Prescription & Compounded Medication Disclosure
Prescription Treatment at OTR Health & Wellness
OTR Health & Wellness provides individualized medical care that may include prescription medication when determined to be clinically appropriate by a licensed healthcare professional.
Prescription treatment is not guaranteed.
Completing an intake form, requesting a particular medication, scheduling or paying for a consultation, enrolling in a membership or program, or communicating with OTR Health & Wellness does not guarantee that a prescription will be issued.
Medication decisions are made following an appropriate clinical evaluation and are based on the individual patient's health history, clinical needs, potential risks and benefits, contraindications, treatment goals, and other relevant factors.
A healthcare professional may determine that a requested medication is not appropriate, that additional evaluation is necessary, or that another treatment option should be considered.
FDA-Approved Medications
When prescription medication is appropriate, a healthcare professional may consider FDA-approved medications based on the patient's individual clinical circumstances.
FDA approval applies to specific products, formulations, indications, dosages, populations, and labeling.
The fact that an active pharmaceutical ingredient is used in an FDA-approved medication does not mean that every product containing that ingredient is FDA-approved.
Compounded Medications
In certain circumstances, a licensed healthcare professional may prescribe a patient-specific compounded medication when determined to be clinically appropriate and when permitted by applicable law.
Compounded medications are not FDA-approved.
The U.S. Food and Drug Administration does not review compounded medications for safety, effectiveness, or quality before they are marketed.
Compounded medications are prepared by appropriately authorized compounding pharmacies or facilities under applicable federal and state requirements.
A compounded medication should not be interpreted as an FDA-approved brand-name medication or an FDA-approved generic medication.
The availability of compounded medication through a treatment program does not mean that a compounded medication is appropriate for every patient.
Compounded Semaglutide & Tirzepatide
Semaglutide and tirzepatide are active pharmaceutical ingredients used in certain FDA-approved prescription medications.
A compounded preparation containing semaglutide or tirzepatide is not the same product as an FDA-approved medication containing that active ingredient.
Compounded semaglutide and compounded tirzepatide are not FDA-approved medications and should not be described or interpreted as FDA-approved generic versions of FDA-approved brand-name products.
Clinical-trial results associated with a particular FDA-approved semaglutide or tirzepatide product should not automatically be interpreted as evidence that a compounded preparation will produce the same safety, effectiveness, quality, or treatment outcome.
When clinically appropriate and permitted by applicable law, a healthcare professional may determine that a patient-specific compounded preparation should be considered based on the individual patient's circumstances.
Medication Availability
The availability of a particular prescription medication may change.
Factors affecting availability may include clinical appropriateness, applicable federal or state requirements, pharmacy availability, supply conditions, product status, and other circumstances.
OTR Health & Wellness does not guarantee continued access to a particular medication, formulation, dose, pharmacy, or compounded preparation.
A patient's treatment plan may need to change when clinically appropriate or when circumstances affecting medication availability change.
Pharmacy Fulfillment
Prescription medications are dispensed or fulfilled through appropriately authorized pharmacy partners based on the prescription, patient location, medication, and other applicable requirements.
The prescribing healthcare professional determines whether a medication is clinically appropriate. The dispensing pharmacy is responsible for dispensing medication in accordance with applicable pharmacy requirements.
Patients should follow the medication instructions and pharmacy labeling provided with their prescription.
Questions involving the preparation, storage, shipment, or dispensing of a medication should be directed to the appropriate healthcare professional or dispensing pharmacy.
Off-Label Prescribing
Healthcare professionals may sometimes prescribe an FDA-approved medication for an indication, dosage, population, or use that differs from the medication's FDA-approved labeling when clinically appropriate and permitted by applicable law.
Off-label prescribing does not mean that the medication itself is unapproved. It means that the prescribed use differs from the FDA-approved labeling for that particular product.
When relevant, patients should discuss the available evidence, potential risks, benefits, alternatives, and treatment considerations with their healthcare professional.
Medication Risks & Monitoring
All prescription medications may involve potential risks, side effects, contraindications, drug interactions, and monitoring requirements.
Patients should provide complete and accurate information regarding their medical history, medications, supplements, allergies, pregnancy status when applicable, and other relevant health information.
Depending on the medication and individual patient, treatment may require laboratory testing, follow-up consultations, physical evaluation, or other clinical monitoring.
A healthcare professional may adjust, pause, or discontinue medication when clinically appropriate.
Memberships & Prescription Medication
Purchasing or enrolling in an OTR Health & Wellness membership or program does not guarantee access to prescription medication.
Depending on the selected program and the patient's individualized treatment plan, program fees may include certain clinical services, monitoring, supplies, or medication when prescribed and specifically included in that program.
Eligibility, medication selection, pharmacy fulfillment, continued treatment, and services included in a particular program depend on clinical appropriateness, the program selected, and applicable law.
A healthcare professional may determine that medication should not be prescribed or should be changed or discontinued even when a patient is enrolled in an ongoing program.
Individual Results
Individual responses to prescription medications vary.
OTR Health & Wellness does not guarantee a particular amount or rate of weight loss, hormone level, improvement in symptoms, change in body composition, improvement in sexual function, or any other specific treatment result.
Results reported in clinical trials involving an FDA-approved medication should not be interpreted as guaranteed results for an individual patient or as expected results from a compounded preparation.
Talk With Your Healthcare Professional
Patients should discuss questions about prescription medications, compounded preparations, potential side effects, risks, benefits, alternatives, dosage, and monitoring with their healthcare professional.
Do not start, stop, change the dose of, or otherwise alter prescription treatment without appropriate medical guidance.
If you believe you are experiencing a serious or life-threatening reaction or other medical emergency, call 911 or seek immediate emergency medical attention.
Contact OTR Health & Wellness
OTR Health & Wellness
307 Canton Highway, Suite A
Cumming, GA 30040
Panama City Beach Location
17320 Panama City Beach Parkway, #107
Panama City Beach, FL 32413
Call or Text: 478-239-0413