English | Español

Over-the-Counter Drugs FDA Compliance

Get Help Registering Over the Counter Drugs with the FDA

Ms. Capote is an experience FDA lawyer helping clients with all matters related to registering their Over-the-Counter Drugs with the FDA including compliance matters

The United States Food and Drug Administration (FDA) monitors pharmaceuticals distributed within the U.S. market. Medication and drug distributions in the United States rely on a two-tier system based on whether the medication is prescribed or not prescribed. Both types are required to get pre-approval by the FDA or meet the qualifications for an FDA-approved over the counter medication. These over the counter drugs are determined to be both appropriate and safe for use without direct health provider supervision. These drugs are available for consumer purchase without a qualified prescription from a medical provider.

Over-the-Counter Drugs FDA registration and complianceTo get the approval necessary for an over the counter drug, there are two steps in the FDA process. A drug company is responsible for submitting a new drug application for OTC (also referred to as an NDA) or they can request an OTC drug monograph. The latter of the two is used more often. The reason for this is that drugs approved using the drug monograph typically are more quickly marketed as long as the company marketing the product has complied with FDA rules regarding labeling and active ingredients.

Capote Law Firm FDA compliance attorneys advise and represent drug companies on the requirements of marketing OTC drugs in the United States. Our dedicated FDA lawyers work with drug manufacturers, distributors, importers and exporters in the U.S. and internationally with FDA requirements, including:

  • FDA OTC drug monograph requirements;
  • FDA rules on OTC drug labeling and OTC drug ingredient lists;
  • FDA OTC DUNS numbers;
  • FDA OTC registration;
  • FDA advertising and marketing regulations;
  • OTC drug advertising and marketing compliance verification in line with FDA and FTC guidelines;
  • OTC drug safety compliance issues;
  • OTC product recalls;
  • Corrective action plans and FDA inspections;
  • Represent OTC drug companies against the National Advertising Division of the Council of Better Business Bureaus (NAD) and the FTC;
  • Export and import compliance.

Our experienced FDA attorneys are ready to help you launch a new OTC drug, introduce a current OTC drug to the U.S. market, and even manage the export of OTC drugs to other countries.

Fill in the form below to contact us: