Starting in November 2023, the final requirements of the Drug Supply Chain Security Act (DSCSA) go into effect. The law, passed in 2013, aims to prevent illegitimate products, including counterfeit or stolen drugs, from entering the pharmaceutical supply chain.
The final step focuses on electronically tracking and tracing all pharmaceutical products at the individual package level through the system as they change hands — from the manufacturer to dispensers.
According to the Food and Drug Administration (FDA), the law defines dispensers as pharmacies and any other persons/entities authorized by law to dispense or administer prescription drugs.1 Although primarily focused on pharmacies, this definition does include physician offices that administer prescription drugs to patients.
Your office may have already implemented some processes or felt the effects of current DSCSA requirements. The final stage may require non-acute care practices to add steps or safeguards to maintain ongoing DSCSA compliance.
What's coming up with the DSCSA
As of 2020, all pharmaceutical products a dispenser receives should have a unique serial number and transaction history, transaction information and transaction statement. A dispenser should not accept products without these records under the law.
The final phase of the law requires electronic, interoperable tracking at the package level and tracing of the drugs each time they change hands.
Non-acute care practices meeting the definition of dispensers have three main responsibilities to address in this phase:2, 3
1 | Keep and maintain an electronic record of the pharmaceutical products
When a product changes ownership, the new authorized owner should receive transaction information and a transaction statement in a secure, interoperable, electronic format. The transaction information should include the product identifier as of November 2023, not just the products themselves.1
Dispensers own the data for each transaction and are responsible for controlling and keeping it. Dispensers must maintain the transaction data they receive and provide for six years. The law allows dispensers to use a third party to maintain their transaction data to help make things easier.2
2 | Have systems in place to verify pharmaceutical products
Since 2015, dispensers must only accept pharmaceutical products with a transaction history, transaction information and transaction statement in print or an electronic format.3 The FDA states it's up to the practice to validate a transaction history.4
Non-acute care practices that dispense pharmaceuticals must prepare to adopt track-and-trace systems or work with a third party to assist with data reporting and storing.
Dispensers and all other trading parties are responsible for providing their data upon request.
3 | Know what to do with suspect products
If there are any discrepancies, you are responsible for taking action under the law. Contact the manufacturer or repackager if you receive incomplete information or can't verify the product.4
If you have a suspected counterfeit product, the law requires dispensers to quarantine the product and investigate. Dispensers also need to keep a record of their suspect product investigations for six years under the DSCSA and notify the FDA of any product found to be illegitimate.
A federal or state official may also question a product's validity and request an investigation. If you receive a suspicious product, you should notify the government and connected trading parties to remove it from the supply chain. The dispenser must also keep all records of the investigation.1
Past DSCSA requirements implementation
Although the DSCSA passed in 2013, some of the earliest provisions went into effect by 2015. A fully electronic, interoperable capability to track and trace drugs may seem overwhelming. Still, it's important to remember that certain parties you're already working with, including McKesson Medical-Surgical, have been working within DSCSA compliance and preparing for this process for years.
In terms of electronically tracking, the Electronic Product Code Information Service (EPCIS) is the only internationally recognized standard that meets the DSCSA's requirement for an interoperable exchange of data. Although EPCIS is a standard used for tracking products throughout a supply chain, its use in healthcare is still in its early stages.2
Your practice already has some familiarity with verifying the legitimacy of products. Since 2015, dispensers must only accept pharmaceutical products with a transaction history, transaction information and transaction statement in print or an electronic format.3 Plus, starting in 2020, practices could only accept products with unique serial numbers unless grandfathered, often by scanning the machine-readable codes.
Looking ahead for solutions to help with DSCCSA compliance
The prospect of tracking and tracing drugs throughout the supply chain can seem daunting, and those involved will undoubtedly have to face a learning curve. Dispensers will need tight inventory control and detailed processes to comply with the DSCSA. But working with other organizations, such as McKesson Medical-Surgical, can help.
McKesson SupplyManagerSM is a comprehensive inventory management solution. In addition to online ordering and customized reporting, SupplyManager meets DSCSA requirements, so you have supply chain integrity assurance and an established audit trail that meets regulations.
DSCSA transaction information and transaction statements will continue to be available in SupplyManager at no cost. If you desire to store your DSCSA data elsewhere, either in an in-house solution or in a third-party solution, you can enroll to have a daily EPCIS DSCSA file sent to your data repository for management.
Overall, the law has designed DSCSA requirements to keep harmful, counterfeit products out of the supply chain, ultimately helping to keep patients safe.
All trademarks and registered trademarks are the property of their respective owners.
© 2022 McKesson Medical-Surgical Inc.