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1 bill on this topic
“Some compounded medicines should have a clear label saying they were compounded for an individual patient and have not been approved by FDA.”
1 bill on this topic
“Compounders should be limited to making 20 compounded versions in one month of a drug already sold in the United States, unless a prescriber says a specific patient needs a meaningful change.”
1 bill on this topic
“Federal compounding rules should make clear that the National Formulary reference includes drug monographs and dietary supplement monographs when deciding which ingredients may qualify for compounding.”
1 bill on this topic
“Before using the urgent pharmacy or physician compounding pathway, prescribers should have to write that they tried and could not get a similar compounded drug from an FDA-registered outsourcing facility.”
1 bill on this topic
“A compounded drug should not be treated as an impermissible copy of a commercial product when it is changed for a specific patient and the prescriber says the change makes a significant difference for that patient.”
1 bill on this topic
“FDA should post annual public updates on its review of bulk drug substances that outsourcing facilities may use for compounding.”
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