Drug Supply Chain Security Act (DSCSA)

In November 2013, Congress passed the Drug Supply Chain Security Act (DSCSA), part of the larger Drug Quality and Security Act (DQSA). The law was enacted in direct response to the fungal infection outbreak 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.

DSCSA requirements related to product tracing and serialization have been rolling out since 2015. Most recently, US Food & Drug Administration (FDA) enforcement of enhanced drug distribution security (EDDS) requirements, including package-level product tracing, went into effect on November 27, 2024 after a one year delay.

NOTE: This page represents ASCA’s best understanding of surgery center requirements related to the DSCSA. This information should not be construed as legal advice, and ASCA advises all facilities to seek local counsel for specific questions about compliance.

Do surgery centers need to comply?

Possibly, depending on your facility's operation. 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).

Surgery centers may be covered 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 the "dispenser" category is primarily intended to cover common pharmacies, a surgery center that administers prescription drugs would also be considered a "dispenser".

What drugs are covered?

The DSCSA is only concerned with prescription drugs in finished dosage form that are being held as general stock. This means that other drugs types, such as over-the-counter drugs, compounded medicines, IVs, etc. are not included in the package-level tracing requirements.

Are there any exemptions?

Yes! On July 12, 2024, the FDA published a letter announcing a two year exemption for “small dispensers” from the EDDS requirements. Per the FDA, a small dispenser is any business in which the “corporate entity that owns the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.”

What information or systems will aid with compliance?

ASCs may 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.