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Complying with DSCSA
What ASCs need to know
BY ALEX TAIRA | SEPTEMBER 2023
In recent months, ASCA has received numerous questions regarding ASC compliance with regulations related to the Drug Supply Chain Security Act (DSCSA). ASCA has reviewed the legislation and regulatory guidance and contacted several pharmacists to get a better understanding of the compliance lift for facilities. ASCA’s best understanding of surgery center requirements as of September 2023 follows. However, this information should not be construed as legal advice. Please seek local counsel for specific questions about compliance.
Of note, last month, the US Food & Drug Administration (FDA) released guidance that delays enforcement of electronic systems for tracking products through the supply chain until November 27, 2024.
Background
Congress passed the DSCSA, Title II of the larger Drug Quality and Security Act (DQSA), in November 2013. The law passed in direct response to the fungal infection outbreak stemming from infected steroids compounded at the New England Compounding Center in 2012. Title I of the DQSA provides new requirements related to drug compounding, while Title II outlines a system for tracing prescription drugs through the supply chain from manufacturing to dispensing.
Who Needs to Comply?
The DSCSA identifies and defines five types of entities in the prescription drug chain that are responsible under the new product tracing requirements: drug manufacturers, repackagers, dispensers, wholesale distributors and third-party logistics providers (3PLs). Of those, ASCs are potentially captured under the category of “dispenser,” which is defined by section 581(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control . . . or any other person authorized by law to dispense or administer prescription drugs.” Although this category is primarily intended to cover common pharmacies, it is possible that an ASC could be considered a dispenser.
An ASC also could be considered an “authorized trading partner” under the DSCSA, which is defined as any dispenser with a valid state dispensing license that “accepts or transfers direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.” The product tracing requirements related to dispenser authorized trading partners only covers drugs that are being held as general stock. The FDA specifically clarifies that “dispensers are not required to provide the product tracing information prior to, or at the time of, a transaction if the product is dispensed to a patient [or sold to another dispenser] to fulfill a ‘specific patient need’.”
What Information or Systems Will Aid with Compliance?
ASCs might want to pursue a Global Location Number (GLN) to meet DSCSA tracing requirements. A GLN is a 13-digit, entity-specific number issued by the GS1 organization that helps identify a product’s physical location as it travels through the supply chain. GLN is not a healthcare specific standard, as numerous other industries use GLNs to monitor and participate in supply chains. However, both GS1 and the FDA recommend that health facilities utilize a GLN and the GS1 Electronic Product Code Information Services standard to meet DSCSA requirements. Entities can use alternative methods to meet product tracing requirements, as long as they conform to the FDA’s drug distribution security requirements outlined in section 582(g)(1) of the FD&C Act. Trading partners are required to capture and maintain applicable transaction information, history and relevant statements for no less than six years after the date of the transaction.
Resources
Write Alex Taira with any questions.