FDA wants feedback on small dispensers’ DSCSA tracking readiness

The US Food and Drug Administration (FDA) is seeking stakeholder input from small dispensers on their technological readiness in complying with the electronic tracing requirements under the Drug Supply Chain Security Act (DSCSA) by the time the law takes full effect this November.

FDA said in a 9 August Federal Register notice that it wants such feedback from dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level.

The agency would like information “regarding issues to be addressed in the assessment related to the accessibility of the necessary software and hardware to such dispensers; whether the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such dispensers; and if the necessary hardware and software can be integrated into business practices.”

The notice is part of a mandate under section 582(g)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the DSCSA, which requires FDA to contract with a private, independent consulting firm to conduct a technology and software assessment that evaluates the feasibility of small dispensers tracing products at the package level.

A 2021 industry survey found that trading partners were lagging in exchanging electronic information with each other; while half of manufacturers and distributors said they were exchanging Electronic Product Code Information Services (EPCIS) data with each other, this data was not being exchanged at all between distributors and dispensers. (RELATED: Pharmaceutical trading partners lagging in exchanging product information, Regulatory Focus 24 September 2021)

The notice also comes on the heels of a letter from members of Congress to FDA expressing concerns about whether trading partners will be ready to implement the tracking portion of DSCSA by the 27 November deadline. (RELATED: Lawmakers, concerned about shortages, urge FDA to assess DSCSA readiness, Regulatory Focus 3 August 2023)

FDA is interested in responses to the following:

Whether dispensers have started to prepare for the interoperable, electronic tracing of products at the package level;
How dispensers are currently exchanging data with trading partners, such as through paper-based methods, electronic methods, or both methods;
If not currently exchanging data now, whether they will be able to do so in the near future;
The barriers to exchanging electronic data, such as the accessibility of the software and hardware; the cost to obtain, install, and maintain the software and hardware; and the integration of the software and hardware into business practices with wholesale distributors;
The type of software systems and hardware they are currently using to exchange data;
The type of new or modified software systems and hardware they plan to put into place to comply with the electronic tracing requirements;
Whether data integrity and security concerns are considered when establishing agreements with solution providers or wholesale distributors for electronic data exchange and maintenance;
Whether they have obtained transaction information from a trading partner that does not match the product received;
The frequency of 2D data matrix barcode not being able to scan or read; and
What additional resources are needed to comply with the interoperable, electronic tracing requirements?

Stakeholders have 30 days to provide feedback. These comments should refer to docket FDA-2023-N-3103.

Notice

FDA wants feedback on small dispensers’ DSCSA tracking readiness

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