Comply with Drug Supply Chain Security Act (DSCSA) requirements.
Comply with Drug Supply Chain Security Act (DSCSA) requirements.
DSCSA requires shippers of prescription drugs to retain proof of delivery signatures for seven years after date of delivery. Stay clear of noncompliance risks with FedEx TranSmart. The secure third-party online system provides a link between each POD and Product Tracing Information form.
Compliance Made Simple
With FedEx TranSmart, a third-party contract service, you can take care of reconciling your shipments in just a few steps:
- Send your prescription drug to a manufacturer, repackager, wholesale distributor or dispenser via FedEx Express or FedEx Ground and upload your shipping file to FedEx.
- Upon delivering the package, the FedEx driver captures the recipient’s signature for proof of delivery (POD) information and matches the POD with the original shipping file.
- The manufacturer, repackager, wholesale distributor or dispenser completes the Product Tracing Information (PTI) form and returns it to FedEx.
- FedEx matches the PTI form to the original shipping file. This becomes the final delivery record.
- FedEx stores and manages all final delivery records and package content data on a secure website for seven years after ship date — exceeding the six-year requirement by the U.S. Food and Drug Administration.
A Variety of Query Options
FedEx TranSmart lets you choose the query options that best fit your needs:
- Pickup date: Displays shipments made based on pickup date range.
- Delivery date: Displays shipments made based on delivery date range.
- Signature Proof of Delivery: Displays shipments with a delivery signature.
- In transit: Displays shipments that have yet to reach the consignee.
- Others: Query by name, tracking ID, state or reference fields.
All options are available as downloads.
Drug Supply Chain Security Act (DSCSA) Frequently Asked Questions
Understand how DSCSA protects consumers from counterfeit, unapproved or potentially dangerous prescription drugs — and how compliance can help protect your business.
The Drug Supply Chain Security Act (DSCSA) was signed into law by President Obama on Nov. 27, 2013. Title II of the Drug Quality and Security Act (DQSA), DSCSA, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Ten years after the enactment of DSCSA, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:
- Enable verification of the legitimacy of the drug product identifier down to the package level
- Enhance detection and notification of illegitimate products in the drug supply chain
- Facilitate more efficient recalls of drug products
Drug manufacturers, wholesale drug distributors, repackagers and many dispensers (primarily pharmacies) will be called on to work in cooperation with the U.S. Food and Drug Administration (FDA) to develop the new system over the next 10 years (through 2023).
Among key provisions that will be implemented over the next 10 years are requirements for:
- Product tracing: Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
- Detection and response: Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved or potentially dangerous.
- Notification: Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) to establish systems and processes to notify the FDA and other stakeholders if an illegitimate drug is found.
- Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to the FDA. This information will then be made available in a public database.
- Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.
This system will enhance the FDA's ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.
FedEx TranSmart is a secure, password-protected, third-party validated online system that helps you to comply with DSCSA without capital investment. The solution allows you to view proof of delivery (POD) signatures for your FedEx Express® and FedEx Ground® packages for up to seven years after ship date and provides a true link between each POD and your Product Tracing Information (PTI) form.
Complete the PTI form by entering one of the following and return it to FedEx:
- Invoice number
- Reference number
- Purchase order (PO) number
- Tracking number found on the FedEx shipping label
Get Started Today
To see if this contract-only solution is right for you, contact your FedEx account executive or call 1.800.463.3339.
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