NABP e-News: June 24, 2009

Arizona Health Associations Sue State for Regulatory Board Funding
Thirteen health professional associations in Arizona are suing the state’s governor and treasurer for essentially transferring the state's regulatory boards' operating budgets to the state’s general fund. The regulatory boards, including the Arizona State Board of Pharmacy, collect licensing fees from the professionals they regulate and previously sent 10% to the state's general fund, retaining 90% for their operations. Under the new state budget plan, implemented with the enactment of House Bill (HB) 2620 and HB 2209, 100% of the boards’ fees are earmarked for the general fund. The plaintiffs are calling the action unconstitutional and akin to illegal taxation, the American Society for Pharmacy Law reports in a recent newsletter. The suit, filed April 8, 2009, in the Maricopa County Superior Court, seeks an order for the transferred funds, amounting to $13.2 million, to be returned to the boards, the Arizona Republic reported on June 19, 2009.

Pharmaceutical Company Manager Sentenced for Off-Label Marketing 
A Branchburg, NJ, woman was sentenced on June 18, 2009, by United States Magistrate Judge Judith Dein to pay a $75,000 fine and serve two years of probation for the distribution of a misbranded drug. According to a June 18 news release from the US Attorney’s Office for the District of Massachusetts, Mary Holloway pled guilty to charges of violating the Food, Drug and Cosmetic Act by marketing the drug Bextra for uses and dosages that were not approved by Food and Drug Administration while employed as a regional manager for a pharmaceutical company. Bextra was withdrawn from the market in April 2005.

Certain Zicam Cold Remedies Linked to Loss of Sense of Smell 
Food and Drug Administration (FDA) issued a warning on June 16, 2009, advising consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:

  • Zicam® Cold Remedy Nasal Gel
  • Zicam Cold Remedy Nasal Swabs
  • Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

FDA received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. More information is available on the FDA Web site.

Eight Additional Facilities Awarded VAWD Accreditation
NABP recently accredited eight additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 349 as of June 19, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • AmerisourceBergen Drug Corporation distributes over-the-counter and prescription drug products, including controlled substances, to community and chain pharmacies, medical clinics, and hospitals. The company received accreditation for its Kent, WA facility.
  • E.R. Squibb & Sons, LLC, dba Bristol-Myers Squibb Company, imports/exports non-controlled substance products to support E.R. Squibb’s mission. The company received accreditation for its Mt. Vernon, IN facility.
  • McKesson Medical-Surgical received accreditation for its two subsidiaries that operate within the same facility in Swedesboro, NJ.
    • McKesson Medical-Surgical Minnesota Supply, Inc provides non-controlled prescription drugs and supplies to extended-care facilities.
    • McKesson Medical-Surgical, Inc provides non-controlled prescription drugs and supplies to primary-care facilities.
  • Midlothian Laboratories distributes a limited number of prescription products custom manufactured for the firm by five generic houses in the United States. The company received accreditation for its Montgomery, AL facility.
  • Professional Veterinary Products, Ltd distributes prescription products and veterinary supplies, ranging from diagnostic equipment to animal identification tags, throughout the US. The company received accreditation for its Omaha, NE facility.
  • RedPharm Drug is the supplier of the products stocked in the InstyMed machines located in 23 states. The company received accreditation for its Eden Prairie, MN facility.
  • UPS Supply Chain Solutions, Inc is a third-party logistics provider for Merck & Co, Inc, distributing non-controlled substance products to customers in 37 states. The company received accreditation for its Duluth, GA facility.

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