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1 bill on this topic
“Licensed pharmacists and doctors should be able to make limited supplies of certain compounded drugs ahead of time for urgent hospital or clinic use, even before a specific patient has a prescription.”
1 bill on this topic
“Drug manufacturers should warn FDA about sharp demand increases, planned production stops, and manufacturing interruptions that could leave current or expected demand higher than available supply.”
1 bill on this topic
“Compounders should have to report bad health events related to urgent-use compounded drugs to FDA's MedWatch program within 15 days after learning about them.”
1 bill on this topic
“FDA should share drug-shortage information with more affected groups, including patient organizations and outsourcing facilities that may help respond to access problems.”
1 bill on this topic
“Hospitals and clinics should be asked to send patient-identifying records back to the compounder within 7 days, and compounders should connect those records to the original urgent-use compounded drug order.”
1 bill on this topic
“FDA-registered outsourcing facilities should be able to treat a drug as shortage-related if it appeared on FDA's shortage list at any point in the previous 180 days before compounding.”
1 bill on this topic
“Pharmacists and doctors should be able to rely on a drug's FDA shortage listing from the previous 60 days when making certain urgent-use compounded drugs or when deciding whether the drug counts as a copy of a commercial product.”
1 bill on this topic
“Urgent-use compounded drugs should have labels showing when they should no longer be used and saying they are only for urgent administration to a patient in a hospital or clinic.”
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