This notice explains the limits of Klarvia Health’s public educational information and important facts about prescription and compounded medications. It should be read together with the Klarvia Health Terms of Use, Telehealth Informed Consent, Website Privacy Policy, and Refund and Cancellation Policy.
1 Klarvia Health Does Not Provide Medical Care
Klarvia Health provides nonclinical technology, administrative support, and care coordination. Klarvia Health is not a medical practice, healthcare provider, pharmacy, laboratory, or emergency service. Klarvia Health does not diagnose conditions, determine whether a treatment is appropriate, prescribe medications, compound medications, dispense medications, or control a clinician’s medical judgment.
Medical services are provided by independent licensed healthcare professionals through the Provider Group identified on the secure patient-care platform. Prescription medications are dispensed only by licensed pharmacies. Provider Groups, clinicians, pharmacies, laboratories, and other healthcare entities are independently responsible for the services they provide.
2 Educational Information Is Not Medical Advice
Information on the website, articles, social media, advertisements, emails, text messages, videos, questionnaires, and other public materials from Klarvia Health is provided for general educational and administrative purposes. It does not constitute individualized medical advice and does not create a clinician-patient relationship with Klarvia Health.
Public information should not be used to diagnose a condition, select a treatment, change a dose, discontinue a medication, or delay professional or emergency care. Health information may not apply to your circumstances and may become outdated as medical evidence, labeling, availability, or law change.
3 Clinical Evaluation and Prescribing Decisions
A prescription is never guaranteed. Before issuing any prescription, a licensed clinician must review the information necessary for an appropriate clinical evaluation and independently determine that the treatment is medically appropriate and legally permitted. The clinician may request additional information, tests, records, an audio or video consultation, or an in-person examination, and may decline, modify, pause, or discontinue treatment.
Eligibility criteria and online questionnaires are screening tools, not diagnoses or promises of treatment. Paying a fee, completing an intake, expressing interest in a medication, or having previously used a medication does not obligate a clinician to prescribe it.
4 FDA-Approved Medications
An FDA-approved medication has been reviewed by the U.S. Food and Drug Administration for the uses, formulation, labeling, and conditions included in its approval. Approval does not mean a medication is appropriate or free of risk for every patient. The treating clinician determines whether the potential benefits outweigh the risks for you and must provide you with, or direct you to, the applicable prescribing information, warnings, contraindications, and instructions.
5 Off-Label Prescribing
A licensed clinician may prescribe an FDA-approved medication for a use, dose, route, population, or treatment schedule not included in its FDA-approved labeling when the clinician determines that doing so is medically and legally appropriate. This is commonly known as off-label prescribing. The FDA has not approved the medication for that particular use, and the evidence and risks may differ from an approved use. Where applicable, the clinician must explain the material risks, benefits, and alternatives as part of the treatment decision.
6 Compounded Medications
A compounded medication is prepared by a licensed pharmacy for an individual patient, based on a valid prescription and the patient’s specific clinical need, subject to applicable law. Compounded medications are not approved by the FDA. The FDA does not review compounded medications for safety, effectiveness, or quality before marketing in the same manner as FDA-approved medications.
A compounded medication is not the same as an FDA-approved generic medication and should not be described or understood as the generic equivalent of an FDA-approved product, unless such a statement is legally and scientifically accurate. The appearance, ingredients, concentration, dosage form, packaging, storage instructions, use-by date, and method of administration may differ from an FDA-approved product or from a compounded medication previously received.
Compounding may serve a patient whose medical needs cannot be met with an available FDA-approved medication. Potential risks include contamination, potency that is too high or too low, formulation or dosing errors, variability between preparations, stability or storage problems, and adverse reactions. The prescribing clinician and dispensing pharmacy must provide medication-specific instructions and address questions about the selected product.
