Two names you will see on a compounded prescription
Personalized Compounded Semaglutide and Personalized Compounded Tirzepatide from Bodi Envi’s pharmacy partner are prepared in formulations that include either cyanocobalamin, which is vitamin B12, or glycine, an amino acid. The medication name on the vial says which one. Neither ingredient is part of the FDA-approved products. Wegovy® lists semaglutide with disodium phosphate dihydrate, propylene glycol, phenol and water for injection. Zepbound® lists tirzepatide with sodium chloride, sodium phosphate dibasic heptahydrate and water for injection. This article explains what the two add-ins are, why a compounding pharmacy includes them, and what is known about them, which is less than the marketing around them suggests.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What vitamin B12 is
Cyanocobalamin is the most common synthetic form of vitamin B12, a water-soluble vitamin the body needs for red blood cell formation, nerve function and DNA synthesis. B12 assists in red blood cell formation, supports myelin sheath that insulate nerve fibers, synthesizes serotonin and dopamine which can help lower anxiety and depression. B12 supports bone density and heart health.
What the fact sheet does not say is that B12 reduces nausea, increases energy in people who are not deficient, or changes weight. No trial has tested B12 combined with semaglutide or tirzepatide for any of those outcomes, and this article makes no such claim.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What glycine is
Glycine is the simplest amino acid. The body makes it, it is present in protein foods, and pharmaceutical manufacturers use it as a buffer or stabilizer in a number of injectable products, which is why it appears in the FDA’s Inactive Ingredient Database. In a compounded GLP-1 formulation it is included as part of the pharmacy’s formulation. Glycine can help with regulating the metabolism, calming brain activity, improve restfulness, supports healthy skin, increases collagen, and supplies energy to muscles.
As with B12, no trial has tested whether glycine changes side effects or results when combined with these medications.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
Why a compounding pharmacy includes them
Under federal law a licensed pharmacy may compound a medication for an individual patient from a prescription, and the FDA has said it will act against compounded products that are essentially copies of a commercially available drug unless the prescriber documents a difference that matters for that patient. A formulation that includes an additional ingredient is one of the ways a compounded product differs from the approved one. The decision to prescribe a formulation with B12 or with glycine, and at what strength, belongs to the licensed provider, informed by the patient’s history. Bodi Envi’s published price is the same whichever formulation the provider selects.
What this means for you
If you take a B12 supplement, have a history of B12 deficiency or pernicious anemia, follow a vegan diet, take metformin, or have any allergy to cobalt or cobalamin, tell your provider, because it is relevant to the formulation choice. If a vial you receive names an ingredient you were not expecting, ask the pharmacy or your care team before injecting. The FDA’s page on unapproved GLP-1 products describes dosing errors and other reports it has received about compounded medications, and the safest practice is to use only what was prescribed, exactly as prescribed, from a pharmacy that is licensed in your state.
This is general information and not medical advice. The labels describe Wegovy® and Zepbound®, the branded products. Personalized compounded semaglutide and tirzepatide are not FDA-approved, were not studied and are not equivalent to the branded products.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.