FDA Warns San Diego Pharmacist Over Unapproved Retatrutide and Tirzepatide Sales
Bernard Gramlich, founder of GRAM peptides and a former Rancho Santa Fe pharmacist, has agreed to stop selling retatrutide and tirzepatide injections online after receiving a formal warning letter from the FDA in March, according to reporting from 10News San Diego. The products were sold alongside bacteriostatic water for injection, despite the site’s stated research use only labeling.
The FDA found evidence the products were intended for human use rather than research purposes, and Gramlich has since removed the listings and stopped offering both compounds to consumers.
Background
Retatrutide remains an investigational compound still in clinical trials and has not received FDA approval in any form. Tirzepatide is FDA approved and legally sold under the brand names Mounjaro and Zepbound, but only through licensed pharmacy channels with a prescription, not as an unregulated injectable sold direct to consumers. The FDA’s warning letter noted that injectable products bypass the body’s natural defenses against contamination, making sourcing and sterility standards a direct safety issue rather than a paperwork technicality.
A Pattern That Predates the Warning Letter
The FDA warning followed a separate and more serious finding from the Medical Board of California. Gramlich surrendered his pharmacist license in July 2025 after being accused of compounding drugs inside the office of Sorrento Valley physician Dr. Ronald Cohen, at Coastal Regenerative Wellness Center, in what investigators described as a non-sterile environment lacking hygiene equipment, air filtration, and easily cleanable surfaces. The board’s accusation states Gramlich continued compounding drugs at the office after surrendering his license, and that his pharmacy, Fairbanks Pharmacy, was never licensed as a compounding pharmacy at all.
A settlement document tied to the case describes vials of medication found stored in a coffee cup inside a freezer with no seals, along with ten vials of a sterile product compounded from non-sterile ingredients. Investigators also found beyond-use dates on labels that postdated when the compounding components had actually expired. Gramlich admitted to the allegations as part of the settlement but disputed how the matter has since been characterized publicly, telling 10News he is not aware of any patient injury or adverse event connected to his compounding work in twenty-five years of practice. Cohen has not yet had his hearing before the medical board.
Where the RUO Label Broke Down
The FDA warning letter is the part of this story most relevant to legitimate research peptide suppliers. Gramlich’s site described its retatrutide and tirzepatide products as research use only, a label that exists to draw a firm line between substances sold for laboratory and research applications and substances marketed for human injection. The FDA’s letter states plainly that despite the RUO claim, the agency found evidence the products were intended for human use. That is the specific violation, not the RUO framework itself.
Implications for Research Peptide Suppliers
This case lands inside a broader pattern. The FDA has spent much of 2026 tightening its posture on compounded GLP-1 and peptide products generally, including a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list altogether. As commentary published on KevinMD has noted, legitimate compounding is a patient-specific practice performed by a licensed pharmacist for a documented clinical need. It is categorically different from mass-marketing a product online while relying on an RUO label to sidestep that requirement. The Fairbanks Pharmacy case shows what happens when that line gets crossed: an unlicensed compounding operation, non-sterile conditions, and a research use only label applied to a product being sold for injection.
For laboratories and researchers sourcing compounds like retatrutide for legitimate research purposes, the standard is the inverse of what this case describes: no human-use claims, no clinical or medical framing, and documentation that supports the research use only designation rather than working around it.
FDA Warns San Diego Pharmacist Over Unapproved Retatrutide and Tirzepatide Sales
FDA Warns San Diego Pharmacist Over Unapproved Retatrutide and Tirzepatide Sales
Bernard Gramlich, founder of GRAM peptides and a former Rancho Santa Fe pharmacist, has agreed to stop selling retatrutide and tirzepatide injections online after receiving a formal warning letter from the FDA in March, according to reporting from 10News San Diego. The products were sold alongside bacteriostatic water for injection, despite the site’s stated research use only labeling.
The FDA found evidence the products were intended for human use rather than research purposes, and Gramlich has since removed the listings and stopped offering both compounds to consumers.
Background
Retatrutide remains an investigational compound still in clinical trials and has not received FDA approval in any form. Tirzepatide is FDA approved and legally sold under the brand names Mounjaro and Zepbound, but only through licensed pharmacy channels with a prescription, not as an unregulated injectable sold direct to consumers. The FDA’s warning letter noted that injectable products bypass the body’s natural defenses against contamination, making sourcing and sterility standards a direct safety issue rather than a paperwork technicality.
A Pattern That Predates the Warning Letter
The FDA warning followed a separate and more serious finding from the Medical Board of California. Gramlich surrendered his pharmacist license in July 2025 after being accused of compounding drugs inside the office of Sorrento Valley physician Dr. Ronald Cohen, at Coastal Regenerative Wellness Center, in what investigators described as a non-sterile environment lacking hygiene equipment, air filtration, and easily cleanable surfaces. The board’s accusation states Gramlich continued compounding drugs at the office after surrendering his license, and that his pharmacy, Fairbanks Pharmacy, was never licensed as a compounding pharmacy at all.
A settlement document tied to the case describes vials of medication found stored in a coffee cup inside a freezer with no seals, along with ten vials of a sterile product compounded from non-sterile ingredients. Investigators also found beyond-use dates on labels that postdated when the compounding components had actually expired. Gramlich admitted to the allegations as part of the settlement but disputed how the matter has since been characterized publicly, telling 10News he is not aware of any patient injury or adverse event connected to his compounding work in twenty-five years of practice. Cohen has not yet had his hearing before the medical board.
Where the RUO Label Broke Down
The FDA warning letter is the part of this story most relevant to legitimate research peptide suppliers. Gramlich’s site described its retatrutide and tirzepatide products as research use only, a label that exists to draw a firm line between substances sold for laboratory and research applications and substances marketed for human injection. The FDA’s letter states plainly that despite the RUO claim, the agency found evidence the products were intended for human use. That is the specific violation, not the RUO framework itself.
Implications for Research Peptide Suppliers
This case lands inside a broader pattern. The FDA has spent much of 2026 tightening its posture on compounded GLP-1 and peptide products generally, including a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list altogether. As commentary published on KevinMD has noted, legitimate compounding is a patient-specific practice performed by a licensed pharmacist for a documented clinical need. It is categorically different from mass-marketing a product online while relying on an RUO label to sidestep that requirement. The Fairbanks Pharmacy case shows what happens when that line gets crossed: an unlicensed compounding operation, non-sterile conditions, and a research use only label applied to a product being sold for injection.
For laboratories and researchers sourcing compounds like retatrutide for legitimate research purposes, the standard is the inverse of what this case describes: no human-use claims, no clinical or medical framing, and documentation that supports the research use only designation rather than working around it.