What is the proposed ACNU rule?
This rule would create and establish regulations for drugs that fall between prescription and over-the-counter (OTC), nonprescription drug products that have an Additional Condition for Nonprescription Use (ACNU). ACNUs are one or more FDA-approved conditions that an applicant must implement to ensure the appropriate self-selection or appropriate actual use (or both) of the nonprescription drug product without the supervision of a healthcare practitioner. To acquire these medications, patients may need to complete a questionnaire or view a video and pass a quiz to ensure their understanding. In addition to meeting the application requirements, applicants must demonstrate that labeling alone is insufficient to be classified as an OTC medication. Existing prescription medications may obtain classification as a nonprescription with ANCU if they are able to demonstrate a meaningful difference between the two products.
This rule may help to address the limited number of indications currently available for OTC medications. Not only are there few disease states covered, but they are also self-diagnosable and self-limiting conditions rather than chronic conditions. This rule would allow for increased access to medications for those who do not have medical insurance and cannot afford to visit a physician, those living in healthcare deserts, and/or those with limited transportation options. Having medication for emergencies and chronic conditions be more readily available could allow for better compliance and improved patient outcomes.
When would this rule come into effect?
If this drafted rule becomes final, the suggested effective date is 60 days after the date that the final rule is published in the Federal Register.
What medications could possibly be covered in this rule?
Although this rule has yet to be finalized, many speculate that nonprescription with ANCU birth control pills could become the first nonprescription drug with ACNU. The FDA approved the first over-the-counter birth control pill in July 2023. Opill is a progesterone only hormonal birth control tablet. Currently, there are no combined hormonal OTC contraceptive options due to the clotting risks associated with estrogen. The risk of clotting is significantly higher in certain populations, such as smokers aged 35 years and up and those with previous major adverse cardiovascular events. The new ACNU rule could allow for proper screening and warnings to ensure safe estrogen use without being under the direct supervision of a physician.
Other medications that may become nonprescription with ACNU include drugs needed to treat emergencies such as anaphylaxis, opioid overdose, and hypoglycemia. Medications like EpiPens, nalmefene auto-injector Zurnai for opioid overdose reversal, glucagon auto-injector Gvoke, and the glucagon nasal spray Baqsimi are medications with potential to become nonprescription with ACNU. Teaching patients and caretakers about the signs and symptoms of life-threatening emergencies like anaphylaxis, opioid overdose, and hypoglycemia can give them the power to use these medications when needed. A short training video for these medications could provide enough information for proper use and administration.
Albuterol rescue inhalers for asthma patients are another medication that could be classified as nonprescription with ACNUs. Both Cardiovascular (CV) and Central Nervous System (CNS) adverse effects are dose related; an informational video could cover proper dosing frequency and administration. The video must also include information about paradoxical bronchospasm and what to do if this reaction occurs. Patients would also have to be screened for previous CV disease or predisposition to CV dysfunction. One issue with this is that patients may incorrectly self-diagnose themselves with asthma, subsequently misusing the medication. However, the overall safety and applicability of this medication could make it a candidate for classification as nonprescription with ACNUs.
While there is mention of chronic medications potentially becoming nonprescription with ACNUs in the FDAs proposed rule, there are currently no promising candidates for oral medications. Most chronic conditions must be monitored for dose adjustments and safety monitoring, meaning that they are not ideal candidates for ACNUs. It is the FDA’s hope that the need for chronic nonprescription drugs will be fulfilled, but there are no current oral candidates suggested at this time.
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