Description
This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. In particular, this document gives guidance on (1) the minimum data elements that should be included in a serious adverse event report, (2) the label that should be included with the report, (3) reporting formats for paper and electronic submissions, and (4) how and where to submit the reports.
Scope & Applicability
Product Classes
5Products marketed without an approved application subject to the Act
Guidance provides a framework for over-the-counter drug products.
Nonprescription human drug products marketed without an approved application.
A dietary supplement is deemed to be food under section 201(ff)
OTC drugs marketed without an approved application
Stakeholders
3Entity required to submit serious adverse event reports; The manufacturer, packer, or distributor whose name appears on the label; The individual or entity required to submit and maintain records of serious adverse events.
The identification of the reporter (primary source) could be prohibited by certain national or regional confidentiality requirements.; Primary source of the case report; Primary source providing causality assessment; Source of words or short phrases in narrative; The primary source of the information who initially reports the facts in the ICSR
available on the Internet at http://www.fda.gov/medwatch/getforms.htm
Regulatory Context
Attributes
2Required information for an ICSR
Timeframe for submitting reports to FDA
Related CFR Sections (4)
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.98§ 314.98 Postmarketing reports.
(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.Read full regulation →
- 21CFR310.305§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
(a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiencRead full regulation →
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
Related Warning Letters (10)
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-05-13
Compounding Pharmacy/Adulterated Drug Products
Tailstorm Health Inc. dba Medivant Health
- 2025-03-25
Compounding Pharmacy/Adulterated Drug Products
Annovex Pharma, Inc.
- 2025-03-04
Compounding Pharmacy/Adulterated Drug Products
ProRx, LLC
- 2024-10-22
Compounding Pharmacy/Adulterated Drug Products
Stokes Healthcare Inc. dba Epicur Pharma
- 2023-08-08
Compounding Pharmacy/Adulterated Drug Products
US Specialty Formulations, LLC
- 2022-01-18
Compounding Pharmacy/Adulterated Drug Products
Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
- 2021-10-26
Compounding Pharmacy/Adulterated Drug Products
Empower Clinic Services, LLC dba Empower Pharmacy
- 2021-08-31
Compounding Pharmacy/Adulterated Drug Products
AnazaoHealth Corporation
- 2021-08-03
Compounding Pharmacy/Adulterated Drug Products
Farmakeio Outsourcing LLC
See Also (8)
- Accelerated Approval – Expedited Program for Serious Conditions (Status: Draft)
- CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action (Status: Final)
- Review of FDA's Implementation of the Drug Export Amendments of 1986 (Status: Final)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Status: Final)
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Status: Final)
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry (Status: Draft)
- Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory: Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities (Status: Final)
- E2BM Data Elements for Transmission Of Individual Case Safety Reports (Status: Final)