NAVARA HEALTH

Functional · Hormonal · Integrative

Patient Authorization & Informed Consent

Compounding Pharmacy
Authorization & Disclosure

Authorization to Use Compounding Pharmacies

I authorize Navara Health, PLLC and its prescribing providers to issue prescriptions through licensed compounding pharmacies that comply with all applicable federal and state laws and regulations, including United States Pharmacopeia (USP) standards, to ensure patient safety, quality, and regulatory compliance.

I understand that Navara Health does not own, operate, or control any compounding pharmacy. Pharmacy selection is based on clinical appropriateness, formulation availability, regulatory compliance, and patient need.

Prescribing Standards & Practitioner-Patient Relationship

I understand that all prescriptions issued through a compounding pharmacy must be based on a valid practitioner-patient relationship. Navara Health requires the prescribing provider to satisfy all applicable legal, regulatory, and professional standards prior to issuing any prescription, including but not limited to:

• Performing a documented patient evaluation, which may occur in person or via live, interactive audio-video telehealth as permitted by the laws of the patient's state
• Obtaining a comprehensive medical history and performing a physical or virtual examination sufficient to establish medical necessity
• Engaging in meaningful clinical dialogue regarding diagnosis, treatment options, risks, benefits, and alternatives
• Developing and communicating an appropriate follow-up care and monitoring plan
• Maintaining complete, accurate, and contemporaneous medical records
• Obtaining verbal and written informed consent prior to providing medical services

State-Specific Legal & Telehealth Compliance

I understand that medical practice, telehealth, prescribing, and compounding regulations vary by state. I acknowledge and agree that:

• My provider will comply with all applicable federal and state laws governing medical evaluation, prescribing, compounding, and controlled substances in the state where I am physically located at the time of service
• Certain medications, services, or prescribing practices may require an in-person evaluation depending on state law
• Telehealth services may be limited, modified, or unavailable for specific treatments in certain jurisdictions
• My care may be modified, deferred, or transitioned to an in-person visit if required to maintain legal or regulatory compliance
• I will inform Navara Health promptly if I relocate or am temporarily located outside my listed state of residence at the time of a scheduled visit

Controlled Substances — Texas Only

Any provider prescribing controlled substances must comply with all applicable federal and state regulations, including but not limited to:

• The Controlled Substances Act and implementing regulations, including 21 CFR § 1301.71(a), requiring effective controls to prevent diversion, theft, or misuse
• The Ryan Haight Online Pharmacy Consumer Protection Act, including in-person evaluation requirements where applicable
• Texas Health & Safety Code Chapter 481 and Texas Medical Board / Board of Nursing prescribing rules
• Mandatory query of the Texas Prescription Monitoring Program (PMP) prior to and during controlled substance therapy
• Accurate documentation, inventory management, and record-keeping in the lawful course of professional practice

By signing this consent, I acknowledge that:

• I will provide my preferred pharmacy information prior to any controlled substance prescription
• If prescribed controlled substances, my prescription history may be reviewed through the Texas PMP or any applicable state database
• I may be required to sign a separate Controlled Substance Agreement and submit to periodic drug screening, pill counts, or other monitoring
• Failure to comply with monitoring requirements, evidence of diversion, doctor-shopping, or misuse may result in immediate modification or discontinuation of therapy and termination of the practitioner-patient relationship

Off-Label Use of Medications

I understand that some medications prescribed by Navara Health may be used for off-label purposes. Off-label use means a medication is prescribed for a condition, dose, route, frequency, or patient population not specifically approved by the U.S. Food and Drug Administration (FDA), based on the provider's clinical judgment, available medical evidence, and accepted standards of care.

