Over-The-Counter Drugs Regulatory Consulting

Over-The-Counter (OTC) Drugs come with their own unique set of requirements, and dicentra’s expertise is by no means confined to dietary supplements, cosmetics and foods. We also assist companies in obtaining licenses to sell their OTC drug products. There are over 300,000 OTC drug products marketed in the United States, due to this large number the FDA conducts a regulatory review based on the active pharmaceutical ingredient and labeling by therapeutic class (e.g. antacids), rather than by assessing individual drug formulations. For each category, an OTC drug monograph is developed and published in the Federal Register under 21 CFR parts 331-358.

There are two regulatory pathways for an OTC drug:

1. OTC New Drug Application (NDA)
2. OTC Drug Monograph

Our services in Over-The-Counter (OTC) Drugs Regulatory Consulting include:

• Drug classification (monograph vs new drug; prescription vs non-prescription)
• Determine whether your product meets Generally Recognized As Safe and Effective (GRASE) conditions
• Conduct Label comprehension studies
• Actual use studies
• Prepare Drug Facts Panel
• Prepare 505(b)(1), 505(b)(2), ANDA or OTC drug monograph applications
• Prescription to OTC switch applications (NDA application)
• Abbreviated New Drug Applications (ANDA) for generic OTCs
• Preparation of compliant draft labels
• Preparation of Citizen Petition or Time and Extent Application (TEA) to amend OTC Drug Monographs
• Prepare professional labeling
• Adverse event reporting (link: See also Adverse event reporting)

Companies producing OTCs are also required to ensure that their product meets the standards for safety and efficacy, is compliant with GMPs and meets the labeling requirements as set out in 21 CFR part 201.66. Let dicentra ensure your OTC application is completed accurately and efficiently.