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SafetyCall International, LLC
3600 American Boulevard W, Suite 725
Bloomington, MN 55431
sales@safetycall.com Privacy Policy

Over-the-Counter (OTC) Medications are sold directly to consumers without the need for a prescription from a healthcare professional.

Regulatory Agencies and Applicable Federal Laws
Food and Drug Administration (FDA)
Health Canada-Marketed Health Products Directorate (MHPD)
Drugs: Nonprescription (OTC)
  • Highlights – Rules & Regulations
  • Your Industry Obligations
Highlights – Rules & Regulations

Several important regulations applicable to the Over-the-Counter Medication Industry are highlighted below:

  • Dietary Supplement and Nonprescription Drug Consumer Protection Act
  • Food and Drug Act
  • Section 3 – Adverse events meeting the FDA-defined criteria for serious must be reported to the FDA within 15 days using FDA Form 3500A and its accompanying data elements.
  • Causalityis not a prerequisite for tracking and reporting adverse events involving OTC drugs sold in the USA.
Your Industry Obligations

Over-the-counter medication registrants must also consider the following compliance obligations:

  • Dietary Supplement and Nonprescription Drug Consumer Protection Act
  • Food and Drug Act