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DSCSA: Dispenser to Dispenser Transactions

Feb 12th, 2018

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 In August 2017, the FDA issued draft guidance for Identifying Trading Partners Under the Drug Supply Chain Security Act, which confirms that dispensers who sell to other dispensers for a specific patient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Click here to view the full DSCSA draft guidance.

 

 

NCPA Offers Comments on Drug Chain Security Act

NCPA has submitted comments to the FDA on the draft guidelines on the DSCSA. The DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. NCPA’s comments focus on dispenser-to-dispenser transactions, asking the FDA to clarify with state entities that a dispenser is not required under the law to obtain a wholesaler license when transactions between dispensers are for a specific patient need. NCPA continues to monitor the FDA’s implementation of the DSCSA to ensure that dispensers can continue to provide care for their patients and safeguard patients’ access to medication.

Click here to view the PDF.