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BI Insight: Mixing, Diluting, or Repackaging Biological Products

Biologic agents are used in high volumes in oncology and auto immune diseases. The FDA acknowledges that at times, patients require different concentrations due to each patient’s genome. Outsourcing facilities are permitted to repackage biologic agents in order to meet personalized dosages and reduce waste. The FDA Biologic Guidance allows 503B facilities to engage in

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BI Insight: Manufacturing Practice for Pharmaceuticals

Pharmaceutical drug products deliver over 446 billion dollars of revenue annually in the United States. The FDA is tasked with protecting the public by minimizing the risks to consumers and ensuring that all medications are safe.. Drug manufacturers are required to apply and implement the regulatory and quality standards of CFR Title 21 CFR Part

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BI Insight: Impact of Drug Quality and Security Act on Compounding Facilities

In 2013, President Obama signed the Drug Quality and Security Act following the FDA‘s request to manage compounding facilities. As a result, the FDA created a new list of registered pharmacy manufacturers called 503B Outsourcing Facilities. The Interim Guidance document provides the provisions and covenants required by outsourcing facilities. The quality and regulatory requirements are

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