In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties


FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.

What is drug compounding? Per 21 USC 353b, compounding is when a facility combines, mixes, dilutes, pools, reconstitutes, or otherwise alters a drug or bulk drug substance to create a product.

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