Section 582(d)(1)(A)(ii) of the FD&C Act states that “a dispenser . . . prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns) shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need.” Section 581(19) of the FD&C Act defines “specific patient need” as the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Section 581(19) further states that this term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.
Under the federal Drug Supply Chain Security Act (DSCSA), dispenser-to-dispenser transactions for a specific patient need are not classified as wholesale transactions and therefore do not require wholesale licensing. The DSCSA defines “specific patient need” as “the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.” DSCSA Section 581(19). In August 2017, the FDA issued draft guidance for Identifying Trading Partners Under the Drug Supply Chain Security Act, which confirms that dispensers who sell to other dispensers for a specific patient need are not wholesale distributors. Section E of the guidance, entitled “Dispensers as Trading Partners Under the DSCSA,” states: Lines 482-484: Transfers of product to another dispenser without a specific patient need may constitute wholesale distribution, subject to the requirements for wholesale distributors in sections 503(e), 582, and 583 of the FD&C Act. Line 491 Table 1 (cont’d) Summary of Authorized Partners: Entities Generally Not Included as a Wholesale Distributor – a dispenser who transfers product to another dispenser for a specific patient need.
Click here to view NCPA Letter Click here to view FDA Guideline Click here to view DSCSA Resources for Dispensers