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HOW DOES AN RX SWITCH TO “OVER THE COUNTER”?


There are more than 1,000 medications that only are available to people in the United States with a doctor’s prescription.* But every now and then, the U.S. Food and Drug Administration (FDA) determines that a prescription drug or class of drugs is safe and effective enough to become available on store shelves for anyone to buy and use.

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FEW MEDICATIONS MAKE THE SWITCH TO OTC

Since 1976, only 106 prescription medications have gone from Rx to over-the-counter, or OTC, the term used for medications you can buy without a prescription. Why so few? There’s a lot more to the process than moving the package from the pharmacy to the drug store aisle.

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MOST DRUGS START AS PRESCRIPTION MEDICINES

After many years of use by consumers as a prescription drug, the manufacturer can submit a New Drug Application (NDA) to the FDA to have the medication considered for OTC status. This document provides the complete history of the drug and a wide range of technical information.

NEXT, THE FDA EXAMINES A DRUG’S SAFETY RECORD

The FDA reviews the NDA and all the scientific data collected on the medicine to determine if it is safe and appropriate to use without consulting a doctor first. This process usually takes about 10 months, but can last significantly longer depending on the amount of data that the FDA needs to review.

Medicine bottle label

THE DRUG’S LABEL ALSO GETS SPECIAL ATTENTION

Next, the FDA considers whether the OTC label can be written in a way that consumers will easily understand. This is essential if consumers are to use the product without the guidance of a doctor or pharmacist.

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A RIGOROUS PROCESS LEADS TO CONFIDENCE

If the FDA issues its approval, the manufacturer begins the process of bringing the medication to store shelves. The end result? A medication that you can use on your own with confidence. So getting the treatment you need is as easy as a trip to the local pharmacy.

Sources:

*MediLexicon filtering of full FDA Drug List at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

 

Facts about Rx-to-OTC Switch, Consumer Healthcare Products Association, http://www.chpa.org/FAQsSwitchPP.aspx
Copyright 2014. Accessed 2014.