US Track & Trace Guidance on Verification Systems

Recommendation

7/8 May 2024

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Challenges and Solutions for Packaging and Single Use Systems

The FDA issued the final guidance on verification systems under the DSCSA (Drug Supply Chain Security Act). The guidance finalizes the revised draft guidance on verification systems issued in March 2022. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify FDA if needed. Amongst others, trading partners (i.e., manufacturers, repackagers, wholesale distributors and dispensers) must have systems in place (including SOPs etc.) to enable quarantines and investigations of suspect product.

"Verification" or "Verify" according to the FD&C Act

The term ‘verification’ or ‘verify’ means determining whether the product identifier (PI) affixed to, or imprinted upon, a package corresponds to the standardized numerical identifier or lot number and expiry date assigned to the product. However, the verification systems requirements discussed in the guideline refer to a trading partner’s individual processes and procedures. Trading partners should consult the Enhanced Drug Distribution Security Guidance and the guidance on DSCSA Standards for the Interoperable Exchange of Information to ensure that individual policies and procedures for verification of the PI are sufficient to satisfy the requirements for the interoperable, electronic tracing of product at the package level.

Wholesale Distributors and Dispensers

In October 2020 the FDA published the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product guidance (the 2020 Compliance Policies). However, the agency decided to extend the 2020 Compliance Policies for an additional year (from 27 November 2023 to 27 November 2024).

Wholesale distributors and dispensers must have systems in place to enable them to comply with a number of verification requirements for determining whether a suspect product is an illegitimate product. Like the other trading partners, during an investigation of suspect product, dispensers must validate any applicable transaction history and transaction information in its possession. Dispensers must also verify the PI with the respective manufacturer or repackager by confirming that the PI corresponds with the information (i.e., the standardized numerical identifier or lot number and expiry date) assigned to the product. The PI must be verified for at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages if there are fewer than 3. Thus, the verification requirement for dispensers differs from that of other trading partners when there are more than three packages of suspect product. In addition, dispensers have the additional requirement to verify the PI by confirming that the lot number corresponds with the lot number assigned to the product. To do this, a dispenser may consult the transaction information and transaction history to verify the lot number and if the dispenser is not able to verify the lot number (e.g., neither the transaction information or transaction history contains the required information) the dispenser should contact the manufacturer or repackager of the product.

Systems for Responding to Requests for Verification of the PI from Authorized Trading Partners

Manufacturers and repackagers must have systems in place to respond to requests for verification of the PI from an authorized trading partner that is in possession or control of a product that they believe to be manufactured or repackaged by the respective manufacturer or repackager not later than 24 hours after receiving such request or in “other such reasonable time” as determined by the agency, based on the circumstances of the request. The FDA interprets the 24-hour requirement as meaning that a manufacturer or repackager should provide a rapid response to such a request for PI verification, a best practice being no later than 1 business day from receipt of the request. The systems must allow the manufacturer or repackager to respond to the trading partner inquiring whether a particular PI corresponds to the standardized numerical identifier or lot number and expiry date assigned to the product. The systems should allow the manufacturer or repackager to respond to the request with a clear statement as to whether the PI has been verified. In addition, these systems should be integrated with SOPs and good practices (GxP) used to identify suspect product and illegitimate product.

More information is available in FDA´s final Guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.