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City governments will be ignoring the advice of the Municipal Technical Advisory Service if they try to institute prescription-only requirements for ephedrine and pseudoephedrine.
Under current state and federal law, a prescription is not required to purchase products containing those substances.
“In my opinion, cities may not impose any additional regulations on the sale of products containing ephedrine, and may not require that persons buying products containing ephedrine have prescriptions,” MTAS legal consultant Melissa A. Ashburn opined earlier this year.
Pseudoephedrine and ephedrine are decongestants in cold- and allergy-relief medications. They are also key ingredients used to make methamphetamine.
After failing to get the Tennessee General Assembly to pass a prescription-only requirement, law-enforcement officials are trying to persuade city governments to institute ordinances prohibiting the sale of ephedrine and pseudoephedrine products without a prescription.
There are questions about the legality of the city ordinances. That’s what prompted the MTAS opinion.
“That opinion is applicable to both ephedrine and pseudoephedrine,” MTAS legal consultant Josh Jones said.
MTAS is part of the University of Tennessee Institute for Public Service. Cities and towns across the state often turn to the agency for advice and assistance.
“Ephedrine is a non-prescription, over-the-counter drug which is regulated by the U.S. Food and Drug Administration,” the MTAS opinion said. “Title 21 of the United States Code ‘National Uniformity for Nonprescription Drugs,’ contains the following language, which preempts any local regulation of non-prescription drug products:
“No State or political subdivision of a State may establish or continue in effect any requirement –
“(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title[this refers to the section governing prescription drugs]; and
“(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
“This language means that a city may not impose any regulations on sales of non-prescription drugs, or at least no regulations that differ from the federal regulations imposed by the FDA.”
The opinion said a city can ask for permission to impose a prescription requirement.
MTAS doesn’t advise that, however.
“If a city is willing to invest a lot of time and money, an application may be made to the Secretary of the FDA for permission to pass an ordinance containing such a regulation, but I am very doubtful that such an attempt will be successful,” the opinion said.
The Tennessee District Attorneys General Conference is one of the groups pushing for a prescription requirement. Officials with the organization recognized there could be some problems with the cities doing that when the issue was brought up during a drug task force meeting in Kingston earlier this year.
“There may be legal obstacles that pop up,” 12th Judicial District Attorney General Mike Taylor said.
At that same meeting Taylor also said, “You know the city can’t make a criminal offense, only the state can do that.”