Legal
Enough! Health Wellness — Required disclosures for compounded prescription medications
Please read before receiving a prescription for any compounded medication.
Required FDA Disclosure
Compounded medications are prepared by a licensed compounding pharmacy and are NOT approved by the U.S. Food and Drug Administration. They are dispensed only pursuant to a prescription from a licensed clinician who has determined the treatment is appropriate for you. Not all patients will qualify. Side effects are possible; your clinician will review your health history with you. Medication options and availability may change at any time without notice. This information is educational and is not a substitute for individualized medical advice.
Platform vs. Prescriber
Open Enrollment, Inc. (d/b/a Enough! Health Wellness) is a health education and program access platform. It is not a licensed medical provider, pharmacy, or compounder. Prescriptions are issued solely by licensed clinicians of OpenLoop Healthcare Partners, PC and its affiliated medical groups. Compounded medications are dispensed by independent, state-licensed compounding pharmacies — not by Enough! Health Wellness.
Compounding is the process by which a licensed pharmacist combines, mixes, or alters ingredients to create a medication tailored to an individual patient's needs. Compounded medications may be prescribed when a commercially available FDA-approved product does not meet a patient's clinical requirements — for example, due to dosage, delivery method, or ingredient sensitivities.
Not FDA-approved: Compounded medications have not been evaluated by the FDA for safety, efficacy, or quality. They are not subject to the same pre-market review as commercially manufactured drugs.
Prescription required: Compounded medications may only be dispensed pursuant to a valid prescription from a licensed clinician. Your clinician determines whether compounding is appropriate for your individual medical need.
Side effects are possible: As with any medication, compounded drugs carry risks. Your clinician will review relevant risks during your consultation. Contact your clinician or a healthcare provider immediately if you experience an adverse reaction.
Pharmacy standards: Compounding pharmacies used through our clinical partner network are licensed in the states in which they operate and are required to comply with applicable USP standards and state pharmacy board regulations.
Availability may change: Compounded medications are subject to ingredient availability, pharmacy capacity, and evolving federal and state regulations. Specific formulations may be discontinued or substituted without prior notice.
Not for emergencies: Compounded medications prescribed through this platform are not appropriate for acute or emergency medical conditions. If you are experiencing a medical emergency, call 911 or go to the nearest emergency room.
Programs offering compounded semaglutide or tirzepatide involve medications that are not the same as branded FDA-approved products such as Ozempic®, Wegovy®, Mounjaro®, or Zepbound®. Compounded versions are prepared by licensed compounding pharmacies and are not manufactured by or affiliated with the holders of those brand names. Compounded GLP-1 medications are not reviewed by the FDA for safety, effectiveness, or quality and are prescribed at the discretion of a licensed clinician based on individual medical need.
Questions about your compounded medication?
Contact your prescribing clinician or reach us at support@enoughhealthwellness.com.
By participating in any Enough! Health Wellness program that includes a compounded medication, you acknowledge that you have read and understood these disclosures.