Compounding Back in the News as FDA Adds 25 Drugs to the Do Not Compound List

The FDA is proposing to update its list of drug products (previously found in its regulations at 21 CFR 216.24) that have been removed from the market for safety or efficacy and cannot be legally compounded.  It has also revised one product relative to its dosage form that allows compounding under the pharmacy compounding exemption.  Since FDA has approved an ophthalmic form of bromfenac, it has removed the restriction to now permit the compounding in certain situations for this drug product but only for ophthalmic use, whereas this drug was previously excluded for any use by the Rule.
The reason for the old Rule withdrawal and replacement is that, since the list last published on January 4, 2000, new information has come to the Agency’s attention that requires a revised list be published.  The entire 34 page Rule in its prepublication form can be found here
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