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Latest From US Pharmacopeia

Compounding Warning Letter Format Unchanged Since Legislation

FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.

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Compounding: Hamburg Asks Purchasers, States To Push Outsourcer Registration

Letters seek help encouraging large-scale compounders to register with the agency as outsourcing facilities; FDA also seeks nominations for its compounding advisory committee.

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Compounding Guidance Creates Subtle Pressure On Traditional Compounders

FDA will enforce USP standards, a regulatory first.

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Compounding Law: How Many “Outsourcing Facilities” Will Emerge?

As bill heads to President, voluntary registration system for compounders likely means not all large-scale operations will subject themselves to FDA oversight.

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