Regulatory Focus™ > News Articles > FDA: New OTC Switch Paradigm Would Require New Regulations

FDA: New OTC Switch Paradigm Would Require New Regulations

Posted 26 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) held a hearing on Friday, 23 March on the prospect of creating a new paradigm for switching more prescription medications to over-the-counter (OTC) status in a move it claims could "increase availability of OTC medicines" to consumers.

FDA is particularly concerned about the conditions in which such an OTC switch would be warranted and how to ensure patients use a medication safely.

"For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test," wrote FDA in a statement. "In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use."

"This will require rulemaking, said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. "We are gathering information from stakeholders about potential impacts of changing OTC regulations."

Read more:

FDA - FDA Considers Expanding Definition of Nonprescription Drugs

Follow FDA's OTC Hearing on Twitter via the Hashtag #OTCPlus

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