OTC Medicines

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Ingredients & Dosages Transferred from Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975.

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

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.

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.

Under a voluntary program which began in November 2007, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines.

FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.

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

CHPA strives to continually reinforce, define, and quantify the value of consumer healthcare products for consumers and the healthcare system. These CHPA research initiatives and products highlight the meaningful ways that consumer healthcare products provide consumers access to trusted, affordable, empowering self-care options.

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