An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions.
OTC drugs are designed, labeled, and approved by various regulatory agencies around the world for use without medical supervision.
OTC drugs generally have the following characteristics:
- their benefits outweigh their risks
- the potential for misuse and abuse is low
- the consumer can use them for self-diagnosed conditions
- has adequate labeling approved by a regulatory agency
Medical supervision is not needed for the safe and effective use of the product. FDA’s review of OTC drugs is primarily handled by the Center for Drug Evaluation and Research (CDER)’s Office of Nonprescription Drugs. CDER oversees the development, review, and regulation of non prescription products.
OTC drugs are developed under either the OTC Monograph process or New Drug Application (NDA) process.
FDA requirements for OTC drugs vary for OTC monograph products and new OTC drugs.
Drugs with active ingredients published in the OTC final monograph can be marketed without prior approval from FDA.
However, if you plan to market OTC drugs with active ingredients that are not part of the OTC monograph, you should obtain FDA approval through the new drug approval process.
The list of OTC monograph ingredients and FDA regulation for OTC drugs can be found in the 21 CFR Part 330.
FDA Requirements For OTC Drugs
- Ingredients, concentration, and purpose should be in accordance with the OTC monograph.
- The content and format of the labeling should be in accordance with FDA OTC drug labeling requirements.
- Manufacturing facilities involved in manufacturing, packing, and processing the drug must be registered with the FDA.
- Drug listing is a mandatory requirement for all the drug products marketed in the USA.
- Manufacturing of the product should be in accordance with Good Manufacturing Practice as defined in the 21 CFR 210 and 211.
- Foreign facilities must appoint US Agent for FDA communication purposes.
OTCsunscreenproducts must meet the additional requirements as per the FDA guidance for OTC sunscreen products marketed without FDA approval.
OTC drug manufacturers must also renew their drug establishment registration between 1st October to 31st December. Also, the NDC drug listing should be updated every year.
Resource Person: BARBARA PIROLA