NABP e-News: November 12, 2008

November 12, 2008 12:00 am

FDA Seizes Contaminated Heparin from Cincinnati Manufacturer
United States Marshals have seized 11 lots of heparin from Celsus Laboratories Inc, in Cincinnati, OH. The five lots of heparin sodium active pharmaceutical ingredient and six lots of heparin lithium were seized on November 6, 2008, at Food and Drug Administration’s (FDA) request. These products, which were manufactured from material imported from China, had been found by FDA to be contaminated with over-sulfated chondroitin sulfate, a substance that mimics heparin's anticoagulant activity.

Celsus has distributed heparin sodium USP and heparin lithium to manufacturers in both the US and abroad. FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to ensure an effective recall.

FDA advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using an y heparin from the seized lots because the product does not meet acceptable quality standards. FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

CMS Extends Deadline for Prohibiting Use of Computer-Generated Faxed Prescriptions
Centers for Medicare and Medicaid Services (CMS) has extended its deadline for prohibiting computer-generated faxed prescriptions used by physicians who participate in Medicare by three years. The new deadline is January 1, 2012. The deadline change is included in the 2009 Medicare Physician Fee Schedule (MPFS) final rule announced by CMS on October 30, 2008. The final rule with comment will appear in the November 19, 2008 Federal Register. Comments on designated provisions are due on December 29, and a final rule responding to the comments will be published at a later date. The text of the MPFS final rule is available via the CMS Web site.

DEA Updates Form for Reporting Theft or Loss of Controlled Substances
Drug Enforcement Administration (DEA) has an updated electronic version of the DEA Form 106 for reporting the theft or loss of controlled substances through its online application system. Available for DEA registrants as of October 28, 2008, the updated electronic DEA Form 106 requires registrants to include the National Drug Code (NDC), which will help to accurately track controlled substances reported as stolen or lost. With the implementation of the NDC number, DEA will no longer require registrants to enter specific information pertaining to lost or stolen product. The paper version of DEA Form 106 is obsolete as of October 28, 2008.

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 292 as of November 7, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Baush and Lomb, Inc, stocks and distributes prescription pharmaceuticals, over-the-counter products, and devices in the areas of vision care, nutritionals, and vision accessories to customers internally. The company received accreditation for its Greenville, SC facility.
• Cardinal Health 200, Inc, dba Cardinal Health serves as a third-party logistics provider for Baxter Health, Inc. The company received accreditation for two of its facilities:
  • The Wilsonville, OR facility distributes peritoneal dialysis solutions and supplies to home dialysis patients, as well as specialized hospital surgical packs to hospitals.
  • The Champlin, MN facility supplies small units of prescription supplies to clinics and floor units of hospitals.
• McKesson Drug Company, a subsidiary of the publicly held McKesson Corporation, San Francisco, CA, is one of 32 regional suppliers of pharmaceutical products within the McKesson business family. The company received accreditation for its Tolleson, AZ facility.
• Patterson Logistics Services, Inc, formerly Patterson Dental Supply, Inc, distributes veterinary and human-dental prescription drugs and supplies to veterinarians, veterinary hospitals, and clinics, and dental offices. The company received accreditation for its Kent, WA facility.
• Smith's Food & Drug Centers, Inc, dba Peyton's Phoenix, owned by the Kroger Company, Cincinnati, OH, supplies general merchandise and pharmaceutical products to businesses in the Kroger family of businesses. The company received accreditation for its Phoenix, AZ facility.