FDA mulls behind-the-counter drug category

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...