Fraudulent, unapproved versions of Botox^® are being sold by unlicensed suppliers to US medical practices, warns FDA. The company selling the fraudulent versions of Botox goes by the names “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” Although the name suggests otherwise, FDA notes that to date, it does not appear that the company is marketing the products over the Internet. Instead, the company has been using “blast faxes” sent to medical practices and offering the products at prices below those of FDA-approved products. FDA indicates that like many companies selling fraudulent products, Online Botox Pharmacy uses a US return address when sending packages to medical practices, even though the products are from foreign sources.

FDA advises that the unapproved Botox products are considered unsafe and should not be used. FDA explains that the outer carton of the product is counterfeit and displays the active ingredient as “Botulinum Toxin Type A,” while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the US. In addition, the lot numbers and expiration dates on the outer carton and accompanying vial do not match. FDA provides examples in a drug safety alert. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow US standards. FDA asks providers to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources to FDA’s Office of Criminal Investigations (OCI) by calling 800/551-3989, or by completing the online report form on the FDA OCI Web page. 

FDA-approved Botox for injection (100 units/vial), manufactured by Allergan, displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. Currently, there is no indication that Allergan’s FDA-approved version is at risk, and this product should be considered safe and effective for its intended and approved uses. 

Information about the unapproved Botox products has been added to a series of FDA alerts and letters to health care providers about the risk of buying medicines from foreign or unlicensed sources. FDA advises that health care providers should purchase prescription drugs either directly from the manufacturer or from wholesale drug distributors licensed in the US and provides a list of state agencies for assistance in verifying licensure. 

Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors^® (VAWD^®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and 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, a survey of their facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo a 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.