Letter From MTAS Legal Consultant States Actions Of City Council Are Beyond Their Authority

MTAS is the Municipal Technical Assistance Service established by the state to help municipalities and to which those municipalities must pay membership dues. 

June 3, 2013

Re: Ability of city to regulate sales of products containing ephedrine

The question has been raised of whether a city may regulate the sale of ephedrine, by requiring a prescription in order to purchase the over the counter drug. Products containing ephedrine are being purchased in large quantities by persons operating illegal methamphetamine labs.

Ephedrine is a non-prescription, over the counter drug which is regulated by the U.S. Food and Drug Administration. 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.).

21 U.S.C.A. § 379r (West)[emphasis added]

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.

If you review the further language of 21 U.S.C.A. § 379, you will note that a political subdivision may make application to the Secretary of the FDA for permission to impose additional regulations. The Secretary may grant the application if three conditions in subsection (b)(1) are met. Although public health and safety is a concern for which this subsection states such permission may be granted, the measure cannot have an adverse impact on interstate commerce. 21CFR§379(b)(1). I have searched the Federal Register for any record of a successful application for exception to the operation of this regulation, and found nothing. This leads me to conclude that exception to this regulation is rarely, if ever, granted.

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. 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.

I hope this information is helpful. Please feel free to contact me should you have any questions or need further assistance.

Thank you for consulting with MTAS.

Sincerely,

Melissa A. Ashburn

Legal Consultant

Why is it so hard for city/county officials to just follow the law?

Another Huge Lawsuit Filed IN Connection With Actions Of EDB/IDC

This time the lawsuit is directed at a very prestigious law firm that has resulted from the actions of the leadership of the Industrial Development Group.  Filed on 11 October 2013 it charges malpractice and conflict of interest. 

Pseudoephedrine Ordinance Passes City Council

The Pulaski Board of Mayor and Aldermen have decided to make the sale of pseudoephedrine available by prescription only.  They have made an amendment to restrict the sale of pseudoephedrine in both pill and liquid gel form. 
Before becoming law, a public hearing must be held.  I believe that public meeting is scheduled for 13 November but I am not completely certain of that date.

While I strongly oppose the making and sell of Meth or any other drug I have to ask where did the City Council come up with the legal authority to interfere with the sale of legally available drugs?  Why, instead of making it harder on the illegal drug dealers have they decided to make it harder and more expensive on the average law abiding citizen?   

Has there been an opinion from the state that conflicts with other opinions delivered from the same office that states such an act is not within the jurisdiction of the city authority? Has the city now become so influential that they can direct interstate commerce, decide which medical products can compete on the open market , can the city really afford another senseless lawsuit, do we really think a large drug company that stands to lose millions of dollars if this becomes acceptable will not fight it? 

PES Power Board Raises Rates

If PES Raising Rates by 2.57 % beginning 1 October was the end of the story there would be no point for me to comment. The fact is that's not the end of the story. Electrical rates have been going up for several years now not just by a regular rate increase but by add ons such as adjustments for fuel cost, ashe clean up, etc. Some of these increases have resulted from legitimate expenses but some have resulted from outrageous salaries and plain mismanagement and incompetency much at the TVA level. 

PES is also asking for 2.5 million in new debt for a substation that was bid in at $861,292 leaving over a million and a half for “site preparation” . The Highway department can pave a mile of road for less than that, so what is required for a site to be “prepared”. 

If what the PES plans to pay for remodeling bathrooms at a warehouse $68,800.00 budgeted and a bid of $74,125.00 bid to do the job I have to ask where do you get golden fixtures in this day and time? $74,125.00 to remodel bathrooms in a warehouse, a whole house with two bathrooms can be built for less than that. Perhaps that is the reason PES is asking the city to double it’s outrageous $200,000.00 a year billing fees to $400,000.00. Oh yes, I know TVA required PES to do a “cost of service adjustment” but how does that translate into a 100% increase. Surely the wiser heads at City Hall will reject this outrage and set up their own billing for gas, garbage, sewage and water. Two people and a couple of computers maybe? It seems with the exit of Wes Kelley the PES has drifted back into their old wasteful ways and perhaps it’s time for another community meeting to get them back on track again. The citizens of the county are being bombarded with more expense on every level while the jobs picture continues to erode for them. As a retirement community it seems we are quickly being overcome with more outgo than income.