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.

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Food and Drug Administration

- Adverse Event Reporting

- Establishment Registrations and Drug Listings

- OTC Drug and Dietary Supplement Labeling

  • 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

Consumer Product Safety Commission

- Poison Prevention Packaging

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.