NABP e-News: August 05, 2009

August 5, 2009 12:00 am

Report Calls on Microsoft to Ban Ads for Rogue Internet Drug Outlets on Bing.com
On August 4, 2009, LegitScript and KnujOn released the first in a series of reports about United States companies that facilitate, and profit from, the illicit sale of prescription drugs. The first report focuses on Microsoft and how rogue Internet drug outlets are being allowed to participate in its online advertising program for bing.com, a search engine recently launched by the company. The authors assert that Microsoft has the ability, and responsibility, to ensure it does not display, much less profit from, Internet ads for Web sites engaged in illegal activities, such as selling prescription drugs without a license or a prescription. The report states that 89.7% of the ads on bing.com for Internet drug outlets that the authors reviewed are acting unlawfully in some way, and some drugs obtained from these sites were found to be counterfeit.

Certain Body-Building Products Linked to Serious Adverse Effects 
Food and Drug Administration (FDA) issued a public health advisory on July 28, 2009, concerning products marketed for body building and increasing muscle mass. FDA sent a warning letter to a manufacturer of body-building supplements that claim to contain steroid-like ingredients but, in fact, contain synthetic steroids. The products named in the warning letter are marketed by American Cellular Laboratories, Inc, and are listed in the FDA public health advisory.  FDA has received reports of serious adverse events associated with the use of these products and other similar products. FDA advises health care professionals to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements, and to report any adverse events related to the use of these products to FDA's MedWatch Adverse Event Reporting program.

CDC Advisory Committee Issues Recommendations for Novel H1N1 Vaccination 
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices has issued recommendations on who should receive novel H1N1 vaccine when it becomes available. Intended to be used alongside the seasonal influenza vaccine, a novel H1N1 vaccine is currently in production and may be ready for the public in the fall, CDC states in a July 29, 2009 news release. The committee recommends the vaccination efforts focus on five key populations:

• pregnant women;
• people who live with or care for children younger than 6 months of age;
• health care and emergency services personnel;
• people between the ages of 6 months and 24 years of age; and
• people between the ages of 25 and 64 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems.

FDA Releases Draft Guidance to Help Manufacturers Thwart Counterfeiting
FDA has released a draft guidance document to assist pharmaceutical manufacturers who want to use physical-chemical identifiers in solid oral dosage forms to thwart drug product counterfeiting. A physical-chemical identifier is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form. Adding a trace amount of an inactive ingredient with a unique physical-chemical characteristic to an existing section of the dosage form makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits. “Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting” is available on the FDA Web site.

Appellate Court Lifts Ban on Mandatory Dispensing Rules in Washington
Pursuant to the July 8, 2009 ruling  of the Ninth Circuit Court of Appeals, the Washington State Board of Pharmacy may enforce its mandatory dispensing rules against pharmacists who refuse to dispense emergency contraceptives for religious reasons. The court vacated an injunction issued by a federal district court judge that prohibited the Board from enforcing these rules if the refusing pharmacist immediately referred the patient to another source to fill the prescription. The appeals court has remanded the case to the district court for reconsideration of the constitutionality of the Board's mandatory dispensing rules. As of July 8, the Board may enforce these regulations fully for all lawful prescriptions. 

Six Additional Facilities Awarded VAWD Accreditation
NABP recently accredited six additional facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 358 as of July 31, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Benco Dental Supply Company, dba Benco Dental Company, provides prescription drugs and dental equipment to dentists, laboratories, and government facilities in 12 states. The company received accreditation for its Wilkes Barre, PA facility.

• Cardinal Health 112, LLC is the hub of the Cardinal Distribution chain. Most of the facility’s inventory and shipments are in bulk, with a smaller portion in smaller quantities. The company received accreditation for its Groveport, OH facility.
• Genetco, Inc is a supplier of generic prescriptions, over-the-counter products, medical supplies, and nutritional supplements. The company received accreditation for its Ronkonkoma, NY facility.
• J Knipper and Company, Inc is a third-party logistics provider engaged in contractual projects on behalf of manufacturers, including distribution of drug samples to prescribers, clinics, and drug representatives. The company received accreditation for its Lakewood, NJ facility.
• Rebel Distributors Corporation provides primary practitioners, clinics/hospitals, oncology groups, surgery centers, and imaging centers ready-to-dispense/administer repackaged/prepackaged pharmaceuticals, including injectables and contrast solutions. The company received accreditation for its Thousand Oaks, CA facility.
• Walgreen Company received accreditation for its Windsor, WI facility, a subsidiary of Walgreen Company Inc in Deerfield, IL. The parent company operates 6,902 drugstores in all 50 states, the District of Columbia, and Puerto Rico.