FDA Regulations of OTC Products

What is an OTC Drug?

In addition to my previous explanation on foods, the FDA regulates drugs, medical devices, electronic products, cosmetics, veterinary products and tobacco products. FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter (OTC) and prescription drugs, including generic drugs. OTC drugs are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician, and they can be purchased by consumers without a prescription. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered OTC drugs.

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Approval of OTC Drugs

OTC drugs are sometimes approved under applications like new prescription drugs, but more often they are legally marketed without an application by following a regulation called an OTC drug monograph. An OTC drug monograph tells what kind of ingredients may be used to treat certain diseases or conditions without a prescription, and the appropriate dose and instructions for use. OTC products that meet a monograph’s requirements may be marketed without FDA review. OTC products that do not fit under an existing monograph must be approved under an application like the applications for prescription drugs.

OTC Requirements

Any firm involved in any aspect of the manufacturing, packaging, and/or labeling of an OTC product must register with the FDA. In addition to registration, all OTC firms must formally list all of their drug products in commercial distribution in the United States with the FDA. It is important to note that registration of a drug establishment with the FDA and submission of a listing with the FDA does not in any way indicate approval of the firm or its product by the FDA. Any reference that infers such approval may constitute mis-branding, as false and misleading information.

The FDA requires that all OTC establishments adhere to Good Manufacturing Practices and follow labeling requirements as specified in 21 CFR Part 201. In addition to the information that must appear on the label or immediate container, the Drug Facts Rule published by the FDA in 1999 standardized the format and content requirements for the labeling of all OTC products. Drug Facts labeling requires, among other things, a description of the active ingredients and their purpose, the products’ uses, warnings, directions, other information, and inactive ingredients.


FDA requirements for all OTC products include drug establishment registration, drug product listing and adherence to GMP regulations. OTC products are also subject to labeling requirements on all written, printed or graphic matters including packaging, product inserts, web sites and other promotional materials.

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