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DSCSA Exemption for Pharmacies and the 6/12/2024 FDA Announcement

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA The DSCSA Adventure continues. On June 12, 2024, the FDA released a notice stating that it is issuing exemptions from specific requirements of the Drug Supply Chain Security Act (DSCSA) to small dispensers (pharmacies) to go into effect on 11/27/2024 to ensure patient access.   The exemption will last until November 27, 2026, for those small dispensers who qualify. Before getting into who qualifies as a small dispenser and what areas of…

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DSCSA: Protecting Your Patients from Illegitimate Medication

We have been on a roll with DSCSA Blogs and Webinars over the past year. So, why not continue this trend by focusing on one of the main goals of DSCSA: protecting patients from medication that may be counterfeit, stolen, contaminated, or otherwise harmful. Why are we here? In 2013, the Drug Supply Chain Security Act (DSCSA) was passed by Congress to ensure the safety and security of the pharmaceutical supply chain in the United States. The main objectives of…

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Drilling Down into The Enhanced Drug Distribution System (EDDS) Requirements

In four months, the Enhanced Drug Distribution System (EDDS) requirements of the Drug Supply Chain Security Act (DSCSA) will go into effect. The EDDS changes the fundamentals of some existing DSCSA provisions that Pharmacies are required to comply with now, which we will discuss in addition to the upcoming EDDS requirements. Where are We Now with the DSCSA? Before moving into the new EDDS Requirements, let’s quickly discuss the existing requirements that Pharmacies should already comply with and have corresponding…

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