National Association of Boards of Pharmacy To Finalize New Guidelines for Prescription Drug Wholesalers
The National Association of Boards of Pharmacy, a group of state regulators, this month plans to finalize "tough new guidelines" for prescription drug wholesalers as part of an effort to "crack down" on counterfeit and diverted medications, the Wall Street Journal reports. According to the Journal, under the current draft of the guidelines:
- States would perform "in-depth background checks" of individuals who seek wholesaler licenses;
- States would limit the definition of "authorized distributor" to wholesalers that have written agreements with pharmaceutical companies or are listed by companies as authorized distributors;
- Wholesalers that are "authorized distributors" would have to maintain paper documentation of the origin of prescription drugs, and all wholesalers by 2007 would have to establish an electronic system to track medications;
- Wholesalers would have to use state-approved technology and equipment that allows them to "authenticate, track and trace drugs and devices";
- Wholesalers would have to randomly authenticate the origin of 10% of the prescription drugs and medical devices that they purchase from other wholesalers and randomly authenticate the origin of 90% of the prescription drugs and medical devices that appear on a state list of products "most at risk for counterfeiting or diversion";
- States would impose "harsher penalties" for wholesalers that violate the guideline because several violations would become criminal offenses; and
- The NABP would establish a national inspection service that states could use if they lack adequate resources to perform their own inspections on wholesalers.
According to the Journal, the guidelines are important because the "complicated network" of prescription drug wholesalers has "opened some windows for counterfeit medicines to get into the hands of consumers." In addition, the guidelines would "significantly tighten" rules for wholesalers and could force many smaller wholesalers to close and raise costs for others, the Journal reports. Catizone said that the guidelines, drafted in conjunction with the FDA, would "really weed out the legitimate wholesale distributors from those who shouldn't be in business." Individual states would have to enact the guidelines before they could take effect. However, state regulators could "face a battle" with wholesalers over some of the provisions in the guidelines, according to the Journal. A spokesperson for the Healthcare Distribution Management Association, which represents wholesalers, said that the group has not drafted a response to the guidelines. However, HDMA has drafted similar guidelines with some "key differences," such as the definition of "authorized distributors" (Wilde Mathews, Wall Street Journal, 1/8). The guidelines, which HDMA released in December, call for wholesalers to increase their scrutiny of past sales records; more uniform state license requirements for wholesalers; improved inspections; improved record maintenance; states to inspect a wholesaler license applicant sites before they issue licenses; and more extensive sales histories of high-priced prescription drugs that appeal to counterfeiters (California Healthline, 12/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.