13
Jun
Information on DSCSA Exemptions Until November 2026 and Other Possible Waiver Exemptions for Small Dispensers - Lachman Consultants

Information on DSCSA Exemptions Until November 2026 and Other Possible Waiver Exemptions for Small Dispensers

Now, don’t get too excited as this likely will not apply to you (see below for more detail for non-small dispensers)! The FDA expects all entities to be fully compliant with the Drug Supply Chain Security Act (DSCSA) by November 27, 2024; however, there are certain exemptions for what the Agency describes as “small dispensers” that […]

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30
Aug
Another Year Reprieve for Another Aspect of Track and Trace Legislation - Lachman Consultants

Another Year Reprieve for Another Aspect of Track and Trace Legislation

This morning, the FDA published a revision to the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies guidance originally issued in draft in 2019 and then finalized in 2020. The revision provides for another one-year delay in enforcement for the […]

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25
Aug

FDA Hears Industry’s Cry – Enforcement Policy Described Ahead of November 27, 2023 DSCSA Deadline

For months (if not years), we have been hearing alarms from industry trading partners who are subject to requirements for enhanced drug distribution security under section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law […]

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16
Mar

FDA Issues Draft Guidance with Definitions of Terms in Drug Supply Chain Security Act (DSCSA)

Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here).  The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]

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