Disclaimer

1. General Disclaimer

The content provided on the ScriptsRx Direct website (the "Site"), including but not limited to text, graphics, images, product descriptions, pricing, clinical references, and other material, is provided for informational and marketing purposes only. Nothing on this Site is intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this Site.

2. Medical Disclaimer

2.1 No Doctor-Patient Relationship

Browsing this Site or purchasing products through the Site does not establish a doctor-patient relationship with ScriptsRx Direct, Breakthrough Health LLC, or any of its affiliates. A doctor-patient relationship is established only when you are evaluated by a licensed healthcare provider through our telehealth consultation process.

2.2 Provider Authority

All medical decision-making rests solely with the prescribing healthcare provider and/or provider group. ScriptsRx Direct does not practice medicine, prescribe medications, or provide medical advice. The decision to prescribe any medication, including the specific formulation, dosage, and duration of treatment, is made exclusively by the treating healthcare provider based on their independent clinical judgment and your individual medical evaluation.

2.3 No Guarantee of Prescription

The availability of any product on this Site does not guarantee that a prescription will be issued. All prescriptions require a medical evaluation by a licensed healthcare provider. If a provider determines that a medication is not medically appropriate for you, no prescription will be issued. Factors that may affect prescribing decisions include your medical history, current medications, allergies, contraindications, and other clinical considerations.

2.4 Individual Results

Results from any medication or treatment vary from person to person. We do not guarantee specific outcomes or results. Factors affecting individual results include but are not limited to starting health status, adherence to treatment protocols, diet, exercise, genetics, age, and concurrent medical conditions. Testimonials or success stories, if any, represent individual experiences and are not indicative of expected results.

3. Compounded Medication Disclaimer

3.1 FDA Status

Compounded medications are NOT FDA-approved. The U.S. Food and Drug Administration (FDA) does not verify the safety, efficacy, or manufacturing quality of compounded medications. Compounded medications are prepared by licensed pharmacies pursuant to valid prescriptions for individual patients. The decision to use a compounded medication is a clinical judgment made by the prescribing healthcare provider.

3.2 503A Pharmacy Compliance

All prescription medications dispensed through ScriptsRx Direct are compounded by licensed and accredited 503A compounding pharmacies. Our pharmacy partners include, but are not limited to, VitaScripts Pharmacy (Tampa, FL), VIOS Compounding (Livonia, MI), Empower Pharmacy (Houston, TX), and Hallandale Pharmacy (Hallandale Beach, FL). All pharmacy partners are:

• Licensed by the applicable state board(s) of pharmacy
• Licensed in the state of residence of the patient, or the state in which the telehealth patient is physically located during the time of their visit
• Compliant with applicable United States Pharmacopeia (USP) compounding standards
• Subject to state and federal regulatory oversight and inspection
• Accredited by recognized pharmacy accreditation bodies where applicable (e.g., PCAB)

3.3 Product Quality Assurance

All products dispensed through our pharmacy partners (VitaScripts Pharmacy, VIOS Compounding, Empower Pharmacy, Hallandale Pharmacy, and others) are:

• Made to use — ready for patient administration upon receipt
• Complete with supplies — all necessary administration supplies, including syringes, are included
• Pharmacist verified — each preparation is verified by a licensed pharmacist prior to dispensing
• Pharmacy manufactured — prepared at 503A licensed and accredited compounding pharmacies

ScriptsRx Direct does not partner with, distribute, sell, or work with any "Research Use Only" or "Professional Use Only" products. All products are intended for patient use pursuant to a valid prescription from a licensed healthcare provider.

4. Product-Specific Disclaimers

4.1 GLP-1 Receptor Agonists (Compounded Semaglutide)

Compounded semaglutide is not the same as any FDA-approved branded semaglutide product. Compounded semaglutide is prepared by licensed 503A compounding pharmacies and has not been evaluated by the FDA for safety, efficacy, or quality. Clinical references on this Site regarding semaglutide relate to the active ingredient and published research on compounded formulations where available. We do not reference or make claims based on clinical trials of branded, FDA-approved semaglutide products, as those studies evaluated specific proprietary formulations that differ from compounded preparations.

Important safety information: GLP-1 receptor agonists carry a boxed warning regarding thyroid C-cell tumors observed in rodent studies. They are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). They should not be used during pregnancy or while breastfeeding. Common side effects include nausea, vomiting, diarrhea, constipation, and decreased appetite. Serious side effects may include pancreatitis, gallbladder disease, kidney injury, and hypoglycemia (especially when combined with insulin or sulfonylureas).

4.2 Dual GIP/GLP-1 Receptor Agonists (Compounded Tirzepatide)

Compounded tirzepatide is not the same as any FDA-approved branded tirzepatide product. Compounded tirzepatide is prepared by licensed 503A compounding pharmacies and has not been evaluated by the FDA for safety, efficacy, or quality. Clinical references on this Site regarding tirzepatide relate to the active ingredient and published research on compounded formulations where available. We do not reference or make claims based on clinical trials of branded, FDA-approved tirzepatide products.

Important safety information: Similar to GLP-1 receptor agonists, tirzepatide carries warnings regarding thyroid C-cell tumors and is contraindicated in patients with MTC or MEN 2 history. Additional side effects and contraindications may apply. Your provider will discuss all relevant risks during your consultation.

4.3 Peptide Therapies

Peptide therapies offered through ScriptsRx Direct (including but not limited to BPC-157, TB-500, CJC-1295/Ipamorelin, Sermorelin, NAD+, GHK-Cu, PT-141, LL-37, Glutathione, Epithalon, MOTS-C, AOD-9604, KPV, Thymosin Alpha-1, Kisspeptin-10, Gonadorelin, IGF-1 LR3, DSIP, 5-Amino-1MQ, PE-22-28, Pinealon, Semax, and Selank) are compounded preparations. The clinical evidence base for peptide therapies varies significantly by peptide. Many peptides have primarily preclinical (animal model) research, while others have varying levels of human clinical data. Clinical references provided on this Site are for educational purposes and do not guarantee similar results in individual patients.

4.4 Hormone Replacement Therapy

Testosterone replacement therapy (TRT) and women's hormone replacement therapy (HRT) are prescription treatments that carry specific risks. TRT may affect fertility and sperm production, increase red blood cell count, and carry cardiovascular considerations. Women's HRT carries risks that vary based on the type of hormones, dosing, route of administration, timing of initiation, and individual risk factors. All HRT patients require regular laboratory monitoring. Your provider will discuss all relevant risks and monitoring requirements during your consultation.

5. Clinical References and Research Disclaimer

Where clinical studies, research papers, or scientific references are cited on this Site, they are provided for educational and informational context only. These references:

• Do not constitute medical advice or treatment recommendations
• Do not guarantee similar results for any individual patient
• May include preclinical (in vitro or animal model) studies that have not been replicated in human clinical trials
• May include observational studies, case reports, or real-world data that have inherent limitations
• Are subject to the limitations and caveats described in the original publications
• For GLP-1 and GIP/GLP-1 receptor agonists, do NOT reference clinical trials of branded, FDA-approved products

We do not make specific claims about percentages of weight loss, treatment success rates, or clinical outcomes based on any studies. Individual results depend on numerous factors and cannot be predicted based on published research.

6. Advertising and Marketing Compliance

6.1 FTC Compliance

The marketing content on this Site is designed to comply with the Federal Trade Commission (FTC) guidelines regarding advertising of health-related products and services. We do not make false, misleading, or unsubstantiated claims about our products or services. Product descriptions are based on the known pharmacological properties of the active ingredients and available published research.

6.2 FDA Advertising Regulations

This Site complies with FDA regulations regarding the advertising and promotion of prescription medications, including compounded medications. We do not promote compounded medications for uses not supported by the prescribing provider's clinical judgment. We do not make comparative claims between compounded medications and FDA-approved branded products.

6.3 State Advertising Laws

This Site is designed to comply with applicable state advertising regulations for prescription medications, telehealth services, and healthcare marketing. State regulations vary and may impose additional requirements or restrictions on healthcare advertising. We monitor and update our content to maintain compliance with applicable state laws.

6.4 Telehealth Advertising

All representations regarding telehealth services on this Site comply with applicable state and federal telehealth regulations. Telehealth services may not be available in all states. The availability of specific medications may vary by state based on state pharmacy and prescribing regulations.

