Image for FDA Considers Reclassifying Some Prescription Drugs as OTC
Copyright 2013 Natural Standard (
February 2012

FDA Considers Reclassifying Some Prescription Drugs as OTC

On March 22 and 23, 2012, the U.S. Food and Drug Administration (FDA) will be holding a public hearing to determine a general opinion about whether certain drugs that currently require a prescription should be reclassified as a nonprescription product if the medication will be used under certain conditions of safe use for that drug.

Currently, the FDA classifies drugs as being either prescription or nonprescription (also referred to as over-the-counter or OTC). According to a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug can be taken only with a prescription if it could cause toxic or harmful effects or if it requires specific methods of use that can only be performed by a licensed medical practitioner. On the other hand, drugs are classified as nonprescription medications if they can be used to treat self-diagnosable diseases, if they do not cause toxic side effects that require a medical practitioner to evaluate the risk/benefit of treatment, and if a nonmedical person can understand how to take the drug.

At this meeting, the FDA plans to evaluate whether a portion of drugs that currently require a prescription should be made more readily available. The FDA believes that some drugs should be reclassified as nonprescription medications if they can be used following certain conditions of safe use. These conditions of safe use may involve, for instance, that a patient speak with a pharmacist about the appropriate use of the nonprescription medication prior to purchasing the product. Also, the conditions of safe use could require that a patient use FDA-approved diagnostic equipment at a pharmacy to determine if he or she is a good candidate for using a particular medication.

In addition, the FDA believes some patients are unnecessarily burdened by the need to get prescriptions from their doctor for initial drug use, as well as for each additional refill. This is often the case for drugs such as rescue inhalers used to treat asthma or allergic reactions, as well as drugs used to treat high blood pressure, high cholesterol, and migraine headaches. Since this need for additional prescriptions requires that patients make multiple trips to visit their primary care physician, the FDA believes that many patients stop using necessary medication.

If this new classification of drugs were to go into effect, pharmacists would have a much more active role in patient care. Pharmacists could help patients decide if a medication is suitable for them based on the results of a diagnostic test and could evaluate if a patient would experience negative side effects or interactions after taking a new medication. In addition, reclassifying drugs this way could prompt medical device companies to invest more money into developing diagnostic tools that can be easily used by pharmacists and patients, rather than only a licensed physician.

At these meetings on March 22 and 23, the FDA would like to get feedback regarding certain questions, including but not limited to: (1) which medical conditions would be most benefitted by having prescription drugs available as nonprescription medications; (2) which technologies that are currently in development may be used to ensure conditions of safe use; (3) what other conditions of safe use besides monitoring by pharmacists and diagnostic technologies could be used to ensure the safe use of a prescription drug if it was reclassified as a nonprescription medication; (4) are diagnostic aids available that could be used by patients or pharmacists in a nonprescription setting; (5) what standards could or should be used to decide which prescription drugs could be reclassified as nonprescription if used following conditions of safe use; (6) what financial impact would such a change have on patients, as well as other members of the healthcare community?

In addition to OTC drugs, many individuals self-treat for a variety of conditions by taking different types of integrative therapies. For more information about the safety and effectiveness of dietary supplements, please visit Natural Standard's Foods, Herbs & Supplements Database.


  1. Natural Standard: The Authority on Integrative Medicine.
  2. U.S. Food and Drug Administration (FDA).
The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited.