Some drugs are initially approved as over-the-counter drugs. More often, however, medications are first approved as prescription drugs and then later switched.
Drugs are commonly switched one of two ways: under an OTC drug review, or by a manufacturer’s submission of additional information to the original drug application.
When considering a prescription to OTC switch, the key question that must be answered is whether the drug can benefit consumers without endangering their safety.
Non Prescription or OTC drugs are considered safe for consumers to use if they can easily follow the directions and warnings on the label. To protect consumers, FDA regulations require that labeling of OTC drugs be written so that ordinary people, including those with low reading comprehension skills, are able to easily find and understand information like:
- Toxicity (a drug, if mg’s potential for poisonous effects) is the major issue in deciding whether to switch a drug from prescription to OTC. Since almost any druisused, can have serious side effects, FDA considers the drug’s overall safety.
- Another consideration in deciding whether or not a drug should be available without a prescription is whether the condition being treated can be self-diagnosed and recognized without the help of a health-care practitioner. Not being able to self-diagnose a medical condition does not automatically prevent a product from switching to OTC status;
FDA evaluates each drug on an individual basis.
- the intended uses and results of the product
- adequate directions for proper use
- warnings against unsafe use, side effects and adverse reactions.
