The rules could make more medicines available over the counter through a process called Supplemental Non-Prescription Use Terms (ACNU).
CLEVELAND — The FDA has approved what could be a landmark new rule that will make more prescription drugs available over the counter through a process called . Additional Conditions for Non-Prescription Use (ACNU).
The new approach, approved just two weeks ago, allows consumers to buy certain medicines without a doctor’s prescription, but there are important pitfalls. Shoppers must first complete a self-testing process, usually through an app or website, to ensure the drug is safe to use.
“The ACNU label will be clearly displayed on eligible products to inform consumers that this additional safety step is required before purchasing,” he said. Teresa Michele, MD, FDA Director of Nonprescription Pharmacy.
The digital screening process serves as a safety checkpoint in place of a traditional doctor’s visit.
However, not everyone supports this new approach. of National Community Pharmacy Association has expressed concern and maintains that these drugs still require consultation with a pharmacist. on the other hand, Consumer Healthcare Products Association Manufacturers believe they need more flexibility in determining ACNU requirements when moving drugs to over-the-counter status without requiring prior FDA approval.
The rule goes into effect on January 27, but no drugs currently have the ACNU designation. Consumers can expect these products to hit store shelves in the coming months and years.
For many Americans, especially those in rural areas with limited access to health care, this could be a game-changer. The new rules aim to improve public health by making certain medicines more accessible while maintaining important safety protocols. This could benefit people in areas with limited access to doctors.
Dr. Michelle, a Northeast Ohio Medical University (NEOMED) alumnus, discussed these developments at the VITALS Health Leadership Speaker Series in collaboration with University Hospitals.
Click to watch her presentation here.
Medical professionals can earn free CME or continuing medical education credits by watching any of the 12 months of NEOMED VITALS recordings.
