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1 bill on this topic
“HHS should be able to replace the fixed $15,000 base fee for outsourcing facilities with an agency-set base fee to pay for compounded drug safety work.”
1 bill on this topic
“FDA should inspect large-scale outsourcing facilities before they start compounding drugs for the first time and inspect each one at least once every two years after that.”
1 bill on this topic
“Outsourcing facilities should have to register with FDA as drug establishments and should not be able to use the registration exemption that would otherwise apply.”
1 bill on this topic
“Pharmacies, facilities, and doctors should have to tell HHS when they make more than 20 covered compounded drugs in one month for patients in other states, including each drug type and monthly count.”
1 bill on this topic
“An outsourcing facility should count as large-scale if it makes any one drug product more than 100 times in a calendar year.”
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