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FDA puts former Rancho Santa Fe pharmacist on notice for selling unapproved weight-loss injections online
Doctor faces hearing for allowing pharmacist to compound drugs in his office
PrevNextManuel Balce Ceneta/AP
The Food and Drug Administration (FDA) building is shown in Silver Spring, Md., Dec. 10, 2020.
By:Austin Grabish
Posted
SAN DIEGO, Calif. — A former Rancho Santa Fe pharmacist has agreed to stop selling unapproved weight-loss injections online after receiving a formal warning from the FDA
Bernard Gramlich, founder of GRAM peptides, received a warning from the FDA in March for selling retatrutide and tirzepatide along with bacteriostatic water for injection
Retatrutide has not yet been FDA-approved and is still in clinical trials. Online websites and med spas have started selling it and users have reported dramatic weight loss on par with bariatric surgery. Tirzepatide is sold legally on the market under the brand names Mounjaro and Zepbound
“Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions,” the FDA’s letter states
The FDA’s warning letter said despite the peptide website’s claim the products were for research use only and not intended for human consumption, there was evidence the products were intended for human use
“With research-only peptide sellers, those are not legal product, and you should not be sourcing from those places,” said University of California San Diego professor Tim Mackey, who studies counterfeit GLP-1 drugs
Clinic lacked hygiene equipment
Gramlich surrendered his pharmacist’s license last July after he was accused of compounding drugs with a Sorrento Valley doctor in a non-sterile environment
According to a June accusation from the Medical Board of California, Dr. Ronald Cohen allowed Gramlich to compound drugs in his office for his patients at the Coastal Regenerative Wellness Center
Investigators alleged when they inspected the clinic last year, it “lacked, among other things, the necessary hygiene equipment, air filtration system and easily cleanable surface areas to ensure the sterility of compounded drugs.”
The accusation alleges Cohen allowed Gramlich, who owned and operated Fairbanks Pharmacy in Rancho Santa Fe, to bring an unknown person to his office to help compound the drugs
Sometimes that person would compound the drugs without Gramlich present, records show
‘Great risk to consumers’
The medical board alleges Gramlich continued to compound drugs in Cohen’s office after he surrendered his license and claims the doctor gave the medications to his patients
According to a settlement document, Gramlich’s pharmacy was never licensed as a compounding pharmacy
“There is a great risk to consumers if poor compounding practices are used,” the settlement document states
The pharmacy board alleged Gramlich claimed compounded semaglutide with L-Carnitine injection was FDA-approved for weight loss when it wasn’t
It said an inspection at his pharmacy revealed “unsafe handling of hazardous drugs” and the “improper storage of drugs.”
State records reveal investigators foundals on theonged to Cohen, who asked Gramlich to store them
The investigation into Gramlich also found he compounded 10
Investigators also said he misbranded drugs with a beyond-use label date that was “false and misleading” because the compounding components expired before the date put on the
Pharmacist says many allegations were inaccurate
The settlement document says Gramlich admitted to each of the allegations, but in a statement sent to Team 10 he refuted many of the pharmacy board’s findings. Instead, he told us that he surrendered his license to avoid spending more money on litigation
“I strongly dispute the way this matter has been characterized. The public record does not tell the full story, and many of the allegations made by the California State Board of Pharmacy were either inaccurate, incomplete, or presented without important context,” he said
Gramlich said he disputes any claim that Fairbanks Pharmacy represented a compounded semaglutide preparation as FDA-approved
“Semaglutide is the active ingredient in FDA-approved medications, but I understand that a compounded preparation itself is not FDA-approved. To the extent any wording was unclear or could have been interpreted otherwise, that was not my intent, and I did not intend to mislead patients or the public.”
He told Team 10 he’s had extensive training in sterile and non-sterile compounding during his career
“In approximately 25 years as a pharmacist, I never had a patient complaint or physician complaint regarding my compounding abilities. I am not aware of any patient injury, contamination event, failed sterility test, or adverse event tied to the compounding issues being described.”
Mackey said consumers should avoid any website that sells GLP-1 medications without a prescription. He said now that a lot of drug shortages have ended, compounded drugs shouldn’t be as available for sale as they are
“Because this environment is so confusing, it really is about patients educating themselves about the risks,” he said
As for the FDA warning, Gramlich said he removed the products after receiving the letter from the agency and is no longer offering retatrutide or tirzepatide to consumers
Cohen didn’t return requests for comment and now faces a hearing with the medical board
Investigative Reporter Austin Grabish can be reached at austin.grabish@10news.com
