 27, 2023, until Nov. 27, 2024. Pharmacies should proceed with plans to comply with verification requirements and use this time to stabilize operations and data exchange with trading partners.
The third piece of guidance is entitled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry. It clarifies what dispensers and other trading partners are required to do to meet the enhanced drug distribution security requirement, effective Nov. 27, 2023 (for specifics, see Section VII in the link). Key to note for NCPA members is that they need a GLN to initiate trace requests and be an authorized trading partner of any distributor. Customers of AmerisourceBergen, Cardinal Health, McKesson, and Smith Drug may already have a GLN and just need to contact customer support to get it and share with other distributors.
