Just because over-the-counter drugs can be used without the supervision of a physician does not mean they do not require in-depth OTC product testing. If a product meets the requirements of an OTC drug monograph, it can technically be marketed without FDA review. However, this marketing does not mean that OTC product testing isn’t a requirement.
The requirements for all OTC drug products include:
When developing over-the-counter products, whether it be a remedy for acne or a wound-healing cream, extensive OTC product testing is not just recommended, it’s required. At CPT℠, we have extensive experience regarding all FDA and EPA guidelines and we help our clients develop products that adhere to these safety and industry standards.
Some examples of OTC products include:
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