REGULATORY REVIEW
Track and Trace Pharmaceutical Supplies Implications of DSCSA for ASCs BY KARA NEWBURY
The Drug Supply Chain Security Act (DSCSA) signed into law by Pres- ident Barack Obama on November 27, 2013, estab-
lished steps for building systems to iden- tify and trace certain prescription drugs as they are distributed in the US. The pri- mary purpose of the law is to ensure that potentially dangerous counterfeit drugs are identified and removed from the supply chain before reaching consum- ers. This will be accomplished through an electronic, interoperable system that will be in place by November 27, 2023. While ASCs may be exempt from many provisions in the DSCSA, it is important for facilities to understand the implications the law might have for their operations. Regardless of any DSCSA require- ments that may or may not apply to individual ASCs, all Medicare-certified ASCs must still meet the requirements regarding pharmaceutical services spec- ified in the Conditions for Coverage (CfCs), §416.48(a). According to the CfCs, an “ASC must provide drugs and biologicals in a safe and effective man- ner, in accordance with accepted profes- sional practice, and under the direction of an individual designated responsible for pharmaceutical services.”
ASCs as Dispensers
Under the DSCSA, a “dispenser” is defined as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distribu- tor, or any other person authorized by law to dispense or administer prescrip- tion drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distribu- tor.” Assuming an ASC is “authorized by law to dispense or administer prescrip-
30 ASC FOCUS OCTOBER 2015
Regardless of any DSCSA requirements that may or may not apply to individual ASCs, all Medicare-certified ASCs must still meet the requirements regarding pharmaceutical services specified in the Conditions for Coverage.”
—Kara Newbury, ASCA
tion drugs,” it would meet the definition of “dispenser” under the DSCSA.
Exemption that Might Apply to ASCs ASCs licensed or authorized by state law to prescribe or administer drugs are most likely exempt from certain provisions in the DSCSA. The dispenser requirements for product tracing and verification explained below do not apply to licensed health care practitioners who are “authorized to prescribe or administer medication under state law or other licensed individuals under the supervision or direction of such practitioners who dispense or administer product in the usual course of professional practice.” The DSCSA does not define the term “licensed health care practitioner,” but the US Department of Food and Drug Administration’s (FDA) regulations implementing the Prescription Drug Marketing Act (PDMA)—the predecessor to the DSCSA—define the term “licensed practitioner” to mean “any person licensed or authorized by State law to prescribe drugs.” A reasonable interpretation is that the DSCSA’s product-tracing and product- verification requirements do not apply to any “person,” which would include any individual, partnership, corporation or association, licensed or authorized by state law to prescribe or administer drugs.
Legal Requirements for Dispensers The DSCSA has a number of require- ments for dispensers, as outlined below, that affect ASCs.
Authorized Trading-Partner Requirements Under the current law, dispensers must be “authorized” trading partners. The DSCSA defines “authorized” dispensers to be those that have a valid license under state law. ASCs should make sure those distributing drugs within their facilities are also “authorized” trading partners, meaning that they are licensed in the state in which the facility is located. In addi- tion, facilities should make sure that those companies with which they do business are appropriately registered or licensed. Drug manufacturers and repack-
agers: According to the FDA’s web site, domestic and foreign establishments that manufacture, repack or re-label drug products in the US are required to register with the FDA. They also are required to list all of their commer- cially marketed drug products, which helps the FDA maintain a catalog of all drugs in commercial distribution in the US. ASCs should also make sure that drug manufacturers and repackagers with which they work meet any state registration or licensure requirements. Wholesale distributors: These entities must have a valid license under state law. To see if a distribu- tor is licensed in your state, go to:
http://www.fda.gov/Drugs/DrugSafety/ DrugIntegr i tyandSupplyChain Security/
ucm281446.htm. Third-party logistics providers: These providers must have a valid license in the states in which they dis- tribute drugs, if that state has a licensure
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