OTC Medicines

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Lawmakers should refrain from imposing unnecessary restrictions limiting consumer purchase quantities or behind-the-counter placement for loperamide, as leading manufacturers have already implemented package adjustments to limit potential abuse of these medications by consumers.

CHPA is instrumental in shaping the policy and regulatory environment in the OTC medicine, dietary supplement, and OTC medical device industries.

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.

CHPA opposes state and local government attempts to restrict the use of FDA-approved color additives as doing so is vital for maintaining a cohesive regulatory framework.

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

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.

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.

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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