Summary — SB 2388 (North Dakota): Over‑the‑Counter Availability of Ivermectin
Status
- Bill number: SB 2388
- Subject: Adds a new section to chapter 19‑02.1, North Dakota Century Code, to allow over‑the‑counter (OTC) sales of ivermectin for human use
- Introduced: March 12, 2025
- Legislative outcome: Failed on second reading (yeas 3, nays 43)
Purpose and intent
- The bill’s stated purpose is to make ivermectin — a medication used to treat certain parasitic infections — available for purchase without a prescription in North Dakota. The change is framed as expanding access by reclassifying ivermectin suitable for human use as an over‑the‑counter drug in state law.
Key provisions
- Creates a new statutory section titled (in the draft) “Ivermectin access.”
- Definitions included in the draft:
- "Ivermectin" — defined as a medication to treat parasitic infections approved by the federal Food and Drug Administration (FDA).
- "Over‑the‑counter" — defined as a medication legally sold and purchased without a prescription.
- Main operative clause (verbatim in the draft): “Notwithstanding any other provision of law, ivermectin suitable for human use may be sold and purchased as an over‑the‑counter medication in this state.”
- The draft contains no additional statutory conditions, age limits, labeling requirements, dosage restrictions, pharmacist counseling requirements, or public‑health safeguards.
Who would be affected
- Consumers: Individuals would be able to buy human‑use ivermectin products without a prescription.
- Pharmacies and retailers: Would be able to sell human ivermectin OTC; sellers would need to decide stocking, labeling and point‑of‑sale practices.
- Healthcare providers and public health agencies: Could see changes in patient behavior, prescriptions, and possible adverse‑event reporting; potential increased demand for clinical guidance.
- Regulatory landscape: State law would permit OTC sales, but actual product availability could be constrained by federal regulatory status and manufacturers’ decisions.
Potential impacts and considerations
- Safety and misuse: The draft does not include safeguards (dosage, age restrictions, warnings), raising concerns about dosing errors, self‑treatment for inappropriate indications, drug interactions, and use of veterinary formulations.
- Regulatory conflict: The bill changes state law but cannot directly change FDA drug classifications; manufacturers and distributors may still be bound by federal requirements and labeling. Practical implementation could depend on manufacturers’ willingness to market OTC human formulations.
- Liability and oversight: The bill does not address liability protections for sellers or responsibilities for pharmacist counseling or adverse‑event monitoring.
- No effective date is specified in the provided draft; the bill failed on second reading and did not advance.
Notes
- The provided materials included other legislative text (from other jurisdictions) mixed into the record; this summary isolates the North Dakota SB 2388 language concerning OTC ivermectin and its legislative status as provided.