Informed Consent for Injectable BPC-157

INTRODUCTION

THIS INFORMED CONSENT FOR COMPOUNDED BPC-157 INJECTABLE MEDICATION (THE "CONSENT") SETS FORTH INFORMATION REGARDING THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (THE "MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").

The purpose of this informed consent form is to give you written information about the potential benefits, risks, uncertainties, and alternatives associated with compounded BPC-157 administered by subcutaneous injection, so that you can decide whether to proceed. This material supplements your discussion with your Superpower Healthcare Provider. Please read it thoroughly and ask any questions before signing or starting treatment.

Your Superpower Healthcare Provider will review your medical history, medications, supplements, any available laboratory results, and treatment goals to determine whether treatment may be appropriate. An in-person examination, additional testing, or specialist evaluation may be required. Completing an intake or signing this Consent does not guarantee a prescription.

General Information and Background

BPC-157, also called Body Protection Compound-157, is a synthetic peptide made up of 15 amino acids. It has been investigated for effects on biological pathways involved in tissue repair, blood-vessel formation, and inflammation. Most research has been conducted in animals or laboratory models. Human studies are limited, and findings from animals or other routes of administration do not establish the safety or effectiveness of repeated subcutaneous injections.

BPC-157 is not FDA-approved for any medical condition. Its ability to heal injuries, relieve pain, improve recovery, or treat gastrointestinal conditions has not been established in reliable human clinical trials.

Potential treatment goals may include improvement in a specific symptom or physical function discussed with your Healthcare Provider. These are goals, not proven benefits. You may experience no improvement, and your underlying condition may persist or worsen. Treatment must not delay appropriate diagnosis, rehabilitation, or other established care.

Compounded BPC-157 Injectable Medication

This Consent covers standalone BPC-157 administered into the fatty tissue beneath the skin. It does not cover injection into a vein, muscle, tendon, or joint, or combination products containing other peptides. Any different product or route requires a separate clinical discussion and appropriate consent.

There is no FDA-approved BPC-157 product against which the compounded preparation can be considered an approved generic or equivalent. Compounded medications do not undergo FDA premarket review for safety, effectiveness, or quality. FDA has identified concerns about BPC-157-related impurities, characterization of the active ingredient, and the possibility of immune reactions, and has stated that safety information is insufficient to determine the risk of harm in humans. HHS has since adopted the interim policy described below, which does not resolve these safety questions.

Products described as "BPC-157" may differ in their actual ingredient or chemical form. The HHS policy described below applies only to BPC-157 acetate. The dispensing pharmacy must confirm that the product supplied matches the prescription. An unknown or unverified product is not covered by this Consent and must not be used.

A safe and effective human dose, maximum safe dose, and treatment duration have not been established. Prescribing schedules may reflect clinical convention rather than validated human dose-finding studies. Your prescribed dose, concentration, frequency, and planned reassessment date will be provided separately.

HHS Enforcement Discretion Policy

BPC-157 is not approved by FDA and is not authorized for sale. Compounded BPC-157 is made available through the Platform solely in reliance on an interim enforcement discretion policy issued by the U.S. Department of Health and Human Services ("HHS") in October 2026. Under that policy, while FDA completes rulemaking on whether BPC-157 may be used in compounding, HHS has stated that it does not intend to take enforcement action against a state-licensed pharmacy or licensed physician that compounds BPC-157 acetate for an individual patient under a valid prescription, subject to conditions that include testing of the ingredient and reporting of serious adverse events. The policy reflects HHS's current enforcement intentions only. It is not an FDA approval or authorization, and it is not a finding that BPC-157 is safe or effective.

HHS may revise or rescind the policy at any time, in whole or in part, including if a safety signal or product-quality issue arises. The policy will also be superseded by FDA's final rule, which may not permit BPC-157 to be used in compounding. State laws may further limit availability. As a result, Superpower and the Medical Groups cannot guarantee continued availability of BPC-157, and your treatment may need to stop before your planned course is complete, with little or no notice. A prescription or signed Consent does not guarantee that BPC-157 can be lawfully compounded or dispensed to you.

Side Effects Risks and Complications

Every treatment involves risk. For BPC-157, the limited human evidence means that the frequency and full range of side effects are unknown. It is not possible to provide a reliable list of "common" BPC-157 side effects or estimate the likelihood of serious harm. An absence of reported problems does not establish safety.

Possible Injection Effects and Symptoms to Report

• Injections can cause pain, burning, redness, itching, swelling, bruising, bleeding, or a lump at the injection site. Poor technique can cause infection or tissue injury.
• Report new headache, nausea, appetite changes, dizziness, palpitations, fatigue, mood changes, or changes in your response to prescribed medications. These are symptoms to monitor; they are not established common effects of BPC-157.
• Report new or worsening bruising, unusual bleeding, new skin lesions, or darkening of the skin or gums. Some changes have been reported with BPC-157-containing products, including combinations, but it is uncertain whether BPC-157 caused them.

Tell your Healthcare Provider about new symptoms even if you are unsure they are related. Do not assume that an adverse symptom means treatment is working.

Possible Drug Interactions

Formal human interaction studies are lacking. BPC-157 may interact with prescription medications, nonprescription products, supplements, or other peptides in ways that are not yet understood.

