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:
Corporate Headquarters and Labs
70 New Dutch Ln
Fairfield, NJ 07004
973-576-5957
Satellite Clinical Lab Location
304 Wootton St.
Boonton, NJ 07005
FDA
Registration# 1000151293
CPT℠ is registered with FDA (FEI # 1000151293) as a Drug Establishment (GMP/GLP/GCP) and a Cosmetic Facility.
DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
Registration# RC0171568 (Researcher)
US EPA/NJ DEP
Registration# NJD982726648