Navara Health — Off-Label Medication Consent

Practice

Navara Health, PLLC
5301 Alpha Road, Suite 34, Room 21
Dallas, Texas 75240

Contact

469-653-3124
contact@navarahealthtx.com

Prescribing Provider

Jessica Boggs, MSN, APRN, FNP-C, ENP-C

Medical Director

Simal Patel, MD

Purpose of This Consent

This is an umbrella consent for off-label medication prescribing at Navara Health, PLLC. Many medications and therapies offered at Navara — including hormone therapies, peptides, GLP-1 medications, certain compounded preparations, and others — are prescribed for indications not specifically approved by the FDA. This consent provides general informed acknowledgment of off-label prescribing as a category. It complements (but does not replace) any treatment-specific consent.

This is an umbrella consent. Treatment-specific consents (TRT Clinical, BHRT Clinical, GLP-1, Peptide, Compounding Pharmacy, etc.) cover the specific risks, benefits, and protocols of individual therapies. This consent addresses off-label prescribing as a general practice.

What "Off-Label" Means

FDA approval. The U.S. Food and Drug Administration (FDA) approves specific medications for specific medical uses ("indications") at specific doses, in specific populations, by specific routes of administration. This is called "on-label" use.

Off-label use. Off-label use occurs when a medication is prescribed:

For a condition or indication not specifically FDA-approved
At a dose different from FDA-approved dosing
By a route different from FDA-approved route
In a population (age group, sex) different from the FDA-approved population
For a use supported by emerging clinical evidence but not yet FDA-reviewed

Important Legal & Clinical Context

Off-label prescribing is legal and common in medical practice. The FDA regulates medication approval and labeling but does not regulate clinical practice. Once a medication is FDA-approved for any indication, licensed prescribers may use it off-label at their clinical discretion, based on evidence, experience, and patient context.

An estimated 20% or more of all prescriptions in the United States are written for off-label uses. Off-label prescribing is particularly common in functional medicine, hormone optimization, pain management, oncology, pediatrics, and psychiatry.

Why Off-Label Prescribing Is Used at Navara Health

Navara Health may prescribe medications off-label for the following reasons:

To treat conditions for which no FDA-approved medication exists
To use medications supported by emerging clinical evidence ahead of formal FDA review
To use older medications for new clinical applications (e.g., low-dose naltrexone for autoimmune conditions)
To use medications in populations not included in original FDA studies (e.g., testosterone in women)
To use functional medicine doses and formulations tailored to individual physiology
To use compounded versions of FDA-approved medications when commercial preparations are unavailable, in shortage, or unsuitable for the patient

Common Categories of Off-Label Use at Navara Health

Hormone Optimization

Compounded bioidentical hormones — not FDA-approved as finished products
Testosterone in women — no FDA-approved testosterone product exists for women in the U.S.
BHRT for wellness/optimization — beyond FDA-approved symptomatic indications
Thyroid optimization — combinations of T4/T3, compounded T3, or NDT outside FDA-approved presentations

Metabolic / GLP-1 Therapy

Compounded GLP-1 medications (when commercial unavailable or unsuitable) — not FDA-approved as compounds
GLP-1 use below BMI 30/27 — off-label for weight optimization
GLP-1 use for non-FDA-approved indications (e.g., PCOS, metabolic optimization)

Peptide Therapy

Compounded peptides — generally not FDA-approved as finished products
Tesamorelin off-label use — FDA-approved for HIV lipodystrophy only
SS-31 / Elamipretide — FDA-approved for Barth syndrome only; all other use off-label
Other peptide therapies for performance, recovery, longevity, or wellness

IV / Injection Therapy

NAD+ infusion — not FDA-approved for anti-aging, longevity, or cognitive indications
High-dose vitamin C — not FDA-approved for wellness indications
Glutathione injection — not FDA-approved as a wellness therapy
Custom vitamin/nutrient cocktails

Aesthetic & Sexual Wellness

PRP for hair, skin, and sexual wellness — off-label applications
Compounded topicals and injectable preparations

General Risks of Off-Label Prescribing

I understand that off-label prescribing carries certain general considerations:

Less FDA-reviewed safety and efficacy data for the specific off-label use compared to FDA-approved indications
Potential side effects may include those identified for the FDA-approved use plus theoretical or emerging risks specific to the off-label application
Long-term effects for off-label use may be less well-characterized
No guaranteed benefit — individual response varies, and off-label use does not guarantee results
Not covered by insurance — most off-label prescriptions are not reimbursed by health insurance plans
Drug interactions — may differ from FDA-approved use patterns
Compounded preparations have additional considerations (covered in separate Compounding Pharmacy Authorization)

Specific risks of any individual off-label therapy are discussed in the treatment-specific consent for that therapy.

My Acknowledgments & Agreements

I understand and agree that:

I have been informed that some or all of the medications and therapies I receive at Navara Health may be prescribed off-label
I have been informed of the general nature of off-label prescribing
I will receive treatment-specific consents covering the specific risks, benefits, and protocols of each off-label therapy I receive
I am free to decline any off-label medication or therapy at any time
I will disclose all medications, supplements, peptides, hormones, and therapies I use, including those from other providers
I will follow prescribed dosing and report any adverse reactions promptly
I will not share, sell, or transfer any prescription medication to another person
I understand that off-label prescribing reflects current clinical judgment and may evolve as new evidence becomes available

Per-Medication Acknowledgment

Documentation of Specific Off-Label Prescriptions

This block may be completed at intake (left blank) or at each prescription. When an off-label medication is prescribed, my provider may complete this table documenting the medication, the FDA-approved indication, and the off-label use intended.

Medication	FDA-Approved Use	My Off-Label Use	My Initials

Visit Date: __________________ Provider Initials: __________________

Communication & HIPAA Authorization

I authorize Navara Health to communicate with me regarding prescriptions, dosing changes, refills, and adverse event reporting through the secure patient portal, email, SMS, and telephone calls to the contact information I have provided. I may revoke any specific channel in writing to contact@navarahealthtx.com.

Assumption of Risk & Release of Liability

I voluntarily assume risks associated with off-label prescribing at Navara Health. To the fullest extent permitted by law, I agree to release, indemnify, and hold harmless Navara Health, PLLC, Jessica Boggs APRN, the medical director, and all affiliated providers, nurses, staff, contractors, and agents from liability related to off-label prescribing, except in cases of gross negligence or willful misconduct. This release does not waive any right that cannot lawfully be waived under Texas law.

Dispute Resolution & Governing Law

Any dispute shall first be addressed by good-faith negotiation. If not resolved within thirty (30) days, the parties agree to submit to binding arbitration in Dallas County, Texas. The parties waive the right to a jury trial. This Consent is governed by Texas law.

Patient Initials — Required for Each Critical Clause

Each of the following requires my separate written initials.

I understand what "off-label" prescribing means and that it is legal and common in medical practice.

Initials

I understand that many therapies at Navara Health may be prescribed off-label, including hormone therapies, peptides, GLP-1s, NAD+, and others.

Initials

I understand off-label medications are not covered by insurance and that I am financially responsible.

Initials

I will receive treatment-specific consents for each off-label therapy that detail the specific risks, benefits, and protocols.

Initials

I agree to binding arbitration as described above and understand I am waiving the right to a jury trial.

Initials

Acknowledgment & Electronic Consent

By signing below (or by typing my full legal name as an electronic signature), I confirm and agree:

I am at least 18 years of age.
I have read and understand this Off-Label Medication Consent in its entirety.
I understand off-label prescribing is legal and common, and that Navara Health may prescribe medications off-label for my care.
I have had the opportunity to ask questions, and all questions have been answered to my satisfaction.
I voluntarily consent to off-label prescribing as part of my care plan.
I voluntarily assume the risks described and agree to the release of liability.
I agree to binding arbitration.
My typed name serves as my legal electronic signature, equivalent to a handwritten signature, and this consent becomes part of my permanent medical record.

Patient Printed Name

Date of Birth

Patient Signature (or Typed Electronic Signature)

Date

Provider Signature — Jessica Boggs, APRN, FNP-C, ENP-C

Date