Are you ready to comply with the track-and-trace law? A January 1, 2015 deadline has already passed for pharmacies to comply with parts of the Drug Supply Chain Security Act (DSCSA), and a July 1, 2015 deadline is approaching fast.
The DSCSA is the track-and-trace portion of the Drug Quality and Security Act (DQSA), which was signed into law in November 2013.
The track and trace requirements of the DQSA are meant to improve drug security throughout the supply chain, including making it easier to track where a drug has been in the supply chain, identifying and removing counterfeit product, and facilitating drug recalls.
All members of the supply chain, including manufacturers, repackagers, wholesale distributors, dispensers (including retail pharmacies) and third-party logistics providers, will have to comply with the law as it’s phased in over the next nine years.
Who’s considered a “dispenser”?
Any business that dispenses prescription products to patients, including pharmacies, clinics, hospitals, physicians’ offices and long-term care facilities, are considered dispensers.
It’s important to note that if a pharmacy resells products to distributors or to other dispensers, that pharmacy must also abide by wholesaler distributor requirements.
The following guidelines outline the requirements for dispensers only.
What are you required to comply with by July 1, 2015?
The July 1, 2015 deadline requires that pharmacies receive the proper paperwork from suppliers, known as “3T” information. The “3T” information includes transaction information, transaction history and a transaction statement. Pharmacies are also required to store this information for six years.
What makes up the “3T” information?
- Transaction information. This information includes the name of the product, strength and dosage form, NDC, container size, number of containers, transaction date, shipment date, name and address of the seller and buyer, and lot number, if applicable.
- Transaction history. This is a paper or electronic statement that includes the transaction information for each prior transaction of the product back to the manufacturer.
- Transaction statement. This is a paper or electronic attestation transferring ownership of the product.
What were you required to comply with by January 1, 2015?
Since the January 1 deadline passed, pharmacies are required to only purchase from authorized trading partners, and to have systems in place to address suspect and illegitimate products.
Helpful questions to ask yourself
- Are you comfortable with the DSCSA’s 2015 requirements?
- Have you updated your procedures?
- Have you identified the staff in your pharmacy responsible for the requirements?
- Are your staff members trained on their new responsibilities?
- How will you handle “exceptions”? For example, if you receive more product than data?
- How will you account for data received with products from more than one supplier?
For more information on the DSCSA, visit the Food and Drug Administration’s website.
