Rx-to-OTC switch is the transfer of proven prescription drugs to nonprescription, OTC status. It is a scientifically rigorous and highly regulated process that allows consumers to have OTC access to a growing range of medicines. For a medicine to be granted OTC status, it must have a wide safety margin, be effective, and bear understandable labeling to ensure proper use.
Thanks to Rx-to-OTC switches, families can conveniently buy and use a wider range of medicines and products without having to go to the doctor.
As more prescription allergy medicines have switched to OTC, there has been a clear shift toward these more convenient and affordable options. Allergy sufferers who use OTCs has gone up from 66 percent in 2009 to 75 percent in 2015.
When nicotine replacement therapies went OTC, there was a 150 to 200 percent increase in their purchase and use in the first year after the switch. Increased access enabled tens of thousands of smokers to use these products to help quit smoking. That’s a $2 billion social benefit every year.
CHPA maintains a list of ingredients and dosages transferred from Rx-to-OTC status (or New OTC Approvals) by FDA since 1975.
2022 Rx-to-OTC Switch Symposium
In April 2022 CHPA supported the Reagan-Udall Foundation for the FDA to fund their Snapshot 2022, an Rx-to-OTC switch symposium. The Regan-Udall Foundation is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA." The half-day symposium featured speakers and participants from Federal agencies, industry, academia, patient groups, provider organizations, and others. Snapshot 2022 examined the current environment for FDA-regulated consumer products and devices, and how healthcare delivery might change in the near future.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Now from coast-to-coast, it is once again legal to purchase cold and allergy medicines containing the decongestant pseudoephedrine (PSE) over-the-counter (OTC). In a major victory for consumers, Oregon has repealed a 15-year-old law that banned OTC sales of certain medicines for colds and allergies containing PSE.
At a June 6 hearing on the FY 2022 FDA Budget, Senate Agriculture-FDA Appropriations Subcommittee Ranking Member, Senator John Hoeven (R-N.D.) asked Acting FDA Commissioner Janet Woodcock about delays with the Non-Prescription Safe Use Regulatory Expansion (NSURE) final rule.
CHPA’s “Insights with Impact” series features Cindy Sanders, Co-Publisher/Managing Editor of Nashville Medical News, who discusses the growing interest in over-the-counter access to oral contraceptives.
The Senate HELP Committee made a strong bipartisan move to modernize the regulatory system overseeing most OTC medicines by approving S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act by voice vote.
CHPA issued the following statement today following the introduction of S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, sponsored by Senators Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.).
