Question

What is the risk management plan for Chloramphenicol regarding aplastic anemia from the EMA and FDA?

What is the risk management plan for Chloramphenicol regarding aplastic anemia from the EMA and FDA?

Homework Answers

Answer #1
  • The EMA recommends an eight-hour time-weighted average workplace environmental exposure level of 0.5 mg/m3.
  • The FDA regulates manufacturers, packers, and distributors to ensure proper labeling, certification, and usage requirements for any drug containing chloramphenicol.
  • The FDA also describes specifications and conditions of use for chloramphenicol tablets, capsules, suspensions, ointments, and solutions for dogs and cats, and requires that chloramphenicol not be used in any food-producing animals.
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