Adverse Event Contact
for OTC Drugs
U.S. FDA requires labels of most Over the Counter (OTC) drugs to include the contact information for an entity in the USA capable of receiving and documenting consumer reports of serious adverse events. Products that don’t meet this requirement are considered “misbranded” by FDA and subject to detention and refusal.
Serious Adverse Event Reporting Requirements for
OTC Drugs
The Dietary Supplement and Non-Prescription Drug Consumer Protection Act includes the following requirements for serious Adverse Event reporting for most OTC Drug Products:
- Reports must include a copy of the label on or within the retail package
- The responsible person must submit the report no later than 15 business days after receiving the initial report
- Serious adverse event reports must be submitted via the MedWatch form. Reports can be submitted on paper or electronically (Form FDA 3500A or the FDA Safety Reporting Portal, respectively)
Adverse Event Contact for OTC Drugs
FDA requires OTC drug labels to include a United States address or phone number to receive consumer reports of serious adverse events. Registrar Corp can serve as your adverse event contact.
Registrar Corp Can Help
As your U.S. Contact for adverse event reports, we’ll:
- Authorize use of our contact information on your OTC drug label for adverse event purposes
- Receive reports of serious adverse events related to your products
- Quickly forward reports to your business
To speak with a Regulatory Specialist, simply complete the form to get started.
