Since the passage of the federal Combat Methamphetamine Epidemic Act in 2005 and state legislation adopted in most states around the same time, retail sales of over-the-counter (“OTC”) cold and allergy products containing pseudoephedrine (“PSE”) have been subject to strict controls. These restrictions include daily and monthly purchase and sale gram limits, logbook requirements and other security measures such as requiring that the products be sold from “behind the counter.” Two states, however – Oregon and Mississippi – have further restricted sales of these products by requiring they be dispensed only pursuant to a prescription and scheduling them as controlled substances under the states’ controlled substance laws. Because of the continued concern about diversion of OTC PSE products, a number of states in this legislative season are contemplating taking similar action.
Last year, Georgia, Illinois, Missouri, and Washington introduced similar bills requiring prescription-only purchases and scheduling the products as controlled substances – most did not emerge from committee review. This year, in what seems to be a trend towards increased state regulation, the legislatures in Hawaii, Indiana, Kentucky, Tennessee and Virginia also recently introduced bills to schedule these substances and to require prescriptions in order to purchase products containing pseudoephedrine or other methamphetamine precursors.
These bills are similar in that they generally propose to schedule or reschedule all PSE products as controlled substances (e.g., Schedule III), thus requiring that the products only be dispensed pursuant to a prescription. For example, in Hawaii, a senate bill introduced on January 20, 2011, adds “any material, compound, mixture, or preparation which contains any quantity of [pseudoephedrine]” to the list of substances classified as Schedule III controlled substances, and amends existing laws to eliminate provisions relating to the procedures for OTC sales of pseudoephedrine products. In Indiana, Senate Bill 474 similarly classifies any “material, compound, mixture, or preparation that contains a quantity of [ephedrine or pseudoephedrine]” as a Schedule III controlled substance, thus available only by prescription. The bill was introduced on January 13, 2011, and to date has not been subject to a vote.
Of the new legislation we have reviewed to date, proposed legislation in Kentucky appears to be the most aggressive. One bill would require that methamphetamine precursors such as ephedrine, pseudoephedrine, or phenylpropanolamine be classified as Schedule IV controlled substances, available only by prescription. The proposed law would also prohibit any practitioner from dispensing more than 9 grams of such products to any one patient over a 30-day period and limits refills over a 30-day period. In a competing bill, another Kentucky senator has introduced legislation that would create a registry of individuals convicted of felonies related to illicit use of precursor chemicals or methamphetamine. Such individuals would be prohibited from purchasing PSE OTC products; however, the current draft of the legislation would exempt individuals who received the product by prescription. This is similar to the current law in Oklahoma, which also has established a registry to block certain individuals from purchasing PSE.
In Nevada, a state senator submitted a “Bill Draft Request” calling for a bill that would, “Require… products containing ephedrine, pseudoephedrine and phenylpropanolamine to be dispensed by prescription only unless the product is formulated to prevent conversion to methamphetamine.” The Nevada legislature convened on February 7, 2011, and we are advised that a bill will be forthcoming.
The introduction of these state bills reflects a perception among the states that the current federal and state restrictions are not sufficient to prevent the diversion of PSE cold and allergy products. It is unclear, however, whether requiring a prescription or scheduling the drug will make a difference in preventing diversion of PSE. Such action will make it more difficult and costly for individuals to obtain these medicines for legitimate use. We will continue to follow these and other similar state bills, and report on significant developments including whether there is any federal legislation introduced along these same lines.