The term specific patient need is defined by the DSCSA 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. Click here to reference FAQ #5 from the FDA’s DSCSA website. Industry interpretation for Specific Patient Need includes situations in which a dispenser has a prescription in hand for an identified patient, a recurring prescription for an identified patient, or written/electronic notice from a provider that a prescription for an identified patient is forthcoming.
Transactions processed for a Specific Patient Need are exempt from the requirements of the DSCSA. Reference DSCSA Section 582(d)(1)(A)(ii). The selling dispenser is not required to pass, and the buying dispenser is not required to receive, the Transaction Information (TI), Transaction Statement (TS), and Transaction History (TH). The MatchRX packing slip and invoice will satisfy DSCSA reporting requirements.
FDA draft Guidance document FDA-2017-D-1956 Industry Identifying Trading Partners Under the Drug Supply Chain Security Act expressly states that a wholesale distributor license is not required when a dispenser transfers a product to another dispenser for a specific patient need.
The National Community Pharmacy Association (NCPA) published in the February 2016 DSCSA Fact Sheet "The transfer of a product from one pharmacy to another (regardless of whether the two pharmacies are affiliated in any way) to fill a prescription for an identified patient is exempt from the definition of Transaction within the DSCSA, and therefore not subject to the
3T requirement. Click hereto view the document or paste the following URL in your browser window: http://www.ncpa.co/pdf/track-trace-fact-sheet.pdf