NABP e-News May 30, 2007

May 30, 2007 12:00 AM

NABP Executive Committee Officer Reports of the 103rd Annual Meeting Now Available
Officers of the NABP Executive Committee presented their reports during the NABP 103rd Annual Meeting, updating members on the state of pharmacy regulation and the status of NABP programs and services that support the mission of the Association and the state boards of pharmacy to protect the public health. The Annual Meeting was held May 19-22, 2007, in Portland, OR. The Report of the Executive Committee, President's Address, Remarks of the Incoming President, Report of the Treasurer, and Report of Counsel are now posted at http://www.nabp.net.

Removal of Pergolide from Market Raises Concerns for Veterinarians, Horse Owners
The removal of pergolide drug products from the market due to their potential for cardiac side effects in humans has raised concerns for veterinarians and horse owners. Aside from managing Parkinson’s disease in humans, pergolide is used to treat Cushing’s Syndrome in horses. Veterinarians have been prescribing the drug under the provisions of the Animal Medicinal Drug Use Clarification Act, which allows veterinary practitioners to prescribe approved human drugs for “extralabel” use in animals. Food and Drug Administration (FDA) is working to ensure that pergolide remains available to treat Cushing’s Syndrome in horses until a new animal drug application is approved for that use. FDA advises that bulk substance used for pharmacy compounding should be labeled for “animal use only,” and that all pharmacy compounding must be done under a valid veterinary prescription to treat an affected horse. The Center for Veterinary Medicine announced that it will work with sponsors to seek approval of a new animal drug application for the use of pergolide to treat Cushing’s Syndrome in horses.

FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin
Food and Drug Administration (FDA) on May 25, 2007, announced that it will take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin. Approximately 20 firms make timed-release products containing guaifenesin that have not undergone FDA review and as a result are considered by the agency to be unapproved drugs. To date, only Adams Respiratory Therapeutics has obtained FDA approval for timed-release products containing guaifenesin (600 mg and 1200 mg) under the trade names of Mucinex and Humibid. This action does not affect products containing guaifenesin in immediate release form. More information is available on the FDA Unapproved Drugs Web site.

DEA Stays Provisions of Combat Methamphetamine Epidemic Act
Drug Enforcement Administration (DEA) announced the temporary stay of certain provisions of the Combat Methamphetamine Epidemic Act of 2005. DEA published an interim final rule with request for comment in the Federal Register (72 FR 17401) on April 9, 2007, implementing provisions of the act that required additional reporting for import, export, and international transactions involving all List I and List II chemicals. After posting the rule, which was to become effective May 9, 2007, DEA received written and verbal comments from the regulated industry requesting the delay of the effective date to allow industry more time to fully comply with the new provisions. In response, DEA has stayed the provisions of the interim final rule to June 8, 2007. More information is available on the DEA Office of Diversion Control Web site.

10 Facilities Awarded VAWD Accreditation
NABP recently accredited 10 new facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^® ) program, bringing the total number of accredited facilities to 137 as of May 29. A full listing of VAWD facilities is available on the NABP Web site.

• Cardinal Health 110, Inc dba Cardinal Health provides a full line of pharmaceutical supplies to pharmacy entities.The company received accreditation for its St Charles, MO facility.
• Corporate Services, Inc is a provider of marketing support services including but not limited to fulfillment, call center, data processing, print services, and software applications. The company received accreditation for its South Bend, IN facility.
• Darby Dental Supply, LLC distributes dental supplies to dentists nationwide. The company received accreditation for its Reno, NV facility.
• Kenco Knoxville provides labor, logistics and management for pharmaceutical distributors. The company received accreditation for its Knoxville, TN facility.
• Miami-Luken, Inc is a full line wholesale pharmaceutical supplier to retail pharmacies in Ohio, Indiana, Kentucky, and West Virginia. The company received accreditation for its Springboro, OH facility.
• MWI Veterinary Supply Co distributes prescription drug products to approximately 1,500 veterinarians and animal clinics in the Rocky Mountain region of the United States. The company received accreditation for its Aurora, CO facility.
• Pharmacy Buying Association provides a broad range of products to community-based pharmacies, as well as hospitals, clinics, and select pharmaceutical chains. The company received accreditation for its Riverside, MO facility.
• Redi-L Corporation dba Redi-Mail Direct Marketing provides marketing support services by offering complete mailing and fulfillment services and also provides data validation for the pharmaceutical and life sciences industries. The company received accreditation for its Fairfield, NJ facility.
• SmithKline Beecham Corporation dba GlaxoSmithKline, a research-based pharmaceutical company, distributes prescription and over-the-counter drug and dental products worldwide. The company received accreditation for its Durham, NC, and Knoxville, TN, facilities.