ShapeUp Weight & Wellness may prescribe compounded medications when, in the professional judgment of the prescribing provider, a compounded medication is medically appropriate for an individual patient.
What is a compounded medication?
Compounded medications are medications prepared by a pharmacy or other authorized compounder to meet a patient's individual medical needs. Compounded medications are not FDA-approved. The FDA does not review compounded medications before they are marketed to determine their safety, effectiveness, or quality in the same manner as FDA-approved medications.
Compounded medications are not generic versions of FDA-approved medications and should not be considered interchangeable with FDA-approved medications.
Why might a compounded medication be prescribed?
Your provider will evaluate your medical history, current medications, health conditions, treatment goals, and other relevant factors when determining whether a particular treatment is appropriate. When an FDA-approved medication is not appropriate or does not adequately meet a patient's individual medical needs, a compounded medication may be considered when permitted by applicable law.
The decision to prescribe a compounded medication is made on an individual patient basis. A compounded medication is not prescribed solely because it may be less expensive or more convenient than an FDA-approved medication.
Important Considerations and Risks
Because compounded medications have not undergone FDA premarket review, there may be greater uncertainty regarding their safety, effectiveness, quality, consistency, labeling, packaging, or other characteristics compared with FDA-approved medications.
Compounded medications may also differ in concentration, formulation, dosage form, packaging, or administration instructions from FDA-approved medications. Patients should carefully follow the specific dosing and administration instructions provided by ShapeUp Weight & Wellness and the dispensing pharmacy.
For compounded injectable medications, dosing errors can occur if patients misunderstand the concentration, volume, syringe markings, or prescribed dose. Patients should not change their dose or method of administration without first contacting their healthcare provider.
Compounded Semaglutide
If compounded semaglutide is prescribed, it is important to understand that the compounded medication is not FDA-approved. ShapeUp Weight & Wellness does not represent or imply that compounded semaglutide is the same as, equivalent to, interchangeable with, or a generic version of any FDA-approved semaglutide product.
The FDA has reported medication errors and adverse events associated with some compounded injectable semaglutide products, including errors related to differences in concentrations and dosing measurements.
Your provider will discuss the prescribed medication, dose, administration instructions, potential benefits, risks, alternatives, and questions you may have before treatment.
Pharmacy and Medication Sourcing
Compounded medications prescribed through ShapeUp Weight & Wellness are dispensed by a pharmacy or other authorized compounding facility selected in accordance with applicable requirements.
ShapeUp Weight & Wellness is not the compounding pharmacy and does not manufacture the compounded medication.
The pharmacy is responsible for compounding and dispensing the medication according to the prescription and applicable requirements.
Your Choices
You may discuss FDA-approved treatment options and other alternatives with your provider at any time. You are not required to use a compounded medication. Your provider will discuss available treatment options and help you determine which option is appropriate based on your individual medical circumstances.
By proceeding with treatment involving a compounded medication, you acknowledge that:
- You understand that compounded medications are not FDA-approved.
- You understand that the FDA does not review compounded medications before marketing for safety, effectiveness, or quality in the same manner as FDA-approved medications.
- You understand that compounded medications are not generic versions of FDA-approved medications.
- You understand that compounded medications may carry additional uncertainties and risks related to formulation, concentration, labeling, packaging, or dosing.
- You agree to follow the dosing and administration instructions provided by your healthcare provider and dispensing pharmacy.
- You agree to contact ShapeUp Weight & Wellness with questions or concerns about your medication rather than changing the dose on your own.
- You understand that FDA-approved treatment options and other alternatives may be available and may be discussed with your provider.
Questions? Email care@shapeupweightwellness.com.