Testing OTC Products
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:
- The highest standards for efficacy and safety
- Manufactured under GMP
- Continuing Stability Testing
- Labeling under 21 CFR 201.66
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:
- NSAIDs that don’t require a prescription
- Cold and cough medications, including decongestants, such as Pseudoephedrine — as well as nasal sprays, including Oxymetazoline
- Drugs that reduce pain and fever in both children and adults, such as Acetaminophen
- Antihistamines, such as Diphenhydramine
- Anti-diarrhea medicines, such as loperamide
- Creams, such as sunscreens and topical analgesics, as well as treatments for eczema or a yeast infection