Drugs

FDA: Website Selling Misbranded, Unapproved Drugs

FDA says its review of a Web site maintained by www.buynetmeds.com determined that it is selling misbranded and unapproved new drugs. A just-released 6/12 Warning Letter says the agency observed that the site introduces into interstate commerce unapproved and misbranded opioid drug products. The letter also says FDA has observed that the site ships unapproved and misbranded semaglutide products, including injectable forms.

Buynetmeds.com is selling tapendatol, an opioid, marketed under multiple brand names, FDA says. The letter quotes evidence from the Web site that establishes that the products are drugs intended for human use.

“While there are FDA-approved versions of tapendatol on the market in the U.S.,” the letter says, “there are no approved drug applications in effect” for the company’s products.

The letter covers the same types of information for the company’s semaglutide products, which also do not have any approved applications.

FDA says the Web site offers prescription drugs for sale without a prescription, which jeopardizes patient safety and misbrands the drugs.

“FDA is sending this Warning Letter to www.buynetmeds.com because of the inherent risk to consumers who purchase misbranded and unapproved new drugs,” the letter says…. “We advise you to review your Web sites, product labels, and other labeling to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violations of the Federal Food, Drug, and Cosmetic Act.”

The Web site owners were told to respond with a list of specific steps they have taken to address the violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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