A Bill Template to Make Nebulized Budesonide and Nebulizer Machines Over-the-Counter

This bill template is designed for legislators at the local, state, or federal level to use in drafting legislation that authorizes the over-the-counter (OTC) sale of nebulized budesonide and nebulizer machines. By expanding public access to this well-documented and effective respiratory treatment, such legislation would help ensure timely and affordable care for individuals in need. Budesonide, a corticosteroid with a strong safety profile, has demonstrated significant efficacy in mitigating severe respiratory symptoms, including those associated with COVID-19, as evidenced by multiple clinical trials such as the Oxford STOIC and PRINCIPLE trials.

Key provisions of the bill include:

• The removal of prescription requirements for nebulized budesonide (respules) and nebulizer machines, enabling direct consumer access.
• Regulatory adjustments to align with existing OTC availability of budesonide in nasal spray form.
• Statutory protections for pharmacists, retailers, and manufacturers against liability when acting in compliance with the law.
• State Board of Pharmacy oversight to ensure proper labeling and consumer education on usage.

The bill is supported by extensive clinical data, including research published in The Lancet Respiratory Medicine, Annals of Internal Medicine, and Science, all of which highlight the benefits of inhaled budesonide in reducing hospitalization, improving recovery times, and mitigating cytokine-driven respiratory distress. Furthermore, international health agencies, including the World Health Organization (WHO) and the U.K. Department of Health, recognize budesonide as an essential medicine for respiratory conditions.

Given the strong safety profile of nebulized budesonide, its efficacy in treating acute respiratory distress, and the demonstrated public health benefits during the COVID-19 pandemic, this bill aims to eliminate unnecessary barriers to access. By allowing OTC sales of nebulized budesonide and nebulizer machines, this legislation prioritizes patient autonomy, ensures timely treatment availability, and supports a proactive approach to respiratory health management.

For full details, references, and supporting clinical studies, please refer to the complete bill text.