Terms of Service

1. Acceptance of Terms

These Terms of Service ("Terms") constitute a legally binding agreement between you ("User," "Patient," or "you") and Alpha 1 Labs ("Company," "we," "us," or "our"). These Terms govern your access to and use of our website, electronic intake portals, telehealth coordination services, and online store (collectively, the "Services").

By accessing the website, checking an agreement box, completing a medical intake form, or purchasing products or blood biomarker panels, you acknowledge that you have read, understood, and agree to be bound by these Terms, our Privacy Policy, and our Informed Telehealth Consent. If you do not agree, you must immediately cease all access to the Services.

3. Telehealth Partners & Regulatory Compliance

Alpha 1 Labs partners with OutfitMD (www.outfitmd.com) and their licensed U.S.-based pharmacy partners to coordinate telehealth clinical services and fulfill medication orders. All partner diagnostic laboratories utilized across our programs are CLIA-certified. All medical providers and fulfillment pharmacies operating within our network hold active, unrestricted state licenses in the jurisdictions where they prescribe and dispense.

• Partner Company & CLIA-Certified Labs: Our clinical coordination partner is OutfitMD (www.outfitmd.com). All diagnostic testing facilities and clinical partner laboratories utilized through OutfitMD maintain active CLIA certification to ensure the highest analytical quality.
• Patient Data & HIPAA Protections: PHI is submitted directly to OutfitMD/lab systems and not retained by Alpha 1. All electronic patient clinical records, medical history questionnaires, and health consultations are managed exclusively within OutfitMD's and applicable partner infrastructure in accordance with applicable privacy and security requirements.
• Medical Consultation Mandate: No 503A compounded medications may or will ever be dispensed without an individualized clinical evaluation and consultation with a prescriber first.
• Legal Compliance: Services are intended to operate in accordance with applicable federal and state healthcare, pharmacy, telehealth, and advertising requirements.
• Transparency: All product details, pricing, compounding disclosures, and clinical mechanisms are presented accurately without false or misleading claims.

4. Establishment of Valid Prescriber-Patient Relationship & Prescriber Evaluation Mandate

You acknowledge and agree that submitting a medical questionnaire or ordering a blood panel does not automatically guarantee that a prescription will be issued. Under no circumstances will any 503A compounded medication be dispensed without an individualized evaluation and clinical consultation with a prescriber first. Prescribers will only issue a prescription after establishing a valid prescriber-patient relationship in accordance with applicable state medical board regulations and the Ryan Haight Act.

A valid relationship requires a complete health history evaluation, review of relevant biomarker diagnostics (analyzed by CLIA-certified partner laboratories), and a synchronous video consultation (or telephone consultation where video is not feasible). Purely asynchronous (store-and-forward) evaluation is not used to issue an initial prescription. Prescribers reserve full independent medical discretion to deny treatment if a protocol is deemed clinically unsafe or contraindicated.

5. Minnesota Telehealth & Federal Statutory Compliance

Services provided to patients located in the State of Minnesota comply strictly with Minnesota Statute § 147.033 (Practice of Telehealth) and Minnesota Board of Medical Practice statutes. Prescribers evaluating Minnesota residents hold active Minnesota professional licenses, or licenses issued through the Interstate Medical Licensure Compact where applicable.

For patients nationwide, care is provided subject to applicable federal and state telehealth, privacy, professional-practice, licensing, and pharmacy requirements.

6. Compounded Preparations & Pharmacy Disclosures

Medications offered through our partner pharmacies are compounded formulations prepared specifically for individual patients pursuant to a provider's valid prescription order issued following an individualized consultation with a prescriber. No 503A preparations may or will be dispensed without this provider consultation.

• Compounded medications are not FDA-approved brand-name drugs and have not been evaluated by the FDA for safety or efficacy as mass-market commercial drugs.
• Formulations are prepared in state-licensed 503A retail compounding pharmacies operating under applicable federal and state compounding requirements, including applicable USP standards where required.
• Ingredients are sourced and tested by partner pharmacies in accordance with their applicable quality-control and compounding requirements, with Certificates of Analysis or other quality documentation available where applicable.

