Drugs: Nonprescription (OTC)
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.
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Your Industry Obligations
OTC medication registrants must also consider the following compliance obligations: