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
Telehealth Service States (Adults 18+)
Texas
Colorado
Connecticut
Florida
Iowa
Oklahoma
Vermont
Virginia
Washington
Critical Disclosure. The peptides described in this consent are compounded preparations dispensed by licensed 503A or 503B compounding pharmacies. They are NOT FDA-approved for any indication, including the wellness, recovery, aesthetic, metabolic, or longevity uses for which they may be prescribed. Compounding availability is subject to FDA action and can change without notice. By signing this consent, I acknowledge that I have read and understand each section below in full.
Purpose of Peptide Therapy
The purpose of peptide therapy at Navara Health is to support tissue repair, inflammation modulation, metabolic and neurologic support, collagen synthesis, stress response, and overall physiologic recovery through a structured, time-limited protocol — typically 8–16 weeks, depending on the peptide and clinical indication.
Peptide therapy is provided as adjunctive wellness support and does not replace primary medical care, surgical care, emergency care, or specialist-directed treatment.
Description of Treatment
I may be prescribed one or more compounded peptides and/or supportive supplements based on individualized clinical assessment, medical history, risk stratification, laboratory data (when indicated), and my treatment goals.
Selection, dosing, route of administration, and duration are determined solely at the discretion of the prescribing provider and may be modified or discontinued at any time for safety or clinical appropriateness. Most peptides are self-administered as subcutaneous (SubQ) or intramuscular (IM) injections at home after written instruction and competency confirmation.
This consent does not cover GLP-1 receptor agonists (semaglutide, tirzepatide, or compounded equivalents). A separate GLP-1 Therapy Informed Consent applies to those medications due to their distinct risk profile, regulatory status, and monitoring requirements.
Regulatory Status & Compounding
I understand and acknowledge that:
- All peptides described in this consent are compounded by licensed 503A (patient-specific) or 503B (outsourcing facility) compounding pharmacies pursuant to the Federal Food, Drug, and Cosmetic Act
- Compounded peptides are not FDA-approved as finished drug products; they do not undergo the same pre-market safety, efficacy, or manufacturing review as commercially manufactured drugs
- The FDA classifies many peptides on category lists that govern whether they may be lawfully compounded; regulatory status can change at any time without notice and may result in a peptide becoming unavailable, restricted, or removed from the prescribing protocol mid-therapy
- Long-term safety and efficacy data for many peptides is limited; some peptides have only investigational, animal, or small-trial human data
- Use of these peptides for the indications described is considered off-label
- Navara Health does not own, operate, or control any compounding pharmacy; pharmacy selection is based on clinical appropriateness, product availability, and regulatory compliance
- A separate Compounding Pharmacy Authorization & Informed Consent applies to all compounded medications and is incorporated by reference
Peptides Commonly Prescribed at Navara Health
I understand that the following peptides may be prescribed at Navara Health, and that not all patients are candidates for all peptides. Additional peptides may be considered in the future based on evolving evidence, patient needs, provider judgment, and regulatory availability.
BPC-157
Body Protection Compound · Tissue Repair
May support tissue repair, inflammation modulation, gut integrity, and musculoskeletal recovery. Typically self-administered as a SubQ injection.
Status: Not FDA-approved for any indication. The FDA has expressed concerns regarding compounding of BPC-157, and compounding availability has been subject to change since 2023. Long-term human safety data is limited; most evidence is preclinical (animal studies).
CJC-1295 / Ipamorelin
Growth Hormone Secretagogue · GHRH / GHRP
Growth hormone-releasing peptides that may support recovery, body composition, sleep quality, and metabolic health through stimulation of endogenous growth hormone signaling. Typically combined and self-administered as a SubQ injection at bedtime.
Status: Not FDA-approved. The FDA reviewed these peptides in 2023 and compounding availability has been subject to change. Long-term safety data is limited. May elevate IGF-1; periodic monitoring may be required.
Sermorelin
GHRH Analog · Growth Hormone Support
A growth hormone-releasing hormone (GHRH) analog that may support physiologic growth hormone production, sleep, recovery, and overall vitality. Typically self-administered as a SubQ injection.
