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Over the Counter Drug Law

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What Are Over-the-Counter Drugs?

Over-the-counter drugs are medicines that can be purchased without a prescription from a physician. These types of drugs include everything from cough syrup to aspirin. With the increase in over-the-counter (OTC) drugs, the local pharmacist is playing an even larger role in self-medication.

Who Regulates Over-the-Counter Drugs?

The Food and Drug Administration (FDA) oversees the regulation of over-the-counter drugs. The FDA requires that every OTC drug be labeled with a set of facts. These labels must include:

  • Active Ingredients
  • Inactive Ingredients
  • Indications
  • Purposes
  • Safety Warnings and Directions for Use

In recent years, some OTC drugs, such as pseudoephedrine, have been subject to other restrictions. This is increasing the role of pharmacists in the medical use of over-the-counter drug.

Legal Liability of Pharmacists

There have been a few cases aimed at injuries caused by pharmacists. Most states recognize that pharmacists only have a limited duty to fill prescription drugs with due care but have no duty to advise on the correct use of that prescription. However, if the pharmacist is alerted to a certain condition with the prescribed drug and facts about the customer, due care and advice still must be given.

With OTC drugs, most courts have ruled that the labeling is adequate enough and manufacturers need not take further steps to advise consumers. Recently, there have been cases in which states have examined the role of pharmacists and their liability.  If a consumer requests advice from a pharmacist about a particular OTC drug, there is an argument that the pharmacist has a duty to give reasonably accurate advice

Should I Seek Legal Help?

If you have been injured from taking an OTC drug on the advice by the pharmacist, you should consult an attorney to preserve your legal rights and to possibly recover from your injuries. 

Photo of page author Matthew Izzi

, LegalMatch Legal Writer and Attorney at Law

Last Modified: 04-08-2015 02:58 PM PDT

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