Designated 503A Partner Pharmacies. All compounded medications offered through Alpha 1 Labs are prepared and dispensed by one of the following licensed 503A compounding pharmacies, pursuant to a patient-specific prescription issued after an individualized clinical evaluation by a prescriber:

Both partner pharmacies hold active state licenses in good standing, are LegitScript-certified, and operate under applicable state board of pharmacy regulations. No 503A compounded medication may or will be dispensed by either pharmacy without a valid, patient-specific prescription issued following a clinical consultation with a licensed prescriber.

Partner pharmacy licensure and LegitScript certification status may be verified directly through the applicable state board of pharmacy and the LegitScript verification registry. Alpha 1 Labs does not independently certify or accredit partner pharmacies; accreditation and verification are maintained by each pharmacy through their respective state regulatory authorities and LegitScript.

7. Fulfillment & Cold-Chain Direct-to-Door Shipping

Strict Door-Delivery Policy: Alpha 1 Labs does not maintain medication inventory at its administrative offices or clinic locations and DOES NOT offer in-clinic medication pickup under any circumstances.

All prescriptions are prepared and dispatched directly from Partner Pharmacies to the patient's residential address using temperature-controlled, insulated cold-chain medical packaging with signature verification where required by state law.

8. Prescriptions, Returns & Refund Policy

In accordance with state pharmacy board statutes, prescription medications cannot be returned or re-dispensed once dispatched from the pharmacy. All prescription sales are final. If a clinician evaluates your intake and determines that you are medically ineligible for treatment before a prescription is issued and medication is compounded, the fee for the prescription medication portion will be refunded in full. Full details, including subscription cancellation, blood panel cancellations, and damaged-shipment handling, are set out in our Refund & Cancellation Policy, which controls in the event of any conflict with this section.

9. Patient Obligations & Truthfulness

You certify and warrant that:

• You are at least 18 years of age.
• All information provided in your medical intake questionnaire, health history, and lab reports is true, current, and complete.
• You will not misrepresent your identity or geographic state location.
• You will use prescribed medications solely for your personal therapeutic use and will never sell, transfer, or share prescription medications with others.

11. Telecommunications & A2P 10DLC SMS Terms

By providing your mobile telephone number and opting in, you consent to receive transactional and clinical text messages from Alpha 1 Labs. Message frequency varies. You may opt out at any time by replying STOP. Reply HELP for assistance. Message and data rates may apply.

12. Intellectual Property Rights

All content, brand emblems, logos, product images, text, and software on this website are the exclusive property of Alpha 1 Labs or its licensors and are protected by United States and international copyright, trademark, and intellectual property laws.

Calculators and interactive tools provided on this site are offered for general educational purposes only. Any underlying methods that implement publicly known or published algorithms are not claimed as proprietary inventions of Alpha 1 Labs.

13. Limitation of Liability & Dispute Resolution

To the maximum extent permitted by law, Alpha 1 Labs and its officers, directors, employees, and agents shall not be liable for any indirect, incidental, consequential, or punitive damages arising out of your use of the Services or reliance on information provided on the platform.

Any dispute, claim, or controversy arising out of or relating to these Terms shall be settled by binding arbitration administered in Hennepin County, Minnesota, or via remote online arbitration under the commercial rules of the American Arbitration Association.

14. Indemnification

You agree to defend, indemnify, and hold harmless Alpha 1 Labs, its independent prescribers, partner pharmacies, and affiliates from and against any claims, liabilities, damages, or costs (including reasonable legal fees) resulting from your violation of these Terms, submission of inaccurate medical data, or misuse of prescribed preparations.

15. Governing Law & Severability

These Terms shall be governed by and construed in accordance with the laws of the State of Minnesota, without regard to its conflict of law principles. If any provision of these Terms is found to be unenforceable or invalid, that provision shall be limited or eliminated to the minimum extent necessary so that these Terms shall otherwise remain in full force and effect.