Ephedrine Products Become OTC in Nebraska

LINCOLN, Neb.--Manufacturers and distributors can now legally sell ephedrine products in Nebraska. On April 17, Mike Johanns, the governor of Nebraska, approved a bill that lifted the state ban on the sale of ephedrine, pseudoephedrine and phenylpropanolamine (PPA) products. In 1996, Nebraska passed a law that made ephedrine-based products prescription-only rather than over-the-counter (OTC). However, this was not due to the potential health problems that have been linked to ephedrine and PPA in various medical journals; rather, it was to keep Nebraskans from making methamphetamine.

Phil Weitl, deputy press secretary for the governor's office, stated that this law basically lifted the ban on ephedrine products while establishing state regulatory practices. "And yes, it does lift the hard and fast ban on ephedrine," he said. Ma huang and ephedra products were not specifically listed in the bill, but may be subject to the "interpretation of the law" when this law takes effect, Weitl stated.

Now that Bill 113 has been signed by the governor (and will more likely than not be approved by the state legislature), products containing ephedrine will have certain guidelines to follow in order to not be viewed as a controlled substance. These guidelines will pertain to labeling, marketing, dosage and quality assurance of ephedrine products. Bill 113 states that labels should carry the total milligrams of ephedrine per product, with a dose limitation set at 25 mg or less; the recommended maximum dosage, which is set at 100 mg for an adult within a 24-hour period; and the adverse events associated with taking ephedrine products. It also states that it is a crime to knowingly distribute the product as a "precursor" to methamphetamine.

As part of the new law, all manufacturers or wholesale distributors of products containing ephedrine must register with the Department of Health and pay a yearly fee of $1,000. Those who do not register are subject to a $5,000 fine and seizure of all products.

In order to regulate these guidelines, the yearly fees will be used to pay for the Ephedra Registration Fund, which is anticipated to bring in $50,000 per year. Monies raised from grants, contracts and donations will create the Methamphetamine Awareness and Education Fund, which will be used by the Nebraska Commission on Law Enforcement and Criminal Justice to educate the public and retailers on methamphetamine. "The ban didn't seem to be working, and it is a much better idea to allow it in certain circumstances but to regulate it," Weitl explained. "As long as [the legislature] can prohibit the people from having it and using it in a way that is detrimental and harmful, that's the kind of thing we want to ban."

As for products containing PPA or pseudoephedrine, they are allowed to be sold without a prescription if 1) they are labeled and marketed to OTC Final Monograph standards; 2) manufactured and distributed for legitimate medicinal use; and 3) packaged in blister packs or, if a liquid, sold in quantities of less than three grams.

For more, visit the state legislature page for Nebraska at www.unicam.state.ne.us and conduct a keyword search.