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ICYMI: FDA issues three pieces of guidance on DSCSA that affect pharmacies - Vimarsana News

ICYMI: FDA issues three pieces of guidance on DSCSA that affect pharmacies

Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete.

Source: ncpa.org
FDA issues guidance on DSCSA that affect pharmacies - Vimarsana News

FDA issues guidance on DSCSA that affect pharmacies

Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete.

Source: ncpa.org
U.S.: FDA enforcement of certain DSCSA requirements delayed until November 2024 | Hogan Lovells - Vimarsana News

U.S.: FDA enforcement of certain DSCSA requirements delayed until November 2024 | Hogan Lovells

The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that...

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA's move to Electronic Tracking | Nelson Mullins Riley & Scarborough LLP - Vimarsana News

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA's move to Electronic Tracking | Nelson Mullins Riley & Scarborough LLP

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into...

Final Guidance Locks In FDA's Definitions For Suspect And Illegitimate Drug - Vimarsana News

Final Guidance Locks In FDA's Definitions For Suspect And Illegitimate Drug

With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate...