The federal government is poised to enact legislation substantially affecting over-the-counter (OTC) pharmaceuticals. Do you know what they are? If not, the American Council on Regulatory Compliance (ACRC) says your business is at risk of losing a potentially high margin, high profit category.
ACRC, a Falls Church, Va.-based coalition of retailers, distributors and manufacturers that produce, distribute and sell OTC pharmaceuticals, says the proposed legislation is threatening to reshape the laws for selling non-prescription pharmaceuticals in the U.S. and the big loser could be the convenience store industry.
The legislative and regulatory efforts of the ACRC are focusing on two major areas: * To ensure that any legislation enacted by the U.S. Congress and numerous state legislatures does not result in “List 1″ chemical products, such as cold medicines currently sold at convenience stores, being classified as “Schedule V” chemicals, which would require them to be sold only by licensed pharmacists.
- Submitting formal opposition to the Food and Drug Administration’s proposedban on certain asthma medications, identified as bronchodilator/expectorantcombination products such as Primatene tablets and Bronkaid. The impact ofa ban on these combinations “would have a devastating effect on consumerswith asthma who depend on fast-acting bronchodilators as their only sourceof relief without a prescription,” said Walt Sanders, ACRC’s legal consultant.
Though the ACRC’s largest customer base is convenience stores, it’s working with other major groups such as the Food Marketing Institute, National Association of Chain Drug Stores and the National Grocers Association to shape compromise legislation an alternative to the more drastic Schedule V classification. These provisions are currently part of part of the Patriot Act, which has been held up in a lobbying effort by several groups including ACRC.
The legislation includes a Patriot Act extension that provides List 1 chemicalmanufacturers, distributors and retailers additional time to comply with salesprovisions that are expected to become law within the next few months. Whilenumerous provisions of the bill will have an impact on all aspects of the industry,there are a few provisions the convenience store industry needs to focus on:
- Products containing pseudoephedrine, ephedrine and PPA are classified as”Scheduled Listed Chemicals” (SLCs);
- All non-liquid (including gel caps) SLC’s sold by retail locations mustbe sold in blister packs with only two dosage units per blister;
- Stores can not sell one customer more than 3.6 grams per day of any of thesechemicals, regardless of the number of transactions;
- Purchases of SLC products will be restricted to 9.0 grams in a 30-day period;
- Stores will be required to place SLC products behind the counter or in alocked container;
- Stores will be required to maintain a log of purchases for two years; and
- Marketers will also be required to submit certification to the U.S. AttorneyGeneral that is in compliance with retail requirements, certify that employeeshave been trained according to Department of Justice guidelines and maintaintraining records at the retail location.
While the regulations sound cumbersome, this legislation is a vast improvement from the drastic measures originally proposed, which was selling these items in pharmacies only.
“I believe without the ACRC and other organizations, taking an interest in both state and national methamphetamine legislation, all of these products being sold in convenience stores would be taken away and be placed in a pharmacy, said John Mudri, compliance officer and retailer consultant for ACRC.
Over the next 12 months, ACRC expects to monitorlegislative initiatives to represent the best interests of the convenience storeindustry and to gain more membership, “thereby having more unified approachto represent the industry with governmental and public opinion,” said Mudri,who served as a DEA agent for more than 30 years.
The group has already experienced numerous successes in shaping methamphetamine legislation. Working with the National Association of Convenience Stores, ACRC has influenced legislation approved by two House Congressional Committees that established more reasonable “behind the counter” controls on pseudoephedrine and ephedrine based products and helped shape legislative proposals in Indiana, Wisconsin and Arkansas to make sales provisions of these items more acceptable to c-store owners.
Going forward, ACRC is looking to bolster its retail membership in order to give the group more clout with lawmakers. To attract members, it is planning a major training initiative to help retailers understand and comply with the complex requirements of the law. Annual dues are $100 for single-store owners and $200 for chains.
For more information, visit www.acrc.us