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Ensuring Patient Access: Best Practices for Compounding Shortage Drugs

Ensuring Patient Access: Best Practices for Compounding Shortage Drugs
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The Alliance for Pharmacy Compounding (APC) advocates for the responsible compounding and dispensing of “essentially copies” of FDA-approved drugs by compounding pharmacies when these drugs are listed as “currently in shortage” on the FDA Drug Shortage List, as permitted by FDA guidance. These best practices are specifically designed for 503A state-licensed compounding pharmacies. It is recommended that pharmacies seek legal counsel before compounding copies of FDA-approved drugs in shortage. APC does not guarantee that adherence to these best practices will protect a pharmacy from lawsuits, regulatory citations, or legal actions. Read More >

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MediZap is the only contract terminal sterilizer by E-Beam | X-Ray irradiation built for compounders. Our 4 Pillar Service includes Advanced Sterilization, Packaging Solutions, Compliance, and Exclusive Partnerships. We offer 48-hour processing, dedicated capacity, group pricing, and a compounding center of excellence. USP 797 and cGMP guidelines start with terminal sterilization, and our technology is the most advanced solution, ensuring low-risk 10-6 SAL and delivers the safest drug products to hospitals, practitioners, and patients.

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RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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This post is related to:

Compounding: USP & Sterile Resources, Compliance, TechnologyContamination Control: Cleanroom Supplies, Disposables, SterilizationDistribution: Pharmacy SuppliesPractice Setting: Infusion Pharmacy Resources
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