Status: Historically held FDA approval as a diagnostic agent (Geref®) which is no longer manufactured. Currently available as a compounded preparation only. Compounding availability remains subject to change.
AOD-9604
HGH Fragment · Metabolic Support
A fragment of human growth hormone (amino acids 176–191) that may support lipolysis and metabolic recovery. Prescribed selectively based on clinical appropriateness.
Status: Investigational. Not FDA-approved for any indication. Compounding availability has been limited and is subject to change.
Selank
Neuropeptide · Anxiolytic Support
A neuropeptide that may support anxiety modulation, stress response, and emotional regulation without sedative effects. Typically administered intranasally.
Status: Not FDA-approved. Developed and used clinically in Russia; no large-scale Western trials. Compounding availability in the U.S. has been spotty and is subject to change.
Semax
Neuropeptide · Cognitive Support
A neuroactive peptide that may support cognitive function, focus, stress resilience, and neurologic recovery. Typically administered intranasally.
Status: Not FDA-approved. Developed and used clinically in Russia; no large-scale Western trials. Compounding availability in the U.S. has been spotty and is subject to change.
Adjunctive Supplement Support
I may also be advised to take adjunctive nutritional or supportive supplements, which may include but are not limited to:
- Vitamin C, zinc
- N-acetylcysteine (NAC)
- Liposomal glutathione
- Collagen or protein supplementation
- Curcumin, Boswellia, or other anti-inflammatory support
- Probiotics or digestive enzymes
Supplement selection is individualized, is not FDA-evaluated for the specific indications recommended, and outcomes are not guaranteed.
Laboratory Testing
Baseline and follow-up laboratory testing may be recommended to assess safety and appropriateness of peptide therapy. Labs may include, but are not limited to:
- CBC, CMP
- Nutrient markers (ferritin, vitamin D, B12)
- Inflammatory markers (hs-CRP, ESR)
- Metabolic markers (fasting insulin, glucose, HbA1c)
- Hormonal or growth factor labs (IGF-1, fasting growth hormone), particularly with growth hormone secretagogue therapy
- Lipid panel
I am financially responsible for all required laboratory testing. Failure to complete recommended labs may result in modification or discontinuation of therapy, and refills will not be issued if monitoring labs are overdue, incomplete, or significantly abnormal.
Potential Benefits (Not Guaranteed)
Individual responses vary, and no outcome is guaranteed. Potential benefits described in clinical literature and patient experience may include:
- Improved tissue repair, recovery, or musculoskeletal healing
- Reduced inflammation or post-procedure discomfort
- Improved sleep quality or stress resilience
- Improved metabolic support or appetite regulation
- Improved cognitive focus or emotional regulation
- Support of body composition goals
- Improved overall sense of well-being
Risks & Side Effects
Common / Expected
Generally Mild & Self-Limited
Injection-site reactions (redness, bruising, swelling, irritation). Headache, dizziness, or fatigue. Gastrointestinal upset or nausea. Temporary appetite or sleep changes. Mood or energy fluctuations.
Possible
Less Common Reactions
Mild allergic reactions (rash, itching, hives). Numbness or tingling at injection site. Persistent injection-site nodules. Water retention or mild edema (with growth hormone secretagogues). Carpal tunnel-like symptoms (with growth hormone secretagogues). Glucose intolerance or insulin sensitivity changes. Elevated IGF-1 (with growth hormone secretagogues). Tachyphylaxis (diminished response over time).
Rare but Serious / Unknown Long-Term
Significant or Theoretical Risks
Severe allergic reaction or anaphylaxis. Injection-site infection or sterile abscess. Theoretical risk of accelerated growth of pre-existing malignancy with growth hormone secretagogues (IGF-1 is a known growth factor). Cardiovascular effects. Hepatic or renal effects.
Unforeseen or unknown long-term effects — long-term human safety data for many peptides is limited or absent.
Important: Long-term human safety data for some of these peptides is limited or absent. I acknowledge that unforeseen risks may exist that are not yet known to medicine or to my provider.
