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Track-and-Trace: Understanding the Requirements of the Drug Supply Chain Security Act

Track-and-Trace: Understanding the Requirements of the Drug Supply Chain Security Act by Elements magazine | pbahealth.com


September 14, 2015


Pharmacies have a central role to play in the Drug Supply Chain Security Act (DSCSA), the latest industry effort to track prescription drugs through the supply chain.

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, to identify and remove counterfeit products, and to simplify drug recalls.

All members of the supply chain—manufacturers, repackagers, wholesale distributors, third-party logistics providers and dispensers, including retail pharmacies—will have to comply with the law as it’s phased in over the next nine years.

What you already need to be doing:

Verifying your trading partners
Effective date: Jan. 1, 2015

Your pharmacy is required to verify that all of your trading partners have a valid license, and are registered per federal and state law. Develop and implement protocols to verify all new trading partners and be sure to regularly audit your current trading partners.

Identifying suspect and illegitimate product
Effective date: July 1, 2015 

Pharmacies need protocols to identify suspect and illegitimate products. These procedures should help you:

 

What you’ll need to do soon:

Accepting, maintaining and providing transaction data
Effective date: July 1, 2015, but it won’t be enforced until March 1, 2016 

Although the product tracing obligations under the DSCSA went into effect July 1, 2015, the FDA won’t enforce them for pharmacies until March 1, 2016. In the meantime, pharmacies need to work toward complying with the requirements, which means only accepting product if the previous owner provides the “3Ts” (transaction information, transaction history and a transaction statement), and capturing and maintaining the “3Ts” for six years from the date of the transaction.

If your pharmacy sells or loans product, you’re currently required to provide the “3Ts” to the subsequent owner, unless the subsequent owner is a patient. The deadline was not extended for this requirement.


 

What are the “3Ts”?

1. Transaction information
This information, which can be provided in paper or electronic format, 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.

2. 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.

3. Transaction statement
This is a paper or electronic attestation transferring ownership of the product.

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