NAVARA HEALTH

Functional · Hormonal · Aesthetic · Integrative

DEA Schedule III · Controlled Substance Agreement

Controlled Substance Policy
& Treatment Agreement

Testosterone Therapy — Texas Only

Purpose of This Agreement

Testosterone is classified as a Schedule III controlled substance by the United States Drug Enforcement Administration (DEA) under the Controlled Substances Act. Because of its potential for misuse, diversion, dependence, and adverse health effects, testosterone therapy is subject to strict federal and state regulations.

This Controlled Substance Policy and Treatment Agreement exists to:

• Protect patient safety
• Ensure full legal and regulatory compliance with federal and Texas requirements
• Establish clear, mutual expectations for prescribing, monitoring, and continuation of therapy
• Document the practitioner-patient understanding required by DEA and Texas Medical Board guidance

By signing this Agreement and receiving testosterone therapy through Navara Health, PLLC ("the practice"), I agree to comply with all terms outlined below for the duration of therapy.

Regulatory Framework

This Agreement is governed by, and the prescribing of testosterone is subject to, the following federal and state authorities:

Authority	Application
Controlled Substances Act	21 U.S.C. § 801 et seq. — federal classification of testosterone as Schedule III
21 CFR § 1301.71(a)	Effective controls to prevent diversion, theft, or misuse
Ryan Haight Act	21 U.S.C. § 829(e) — in-person evaluation requirement for controlled substance prescribing via telemedicine
Texas H&SC Ch. 481	Texas Controlled Substances Act
Texas PMP	Mandatory Prescription Monitoring Program query before and during therapy
Texas Medical Board / BON	Prescribing rules, APRN scope, and collaborative practice requirements

Medication Use, Adherence & Authorized Routes

I understand and agree that:

• Testosterone must be used exactly as prescribed — same dose, same frequency, same route, same injection technique
• I may not alter the dose, frequency, route, injection technique, vial, or schedule without explicit written authorization from my prescribing provider
• I will use only the testosterone product, ester (cypionate, enanthate, etc.), and concentration that my provider has prescribed
• I will not combine my prescribed testosterone with any product obtained outside of Navara Health (research chemicals, "grey market" products, internet-sourced testosterone, peer-shared vials, etc.)
• I will not use my prescribed testosterone for any purpose other than the indication for which it was prescribed
• I will store testosterone securely, out of reach of children, and in a manner consistent with state and federal law

No Early Refills

I understand and agree that:

• Early refills are not permitted under any circumstance, including but not limited to: travel, vacation, scheduling conflicts, missed doses, perceived need, or running out early
• Prescriptions will only be renewed on schedule and only if all monitoring requirements are current
• Requests for early refills will be denied and may trigger additional clinical review, PMP audit, or discontinuation of therapy
• It is my responsibility to plan ahead and request refills with adequate lead time

Lost, Stolen, Damaged, or Confiscated Medication

I understand and agree that:

• I am solely responsible for the secure storage and handling of my testosterone medication
• Theft of controlled substances must be reported to local law enforcement, and I must provide the practice with a police report number upon request
• Even with a documented police report, replacement will not be provided
• Repeated reports of lost or stolen medication may result in discontinuation of therapy and PMP investigation

PMP Monitoring & Disclosure Requirements

I understand and acknowledge that:

• The practice routinely queries the Texas Prescription Monitoring Program (PMP) before initiating therapy, at each refill, and at any time clinically indicated, as required by Texas law
• I must disclose all controlled substances currently or recently prescribed to me by any other provider, including but not limited to opioids, benzodiazepines, stimulants, sleep medications, ketamine, and any other testosterone or anabolic steroid prescriptions
• I will not seek or accept controlled substance prescriptions from another provider for the same condition without notifying Navara Health
• Receiving testosterone or other controlled substances from multiple providers without disclosure is considered diversion
• Inconsistent PMP findings, undisclosed prescriptions, or evidence of doctor-shopping will result in immediate discontinuation of therapy and may result in dismissal from the practice and reporting as required by law

Required Laboratory Monitoring

Testosterone therapy requires ongoing laboratory monitoring to ensure safety and effectiveness. Navara Health follows a structured monitoring cadence:

Baseline Panel (Prior to Initiation)

• Total & Free Testosterone, SHBG — to confirm hypogonadism diagnosis and establish baseline
• Estradiol (sensitive assay)
• LH and FSH — to characterize primary vs. secondary hypogonadism
• Prolactin — to rule out pituitary contribution to hypogonadism
• PSA (Prostate-Specific Antigen)
• CBC with Hemoglobin / Hematocrit — erythrocytosis screening
• CMP — liver and kidney function, electrolytes
• Lipid panel
• Thyroid panel — TSH, free T3, free T4
• Vitamin D
• HbA1c (when indicated)
• DHEA-S (when indicated)

Titration Phase (Quarterly During Dose Adjustment)

• Total & Free Testosterone, SHBG — guide dose titration
• Estradiol (sensitive assay)
• CBC — erythrocytosis monitoring
• CMP, lipid panel as clinically indicated

Maintenance Phase (Annual Once Optimized)

• Total & Free Testosterone, SHBG
• Estradiol (sensitive assay)
• CBC
• CMP, lipid panel
• PSA (yearly with annual prostate assessment)
• Prolactin (repeat as clinically indicated)
• Thyroid panel and other markers as clinically indicated

Additional labs as determined by provider clinical judgment. More frequent monitoring may be reinstated at any time based on lab abnormalities, new symptoms, dose changes, or clinical concern.

