In the United States, it is the Federal Drug Administration (FDA) who determines through a series of studies case by case whether a drug can be made available with no prescription. Making drugs available over the counter (OTC) with no prescription necessary means providing consumers with drugs that will not be monitored by a physician. For this reason, the FDA does not enter lightly into the decision to make a drug available OTC.
Examples of drugs for which no prescription is necessary where one was previously required include: Rogaine (minoxidil), Nicotine patches and gum, Zantac, Pepcid AC, Tagament, and Prilosec. There are hundreds of others that up until the nineties and more recently, did require a prescription. Making drugs available without a prescription may not be an easy task for the FDA, but it definitely saves time and money.
When determining if a drug can be made available to consumers with no prescription, the FDA must consider several factors. One of the most important aspects taken under advisement include what symptoms or conditions the drugs treat and whether or not consumers can diagnose their symptoms or conditions without a doctor. For example, drugs that treat vaginal yeast infections were not always available without a prescription, but was obviously deemed a self-diagnosable condition. If a drug is meant to treat a condition that can only be diagnosed by a doctor, or if the drug is habit forming or toxic, it will not be approved for OTC sale.
Other factors that must be met before FDA approval is granted for a drug to become OTC are clear directions, intended uses, and side effects. Since no drug is without risk, the FDA must determine if the benefits of using the drug to self-medicate outweigh any risks. Further, the labeling must be made clear and able to be understood by the average consumer.
Rarely, drugs are developed and given FDA approval for direct OTC sales, but the majority is given FDA approval for sale by prescription only. After a period of time, the manufacturer typically requests review for the drug to be made available with no prescription. The FDA, in conjunction with a panel of medical experts, will then review the drug and determine whether OTC status should be granted.
Disclaimer: Cliff Schaffer does not personally endorse or support any of the comments made within the writings of this article.