NABP e-News May 2, 2007

May 2, 2007 12:00 AM

Improperly Compounded Colchicine Responsible for Recent Deaths
Compounded colchicine that was 10 times as potent as labeled was responsible for two recent deaths in Oregon and Washington, the Portland Tribune reported on April 27, 2007. State officials are investigating the drug’s role in a third death, also in Oregon. The drug was sent to a Portland, OR clinic by ApothéCure Inc, a Dallas, TX-based compounding pharmacy that distributes its drugs throughout the country. The two patients who died had received injections of colchicine as a treatment for back pain. Lab tests revealed that the colchicine administered in the two deaths had a potency of 4 mg/ml, rather than the 0.5 mg/ml stated on labels. According to Gary Schnabel, executive director of the Oregon State Board of Pharmacy, ApothéCure, a licensed Texas pharmacy, may be operating as a manufacturer. Both the Oregon Board and the Texas State Board of Pharmacy have opened investigations into the incident. The Texas Board advised ApothéCure to stop making colchicine; the company agreed, the Portland Tribune reports. The full article is posted on the Portland Tribune Web site at http://www.portlandtribune.com/news/story.php?story_id=117762598274410600.On May 2, Food and Drug Administration announced the recall of all strengths, sizes, and lots of injectable colchicine compounded and sold by ApothéCure within the last year. View FDA's MedWatch Safety summary on this issue at http://www.fda.gov/medwatch/safety/2007/safety07.htm#Colchicine.

FDA Evaluates Creating Behind-the-Counter Class of Drugs
Food and Drug Administration (FDA) officials recently announced that the agency is considering the development of a regulatory process for a behind-the-counter class of drugs. Medications in this new class would be available without a prescription but not without consultation with a pharmacist, who could address any potential concerns about the drugs. Officials said FDA will begin working with key stakeholders in the near future to evaluate whether existing regulations will allow for the development of a new class of drugs, or if legislation is needed before the change can take place. Proponents such as the American Pharmacists Association and the American Society of Health-System Pharmacists note that creating a third class of drugs might expand access to certain medicines that currently are available only by prescription. Critics such as Consumer Healthcare Products Association, however, express concern that moving over-the-counter medications behind the counter would result in a reduced number of outlets where consumers could purchase the products, limited competition, and increased drug prices.

DEA Issues Rule to Control Chemical Used in Illicit Manufacture of Fentanyl
In response to hundreds of fentanyl-related deaths that authorities have linked to illicit manufacturing activities, Drug Enforcement Administration (DEA) has issued an interim rule to control access to a chemical used in illegal production of the drug. Effective April 23, 2007, this rulemaking classifies the chemical N-phenethyl-4-piperidone (NPP) as a List I chemical under the Controlled Substances Act. NPP has been identified as the starting material in several seized fentanyl clandestine laboratories. DEA is accepting comments on this interim rulemaking by e-mail at dea.diversion.policy@usdoj.gov or via the electronic comment form available at http://www.regulations.gov.

NABP Passes Milestone with Accreditation of Over 100 Wholesale Distributors
NABP reached a milestone in late April 2007 with the accreditation of the 100th facility through its Verified-Accredited Wholesale Distributors^® (VAWD^® ) program. The accreditation of 15 additional facilities as of April 27 brings the total number of accredited facilities to 106. A full listing of VAWD facilities is available in the VAWD section of the NABP Web site at http://www.nabp.net.

• BD, dba BD Distribution Center, distributes products manufactured by BD’s manufacturing divisions worldwide to other warehouse distributors and Walgreen distribution centers. The company received accreditation for its Plainfield, IN facility.
• Becton, Dickinson and Company, dba BD Distribution Center supplies syringes, home insulin kits, vacutainer systems, and various medical devices to distributors throughout the western United States. The company received accreditation for its Redlands, CA facility.
• Benco Dental Supply Company provides prescription drugs and dental equipment to dentists, laboratories, and government facilities in 12 states. The company received accreditation for its Fort Wayne, IN facility.
• Caremark, Inc specializes in distributing injectable prescription drugs to hospitals, practitioners, and retail pharmacies. The company received accreditation for its Redlands, CA facility.
• CVS New York, Inc provides prescription products and general merchandise to CVS pharmacies in New York, New Jersey, Pennsylvania, and Delaware. The company received accreditation for its Lumberton, NJ facility.
• HD Smith Wholesale Drug Company distributes prescription drugs, durable medical equipment, and over-the-counter products to retail pharmacies, practitioners, and hospitals in the Midwest. The company received accreditation for its Springfield, IL facility.
• McKesson Drug distributes to independent and chain pharmacies, hospitals, and mail-order pharmacies, primarily in the Midwest. The company received accreditation for its O’Fallon, MO facility.
• McKesson Medical-Surgical, Inc distributes prescription drugs, over-the-counter products, and medical devices. The company received accreditation for its Glendale Heights, IL; Kansas City, MO; and Grove City, OH facilities.
• Moore Medical, LLC provides prescription drugs and related supplies to emergency medical services organizations, physicians, occupational health clinics, and federal/state agencies. The company received accreditation for its Visalia, CA; Jacksonville, FL; and New Britain, CT facilities.
• Stericycle, Inc is a full-service reverse distributor for pharmaceutical products, medical devices, and durable goods. The company received accreditation for its Conyers, GA facility.
• Walgreen Company’s distribution center for Schedule II products to pharmacies in the Walgreen chain; also distributes Schedule III-V controlled drugs, non-controlled drugs, and other pharmacy supplies to Walgreen’s pharmacies on the west coast. The company received accreditation for its Woodland, CA facility.