OTC Medicines

Select an Issue

Browse OTC Medicines Content

Dosing cup with purple liquid medicine
Background Summary: Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Oligohydramnios

FDA Announcement of a proposed safety-based Administrative Order to update the pregnancy warning labeling for NSAID-containing drug products.

blue and orange stacked shipping containers
Supply Chain in the States

CHPA supports a review of existing rules and coordination efforts to identify opportunities that could mitigate shortage risks during times of peak need.

Orange CHPA logo on dark blue background
Regulation
Family outside taking a selfie with Orange CHPA overlay
Guidelines for Unsolicited Consumer Sampling of Nonprescription Medicines

The purpose of these guidelines is to catalog and strengthen standards of care that have evolved in the practice of providing unsolicited free samples of OTC medicines to consumers to promote their products.

African American Woman and Colleagues in a corporate setting
Meetings and Education Calendar

Save the date for upcoming CHPA meetings and events!

two flasks and a beaker on a table in a lab
Ingredient Disclosure

Since existing federal laws already mandate comprehensive disclosure of all clinically relevant ingredients plus extensive post-market oversight, further state and local requirements layered on may afford minimal practical advantages.

Women Socializing at a Restaurant
Analysis of Reportability of Changes to NDA OTC Product Labeling

The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.

Same Sex Couple with Their Baby in the kitchen

FAQs

FAQs About HSA/FSA Accounts and the CARES Act
Smiling group of women
Regulation of OTC Medicines
Female Scientist wearing goggles
Guidelines for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA

Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.

Filter Results