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Life Sciences › Federal Food Drug and Cosmetic Act (FFDCA) › Pharmacies

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FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements

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On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

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The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

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On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

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