OTC (over-the-counter) medicines are safe and effective drugs used by the general public without prior recourse to a healthcare professional.
Similarly, cosmetic products can be considered as OTCs. Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic. Likewise, certain active ingredients can cause a product to be considered a drug owing to their therapeutic use.
OTC products compliant with the OTC drug monograph may be marketed without prior FDA approval.
For example, in the U.S., antidandruff shampoos and sunscreen products (link to sunscreen products) are considered to be OTCs.
OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption.
Mérieux NutriSciences can help with cGMP compliance in relation to the following:
- Method development and validation
- Quality control
- Stability testing
For more in-depth information on the analytic services that Mérieux NutriSciences can provide for OTC drugs and cosmetics, please refer to the Pharmaceuticals section (link to Pharmaceuticals).