Off-label prescribing is legal in the United States and is a recognized component of medical practice. I acknowledge that:

• The risks, benefits, and alternatives of any off-label use have been or will be discussed with me
• I have the opportunity to ask questions prior to initiating therapy
• Off-label use does not imply that the medication is experimental, investigational, or unsafe
• Long-term safety and efficacy data for some off-label uses may be limited

Compounded Medication Disclosure

I understand that compounded medications:

• Are prepared by licensed compounding pharmacies pursuant to Section 503A (patient-specific) or Section 503B (outsourcing facility) of the Federal Food, Drug, and Cosmetic Act
• Are not FDA-approved and do not undergo the same pre-market approval process as commercially manufactured drugs
• Are prescribed when an FDA-approved alternative is unavailable, in shortage, inappropriate for the patient, or requires patient-specific customization (such as a different strength, route, or excluded allergen)
• May be prepared as sterile injectables, oral troches, topical creams, capsules, or other dosage forms depending on the clinical need

While compounded medications are prepared under quality and safety standards established by USP <795>, <797>, and <800> (where applicable), I acknowledge that:

• Compounded medications may carry risks that differ from FDA-approved products, including variability in potency, sterility, stability, and bioavailability
• Adverse events, allergic reactions, contamination, or inadequate therapeutic response remain possible despite quality controls
• I have been advised to report any unexpected reaction, adverse event, or concern promptly to Navara Health and, where appropriate, to the dispensing pharmacy

Financial Responsibility & Insurance

I understand that medications dispensed by compounding pharmacies are not covered by insurance. I agree to be fully responsible for all costs associated with compounded medications, including consultation, compounding, dispensing, shipping, and pharmacy fees.

I acknowledge that:

• Full payment is due at the time of purchase
• Navara Health does not control pharmacy pricing, discount programs, refund policies, turnaround times, or shipping practices
• Refunds, returns, or replacements for compounded medications are governed solely by the dispensing pharmacy
• Navara Health is a cash-pay practice and does not bill, verify, or submit claims to insurance plans, Medicare, or Medicaid

Communication & HIPAA Authorization

By signing this consent, I authorize Navara Health to communicate with me regarding compounded prescriptions, pharmacy coordination, refill reminders, monitoring, and follow-up through:

• The secure HIPAA-compliant patient portal
• Email to the address I have provided
• SMS / text message to the mobile number I have provided
• Telephone calls to the number I have provided

I understand that email and SMS are not fully secure channels and that limited protected health information may be transmitted through them at my request and acknowledged risk. I may revoke authorization for any specific communication channel by written request to contact@navarahealthtx.com, except where the channel is required for legally mandated notices.

Pharmacy Selection & Information Sharing

I authorize Navara Health to:

• Transmit my prescription, demographic, clinical, allergy, and shipping information to the selected compounding pharmacy
• Receive dispensing confirmations, refill reports, adverse event reports, and clinical communications from the pharmacy
• Substitute pharmacies as needed due to supply, regulatory, or quality considerations, with notice to me

I understand that compounding pharmacies are independent third parties and that Navara Health is not responsible for the pharmacy's dispensing, shipping, billing, or business practices.

Withdrawal of Consent

I understand that I may withdraw this consent at any time by providing written notice to contact@navarahealthtx.com. Withdrawal of consent will not affect any prescription already lawfully issued or any medication already dispensed, but will prevent the issuance of new compounded prescriptions under this authorization.

Dispute Resolution & Binding Arbitration

Any dispute, controversy, or claim arising out of or relating to this Authorization, the prescribing of compounded medications, or the practitioner-patient relationship — including any claim of medical malpractice, billing dispute, or breach of contract — shall first be addressed by good-faith negotiation between the parties.

If the matter cannot be resolved through negotiation within thirty (30) days, the parties agree to submit the dispute to binding arbitration administered by a recognized arbitration body (such as the American Arbitration Association) under its applicable rules, with the arbitration to take place in Dallas County, Texas, unless otherwise required by the laws of the patient's state of residence.

The parties acknowledge that by agreeing to arbitration, they are waiving the right to a jury trial. This provision does not waive any right that cannot lawfully be waived under the patient's state law. Either party retains the right to seek injunctive or equitable relief in court where appropriate.

Governing Law & Severability

This Authorization shall be governed by and construed under the laws of the State of Texas, except where the laws of the patient's state of residence require otherwise for healthcare services delivered to residents of that state. If any provision of this Authorization is found unenforceable, the remaining provisions shall remain in full force and effect.

Adverse Events & Emergency Care

Non-emergent adverse events, side effects, or concerns should be reported to Navara Health through the patient portal or by calling 469-653-3124. Patients are also encouraged to report suspected drug-related adverse events to the FDA MedWatch program at 1-800-FDA-1088 or fda.gov/medwatch.