Contraindications & Exclusions
Peptide therapy may be contraindicated or restricted in patients with:
- Pregnancy, possible pregnancy, or breastfeeding
- Active cancer or a history of hormone-sensitive malignancy (particularly with growth hormone secretagogues, due to theoretical proliferative risk via IGF-1)
- Known allergy or hypersensitivity to a prescribed peptide or formulation component
- Significant uncontrolled medical conditions (severe cardiac, hepatic, or renal disease)
- History of severe adverse reaction to injectable therapies
- Active critical illness
- Significant uncontrolled diabetes (caution with growth hormone secretagogues)
- Diabetic retinopathy (caution with growth hormone secretagogues)
- Active substance use disorder
Final determination of eligibility is made by the prescribing provider. I will disclose any new diagnosis, pregnancy, or significant medical event during therapy.
Self-Administration & Storage Responsibilities
Most peptides at Navara Health are self-administered at home. I acknowledge and agree that:
- I will receive written and/or video instruction on reconstitution (if applicable), injection technique, site rotation, dose preparation, storage, and sharps disposal
- I will not administer my first dose until I have confirmed I understand the instructions
- I will store peptides as directed by the prescribing provider and dispensing pharmacy (typically refrigerated, protected from light, with reconstituted product used within the manufacturer-specified window)
- I will not share, sell, transfer, or allow another person to use any peptide prescribed to me
- I will use a proper sharps container and dispose of needles in accordance with state and local regulations
- I will not exceed the prescribed dose, frequency, or duration without prior approval
- I will complete required follow-up labs and appointments
- I will contact Navara Health before the next dose if I experience an unexpected reaction, technique concern, or significant side effect
When to Stop and Call Navara Health
- Hives, swelling of face/lips/tongue, or any sign of allergic reaction
- Difficulty breathing, throat tightness, or wheezing
- Severe injection-site infection (spreading redness, warmth, drainage, fever)
- Significant chest pain, palpitations, or shortness of breath
- Severe headache, vision changes, or one-sided weakness
- Persistent severe mood or psychiatric symptoms
- Any reaction I am uncertain about
Alternatives
Alternatives to peptide therapy include, but are not limited to:
- No peptide therapy
- Lifestyle modification alone (sleep, nutrition, exercise, stress management)
- FDA-approved pharmaceutical alternatives where available for a similar indication
- Physical therapy, rehabilitation, or specialist-directed care
- Over-the-counter supplements
- No treatment
Financial Disclosure
- Peptide therapy is elective and not covered by insurance
- Navara Health is a cash-pay practice and does not bill, verify, or submit claims to insurance, Medicare, or Medicaid
- Payment is due at the time of service or medication ordering
- No refunds are issued once medication has been prepared, opened, or shipped, or once an injection has been administered
- Pricing, refund policies, and shipping practices for compounded peptides are governed by the dispensing pharmacy and are outside Navara Health's control
- I am financially responsible for all required monitoring labs and any additional services
Communication & HIPAA Authorization
I authorize Navara Health to communicate with me regarding scheduling, pharmacy coordination, refills, 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. I may revoke authorization for any specific channel in writing to contact@navarahealthtx.com, except where required for legally mandated notices.
Assumption of Risk & Release of Liability
I voluntarily assume all known, unknown, and unforeseen risks associated with peptide therapy. 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 for:
- Adverse reactions or complications
- Side effects
- Unexpected outcomes or lack of benefit
- Treatment failure
- Long-term or delayed effects not yet known to medicine
- Effects related to FDA regulatory changes that affect compounding availability
This release does not apply to cases of gross negligence or willful misconduct, and does not waive any right that cannot lawfully be waived under the laws of my state of residence.
Dispute Resolution & Binding Arbitration
Any dispute, controversy, or claim arising out of or relating to this Consent, the prescribing of peptides, 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 Consent 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. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.
Emergency & Adverse Event Reporting
For emergencies, call 911
Call 911 or go to the nearest emergency room for:
- Difficulty breathing, swelling of face/lips/tongue/throat, or anaphylaxis
- Severe chest pain or palpitations
- Sudden severe headache, vision changes, or one-sided weakness
- Spreading injection-site infection with fever
For mental health crises, call or text 988 (Suicide & Crisis Lifeline).
Non-emergent adverse events should be reported to Navara Health through the patient portal or by calling 469-653-3124. Suspected drug-related adverse events may also be reported to the FDA MedWatch program at 1-800-FDA-1088 or fda.gov/medwatch.
