Drugs: Nonprescription (OTC)

Our status as a licensed health care practice works to the benefit of product manufacturers in helping to demonstrate effective product stewardship.

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

The health care professionals at SafetyCall have over thirty years of experience responding to issues related to OTC medications. All adverse events are reported, documented and stored in SafetyNotes, our proprietary case management software application. Clients have access to their incident data 24/7 utilizing SafetySearch, a secured password protected web-based search engine.

Regulatory Agencies Applicable Federal Laws
Food and Drug Administration (FDA) PLAW-109publ462.pdf
Health Canada-Marketed Health Products Directorate (MHPD) Food and Drug Act

Highlights – Rules & Regulations

Several important regulations applicable to the OTC 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.
  • Causality is not a prerequisite for tracking and reporting adverse events involving OTC drugs sold in the USA.

Click for more details on Regulatory Compliance services available from SafetyCall.

Your Industry Obligations

OTC medication registrants must also consider the following compliance obligations: