FDA screens GLP-1 ingredients at the border and warns of vials tied to pharmacies that do not exist

Federal regulators have added GLP-1 active ingredients to a border screening list and warned that vials sold in the United States carry labels naming pharmacies that do not exist ^[1]. The step extends an enforcement campaign against unapproved versions of the diabetes and weight loss drugs, and it comes as California poison control centers report a surge in calls about unapproved GLP-1 products, including dosing errors from vials that patients draw themselves ^[1][2].

The FDA created what it calls a green list import alert covering GLP-1 ingredients with potential quality concerns ^[1]. The alert is designed to stop those ingredients from entering the U.S. supply chain while allowing continued importation from manufacturers that appear to meet the agency's manufacturing standards, based on inspection or other information ^[1]. Guidance updated the week of the announcement describes problems that reach patients directly, including medicine arriving warm and vials labeled with pharmacies that do not exist ^[1].

The California Poison Control System says it is receiving constant calls from people reporting that they got sick, and in some cases were hospitalized, after taking GLP-1 drugs — many of them unapproved compounds ^[2]. The FDA says unapproved GLP-1 medications can be riskier than approved ones because they do not undergo the same federal review for safety, effectiveness and quality before they are marketed ^[2].

The agency has also warned publicly about telehealth companies making claims such as compounded drugs being the same as FDA-approved drugs. According to the FDA, warning signs include significant discounts that seem too good to be true, a lack of instructions, and a lack of screening by a licensed doctor ^[2].

One patient's account in the reporting shows how a dosing problem can play out. Shawn Rose, who was living in Chicago, said his insurance denied coverage of a GLP-1 prescription in January and his primary doctor suggested telehealth ^[2]. He downloaded the Mochi Health app, paid about a couple hundred dollars a month, and received shipments of compounded semaglutide, the active ingredient in approved products such as Ozempic. He said the price was about a 75% saving compared with a doctor's office. The first vial seemed to go okay, he said, and then his dose was increased. Within about an hour to an hour and 15 minutes, he was rushed to the emergency room, and medical documents he provided show he went to the hospital multiple times ^[2]. Rose said Illinois state regulators are looking into his case and his complaint against a Mochi nurse. He also showed vials he said he received with no labels ^[2]. Mochi Health did not respond to the news outlet's questions, and its chief executive declined to answer questions in person at a health conference earlier this year ^[2].

The NBC Bay Area Investigative Unit reported in June that a pharmacy Mochi used in Washington closed after state investigators found it allowed and even directed untrained pharmacy assistants to compound GLP-1 drugs. Regulators also found unlicensed workers processing prescriptions and expired medications about to be sent to patients ^[2].

The Partnership for Safe Medicines, a safe-medicine advocacy group, says it has tracked 50 actions by state boards of pharmacy against compounders operating unsafely since last year, including probation and revoked licenses, along with 160 FDA letters to telehealth companies and compounders warning about deceptive marketing ^[2]. Its executive director, Shabbir Imber Safdar, said "the warning letters are only the start of the conversation about enforcement" and added, "You're not seeing enough of these get referred to the Department of Justice" ^[2]. The American Telemedicine Association said the problem is "not a telehealth issue, it's a bad actor issue" and that "a subset of bad actors shouldn't be used to cast doubt on telehealth as a delivery model" ^[2]. The FDA told the outlet it "will continue to take action, where appropriate, to protect public health" ^[2].

Why it matters for patients

Approved GLP-1 products — semaglutide sold as Ozempic, Wegovy and Rybelsus, and tirzepatide sold as Mounjaro and Zepbound — are reviewed by the FDA before they reach the market. Unapproved compounded versions are not ^[2]. That gap matters most when a vial is unlabeled or drawn by hand, because the person using it cannot confirm the drug, the concentration or the dose. Poison control centers have reported dosing errors from self-drawn vials ^[1].

Labels that name pharmacies with no registration remove another check, because a patient cannot look up the seller. The FDA has not published a list of the pharmacies named on the labels it warned about, and no national tally of illnesses tied to unapproved GLP-1 products has been disclosed ^[1][2]. The FDA also has not said how many shipments it has stopped at the border under the new import alert ^[1].

What happens next

The import alert remains in place while the agency screens inbound GLP-1 ingredients ^[1]. The FDA has said it will keep taking action where it considers it appropriate, but no dates for further enforcement steps, recalls or referrals have been announced ^[2].