OTC Product Testing

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

Our Capabilities

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

Get In Touch

Our facilities will be closed on Monday, May 30th in observance of Memorial Day.

Due to the forecast calling for snow and out of an abundance of caution we will be having a delayed opening tomorrow. Our facilities will now be opening at 10 AM on January 7th, 2022.