FDA mulls behind-the-counter drug category
The FDA said it may create a new “behind-the-counter” (BTC) category of drugs made available at drugstores to patients without a prescription, but only after consultation with a pharmacist.
The agency will hold a public meeting to hear feedback about on the BTC concept on Nov. 14. The purpose of the meeting is to solicit information and views on specific issues associated with BTC availability.
There are currently only a few drugs available BTC in the US – one is Barr's Plan B birth control drug.
However, countries such as Australia, Canada and New Zealand use the BTC system more widely.
According to the FDA, the criteria generally used BTC status in other countries include suitability for self-diagnosis and a low potential for serious side effects and overdose.
“Because pharmacists have the training and knowledge to provide certain interventions, they may be able to ensure that patients meet the conditions for use and educate patients on appropriate use of the drug product,” the FDA said in a Federal Register notice.