7. State and Federal Regulatory Compliance

7.1 Federal Regulations

Our operations comply with applicable federal regulations, including:

• Federal Food, Drug, and Cosmetic Act (FDCA): Section 503A governing pharmacy compounding
• Health Insurance Portability and Accountability Act (HIPAA): Privacy and security of protected health information
• Federal Trade Commission Act: Truth in advertising and marketing
• Ryan Haight Online Pharmacy Consumer Protection Act: Requirements for online prescribing (note: we do not dispense controlled substances)
• CAN-SPAM Act: Requirements for commercial email communications
• Telephone Consumer Protection Act (TCPA): Requirements for telephone and text communications

7.2 State Regulations

Our operations comply with applicable state regulations, including:

• State medical practice acts governing telehealth and telemedicine
• State pharmacy laws governing compounding and dispensing
• State consumer protection laws
• State privacy and data protection laws
• State advertising and marketing regulations for healthcare services
• State-specific telehealth consent and disclosure requirements

7.3 Pharmacy Licensing

All pharmacy partners — including VitaScripts Pharmacy (Tampa, FL), VIOS Compounding (Livonia, MI), Empower Pharmacy (Houston, TX), and Hallandale Pharmacy (Hallandale Beach, FL) — maintain appropriate state licenses for compounding and dispensing medications to patients in the states they serve. Pharmacy partners are licensed in the state of residence of the patient, or the state in which the telehealth patient is physically located during the time of their visit. Pharmacy licenses are maintained in good standing with applicable state boards of pharmacy.

7.4 Provider Licensing

All healthcare providers who conduct medical evaluations through our platform are independently licensed to practice medicine in the state where the patient is physically located at the time of the telehealth consultation. Provider credentials are verified and maintained in accordance with applicable state requirements.

8. Telehealth Consent and Disclosure

By using our telehealth services, you acknowledge and agree that:

• Telehealth involves the use of electronic communications to enable healthcare providers to deliver care at a distance
• Telehealth has limitations, including the inability to perform a physical examination
• The provider may determine that telehealth is not appropriate for your condition and may recommend an in-person visit
• Technical difficulties may occur that could interrupt or prevent the consultation
• You have the right to withhold or withdraw consent to telehealth services at any time
• Your medical information will be shared with the treating provider and pharmacy as necessary for treatment
• You are responsible for being in a state where the provider is licensed at the time of the consultation

9. Self-Pay and Financial Disclosure

All services provided through ScriptsRx Direct are self-pay. We do not accept insurance, Medicare, Medicaid, TRICARE, or any other third-party payer. You acknowledge that:

• You are paying for the all-in expense of the provider consultation, the provider group, the service, system access, administrative support, and the cost of prescription medication (if prescribed)
• Prices are subject to change and will be disclosed at the time of purchase
• Compounded medications may not be covered by insurance even if submitted independently
• You are responsible for understanding your financial obligations before proceeding with services

10. Website Disclaimer

THE SITE AND ALL CONTENT, MATERIALS, INFORMATION, SERVICES, AND PRODUCTS AVAILABLE THROUGH THE SITE ARE PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT.

We do not warrant that the Site will be uninterrupted, error-free, or free of viruses or other harmful components. We do not warrant the accuracy, completeness, or timeliness of any information on the Site. Your use of the Site is at your own risk.

11. Third-Party Disclaimer

Any third-party partners, referral partners, or affiliated companies referenced on this Site are independent entities not owned or controlled by ScriptsRx Direct or Breakthrough Health LLC. Any claims, fulfillment, or services rendered by third parties are their sole responsibility. All due diligence regarding third-party services should be performed independently by the party engaging with such companies.

12. Open Payments Notice (Sunshine Act)

In accordance with the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act), ScriptsRx Direct and Breakthrough Health LLC disclose the following:

• ScriptsRx Direct is a technology platform that facilitates connections between patients and licensed healthcare providers. It does not make payments to physicians for the purpose of influencing prescribing decisions.
• Healthcare providers who conduct medical evaluations through our platform are compensated for their professional medical services, not for prescribing any specific medication or treatment.
• Provider compensation is based on the volume and complexity of medical evaluations performed, not on the number or type of prescriptions written.
• Patients may search the Centers for Medicare & Medicaid Services (CMS) Open Payments database at openpaymentsdata.cms.gov for information about payments made to physicians and teaching hospitals.

ScriptsRx Direct is committed to transparency in all aspects of its operations and encourages patients to discuss any concerns about provider relationships with their treating healthcare provider.

13. Contact Information

For questions about this Disclaimer, please contact us at:

ScriptsRx Direct (operated by Breakthrough Health LLC)
6051 Mid Rivers Mall Drive
Cottleville, MO 63304
Email: [email protected]