• •FDA approved a higher dose semaglutide on March 19, 2026 under the CNPV program
• •CNPV targets 1-2 month review times vs. 6+ months for standard priority review
• •FDA held a public hearing on June 4, 2026 to gather feedback on the CNPV pilot

The FDA published a list of websites selling unapproved products that claim to treat serious diseases like diabetes and cancer. One company, MGX Essentials, was cited for selling a product called GLP-1 Pro Six In-One Health Solution that was marketed for health purposes without FDA approval.

• •MGX Essentials Co. (dba MuscleGymX) cited for selling 'GLP-1 Pro Six In-One Health Solution Oral Liquid'
• •Companies have 30 days to fix violations or be listed as non-compliant
• •FDA warns some sites falsely suggest their products are endorsed or approved by FDA

• •FDA inspected Pharmathen International S.A. in Greece, Nov 10–21, 2025
• •Warning letter cites sterile manufacturing violations including gram-negative microbes in ISO 5 air samples
• •Firm's Dec 15, 2025 response deemed inadequate by FDA

The FDA warned NativeMed, a Miami-based compounding pharmacy, for making false claims about its weight-loss drugs semaglutide and tirzepatide. The agency said NativeMed's website falsely suggested the compounded versions were FDA-approved and implied NativeMed made the drugs when it did not.

• •FDA reviewed NativeMed's website in March 2026 and issued warning letter on June 8, 2026
• •NativeMed's logo appeared on tirzepatide product labels, falsely implying it was the compounder
• •Website claimed compounded semaglutide contained 'The same active ingredient in Ozempic® and Wegovy®'

The FDA warned Eden Health International for making false claims about its compounded semaglutide and tirzepatide drugs. The company falsely labeled itself as the maker of the drugs and claimed its suppliers were "FDA-licensed," which doesn't exist—the FDA does not formally license compounding pharmacies.

• •FDA issued warning letter to Eden Health International (Denver, CO) on June 8, 2026
• •Eden labeled itself as compounder of semaglutide and tirzepatide products when it is not
• •Eden falsely claimed suppliers were 'FDA-licensed 503(a) outsourcing facilities' — no such designation exists

The FDA sent Altru Telehealth a warning letter for making false claims about compounded semaglutide and tirzepatide drugs on its website. The company claimed the drugs were FDA-approved and that compounding pharmacies were FDA-licensed, which is illegal — compounded drugs are not FDA-approved, and pharmacies don't receive FDA licenses.

• •FDA sent Altru Telehealth a warning letter dated June 8, 2026 (ref MARCS-CMS 728274)
• •Altru claimed compounded semaglutide 'offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy'
• •Altru must respond in writing within 15 business days or face seizure and injunction

The FDA warned AM RX, an online pharmacy, for making false claims about its compounded semaglutide and tirzepatide products. The company falsely suggested its products were FDA-approved and implied it made the drugs when it didn't.

• •FDA issued warning letter to FitRX LLC dba AM RX on June 8, 2026 (ref MARCS-CMS 728275)
• •AM RX labeled products as 'AM Rx' despite not being the actual compounder of the drugs
• •Website claimed semaglutide was 'the active ingredient in FDA-approved medications' — compounded drugs are not FDA-approved

The FDA warned Harper Meds, an online pharmacy, for making false claims about compounded semaglutide and tirzepatide drugs on its website. The agency said Harper Meds falsely claimed the drugs were FDA-approved and came from FDA-licensed facilities, which is illegal.

• •FDA issued warning letter MARCS-CMS 728281 to Harper Meds on June 8, 2026
• •Harper Meds falsely claimed compounded semaglutide had 'Same active ingredient as Ozempic & Wegovy'
• •Site falsely stated products came from 'FDA-licensed 503A Outsourcing Facilities' — no such designation exists

The FDA told D&H Medical Services to stop making false claims about its compounded weight-loss drugs semaglutide and tirzepatide. The company claimed its copies were the "same ingredient" as the brand-name drugs Ozempic, Rybelsus, and Mounjaro, but compounded drugs are not FDA-approved and cannot make those claims.

• •FDA issued warning letter MARCS-CMS 728238 to D&H Medical Services on June 8, 2026
• •D&H claimed compounded semaglutide/tirzepatide were 'Same ingredient as Ozempic®', 'Same ingredient as Mounjaro®'
• •FDA reviewed D&H's website in March 2026; company must respond within 15 business days

The FDA issued a warning letter to Amie Health for making false claims about compounded semaglutide and tirzepatide on its website. The company claimed these copies contain the same ingredients as brand-name drugs and used FDA-approved language, but compounded drugs are not FDA-approved.

