SAN DIEGO - While retailers are recuperating from sales restrictions on cough and cold products containing pseudoephedrine, the National Association of Chain Drug Stores, Alexandria, Va., cautioned that another round of provisions is on the way.
At its Marketplace Conference held here late last month, Kevin Nicholson, NACDS vice president of pharmacy regulatory affairs, warned retailers that federal provisions on employee training, product placement, and identification and logbook requirements, under the Federal Combat Methamphetamine Act of 2005, go into effect on Sept. 30.
Sales limits went into effect April 8.
Affected products include all non-prescription PSE, ephedrine and phenylpropanolamine products classified under the federal Controlled Substances Act. Another cough and cold ingredient - dextromethorpham, or DXM - may also be subject to increased regulatory scrutiny.
Under the Combat Methamphetamine Act, all retail locations are to have employees trained in the regulation of products containing these ingredients and to have that training certified via a website that the U.S. Drug Enforcement Administration has said it will develop, according to Nichols.
"But it is almost July and no website or rules on training have even been posed yet, so we are getting nervous about having time to comply by Sept. 30," Nichols said. "This is especially true for large chains."
In response, NACDS and LearnSomething, Tallahassee, Fla., have developed MethGuard Combat Methamphetamine Epidemic Act of 2005 online training program for pharmacists and pharmacy technicians.
"Our goal is to have the Drug Enforcement Agency verify this training as compliant with their requirements," Nichols said.
Also starting Sept. 30, affected products must be stored behind a counter or in a locked cabinet, consumers must show an acceptable form of federal or state issued photo ID or a form of ID acceptable by the Immigration and Naturalization Service/Department of Homeland Security, and consumers must sign a written or electronic logbook for which criteria is to be developed by the Drug Enforcement Administration. However, Nichols said local and state laws pre-empt the federal requirements.
"It is a challenge, but retailers must comply with three levels of regulation: local, state and federal," Nichols said. "Retailers may have to consult legal counsel to help them decide which of the laws to follow."
Complying with what can be several different sets of regulations can be a challenge, Jim Newhouse, senior buyer, OTC/health Aids, ShopKo Stores, Green Bay, Wis., told SN at the show. "Our number of planograms has gone from four to 29 since these laws started passing."
To keep customers aware of PSE products, "we have a card system," Newhouse said. "Customers see cards on the shelf with the names and information of PSE products. Then, if they want the product, they just take the card to the pharmacist. This helps bring ease of delivery to the customer."
DXM could garner legislative attention as well, Nichols said.
Medicine containing this cough suppressant is being used by teens for "pharming," the mixing of a number of legal household products to achieve a hallucinogenic high. But unlike PSE, which is being replaced with alternative ingredient phenylephrine in new products by many manufacturers, DXM has "no practical alternative," Nichols said.
To put a stop to abuse of any type of household products and avoid the possibility of sales restrictions being placed on safe and useful products containing DXM, Nichols said, "We believe the proper approach is to engage people in [a discussion of] the dangers of pharming."
