District Court Ruling Overturned in Pharmacy Compounding Case
The US Court of Appeals, Fifth Circuit, on July 18, 2008, issued a decision in the case of Medical Center Pharmacy, et al, v Mukasey on the issue of pharmacy compounding. The case originated in the US District Court for the Western District of Texas, when 10 pharmacies specializing in compounding prescription drugs for human and animal use sued the US Food and Drug Administration (FDA) for declaratory and injunctive relief, permitting them to continue compounding drugs without obtaining the FDA approval required for “new drugs.” FDA appealed the case after the district court issued a ruling declaring pharmacy compounding “an approved and legal practice” and that compounded drugs are not “new drugs” under the US Food, Drug and Cosmetic Act. (See the September 8, 2006 NABP e-News under News/Press on the NABP Web site, www.nabp.net.) The appellate court clarified the extent to which the Act permits FDA to regulate compounding. Concluding that the Act, as amended, permits compounded drugs to avoid the new-drug approval process only in certain statutorily delimited circumstances, the appellate court overturned the judgment and returned the case to the district court for further proceedings as appropriate. The court’s opinion is available at www.ca5.uscourts.gov/opinions/pub/06/06-51583-CV0.wpd.pdf.
Study Highlights Continued Prevalence of Rogue Internet Drug Outlets
A July 9, 2008 New York Times article, “Abuses Are Found in Online Sales of Medication,” highlights the continued prevalence of Internet drug outlets that operate in conflict with pharmacy practice laws. The article cites the recent report of the National Center on Addiction and Substance Abuse at Columbia University (CASA), “’You’ve Got Drugs!’ V: Prescription Drug Pushers on the Internet.” CASA reports that 85% of Web sites selling controlled substance prescription medications do not require a valid prescription, and of those that do, half permit the prescription to be faxed, allowing significant opportunity for fraud. The New York Times article and related media coverage are available under “In the News” in the Internet Pharmacies section of the NABP Web site, www.nabp.net.
NABP Names Additional 51 Internet Drug Outlets out of Compliance with Pharmacy Practice Standards
NABP recently named an additional 51 Internet drug outlets that appear to be out of compliance with state and federal laws and NABP patient safety and pharmacy practice standards. These findings bring the number of sites listed as “not recommended” on the NABP Web site to 400 as of July 18, 2008. Four sites have been identified as potentially legitimate, pending verification of licensure and other criteria. Thus far, however, no additional sites have been posted to the Reviewed Internet Pharmacy Practice Sites list. Program criteria, patient information, and a full listing of recommended, reviewed, and not recommended sites are available under Internet Pharmacies on the NABP Web site, www.nabp.net.
Texas Hospital Administers Heparin Overdose of to 14 Infants
A statement released July 10, 2008 by the Corpus Christi, TX hospital that administered heparin overdoses to 14 infants said the overdose was the result of a mixing error in the hospital pharmacy. According to the statement given by the hospital’s chief medical officer, the error was unrelated to product labeling or packaging. The mixing error is believed to have occurred July 3, and that heparin batch was first administered in the neonatal intensive care unit July 4. When nurses noticed the overdoses during routine blood work, they stopped using the heparin immediately and gave the infants medications to counter its effects. Two of the infants, a twin brother and sister born a month prematurely, died the following week, though the hospital said its physicians have found no direct links to the overdose of heparin. Hospital officials said autopsies were being conducted, and the Texas Department of State Health Services is conducting a review.
Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 278 as of July 18, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site, www.nabp.net.
- Kenco VPI is part of Kenco Group, Inc, which operates approximately 100 third-party logistics facilities for a myriad of manufacturers. The company received accreditation for its Chattanooga, TN facility.
- Priority Healthcare Distribution, Inc, dba CuraScript SD Specialty Distribution is a subsidiary of Priority Healthcare Corporation. The company received accreditation for the following two facilities:
- The Groveport, OH facility provides third-party logistical services for Reliant and Parenta prescription drug manufacturers.
- The Grove City, OH facility provides a full range of prescription and sundry items to physicians and surgery centers in 45 states.