Patient Initials — Required for Each Critical Clause
Each of the following requires my separate written initials. By initialing, I confirm that I understand and agree to each individual clause.
I understand that all peptides described in this consent are compounded and not FDA-approved, and that they are prescribed for off-label indications.
I understand that compounding availability is subject to FDA action and can change without notice, which may affect my ability to continue therapy.
I understand that long-term human safety data for some peptides is limited or absent, and that unforeseen risks may exist.
I understand the theoretical risk that growth hormone secretagogues may accelerate growth of pre-existing malignancy via IGF-1 elevation, and I have disclosed any cancer history.
I understand that I am self-administering these injections at home and accept the responsibilities outlined in Section 10.
I agree to binding arbitration as described in Section 15 and understand that I am waiving the right to a jury trial.
Optional Sub-Consent · Conditional
Emergency Preparedness & Anaphylaxis Safety
Although rare, severe allergic reactions can occur with any injectable therapy, including peptides. In select patients, an epinephrine auto-injector (EpiPen® or equivalent) may be prescribed as a precautionary safety measure. This does not indicate a known allergy — it reflects an abundance of caution based on clinical judgment, treatment plan, distance to emergency care, or patient preference.
This sub-consent applies only if an epinephrine auto-injector is prescribed. Please select one option below.
Option A · Accept Auto-Injector Prescription
I consent to receive an epinephrine auto-injector prescription as recommended by my provider. I acknowledge that:
- I understand the purpose of prescribing an epinephrine auto-injector
- I understand how and when to use it (severe allergic reaction with breathing difficulty, throat tightness, hives with systemic symptoms, anaphylaxis)
- I understand that epinephrine is for emergency use only
- I understand I must seek immediate emergency medical care (call 911) after use, even if I feel better, as symptoms can recur
- I will keep the auto-injector with me when self-administering peptide injections and will not allow it to expire
- I accept the cost of the auto-injector and any associated training
Option B · Decline Auto-Injector Prescription
I have been offered an epinephrine auto-injector prescription and I am declining at this time. I acknowledge that:
- I understand the risk of severe allergic reaction is rare but real with any injectable therapy
- I understand I assume responsibility for accessing emergency care (call 911) in the event of a severe allergic reaction
- I may revisit this decision at any future visit
Option C · Not Applicable
A prescription for an epinephrine auto-injector was not recommended by my provider at this time. I understand this may change based on my treatment plan or clinical risk profile.
By signing below, I confirm my selection above.
Patient Signature (EpiPen Sub-Consent)
Consent & Acknowledgment
By signing below (or by typing my full legal name as an electronic signature), I acknowledge and affirm:
- I am at least 18 years of age or legally authorized to consent.
- I have read and understand this Peptide Therapy Informed Consent in its entirety.
- I understand the purpose, potential benefits, risks, limitations, and alternatives of peptide therapy.
- I understand that the peptides prescribed are compounded, not FDA-approved, and used off-label.
- I understand that compounding availability is subject to FDA action and may change.
- I understand that long-term human safety data is limited for some peptides.
- I have disclosed a complete and accurate medical history, including any cancer or hormone-sensitive malignancy history.
- I understand and accept the self-administration responsibilities described in Section 10.
- I have had the opportunity to ask questions, and all questions have been answered to my satisfaction.
- Participation is voluntary and may be discontinued by me at any time.
- I authorize communication through the channels described in Section 13.
- I voluntarily assume all known, unknown, and unforeseen risks and agree to the release of liability described in Section 14.
- I agree to binding arbitration as described in Section 15 and understand that I am waiving the right to a jury trial.
- I have initialed each critical clause and completed the conditional EpiPen sub-consent above.
- I consent to peptide therapy as determined clinically appropriate by Navara Health, PLLC.
- My typed name serves as my legal electronic signature, equivalent to a handwritten signature, and this consent becomes part of my permanent medical record.
State of Residence at Time of Signing
Peptide(s) Consented (list)
Patient Signature (or Typed Electronic Signature)
Provider Signature — Jessica Boggs, APRN, FNP-C, ENP-C