I acknowledge that:

• Refills will not be issued if required labs are overdue, incomplete, or significantly abnormal
• Failure to complete labs in a timely manner may result in dose hold, therapy suspension, or discontinuation
• I am financially responsible for all required laboratory testing
• I will complete labs at the laboratory designated by my provider unless an alternative is approved in writing

Drug Screening Requirements

I understand and agree that:

• I may be required to complete urine drug screening, blood testing, or other toxicology testing prior to initiation of therapy and at any time during therapy at the provider's discretion
• Drug screens may test for: testosterone metabolites, other anabolic steroids, controlled substances, stimulants, illicit substances, and any other substances the provider deems clinically relevant
• Refusal to complete required testing within a reasonable timeframe will result in immediate discontinuation of testosterone therapy
• Abnormal or concerning results may result in additional evaluation, dose adjustment, suspension, or termination of treatment
• Drug screening costs may be my financial responsibility unless otherwise covered

Elective Treatment & Provider Discretion

I understand and acknowledge that:

• Testosterone therapy is an elective treatment based on clinical indication and is not medically required in all cases
• The provider may adjust, hold, suspend, or discontinue therapy at any time if:
  • Laboratory values are unsafe (e.g., hematocrit > 54%, significantly elevated PSA, abnormal LFTs)
  • Side effects or adverse reactions occur
  • Dosing or compliance concerns arise
  • Cardiovascular, hematologic, or prostate risk factors emerge
  • Policy non-compliance is suspected or confirmed
  • Clinical judgment determines that continued therapy is not in my best interest
• The provider's decision is based on patient safety, current medical standards, and regulatory compliance
• I have the right to seek a second opinion at any time

Outside Prescriptions & Dosing Limitations

I understand and agree that:

• If I am or have been receiving testosterone from another provider, Navara Health is not obligated to continue or match that regimen
• Navara Health's treatment plans follow evidence-based, physiologic optimization guidelines consistent with current Endocrine Society, American Urological Association, and Texas Medical Board standards
• The practice will not prescribe or maintain supra-physiologic, non-therapeutic, or performance-enhancing dosing, regardless of prior treatment history or patient preference
• The practice does not prescribe testosterone for the purpose of athletic enhancement, bodybuilding, or performance optimization
• The practice does not prescribe testosterone in conjunction with anabolic steroid stacking, SARMs, or other unapproved performance agents
• Requests for dose escalation beyond clinically appropriate ranges will be declined

In-Person Evaluation & Continued Eligibility

Consistent with the Ryan Haight Act, Texas Medical Board telemedicine rules, and DEA requirements, I understand and agree that:

• An initial in-person evaluation is required before testosterone may be prescribed
• I must be physically located in Texas at the time of each visit, prescription, and refill
• Periodic in-person follow-up visits may be required at the provider's discretion to maintain compliance and continue therapy
• Telemedicine visits may be used for interim follow-up only after the practitioner-patient relationship has been established in person and only as permitted by then-current state and federal law
• If I permanently relocate outside of Texas, testosterone therapy through Navara Health will be discontinued and I will be referred to a provider licensed in my new state of residence

Risks & Side Effects of Testosterone Therapy

I have been counseled on the risks of testosterone therapy, which include but are not limited to:

• Erythrocytosis (elevated hematocrit), with associated risk of thromboembolic events
• Acne, oily skin, hair loss / male pattern baldness, body hair changes
• Gynecomastia (breast tissue development), particularly with aromatization
• Testicular atrophy and impaired fertility / infertility
• Mood changes, irritability, aggression, or sleep disturbance
• Worsening of obstructive sleep apnea
• Cardiovascular effects, including changes in lipid profile and blood pressure
• Hepatic effects (especially with oral formulations)
• Prostate effects, including possible increase in PSA
• Injection-site reactions, pain, infection, or sterile abscess
• Fluid retention and edema
• Possible worsening of benign prostatic hyperplasia (BPH) symptoms
• Increased risk of certain hormone-sensitive cancers in susceptible individuals
• Dependence and withdrawal symptoms with abrupt discontinuation after prolonged use

I understand that the long-term effects of testosterone therapy are still being studied and that current evidence is evolving.

Pregnancy, Fertility & Partner Exposure

I understand and acknowledge that:

• Testosterone therapy can significantly reduce fertility and may cause infertility, which may be irreversible
• If fertility is a current or future concern, I will discuss fertility preservation options (sperm banking, HCG, clomiphene) with my provider before initiating therapy
• Testosterone is teratogenic and can cause virilization of a female fetus; I will take precautions to avoid skin-to-skin transfer to pregnant women, women of childbearing potential, or children
• Topical testosterone formulations require additional precautions to prevent secondary exposure to household members

Communication & HIPAA Authorization

I authorize Navara Health to communicate with me regarding scheduling, refills, lab results, PMP findings, and monitoring 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. I may revoke authorization for any specific channel in writing to contact@navarahealthtx.com, except where required for legally mandated notices, controlled substance documentation, or law enforcement cooperation.

Prohibited Conduct & Grounds for Termination

Termination of the practitioner-patient relationship for controlled substance non-compliance will be documented in the medical record. Where required by law, the practice will provide a reasonable continuity-of-care notice (typically 30 days) for the patient to establish care elsewhere, except where immediate termination is warranted by safety, legal, or law enforcement concerns.

Dispute Resolution & Binding Arbitration

Any dispute, controversy, or claim arising out of or relating to this Agreement, the prescribing of testosterone, 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.

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 Texas law, and does not limit the practice's obligations to report to regulatory authorities or law enforcement as required by law. Either party retains the right to seek injunctive or equitable relief in court where appropriate.

Governing Law & Severability

This Agreement shall be governed by and construed under the laws of the State of Texas and applicable federal law. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.