The Food and Drug Administration today released for public comment a revised draft memorandum of understanding for states regarding interstate distribution of “inordinate amounts” of compounded drugs by licensed pharmacists or physicians. Under the prior draft, issued in 2015 and on which AHA commented, inordinate amounts was defined as equal to or greater than 30 percent of all drug products dispensed or distributed by the compounder. “Some were worried that this provision could impede patients’ access to compounded drugs for which they have a medical need,” said FDA Commissioner Scott Gottlieb, M.D. Under the revised draft, states would agree to identify compounders that distribute more than 50 percent of their total prescription orders for compounded drugs interstate and report certain information to the FDA about those compounders. The draft MOU will be published in the Sept. 10 Federal Register with comments accepted for 90 days.
Northern Maine Medical Center – Fort Kent, Maine
AHA comments on the Department of Health and Human Services’ Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
The undersigned groups thank the Drug Enforcement Administration (DEA) for the opportunity to comment on its proposed rule regarding controlled sub
We concur with the DEA that setting quotas for the production of opioid medications can be an effective step in “preventing the accumulation of con
Sutter Health, located in northern California, uses an artificial intelligence platform to reduce inpatient drug spending, decrease lengths of stay and improve…