FDA again delays Drug Supply Chain Security Act enforcement

Pharmacies with 25 or fewer full-time employees now have until late 2026 to fulfill requirements of the Drug Supply Chain Security Act, according to the FDA. 

The agency announced the exemption June 12 to offer small dispensers more time "to stabilize their operations and fully implement the enhanced drug distribution security requirements" of the law. 

The FDA has already delayed enforcement of the law legislators approved in 2013. The law aims to enhance tracking of packaged therapies and grant the FDA more power to regulate compounded medications. An enhanced drug distribution security requirement was originally planned to go into effect November 2023, but after input from pharmacy organizations, the agency delayed enforcement of some policies until November 2024. 

The most recent postponement for small dispensers applies to the same policies, which demand medication transaction information to be sent in a "secure, interoperable, electronic manner."

Where applicable, trading partners of small dispensers are also exempted from the provisions until Nov. 27, 2026. 

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