OTC Medicines

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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.

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Meetings and Education Calendar

Save the date for upcoming CHPA meetings and events!

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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.

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Dispensing Authority

Given pharmacists' drug knowledge and public accessibility, states are exploring expanding their scope of practice permanently after the pandemic emergency measures expire. Empowering pharmacists to dispense products like oral contraceptives, and other consumer healthcare products could improve access and outcomes.

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OTC Medications in the States
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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.

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Insurance Coverage

Providing coverage for clinically-validated, over-the-counter products capable of preventing complications or replacing higher cost prescriptions through flexible spending arrangements aligns with value-based models working to improve access and outcomes across populations.

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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.

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FAQs

FAQs About HSA/FSA Accounts and the CARES Act
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Labeling OTC Medications in the States

Having individual states impose distinct labeling rules would create confusion around critical health details printed on packaging.

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