FDA issued two guidance documents on DSCSA implementation. The first guidance document includes standards necessary for pharmacies that are authorized trading partners under the DSCSA to facilitate adoption of secure, interoperable, electronic data exchange for DSCSA implementation on Nov. 23, 2023, including enhanced drug distribution security requirements, electronic only methods, and product tracing and verification of product at the package level. This draft guidance recommends that authorized trading partners use GS1’s Electronic Product Code Information Services (EPCIS) standard to provide and maintain the electronic data associated with transaction information and transaction statements. Additionally, FDA advises that authorized trading partners should use data standards that facilitate a uniform process for product tracing and ensure the protection of confidential commercial information and trade secrets. FDA is soliciting comments on this guidance document, which are due to FDA by Sept. 6. The second guidance document includes a re-iteration of the “5 percent rule,” namely that FDA generally does not consider a licensed retail pharmacy that sells drugs to a licensed practitioner for office use in minimal quantities at or below such 5 percent threshold to be subject to the wholesale distributor requirements under the DSCSA based on those sales alone. However, such a licensed retail pharmacy may still be considered a wholesale distributor based on other activities. The guidance also discusses that dispensers are not required to provide product tracing information if the product is dispensed to a patient or if it is a sale by a dispenser to another dispenser to fulfill a “specific patient need.” Additionally, the guidance spells out specific requirements for dispensing pharmacies to be considered authorized trading partners under the DSCSA. FDA is soliciting comments on this second guidance document, which are due to FDA by Sept. 6.
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