7 Compounded GLP-1 Medications
If a clinician prescribes a compounded GLP-1 medication, including compounded semaglutide or tirzepatide, that product is not FDA-approved and is not the same as an FDA-approved brand-name product. Availability depends on federal and state law, the patient’s specific medical need, the clinician’s judgment, pharmacy authority and capability, ingredient availability, and current regulatory conditions. Availability, formulation, concentration, price, and pharmacy may change or be discontinued without prior guarantee.
Compounded GLP-1 products may be supplied in multidose vials and may require the patient to measure a dose using a syringe. Concentrations and dosing units may differ. Measuring or administering the wrong amount can cause serious harm. Follow only the current prescription label and instructions provided for your specific medication. Do not transfer dosing instructions from another product, concentration, vial, pen, website, or person. Ask the clinician or dispensing pharmacy to clarify any question before administering a dose.
Do not use medication that arrives damaged, appears tampered with, lacks clear labeling or pharmacy instructions, or has not been stored within the temperature conditions indicated on the label. Contact the dispensing pharmacy immediately about shipping, storage, product-quality, missing-supply, or labeling concerns.
8 Medication Risks and Outcomes
All medications can cause side effects, allergic reactions, interactions, treatment failure, or unexpected outcomes. Risks can be serious and may differ based on your diagnoses, age, pregnancy status, allergies, medications, laboratory values, and other circumstances. Results vary, and no weight-loss, symptom, cosmetic, sexual-health, hair-growth, metabolic, or other outcome is promised.
Tell the clinician about all prescription and over-the-counter medications, supplements, allergies, medical conditions, pregnancy or plans for pregnancy, and adverse reactions. Read the pharmacy label and patient instructions, use only the prescribed dose, do not share medications, and attend required follow-ups or tests.
9 Emergencies, Adverse Events, and Product Issues
Klarvia Health’s website and support channels are not emergency services. If you are experiencing a medical emergency, call 911 or go to the nearest emergency room. For urgent symptoms or a suspected serious medication reaction, seek immediate medical care and then notify the treating clinician when it is safe to do so.
Report side effects, dosing questions, or clinical concerns to the treating clinician through the secure patient-care platform. Report concerns about dispensing, packaging, shipping, storage, damage, or product quality to the dispensing pharmacy using the contact information on the label or shipment. Patients and healthcare professionals may also report serious adverse events or product problems to FDA MedWatch at www.fda.gov/medwatch.
10 Pharmacy and Product Availability
A prescription may be sent to a licensed pharmacy authorized to dispense in your location, subject to applicable law and patient-choice requirements. The pharmacy determines whether it can fill a prescription and is responsible for compounding or dispensing, labeling, packaging, counseling, substitutions where permitted, shipping, and pharmacy records. Klarvia Health does not guarantee pharmacy acceptance, inventory, delivery time, uninterrupted access, or a particular manufacturer, compounder, formulation, or price.
11 No Endorsement or Comparative Claims
References to a medication, ingredient, treatment category, manufacturer, pharmacy, study, or public source do not mean that Klarvia Health endorses it, or that it is superior, equivalent, safe, effective, or appropriate for you. Product images are illustrative unless expressly identified as the exact product to be dispensed. Trademarks belong to their respective owners. Klarvia Health is not affiliated with a brand manufacturer merely because a product is mentioned.
12 Changes and State Requirements
Medication availability and legal requirements can change quickly. Klarvia Health may update, restrict, or remove public information or program offerings to reflect changes in law, safety information, supply, pharmacy capacity, or operations. State-specific notices, clinician disclosures, pharmacy notices, medication consents, and patient instructions apply in addition to this notice and control when required by law.
13 Contact Klarvia Health
For nonclinical questions or help accessing the secure patient-care platform, contact Klarvia Health below. Do not send emergencies or detailed medical information to the general support email. Use the secure patient-care platform for clinical questions and the dispensing pharmacy’s contact information for questions about the product or dispensing.
Klarvia Health
10601 Clarence Drive, Suite 250
Frisco, TX 75033
Email: support@klarvia.health
Website: www.klarvia.health
