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

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