Prescription versus Over-the-Counter Drugs - Pharmacology

The 1952 Durham-Humphrey Amendment to the Food, Drug and Cosmetic Act requires that certain classifications of drugs be accessible only by prescription from a licensed practitioner. These are commonly referred to as prescription drugs or legend drugs because the drug label must display the legend “Caution: Federal law prohibits dispensing without prescription” on the label of the drug.

Drugs that fall under this classification are:

  • Those given by injection.
  • Hypnotic drugs (drugs that depress the nervous system).
  • Narcotics (drugs that relieve pain, dull the senses and induce sleep).
  • Habit-forming drugs.
  • Drugs that are unsafe unless administered under the supervision of a licensed practitioner.
  • New drugs that are still being investigated and not considered safe for indiscriminate use by the public.

Non-prescription drugs are called over-the-counter (OTC) drugs and are available to the public without prescription. Some over-the-counter drugs were at one time available by prescription, but later were considered safe for use by the public or reformulated for over-the-counter use. Some drugs can be sold in lower doses over-the-counter (OTC) while higher doses of the same drug require a prescription as per FDA requirements.


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