How, When, and Why Does a Prescription Drug Go Over the Counter?

By Patricia Raymond, Michelle Beaver

There are a wide variety of reasons why any particular drug goes from a prescription medication to an over-the-counter version. Some of these reasons are for the patient’s good; others are for the good of the drug manufacturer.

For example, advertising for over-the-counter drugs have much lower standards for informing consumers about potential side effects, drug interactions, and new research. This is possible because prescription drugs are regulated by the Food and Drug Administration (FDA), while over-the-counter drugs are regulated by the U.S. Federal Trade Commission (FTC), which applies lower standards about the scientific basis of safety and efficacy.

Making a drug over-the-counter can also make it easier for drug companies to get their products directly in the hands of consumers without the “interference” of doctors through direct-to-consumer advertising.

But before you start viewing over-the-counter drugs as risky cash grabs by greedy pharmaceutical companies, there are several facts to consider about the process of turning a prescription drug into an over-the-counter medication.

On the positive side, being over-the-counter makes it easier for consumers to obtain the medication. If you’re busy, finding time to see the doctor just to get a prescription to deal with your heartburn or reflux can be a hassle.

Whatever the reason that a particular manufacturer decides to make a drug over-the-counter instead of prescription, the process is the same.

First, the drug has to qualify for over-the-counter use. Drugs are generally denied over-the-counter status if they can’t be used safely without instruction or supervision, they’re habit forming, or they have too great a potential for harmful side effects. In order for a drug to switch to either a prescription or over-the-counter form, it must go through the “over-the-counter drug review.”

This can be done through a nongovernment professional review panel that assesses the drug’s success rate, as well as its risks, to determine if it should be made available over-the-counter. It can also be done by submitting a new drug application. During this process, the drug’s manufacturers submit research and evidence that the drug is appropriate and safe for self-administration.

In both cases, the FDA will consider whether patients will be able to achieve the desired results without endangering their safety. If for any reason the FDA determines this isn’t possible, the drug won’t be allowed to be sold over-the-counter. No drug is completely safe, but the FDA’s decision will be based on a risk-benefit analysis.

When in doubt, the FDA will side with patient safety. This is why you can be fairly certain that your over-the-counter medication will be safe.

But remember, just because it’s okayed for over-the-counter use doesn’t mean it isn’t potentially harmful — all biologically active substances have side effects. Be sure to consult with your doctor or pharmacist when starting any over-the-counter treatment regimen, and follow the drug’s usage instructions carefully.