An over-the-counter (OTC) can be purchased without a prescription. These drugs must meet certain criteria to be sold.
Intent:
(1) easier access to drugs
(2) cheaper access to drugs
Key criteria:
(1) generally recognized as safe and effective
(2) relatively safe if taken according to the instructions
(3) low potential for misuse
Requirements:
(1) meet regulatory approval (either meet the requirements outlined in an OTC monograph or have been been submitted to the FDA)
(2) all ingredients listed
(3) properly labeled
Just because a drug is over-the-counter does not mean:
(1) that the drug is safe if taken in a manner inconsistent with instructions
(2) that the drug is not potentially addictive
(3) that the drug will not interact with other medications
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Specialty: Pharmacology, clinical
