DSCSA Compliance: Safely Riding the Wave of Change in Pharmacy

Prescription drug safety is an ever-evolving effort for everyone within the medication supply chain. Our goal at Pharmacy Marketplace is to help our members be smarter with drug purchasing and solve complex problems by anticipating and innovating solutions in advance of changes. We invest our time and resources in giving independent pharmacies everything they need to ride the wave of change and safely navigate industry requirements while giving the best care possible to their patients. 

Getting Amped for Changes in FDA Requirements 

As pharmacists, you are at the critical inflection point of care and trust. Protecting patients has always been built into the role. However, the industry is at a new crest for managing drug safety and security. The Drug Supply Chain Security Act (DSCSA) is designed to achieve electronic tracing of products at the package and product level to identify and trace prescription drugs and ensure a secure chain of custody. The purpose of the act is to better ensure the FDA's ability to help "protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful."  

DSCSA Compliance Big Sea:

DSCSA can feel more than a little intense. There is a countdown to compliance that pharmacies and suppliers must keep top of mind. 

On November 27, 2023, in addition to the previous requirements for DSCSA transaction information, the DSCSA will require that the serialized product identifier information be added to the DSCSA Transaction information.

While DSCSA does not specify the system that pharmacies are required to use for trackability, they have determined maneuvers stores need to be prepared to make with drug tracking, including:   

Product Traceability: The DSCSA mandates a comprehensive system for tracking and tracing prescription drugs throughout the supply chain at the serial number level. Pharmacies need to ensure they can accurately and electronically trace the history, origin, and chain of custody of each medication, promoting transparency and accountability. 

Unique Product Identifiers: Manufacturers, repackagers, and distributors are required to assign unique product identifiers, including information such as serial numbers, lot numbers, and expiration dates, to individual saleable units of medication. 

Verification and Notification: Pharmacies are responsible for verifying the authenticity of the drugs they receive and reporting any suspect or illegitimate products to the appropriate authorities within 24 hours of determining a product is suspicious or illegitimate using FDA Form 3911. Effective verification systems and robust notification processes are essential to maintain patient safety.

Download a PDF of Form 3911. Requires Adobe Acrobat to use. Or download a .doc version of the form. 

What Pharmacies Need to Know to Avoid the Undertow:

If all of these requirements feel like "men in gray suits" are circling, stay calm. You can rest assured that Pharmacy Marketplace has been on dawn patrol to research and share what you need to know for DSCSA compliance.  

Two Things Stores Will Need As Of November 27, 2023: 

1. A Global Location Number (GLN) - this is a unique location identification for a single location or business entity in the drug supply chain. While stores will need a GLN, most primary wholesalers are planning to provide GLNs to stores. Stores also have the option to purchase a GLN. However, we recommend you save the fee and wait for a wholesaler-provided GLN. McKesson and Cardinal customers with 9 locations or less should review the tops of their invoices to see if a GLN has already been provided. Stay tuned; we will provide an update on the specifics of wholesaler-provided GLNs ASAP. 
2. The ability to electronically store and access Electronic Product Code Information Service (EPCIS) at the product level for six years - In the event of an audit by the FDA, stores will need to provide EPCIS information within 48 hours of the request. Service providers for storing EPCIS for pharmacies include Tracelink, RFXCEL, LSPedia and Advasuar.

We are working closely with our wholesaler partners and will keep you informed on DSCSA requirements and alert you to the required actions. Further, our tech developers continue to work with our partners and members to provide the Kahuna of solutions for independent pharmacies. You can count on Pharmacy Marketplace to keep your store waxed and ready to navigate the gnarliest of industry changes.  

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