A doctor running a largely online obesity practice has urged the US Food and Drug Administration to take tougher action against companies selling compounded GLP-1 drugs through telemedicine platforms.
The doctor said the FDA should make clear that lower cost alone is not a medical justification for compounding, and that unapproved versions of GLP-1 medicines should not be presented as equivalent to commercially approved treatments.
The call comes as demand for GLP-1 drugs has fuelled a growing market for compounded versions promoted as cheaper and more accessible alternatives. The products can have similar names, claims and injector pens to approved medicines, despite undergoing different levels of oversight.
Concerns over compounded GLP-1 medicines
Compounded drugs are not subject to the same inspections and reviews as commercially manufactured medicines. While some compounding pharmacies follow proper procedures, provide certificates of analysis and arrange third-party testing, others do not, the doctor said.
Patients buying medicines online may not know which version they are receiving, or whether they have been told clearly that the product is compounded. The doctor also raised concerns about sterility failures, dosing mistakes and whether the contents of a vial match its label.
Earlier this year, the FDA sent warning letters to 30 telehealth companies over advertising that allegedly blurred the distinction between approved and compounded GLP-1 drugs. The doctor argued that warnings alone had not done enough to deter companies from selling the products.
Federal law allows pharmacies to compound medicines for an individual medical need, such as an allergy to an ingredient or an inability to swallow a tablet. It also permits compounding to address temporary shortages.
However, after GLP-1 shortages ended more than a year ago, some sellers began adding substances such as vitamin B12 and marketing the resulting products as personalised medicines, according to the doctor. The combinations have not been studied in people, the doctor said, arguing that mass production of such products could not reasonably be regarded as a medical necessity.
The doctor said patients prescribed obesity medicines should receive continuing medical supervision rather than simply completing an online questionnaire. Relevant considerations include a history of diabetes, sleep apnoea or an eating disorder, as well as possible interactions with other medicines.
Monitoring body composition during treatment was also described as important because rapid weight loss without adequate protein could compromise muscle and bone. A recent study of compounded GLP-1 sellers found little clinician involvement, with some orders reportedly approved in less than five minutes.
The doctor acknowledged that high prices and inconsistent insurance coverage had helped create demand for lower-cost alternatives. But they argued that patients could not be sure they were receiving a safe product, making the apparent saving potentially misleading.
Concerns were also raised about a recommendation by an FDA advisory panel last month to add six unapproved peptides to the list of substances that can be compounded in bulk, despite what the doctor described as limited human evidence.
The doctor said telemedicine could widen access to specialist care, particularly for chronic conditions, but maintained that digital convenience should not replace clinical judgement or regulatory safeguards.
The FDA was urged to state that prescribing compounded GLP-1 medicines without a genuine medical need could put patients at risk and leave doctors’ licences exposed to scrutiny.
