How Are Over the Counter Drugs Classified?

OTC drugs (or over the counter drugs) are highly convenient to the customer. However, the desired medication isn’t always available without a prescription. How are these drugs classified, and can their status change?

The History of OTC Drugs

The concept of over the counter drugs is a relatively recent one. In centuries past, the main barriers to acquiring a medication was its availability and cost. In the United States, that changed in the early 20th century.

The original Federal Food, Drug, and Cosmetic Act of 1938 did not clearly distinguish between prescription and OTC drugs. In 1951, several amendments were passed that clarified which drugs required prescriptions and professional supervision. These included:

  • potentially toxic medications
  • habit-forming medicines
  • medications with a great potential for harmful side effects
  • medicines for conditions that are difficult to self-diagnose

All other drugs could be sold OTC.

Transitioning Between Prescription and OTC Status

Medications can and do switch from one class to another, acquiring or shedding restrictions on their sale. This is often due to an evolving understanding of the drug’s safety and ease of use.

For instance, consider codeine. It was once freely available around the world. Due to rising addiction issues and the accidental overdose of a number of infants and children, the US Food and Drug Administration has placed restrictions on codeine. These restrictions include requiring a prescription and strict limitations on how much of the drug can be purchased.

Reclassification can move in the other direction as well. Here are a few well known medications that can now be sold OTC:

  • Nicorette gum
  • Nicotine patches like NicoDerm CQ
  • Pain and fever reducers like Children’s Advil, Children’s Motrin, and Aleve
  • Femstat 3, a treatment for vaginal yeast infection
  • Heartburn medications like Zantac 75 and Prilosec OTC
  • Rogaine for hair growth
  • The non-sedating antihistamine Claritin
  • Voltaren, a topical gel that may relieve arthritis related pain

How Do Drugs Change Status?

Drugs change from prescription to over the counter status via an “Rx to OTC switch.” This is done by two main mechanisms: a drug review, or the manufacturer submits an update to their original drug application.

In both cases, independent panels will review the information on the drug’s active ingredients and use. They seek to determine several key questions:

  • Can the patient, working without a doctor’s supervision, correctly self-diagnose the condition that the drug is designed to treat?
  • Can the patient determine an appropriate dosage and achieve the medical benefit without endangering their safety?
  • Does the potential benefit outweigh the potential for poisonous or dangerous side effects?

OTC drugs tend to be more affordable and widely available than their prescription counterparts. However, this customer convenience needs to be balanced against customer safety.

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