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.
Federal legislation is also being drafted. U.S. senators Jim Talent (R, Mo.) and Dianne Feinstein (D, Calif.) and Rep. Roy
Blunt (R, Mo.) are spearheading the effort, and NACDS is trying to represent the best interest of chain drugstores in the
process. The major provisions include:
- Any product containing pseudoephedrine will be designated as Schedule V. Products may be sold only by a licensed R.Ph. or
licensed pharmacy technician. Wagner noted that few states have licensing programs for pharmacy technicians.
- Purchasers must show a photo ID with date of birth and sign a written log/ receipt showing name, date, and name and quantity
of product. Sales will be limited to nine grams within a rolling 30-day period (more requires an Rx).
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:
- Federal legislation should preempt retailer requirements in state laws.
- Pseudoephedrine products should not require an Rx. Single-entity products should be sold from behind the counter by a pharmacist
or other pharmacy personnel. Sales of combination products should be handled in the same way by Jan. 1, 2007.
- A written or electronic log of purchases should be maintained to assist in law enforcement efforts. Sales should be limited
to nine grams within a 30-day period.
- Distribution center storage requirements should be limited.
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.
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