• •FDA issued warning letter to Amie Health (Miami, FL) on June 8, 2026
• •Amie's site claimed Ozempic, Mounjaro, and Wegovy contain same active ingredients as its compounded versions
• •Amie claimed to use FDA-approved active ingredients; compounded drugs are not FDA-approved

The FDA warned Medica Weight Loss for making false claims about compounded semaglutide and tirzepatide on its website. The company falsely claimed the drugs were FDA-approved and sourced from an 'FDA-approved pharmacy'—neither statement is legal for compounded drugs.

• •FDA warned Medica Weight Loss (Aventura, FL) on June 8, 2026 for false claims about compounded semaglutide and tirzepatide
• •Website falsely claimed compounded drugs were 'FDA-approved' and sourced from an 'FDA-approved pharmacy'
• •Medica must respond in writing within 15 business days or face seizure and injunction

The FDA warned HydraMed, a Colorado pharmacy, for making false claims about its compounded semaglutide and tirzepatide products. The company falsely labeled itself as the maker of these drugs and claimed to be an FDA-approved pharmacy, which doesn't exist.

• •FDA issued warning letter to HydraMed IV LLC, Denver CO, dated June 8, 2026
• •HydraMed falsely labeled itself as maker of compounded semaglutide and tirzepatide products
• •HydraMed falsely claimed products came from an 'FDA-approved pharmacy,' a designation that does not exist

The FDA fined Nova Vascular (NOVARX), a compounding pharmacy, for making false claims about cheap copies of semaglutide and tirzepatide on its website. The company claimed its drugs were FDA-approved and sourced from FDA-approved pharmacies, which is illegal — compounded drugs are not FDA-approved, and pharmacies don't get FDA licenses.

• •FDA issued warning letter to Nova Vascular LLC dba NOVARX on June 8, 2026
• •NOVARX website claimed compounded drugs sourced from 'FDA Approved Pharmacies' — false per FDA
• •FDA reviewed NOVARX website at https://novarx.co in March 2026; FEI 3044022416

The FDA fined Momentum Health 360 for making false claims on its website about compounded weight-loss drugs like semaglutide and tirzepatide. The company falsely said its compounded drugs were FDA-approved and that it was a licensed compounder, when compounded drugs are not FDA-approved and pharmacies don't get FDA licenses.

• •FDA issued warning letter MARCS-CMS 728286 to Momentum Health 360 on June 8, 2026
• •Website falsely claimed compounded semaglutide and tirzepatide were from an 'FDA-licensed' facility
• •Violations found during FDA website review conducted in March 2026; company has 15 business days to respond

The FDA warned OrderlyMeds, a compounding pharmacy, that it made false claims about selling weight-loss drugs like semaglutide and tirzepatide. The company falsely said it was an FDA-licensed pharmacy and put its logo on drug labels it didn't actually make.

• •FDA issued warning letter MARCS-CMS 728291 to OrderlyMeds LLC, Decatur GA, on June 8, 2026
• •OrderlyMeds falsely claimed its compounded drugs came from an 'FDA-licensed pharmacy'
• •OrderlyMeds placed its own logo on drug labels for products it did not actually compound

The FDA warned Fitish, a compounding pharmacy, that it broke federal law by selling homemade versions of semaglutide and tirzepatide (weight-loss drugs) with false claims on its website. The company falsely suggested it made the drugs itself and implied they were FDA-approved, which is illegal for pharmacy-made copies.

• •FDA issued warning letter MARCS-CMS 728280 to Fitish, Fort Worth TX, dated June 8, 2026
• •Fitish website offered compounded semaglutide and tirzepatide with FITISH label, despite not being the compounder
• •FDA review was conducted in March 2026; Fitish has 15 business days to respond

The FDA warned Joi + Blokes, a Colorado company, for making false claims about compounded semaglutide and tirzepatide (copycat versions of Ozempic, Wegovy, and Mounjaro). The company's website falsely suggested these drugs were FDA-approved and that Joi + Blokes made them, when neither is true.

