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FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

23 February 2015

Pharmaceutical and Biotechnology Alert

On February 13, 2015, the FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation of outsourcing facilities under the Drug Quality and Security Act (DQSA), enacted in November 2013.

Read more: FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

The team

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