A medical office manager in Tennessee pled guilty to misdemeanor charges that she imported non-FDA-approved cancer medications from the United Kingdom to the clinic where she worked in Chattanooga. The information sheet indicates that the medical office manager received the misbranded drug Taxotere®. A misbranded drug is a “drug that was manufactured, prepared, propagated, compounded, and processed in an establishment not duly registered with the FDA.” The information sheet also states “that the drug came from a foreign drug establishment and that drug was not annually listed with the FDA by that establishment as one of the drugs which was being manufactured for commercial distribution in the United States at that drug establishment.”
Chattanoogan.com reports that the medical office manager ordered the drugs from Quality Special Products in Winnipeg, Canada, but the drugs originated from Great Britain. Quality Special Products was offering US health care providers drugs for sale that had been obtained from foreign sources and had not been approved by FDA for distribution or use in the US, notes the Chattanoogan.com article.
FDA is urging health care providers to purchase drug products from legitimate suppliers only. Additional information about rogue wholesale drug distributors and how to safely purchase prescription drugs is provided in an FDA resource, “Know Your Source: Protecting Patients from Unsafe Drugs,” available on FDA’s website.
One way health care providers can be assured of the legitimacy of a wholesale drug distributor is to verify that they are accredited through the NABP Verified-Accredited Wholesale Distributors®(VAWD®) program. Providers may check NABP’s website for a list of VAWD-accredited facilities. Wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws, as well as NABP’s VAWD criteria. In addition, many states recognize VAWD as a component of licensure in their state. Wholesale distributors that have VAWD accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo an on-site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.