Food and Drug Administration (FDA) is alerting health care providers that a counterfeit version of Botox® has been found in the United States, and may have been sold to doctors’ offices and clinics throughout the country. The counterfeit products may be identified by a missing lot number on the vial, missing information on the carton (next to LOT, MFG, and EXP), and a displayed active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.” The counterfeit products were sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the US, according to an FDA Drug Safety Alert. The agency advises health care providers to confirm that the distributor from which they purchase Botox is authorized by Allergan, the drug’s manufacturer. No adverse events related to this product have been reported to FDA.
Medical practices that purchase and administer counterfeit, illegal, and unapproved medications from unlicensed or foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment, warns FDA. Wholesale drug distributors must be licensed in the states where they conduct business. Suspicious Botox products may be reported to FDA’s Office of Criminal Investigations.
One way pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors® (VAWD®) Seal. Wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws, as well as NABP’s VAWD criteria. Wholesale distributors that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, 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.