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New draft documents related to compounding of human drugs issued by FDA

It includes information on drug repackaging, as well as mixing, diluting, and repackaging biological products.

The FDA released five draft documents related to drug compounding and repackaging aimed at helping companies comply with important public health provisions.

The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.

The documents include draft guidances on outsourcing facility registration, outsourcing facility adverse event reporting, drug repackaging, mixing, diluting, and repackaging biological products, and a draft Memorandum of Understanding with the states.

The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.

They can all be accessed by clicking here.

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