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Over-The-Counter Medicines (OTC Medicines)

Drugs that are available without a prescription


Over-the-counter medicines (OTC medicines) are sold without a prescription. They are sold from pharmacies but also many more locations than prescription drugs—from supermarkets to convenience stores and airports.

Examples of over-the-counter drugs are painkillers such as ibuprofen (brand: Advil) and acetaminophen (brand: Tylenol), decongestants, anti-fungal creams, laxatives, acne creams and sunscreens.

Contrary to their name, OTC medicines in the U.S. are not purchased over a counter, but are instead available on the customer side of the pharmacy counter, available on shelves.

These drugs are regulated by their active ingredients—or active pharmaceutical ingredients—which are the biologically active contents of the drug that make it effective in curing patients’ ills. These active ingredients are typically listed on medication packaging.

The inactive ingredients are the delivery method of the drug—the tablet, gel cap or liquid that is used to dose the medicine.

The Food and Drug Administration (FDA) oversees the OTC industry, both from a manufacturing and a sale standpoint.

It is required that all new OTC drugs obtain an NDA (New Drug Application) before being marketed and sold. The FDA reviews all NDAs to ensure that:

• The drug is safe and efficacious and helps cure the problem for which a patient would take it, if taken as directed

• The benefits of taking the drug outweigh the dangers of taking it

• The drug’s packaging/package insert contains appropriate information

However, some older drugs are exempt from having to obtain an NDA, because they’re generally recognized as safe and effective (GRASE, GRAS/E or GRAS/GRAE). These drugs have been on the market for many years and the “safe and effective” rating is, of course, dependent on a user taking the drug as directed. Even aspirin, for example, is not safe if consumed to excess.

And some new drugs can avoid applying for an NDA if they comply with one of the FDA’s monographs, or rules, for an OTC drug.

Thee monographs state the requirements for OTC drug categories including which ingredients can be used and their intended use. Acne medications, psoriasis treatments and sunscreens are just some of the OTC products covered by monographs.

The Federal Trade Commission regulates OTC advertising. The FDA, meanwhile, regulates the prescription drug industry.

All OTC products must be labeled with a Drug Facts panel so patients can understand their medications. These must comply with a generic format so they are easy to comprehend. The labels must provide information on active ingredients, indications (i.e.: what the drug does), safety warnings, directions for use and inactive ingredients.

Occasionally prescription products become over-the-counter drugs. The most recent example of this is allergy medication Allegra (fexofenadine) from Sanofi-Aventis. A large media campaign ran in pharmacies and drug stores with eye-catching point of sale merchandising.

Drugs make the switch to OTC typically once they’ve proven themselves safe and efficacious. Another drug that made the switch was Benadryl (diphenhydramine).

Some OTC products really are sold over-the-counter. They are technically classified as OTC products, but are only sold from a pharmacy that’s overseen by a pharmacist.

Examples are:

• Pseudoephedrine, a decongestant, with brand names such as Sudafed and Cenafred. These products are now kept behind the pharmacy counter in an attempt to prevent them being used to produce the street drug methamphetamine.

• Emergency contraception, such as Plan B, which is a legal over-the-counter product for women aged 17 and older but is a prescription drug for younger girls. Providing these products over the counter allows pharmacist to provide counseling and education.

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