Additional Information

Description

Semaglutide Compound BPI 1 mg/ml is a compounded medication prepared with semaglutide (a GLP-1 receptor agonist) intended for use in specific clinical circumstances by licensed healthcare professionals. This product is compounded from base-form semaglutide sourced from FDA-registered manufacturers and produced according to stringent quality controls. It is not FDA-approved and may only be used where FDA-approved alternatives are unavailable or clinically inappropriate in accordance with FDA regulations. Not for general consumer use.

This product is compounded by BPI LABS, a licensed pharmacy, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) sections 503A or 503B, as applicable to BPI LABS's registration status. IT IS NOT AN FDA-APPROVED DRUG. The FDA has not evaluated this compounded preparation for safety, efficacy, or quality. It does not carry an FDA-approved label. 

This semaglutide sodium (GLP-1) compound is prepared for an identified individual patient based on a valid prescription from a licensed practitioner, meeting the requirements of applicable state and federal compounding laws. It is intended for use when an FDA-approved drug product is not suitable or available to meet the specific medical needs of that patient (e.g., specific strength, dosage form, or allergen exclusion).

This compounded product is NOT a therapeutic equivalent or generic version of any FDA-approved semaglutide product (such as Ozempic®, Wegovy®, or Rybelsus®). It should not be substituted for an FDA-approved product without the explicit direction of the prescribing practitioner based on individual patient need. 

Dispensed only pursuant to a valid prescription order for an individual patient. The product is explicitly supplied for office use under applicable regulations. This product contains Semaglutide Sodium as the Active Pharmaceutical Ingredient (API), which is sourced from an FDA-registered facility. Other ingredients (e.g., solvent, preservative if used, and pH adjuster) comply with USP standards where applicable. Specific inactive ingredients may vary per prescription order. For subcutaneous injection only. Dosing must be determined and supervised by a qualified healthcare professional.

Supplied in a sterile, single-dose or multi-dose vial (as specified on the pharmacy prescription label), intended for single-patient use only. Compounded for the treatment of conditions as determined by the prescribing healthcare professional, consistent with the medical need justifying compounding.

Important Safety Notice: Compounded drugs, including this Semaglutide Sodium Injection, do not undergo the same pre-market FDA review for safety, effectiveness, and quality as FDA-approved drugs. Patients and prescribers should be aware of this difference.