OTC Compliance, LLC provides regulatory and quality consulting services to pharmaceutical companies involved in the manufacture, sale and distribution of OTC drug products and dietary supplements.  The company offers over 20 years of industry experience plus a thorough knowledge of federal laws and regulations.

2019CHPA_memberlogo_COLOR (002).jpg


Food and Drug Administration

- Adverse Event Reporting

- Enforcement Policy

- Establishment Registrations and Drug Listings

- Good Manufacturing Practice

- OTC Drug and Dietary Supplement Labeling

  • General Labeling Provisions

  • Drug Facts / Supplement Facts Format and Content

  • OTC Drug Monographs (both Tentative and Final)

  • Dietary Supplement Specific Nutrition Labeling Requirements and Guidelines

  • Nutrient Content Claims and Health Claims

  • Allergen Labeling (Food Allergen Labeling and Consumer Protection Act)

Consumer Product Safety Commission

- Poison Prevention Packaging

- Consumer Product Safety Improvement Act

Federal Trade Commission

- Advertising and Promotion


Not a blank canvas.

The constantly changing Federal regulatory environment necessitates expert guidance for any company with OTC products.