OTC Drug Compliance – FDA

The distribution of drug in the United States is based on a two-class system: prescription and nonprescription drugs.  Prescription and nonprescription drugs must either receive premarket approval by FDA (NDA) or conform to the specification of an OTC monograph regulation. Our FDA compliance attorneys counsel drug companies on the requirements for marketing OTC drugs in the U.S.

Nonprescription drug products, known as over-the counter (OTC) drugs are drugs that have been found to be “safe and appropriate for use without the supervision of a health care professional such as a physician, and can be purchased by consumers without a prescription.”   The FDA has established two regulatory pathways for OTC drugs: the OTC new drug application (NDA) process  and the more often utilized OTC drug monograph.  OTC monographs represent regulatory standards for the marketing of non-prescription drug products not covered by new drug applications.  Drugs that comply with an existing OTC monograph may be marketed without FDA pre-market approval, provided the drug product complies with the specification of the OTC monograph including the active ingredients, labeling, and other general requirements.

The FDA compliance attorneys at Gaitan Law Group possess a wealth of experience and knowledge of drug regulation, particularly the development and marketing of OTC drug products.  Our lawyers understand the complex regulatory framework affecting OTC drugs and how it differs from homeopathic drugs, medical foods, dietary supplements, and cosmetic products.

Working with drug manufacturers, distributors, importers and exporters from across the globe, our attorneys assist drug firms with FDA’s requirements, including:

  • FDA OTC drug monograph requirements including labeling and ingredient specifications
  • FDA OTC drug establishment registration and obtaining DUNS number
  • FDA OTC drug listing submissions
  • U.S. Agent services
  • OTC drug advertising and marketing compliance in accordance with FDA and FTC requirements
  • Advise on OTC drug safety compliance issues, including product recalls, Warning Letter responses, FDA inspections and Corrective Action Plans, and Import Alert petitions
  • Counsel on FTC advertising and marketing requirements, as well as representation before the FTC and National Advertising Division of the Council of Better Business Bureaus (NAD)
  • Respond to FDA Notice of Action, counsel on appropriate reconditioning options when submitting FDA Form 766 and negotiate releases of FDA detained goods
  • Import and Export compliance

Whether you are seeking the insight of an experienced FDA attorney to help you launch a new drug product, introduce an existing drug product to the U.S. market, export OTC drugs to foreign countries, or otherwise, our attorneys have the specialized perspective you need to ensure the compliance with all applicable rules and regulations.

To speak with an established FDA attorney, e-mail Gaitan Law Group at [email protected] or call us at 786.440.8115. We offer flexible fee arrangements.

If you are establishing a drug manufacturing, repackaging, and/or distribution company in the State of Florida, our attorney can assist you with DBPR’s permitting requirements.

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