In November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law. This legislation included extensive provisions establishing a national traceability system for prescription drugs in finished dosage form. H. D. Smith has been in the forefront of patient safety and supply chain integrity for many years. The DSCSA is welcomed and brings national clarity for addressing inconsistent and conflicting state law requirements.
What are the new terms associated with the traceability law?
Let’s first start with the term transaction, which is defined as a change in ownership. This is important because it is the basis for all traceability requirements. When product changes ownership through a transaction, we will be exchanging transaction history, transaction information and transaction statements.
- Transaction Information (TI): The transaction information is largely drug information – its name, strength, number of pills, etc., which generally appear on invoices. Some new pieces of data will be a part of transaction information – most notable is the supplier name and address for each drug.
- Transaction History (TH): the transaction history is a sum of all the transaction information going back to the original manufacturer.
- Transaction Statement (TS): the transaction statement, which is essentially a statement of authenticity that says we are complying with the law.
There are two new terms related to regulatory requests for information: Suspect product and illegitimate product. A suspect product means there is reason to believe the product is counterfeit, adulterated or is a part of a fraudulent transaction. Whereas, illegitimate product has credible evidence to support a conclusion that a product is counterfeit, adulterated or is a part of a fraudulent transaction.
There are two critical dates in 2015.
The first date – Jan. 1, 2015 – requires drug manufacturers and wholesale distributors to ensure transaction information, transaction history and transaction statements are being communicated with each change of ownership. Additionally, all supply chain participants are required to respond to federal or state authorities in a request for information.
The second critical date – July 1, 2015 – requires dispensers to obtain transaction information, transaction history and transactions statements prior to receiving products purchased.
For more information specific to dispenser requirements, visit the National Community Pharmacy Association website.
What do H. D. Smith’s partner pharmacies need to do right now?
To help with this transition, H. D. Smith’s systems partner in complying with the DSCSA legislation is TraceLink. TraceLink will be contacting our partners in September to begin the onboarding process. TraceLink will be the application for you to access transaction histories for all prescription drug products purchased through H. D. Smith. Access to and training on TraceLink’s customer portal, called Product Track, will be provided by TraceLink to H. D. Smith’s customers, free of charge. As a customer, you must register to use the Product Track application by Dec. 31, 2014.
I am an H. D. Smith customer in Florida who already uses TraceLink. Am I impacted?
Yes. Florida customers who have been using TraceLink for compliance with Florida drug pedigree legislation will need to register with the new Product Track application for access to the information required by DSCSA.
What is H. D. Smith doing to be ready by Jan. 1, 2015?
We are working to ensure we are ready, and our trading partners are aligned for compliance. These efforts include:
Together with other members of the Pharmaceutical Distribution Security Alliance (PDSA) we are working with regulators as they establish final DSCSA guidance, rules and standards
Developing internal capabilities to comply with the DSCSA requirements across all H. D. Smith businesses
Preparing to receive trading partner data to support product receipts
As always, we want to hear from you, our customers regarding questions you may have about this new law and how it will impact your business. Should you have any questions, talk to your sales representative or contact us via email at email@example.com.
- Consult with H. D. Smith Sales Representative
- Complete New Account documents
- Provide required documents such as licenses, CSOS registration and usage report
- Receive account approval