• •FDA issued warning letter MARCS-CMS 728283 to Joi + Blokes of Denver, CO on June 8, 2026
• •Joi + Blokes website falsely labeled products with its own name, implying it was the compounder when it was not
• •Website claimed compounded semaglutide was 'bioidentical with more expensive brands' like Ozempic and Wegovy

• •Number of registered outsourcing facilities has remained relatively stable since 2019
• •FDA launched a cross-sector stakeholder group in 2022 with agency and outsourcing facility reps
• •Studies show wide variation in CGMP expertise and resources across outsourcing facilities

The FDA warns that compounded drugs are not reviewed for safety before being sold, and poor quality drugs can cause serious harm or death. The agency is working to balance letting patients access compounded drugs they need while protecting them from unsafe products made in dirty facilities.

• •Compounded drugs are not FDA-approved and not reviewed for safety, effectiveness, or quality before marketing.
• •FDA continues to find insanitary conditions at compounding facilities during inspections.
• •Poor-quality or contaminated compounded drugs can cause serious injury or death.

• •FDA issued guidance to telehealth companies on promoting compounded drugs
• •Compounded drugs are not FDA approved — FDA does not review safety, effectiveness, or quality
• •FDA compounding program aims to protect patients while preserving access for those with medical need

The FDA warned telehealth companies to stop making false claims when selling compounded GLP-1 drugs and other medicines. The agency said companies cannot claim these drugs are FDA-approved, generic, or the same as name-brand versions—because compounded drugs are not reviewed by the FDA before they're sold.

• •FDA warns telehealth companies against calling compounded GLP-1s FDA-approved or generic versions of brand drugs.
• •Compounded drugs are not reviewed by FDA for safety, effectiveness, or quality before they are sold.
• •FDA has already issued warning letters to telehealth companies; searchable via 'telehealth' in its warning letter database.

• •FDA launched AEMS on March 11, 2026, replacing the FAERS database
• •AEMS consolidates adverse event reporting across all FDA-regulated product categories
• •AEMS uses AI-based redaction and digitization tools for safety surveillance

• •1-13-2026: FDA requests removal of suicidal behavior and ideation warning from GLP-1 RA medications
• •6-10-2026: FDA approves labeling changes for OTC weight loss drug alli (Orlistat) to warn of kidney stones and kidney injury
• •1-11-2024: FDA update on ongoing evaluation of suicidal thoughts in patients taking diabetes and obesity medicines

The FDA tracks complaints and safety problems with compounded drugs—medicines mixed by pharmacies instead of drug makers—through its Compounding Incidents Program. The program investigates reports of bad reactions, contamination, or quality issues and can inspect facilities, issue warnings, or ask states to take action.

• •FDA's Compounding Incidents Program reviews adverse events and product quality complaints from 503A and 503B facilities.
• •In FY2021, the program issued 72 notification letters to 19 states across multiple regulatory boards.
• •503B outsourcing facilities must report serious unexpected adverse events to FDA within 15 calendar days.

The FDA warns that compounded drugs (custom-made medicines from pharmacies) are not reviewed for safety before sale and can have quality problems like contamination. The agency says people should ask their doctor if their medicine is compounded and report any bad side effects to the FDA.

• •Compounded drugs are not FDA-approved and not reviewed for safety or effectiveness before sale.
• •Poor compounding practices can cause contamination or wrong drug strength, leading to patient injury or death.
• •FDA says some compounders made false claims that their drugs were safe and effective for serious diseases.

The FDA warned patients and doctors about risks from unapproved weight-loss drugs like semaglutide and tirzepatide made by compounding pharmacies. The agency found problems with storage, fake products, wrong doses, and counterfeit versions that could harm patients.

• •As of July 31, 2025, FDA received 605 adverse event reports for compounded semaglutide
• •As of July 31, 2025, FDA received 545 adverse event reports for compounded tirzepatide
• •Retatrutide and cagrilintide cannot be used in compounding under federal law

• •FDA Compounding Quality Center of Excellence offers free recorded webinars
• •Topics cover cleanrooms, environmental monitoring, and outsourcing facility inspections
• •One webinar explains Form 483 inspection observations and how compounders should respond

• •FDA issued warning letter 320-26-77 to Alchymars ICM SM Private Limited on May 21, 2026
• •Inspection found cracked gaskets, rust on product-contact surfaces, and standing water on production floors
• •Facility located in Alathur, Tamil Nadu, India; inspected November 28 to December 4, 2025