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MatchRX is DSCSA Ready!

Feb 29th, 2016

 

Transactions between dispensers for a “Specific Patient Need” Section 582(d)(1)(A)(ii), or “Declared Public Health Emergency” Section 581(24)(B)(iii), are exempt from the DSCSA.

What does this mean?  Unique to dispensers within the DSCSA is an exemption that allows for the purchase of pharmaceuticals from other dispensers without the 3T requirement, if the purchase is for a “Specific Patient Need”, DSCSA Section 582(d)(1)(A)(ii).   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”, DSCSA Section 581(19). Click here and reference FAQ #4 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 notice from a provider that an identified patient has a prescription forthcoming.

To create additional awareness of this exemption, 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 here to view the document.  Additionally, the American Pharmacists Association (APhA) published a DSCSA Checklist for Pharmacies which included reference to the Specific Patient Need exemption.  Click here to view the document.

What changed in the marketplace on March 1, 2016?  Since inception, MatchRX members have purchased small quantities of prescription drugs from other members to meet the need of identified patients.   Beginning March 1 2016, buyers will be required to select Specific Patient Need or Declared Public Health Emergency as a reason for purchase when adding an item to the cart.  A Declared Public Health Emergency is an emergency notice issued by the Department of Health and Human Services, and is also exempt from the passing of the 3T’s, DSCSA Section 581(24)(B)(iii).  The reason for purchase will be captured with every item and displayed on the packing slip and invoice.  Sellers will continue to post items to the marketplace as before without the requirement of passing additional documentation at the time of sale. Please reference the DSCSA FAQ’s for additional information.  Direct all questions and inquiries to compliance@matchrx.com.

 

Thank you for your continued membership and use of MatchRX.