This medication is a compounded preparation of tirzepatide with vitamin B6, prepared by a licensed pharmacy. It is not FDA-approved, and has not been evaluated for safety, efficacy, or quality by the
This compounded preparation may differ in strength, purity, sterility, and stability compared to FDA-approved products.
28-Day Sterility Guidance
Under United States Pharmacopeia (USP) <797> and <787> compounding standards, pharmacies are required to apply a 28-day beyond-use date (BUD) once a multi-dose vial is first punctured. The manufacturer has not guaranteed sterility beyond 28 days after puncture. Use of this vial beyond that timeframe carries increased risk of contamination and infection. You may choose, in consultation with your prescriber, whether to continue use after this date, but you acknowledge that such use is at your own risk.
Patient Responsibilities
- Store medication properly (refrigerated at 36-46°F / 2-8°C
- Inspect solution before each use (discard if discolored, cloudy, or contains particles.
- Use aseptic injection technique as instructed by your healthcare provider.
- Record the date of first vial puncture.
- Do not share this medication with others.
Risks and Side Effects
Possible side effects include nausea, vomiting, diarrhea, abdominal pain, decreased appetite, injection site reactions, pancreatitis, gallbladder problems, hypoglycemia (especially if on other diabetes meds), and other unanticipated risks. Contact your provider immediately for severe abdominal pain, persistent vomiting, jaundice, or signs of infection.
Legal Acknowledgment
By signing below, I acknowledge and agree that:
- I understand this medication is not FDA-approved and is a compounded preparation.
- I understand the risks of using medication beyond 28 days after puncture and accept full responsibility for my decision to continue or discontinue use.
- I release, discharge, and hold harmless the dispensing pharmacy, its pharmacists, employees, contractors, and the prescribing provider from any and all liability, damages, claims, or causes of action arising from the use or misuse of this compounded medication.
- I assume full responsibility for proper storage, handling, and administration of this
- I understand no guarantee or warranty of safety, efficacy, or effectiveness has been made
Assumption of Risk and Release
I voluntarily choose to receive this compounded medication and accept all associated risks. I agree not to hold the pharmacy or prescriber liable for any adverse outcomes related to its use, including but after the 28-day BUD has passed.