DSCSA 2023: Dispensers’ Role and Responsibilities
Healthcare Distribution Alliance (HDA) is hosting a webinar series to discuss the upcoming Drug Supply Chain Security Act (DSCSA) requirements. These webinars, which focus on education specific to dispensers, will lead up to HDA’s annual Traceability Seminar on October 12-14 in Washington D.C.
At HDA’s third Traceability Webinar on September 15, HDA’s Elizabeth Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, spoke to Perry Fri, Executive Vice President, Industry Relations, Membership and Education, HDA; and Chief Operating Officer, HDA Research Foundation to dispel myths and offer clarity around the dispenser’s role and legal responsibilities per DSCSA requirements.
Gallenagh discussed that while many drugs are under the purview of the DSCSA, there are some exemptions. Generally, drugs subject to the DSCSA are prescription products intended to be dispensed to patients in the U.S. Exceptions include OTC drugs and grandfathered products that were not originally serialized. Pharmacies do not have to scan every product and are not obligated to use the GS1 US Electronic Product Code Information Services (EPCIS) standard (which FDA has endorsed for DSCSA-related data exchange), but they need a database or means to store electronic transaction information and transaction statements. Dispensers have the choice of:
- Working with third-party service providers to help them create a database to store the transaction data;
- Working with individual wholesalers to store that information in their proprietary portals; or,
- Creating their own custom systems.
However, if dispensers work with multiple distributors to store this information, they need to know which products are coming from which distributor, so they know where to go and how to access the transaction data for each product. “Working with wholesale distributors to store data on their portals doesn’t absolve dispensers to know that the data is there. Dispensers have to know how to retrieve it if asked for it and are required to have written agreements with distributors under the law,” said Gallenagh.
Should dispensers loan, share or sell product to other pharmacies, they must obtain licensure and comply with DSCSA requirements as wholesale distributors. Gallenagh discussed several exceptions where this does not apply such as:
- Transferring product to an affiliate;
- Selling to healthcare practitioners for office use (if the product comprises less than 5 percent of sales);
- Selling or lending product based on a specific patient need; and,
- Initiating any transfers between hospitals or institutions under common control.
After the 2023 deadline for DSCSA, in the event of a suspect product investigation, dispensers must be able to verify the product identifier for at least three packages or 10 percent of the suspect product in question. While dispensers do not have to report suspect product, they are required to provide information to the FDA or distributors when an investigation calls for information from dispensers.
To learn more, watch the September 15 webinar recording.
More resources are located at DSCSA.pharmacy.
Those interested in continuing their DSCSA preparation and learning should consider registering for HDA’s upcoming Traceability Seminar.
For more information, contact Jaidalyn Rand, Director, Industry Relations.