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OSHA Hazard Communication Programs Update For Compounders

Compounders who have read USP〈800〉carefully are aware that there is a mandate for a “Hazard Communication Program,” but few of them actually may underst...
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What is a 503b Pharmacy (Outsourcing Facility)?

Medication production for patient use has always traditionally come from one of two sources: large scale pharmaceutical manufacturers, typically producing tens...
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FDA Warning Letters – Significance and Implications

The scope of the regulatory responsibilities of the U.S. Food and Drug Administration is vast. Their mission is to protect the public health and they employ 16,...
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Can the FDA Inspect a 503a Compounding Pharmacy & Facility?

The vast majority of compounding pharmacies in the US are state licensed facilities classified under section 503A of the Federal Food, Drug, and Cosmetic Act (F...
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