Pseudoephedrine regs may give unprepared R.Ph.s headaches

July 11, 2005

Attendees at the National Association of Chain Drug Stores Marketplace 2005 Conference in New Orleans got an idea of what lies ahead regarding the regulation of pseudoephedrine-containing products.

Attendees at the National Association of Chain Drug Stores Marketplace 2005 Conference in New Orleans got an idea of what lies ahead regarding the regulation of pseudoephedrine-containing products. In a joint presentation entitled "Planning for the Unplanned: Understanding the Impact of New and Potential State Legislation on the Cough/Cold Category," Mary Ann Wagner, VP, Pharmacy Regulatory Affairs, NACDS, provided a legislative update, and Robert Doyle, senior VP, Information Resources' (IRI) Healthcare Soluions Group, discussed market impact. Most pharmacies, they said, are not yet prepared to comply with the new legislation, and consumers are completely in the dark about the impending changes and how they will affect their purchasing habits.

Widespread legislation has attempted to restrict the availability of products containing pseudoephedrine, creating a new "behind-the-counter" classification for the drugs and new practices for retailers and manufacturers. Most states have laws enacted or legislation pending, and a number of states are working to strengthen their existing laws.

The restrictions vary widely from state to state. All have some sort of sales limit; most have placement restrictions; two-thirds require presentation of identification and the use of logbooks (onerous for retailers); about half have age restrictions; and about a quarter have given pseudoephedrine a Schedule V status. Some states require Rxs; others call for retailers to retain invoices. Because there is currently no electronic network documenting sales, it is difficult to control the amount sold-a customer who has reached the legislated sales limit in one store merely goes to another.

Funds will be appropriated for enforcement, clean-up, diversion, and abuse prevention efforts.

Federal legislation would not necessarily eliminate complexities at the state level, Wagner said. For example, if pseudoephedrine is made a Schedule V drug, a prescription will be required in 15 states and purchasers would have to sign a logbook or register receipt in 18 states; wholesalers would be required to store pseudoephedrine in a locked cage or provide warehousing, as with other controlled substances. She went on to list the national standards advocated by NACDS:

NACDS favors an electronic log, but issues regarding responsibility for cost and maintenance are yet to be worked out. When the draft federal legislation will be completed is hard to estimate, but Wagner said the bill will not be debated-it will just be simply an up or down vote. NACDS will be sending out one-page fact sheets to all members.

The market has already begun to react to the pending legislation. Ten major retailers voluntarily moved OTC pseudoephedrine products behind the pharmacy counter. This move is more restrictive than the legislation in many states, but other varying state requirements have not been met. Manufacturers have also taken action by reformulating their products. Pfizer has already introduced a new Sudafed, and Hogil's reformulated Sine-Off brand will be introduced in August.