FDA to Solicit Comments about BTC Status for Drugs

October 11, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration will hold a public meeting on November 14, 2007 to solicit comments about the proposed behind-the-counter (BTC) availability of drugs.

Rockville, MD (Oct. 4)-The US Food and Drug Administration will hold a public meeting on November 14, 2007, to solicit comments about the proposed behind-the-counter (BTC) availability of drugs. BTC drugs would be nonprescription drugs that require the intervention of a pharmacist to be dispensed. The meeting will be part of FDA’s investigation of the public health benefit of BTC status for drugs.

According to the agency’s announcement in Federal Register, “pharmacist interaction with the consumer could ensure safe and effective use of a drug product that otherwise might require a prescription.” Pharmacists could potentially verify that patients meet the conditions to use certain drugs, explain how to use drugs correctly, and improve access to underused drugs. The agency also will explore whether making prescription drugs available BTC would give uninsured patients access to more medications.

FDA is exploring the effects BTC dispensing would have on patient access, including drug prices, drug safety and effectiveness, and patient compliance. During the meeting, FDA will seek the public’s responses to the following questions:

  • Should there be BTC availability of certain drug products?

  • What should the criteria or standards be for a drug to be treated as BTC?

  • Should BTC availability be used as a temporary status for drugs that move from prescription status to over-the-counter?

  • How could FDA evaluate whether BTC improves patient access to medications?

  • What dispensing procedures should be associated with BTC medications?

Countries such as Australia, Canada, France, New Zealand, the United Kingdom, Denmark, Germany, Italy, the Netherlands, Sweden, and Switzerland already use variations of a BTC status. These countries’ criteria for switching a drug to BTC status include whether the drug is suitable for self-medication or self-diagnosis, and whether it has a low potential for side effects or overdose.

To register to attend the meeting, click here.