Role of Small Dispensers

The Drug Supply Chain Security Act (DSCSA) recognizes the role of small dispensers (pharmacies) in the drug supply chain. FDA provides ways to assist small dispensers that provide drugs to patients with a prescription meet the requirements of the law.

Small Dispensers Assessment

DSCSA directs FDA to contract with a private, independent consulting company to conduct a technology and software assessment that looks at the feasibility of small dispensers conducting interoperable, electronic tracing of products at the package level. The assessment must determine whether for such dispensers:

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

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 the enhanced drug distribution security requirements would result in undue economic hardship.

Federal Register Notice

FDA published a Federal Register notice on August 10, 2023, that requested comments on proposed topics and questions the agency plans to include in the small dispensers assessment. Interested parties also had the opportunity to provide other relevant information to inform FDA’s small dispensers assessment.

FDA is conducting the small dispensers assessment and will provide updates as appropriate.