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  6. Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers
  1. Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act (DSCSA) Assessment of Small Dispensers

DSCSA recognizes the role of small dispensers in the drug supply chain and provides for ways to assist small dispensers (businesses providing drugs to patients with a prescription) in meeting the requirements of the law. Specifically, the law specifies several provisions, which FDA is working to implement.

Who is considered a small dispenser under DSCSA?

The law describes small dispensers as having 25 or fewer full-time employees.

What does DSCSA direct FDA to accomplish related to small dispensers?

DSCSA directs FDA to enter into a contract with a private, independent consulting firm with expertise to conduct a technology and software assessment that looks at the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level. The assessment must determine whether:

  • the necessary software and hardware is readily accessible to such dispensers;
  • the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such dispensers; and
  • the necessary hardware and software can be integrated into business practices, such as interoperability with wholesale distributors, for such dispensers.

The law also instructs FDA to consider the assessment and provide provisions for alternative methods of compliance including establishing a process for small dispensers to request a waiver and establishing timelines for compliance if it is determined that the 2023 enhanced drug distribution security requirements would result in undue economic hardship.

What are the next steps for the small dispensers assessment?

FDA published a federal register notice on August 10, 2023, that requests comments on proposed topics and questions that FDA plans to include in the small dispensers assessment. Interested parties can provide other relevant information to inform FDA’s development of the small dispensers assessment under the DSCSA.

FDA will conduct the small dispensers assessment and will provide updates via this webpage and the DSCSA mailing list with emerging information as appropriate.

 
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