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NABP e-News January 23, 2008
FDA Advises against Using OTC Cold Medicines in Children Younger than 2
Food and Drug Administration (FDA) issued a public health advisory on January 17, 2008, recommending that over-the-counter (OTC) cough and cold medicines should not be used to treat infants and children younger than 2 years of age, citing the risk of “serious and potentially life-threatening side effects.” FDA held a public advisory committee meeting October 18-19, 2007, to discuss the issue, after which many pharmaceutical manufacturers voluntarily withdrew cough and cold medicines marketed for use in this age group. FDA says the agency is in the process of evaluating the safety of OTC cough and cold medicines in children 2-11 years of age and will announce its recommendations “in the near future.” The public health advisory is available on the FDA Web site.
FDA Takes Action against Compounded Menopause Hormone Therapy Drugs
FDA sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA has expressed concern that unfounded claims like these mislead women and health care professionals. The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of "bio-identical" as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis. The FDA news release is available at www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html.
NABP to Discuss Current, Emerging Board of Pharmacy Issues at ASAP Meeting
NABP will lead a presentation, “Current and Emerging Board of Pharmacy Issues,” at the American Society for Automation in Pharmacy (ASAP) 2008 Annual Industry and Technology Issues Conference, to be held January 24-26 at the Ritz-Carlton, Amelia Island, FL. Topics of discussion will include drug counterfeiting, durable medical equipment accreditation requirements, medication errors and peer review, and pseudoephedrine regulation. More information on the meeting is available on the ASAP Web site at http://www.asapnet.org.
Four Additional Facilities Awarded VAWD Accreditation
NABP recently accredited four new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 234 as of January 18, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.
- Exel, Inc is a publicly traded company based in Westerville, OH, with 250 facilities in 130 countries. The company received accreditation its Middletown, PA facility, a third-party logistics provider for the specialty dental supply company Dentsply.
- Exel, Inc also received accreditation its Kingstown, PA facility, a third-party logistics provider exclusively for the generic pharmaceutical drug manufacturer Sandoz.
- Kroger Limited Partnership I, dba Peyton’s Southeastern, a subsidiary of the Cincinnati, OH-based Kroger Company, distributes prescription drug products to Kroger pharmacies in 15 states. The company received accreditation for its Cleveland, TN facility.
- Midwest Veterinary Supply, Inc supplies over-the-counter and prescription drug products to veterinary practices. The company received accreditation for its Wayne, IN facility.
