Over-the-counter (OTC) drugs play a vital role in the U.S. healthcare market, allowing consumers to access safe and effective treatments without a prescription. To ensure public safety, the U.S. Food and Drug Administration (FDA) regulates OTC products under the OTC Drug Monograph system. Compliance with these monographs is mandatory for manufacturers, packers, relabelers, and distributors of OTC medicines.

An OTC Drug Monograph specifies the active ingredients, dosage forms, labeling requirements, and testing standards for categories of OTC drugs such as cough and cold remedies, pain relievers, antacids, sunscreens, and anti-dandruff shampoos. Products that meet the monograph requirements can be legally marketed in the U.S. without submitting a New Drug Application (NDA). However, failure to comply with the detailed monograph regulations may result in misbranding or adulteration issues, leading to FDA enforcement actions.

Key areas of compliance include:

• Formulation checks to ensure only permitted active ingredients and concentrations are used.
• Labeling reviews in line with FDA requirements, including drug facts panels, directions, and warnings.
• Claims assessment to avoid crossing into prescription-only or unapproved drug territory.
• Good Manufacturing Practices (GMP) compliance under 21 CFR Part 210/211.

At XPRO America, we provide specialized support to help pharmaceutical companies, contract manufacturers, and distributors achieve OTC drug monograph compliance with confidence. Our services include:

• Comprehensive formulation and ingredient reviews
• Labeling compliance checks for FDA-approved Drug Facts formatting
• Guidance on transitioning to the new OTC Monograph Reform system under the CARES Act
• Regulatory strategy for products that fall outside an existing monograph (requiring NDA or alternative pathways)
• Ongoing compliance monitoring to keep pace with FDA updates

By working with XPRO America, companies can reduce regulatory risks, accelerate market access, and maintain FDA compliance for their OTC products. Whether you are marketing cough syrups, pain relievers, sunscreens, or other self-care medications, our expert team ensures your products meet the highest standards of safety, efficacy, and regulatory approval.

XPRO America helps companies achieve FDA OTC Drug Monograph compliance with formulation checks, labeling reviews, and regulatory guidance for safe U.S. market entry.