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FDA alerts providers to medication pump danger
The Food and Drug Administration yesterday warned the health care community about complications that arise when pairing pain medications with intrathecal implanted pumps when the medications are not approved for use with those devices, which deliver medicine into spinal fluid.
Compounder prohibited from making, distributing drugs
The U.S. District Court for the Western District of Pennsylvania has entered a consent decree prohibiting Ranier’s Rx Laboratory Inc. from manufacturing or distributing compounded drugs until they comply with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration regulations.
FDA launches pilot program for enhanced system to track and trace drugs
Members of the pharmaceutical distribution supply chain, including dispensers such as hospitals and pharmacies, can apply through March 11 to participate in a Food and Drug Administration pilot program.
NASEM workshop on preventing medical product shortages in disasters
The National Academies of Sciences, Engineering, and Medicine will host a public workshop Sept. 5-6 on “Medical Product Shortages during Disasters: Opportunities to Predict, Prevent and Respond.”
AHRQ releases opioid management toolkit for primary care providers
The Agency for Healthcare Research and Quality has released an online toolkit to help primary care practices improve care for patients taking opioids for chronic pain.
DEA proposes reducing opioid production quotas for 2019
The Drug Enforcement Administration today issued its proposed 2019 aggregate production quotas for certain controlled substances, which the agency said would reduce manufacturing quotas for six frequently misused opioids by an average 10 percent.
FDA seeks stakeholder input on impact of drug shortages, solutions
The Food and Drug Administration will hold a public meeting Nov. 27 to receive stakeholder input on the underlying systemic causes of drug shortages and recommendations to mitigate them.
FDA Issues Advisory on Wearable Heart Device
The Food and Drug Administration yesterday issued an update for health care providers treating patients at risk for sudden cardiac arrest using a Zoll LifeVest 4000 wearable cardioverter defibrillator.
ASHP Updates Guidelines for Managing Drug Shortages
The American Society of Health-System Pharmacists this week published updated guidelines for managing drug shortages.
FDA revises draft MOU on interstate distribution of compounded drugs
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.