Over the counter drug registration in the US

An OTC drug or over-the-counter drug is a product that has generally been considered safe to use without a doctor’s prescription.

Many people in the United States need drugs to treat certain ailments and at times when the condition being treated doesn’t necessarily require a visit to the clinic or a thorough doctor’s analysis, then an OTC drug will come in handy.

The otc market has grown in recent tales with up to 300,000 products and annual sales of $32billion.

Just like how you can walk into a random convenience store and get your favorite cosmetic products to treat a skin concern, in a similar way you can get over-the-counter drugs to treat a certain ailment.

However, there is a fine line between products that are considered as over-the-counter drugs and those that are cosmetics products.

Although over-the-counter drugs aren’t as regulated as drugs that you’ll need a doctor’s prescription for, they still need pre-approval before hitting the market, unlike cosmetic drugs.

Difference between an over-the-counter drug and cosmetics

According to the Federal Food, Drug, and Cosmetic Act, cosmetic products are articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. 

Drugs are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or articles (other than food) intended to affect the structure or any function of the body of man or other animals [FD&C Act, sec. 201(g)(1)]. 

There are times when a cosmetic product has crossed the line that differentiates it from an over-the-counter drug. For example, an anti-dandruff shampoo not only cleanses the hair, but it’s used to treat dandruff or other scalp conditions.

Products that should be considered/registered as OTC drugs rather than cosmetics

As has already been established, an OTC or cosmetic product is classified based on its intended use. The intended use can be based on either claim stated on the product’s labeling or promotional packaging or the consumer’s perception of the product and its plausible benefits or the ingredients having a known therapeutic use.

If the product being used was purchased based on these aforementioned intentions and the product has been proven to alter the structure or function of the body, then it is to be registered as a drug.

How OTC drugs are registered

FDA’s review of over-the-counter drugs is primarily handled by the Center for Drug Evaluation’s Office of Nonprescription Drugs (ONPD). OTC drugs can be registered in either of two ways:

• OTC monograph process
• New drug application

In the case of the OTC monograph process, the active ingredients are generally recognized and considered as safe and effective after being reviewed by appropriate scientific personnel.

If the product complies with the restrictions outlined in Monographs 21 CFR 330 then it doesn’t need pre-approval from the FDA.

In the new drug application, the active ingredients are unknown or not recognized as generally safe and effective unlike in the case of drugs under the OTC monograph process. Therefore, these drugs require FDA approval and an extensive dossier including clinical trials to prove safety and efficacy before the marketing of said product can commence.