• Tell your Healthcare Provider if you take anticoagulants or antiplatelet medications, including warfarin, apixaban, rivaroxaban, aspirin, or clopidogrel. Animal studies raise questions about clotting effects; the direction and significance in humans are unknown. Additional assessment may be needed.
• Disclose diabetes medications, blood-pressure medications, stimulants, psychiatric medications, cancer treatments, immunosuppressants, and all other medications and supplements. Any personal history of cancer excludes participation in this treatment program. A lack of documented interactions does not establish that a combination is safe.
• Do not stop or change established treatment, add another peptide, or combine products without review by a clinician who knows everything you are taking.

Potential Serious Side Effects and Complications

• Severe allergic reactions. BPC-157 or another ingredient could cause a serious reaction, including anaphylaxis, with swelling, difficulty breathing, or collapse. The frequency is unknown.
• Immune reactions. Your immune system may react to the peptide, impurities, or aggregates in the preparation. Possible consequences include hypersensitivity or antibody formation. The likelihood and long-term significance are uncertain, and routine laboratory testing cannot rule them out.
• Infection and product-quality problems. Contamination, an incorrect ingredient or concentration, improper storage, or dosing errors may cause serious injury. Injection-related infection can progress to an abscess or bloodstream infection. Serious infections and severe allergic reactions can be life-threatening.
• Liver and metabolic effects. Animal studies have identified changes in liver-associated blood tests, glucose, and triglycerides. Whether these findings occur at prescribed doses in humans is unknown. Laboratory monitoring is precautionary and does not establish safety.
• Bleeding or clotting effects. Animal studies have shown changes in clotting measures in different directions. Human risks are not established, including in people taking blood thinners or having surgery.
• Uncertain effects on abnormal tissue growth. Laboratory and animal research suggests effects on blood-vessel formation and tissue signaling. Whether BPC-157 could affect an existing cancer or precancerous condition is unknown. Adequate long-term studies have not established its cancer risk. This is an unresolved concern, not proof that BPC-157 causes cancer.
• Other unknown harms. Long-term, reproductive, and repeated-exposure risks remain insufficiently studied. Unexpected reactions, including serious or lasting harm, may occur.
• Delayed care or reinjury. Symptom improvement does not prove that an injury has healed. Delaying diagnosis, increasing activity too quickly, or substituting BPC-157 for recommended treatment can worsen your condition.

This is not a complete list of possible risks or complications. Following instructions and completing monitoring cannot eliminate all risks.

Contraindications and Additional Information Regarding Potential Risks

Because BPC-157 has no FDA-approved prescribing information, there is no established label-based list of contraindications. The following are precautionary exclusions and requirements for this treatment program.

Do Not Start or Continue Treatment if Any of the Following Apply

• You are under 18 years of age.
• You are pregnant, breastfeeding, or attempting to conceive.
• You have a known allergy to BPC-157 or an ingredient in the dispensed preparation, or have had a serious reaction to a previous dose.
• You have any personal history of cancer, regardless of cancer type, stage, or time since diagnosis or treatment. You must also not start or continue treatment if you have a precancerous condition under surveillance or if cancer is suspected, including a new finding being evaluated for possible cancer.
• You cannot verify the medication, concentration, dose, or instructions, or you cannot administer and store it safely.

Pregnancy, breastfeeding, and fertility: Effects on fertility, an unborn baby, and a breastfed infant are not adequately known. If you could become pregnant, discuss effective contraception with your Healthcare Provider. Stop treatment and contact your Healthcare Provider promptly if you become pregnant or decide to attempt conception. No evidence-based preconception washout period has been established.

Before treatment, disclose liver or kidney disease, diabetes, bleeding or clotting disorders, immune-system conditions, active infection, and planned surgery or procedures. These may require additional evaluation, coordination with another clinician, or deferral of treatment. Do not inject through infected, inflamed, damaged, or otherwise abnormal skin.

Competitive sports: BPC-157 is prohibited at all times under the World Anti-Doping Agency Prohibited List, including during and outside competition. A prescription does not automatically exempt you from anti-doping rules. Tell your Healthcare Provider if you participate in a sport or competition subject to testing; use may affect eligibility and result in sanctions.

When to Seek Medical Attention

Stop using the medication and call 911 or seek emergency care immediately for difficulty breathing; swelling of the face, lips, tongue, or throat; collapse or fainting; chest pain; sudden weakness or difficulty speaking; or severe or uncontrolled bleeding. Do not wait for a message through the Platform.

Hold further doses and seek prompt medical assessment for a spreading, hot, painful, or draining injection site; fever or chills; black or bloody stools; blood in the urine; unusual large bruises; persistent vomiting; severe abdominal pain; yellowing of the skin or eyes; dark urine; or a new lump or suspicious skin change. Severe or rapidly worsening symptoms require emergency care.

For other new or persistent symptoms, contact your Healthcare Provider before your next dose. Do not restart after a suspected serious reaction unless specifically instructed following evaluation.

Under the HHS policy, the compounding pharmacy must report serious adverse events and product-quality issues to FDA and applicable state authorities. You may also report side effects directly to FDA's MedWatch program at www.fda.gov/medwatch or 1-800-FDA-1088.

Alternatives

You may choose not to use BPC-157 or may defer treatment while pursuing further evaluation. Depending on your diagnosis, alternatives may include physical therapy, activity modification, supervised rehabilitation, appropriate pain-management medications, established treatments for arthritis or gastrointestinal disease, specialist assessment, or surgery when indicated. Participation in a properly authorized clinical trial may be an option if one is available and you qualify.

Your Healthcare Provider should discuss the expected benefits and risks of alternatives relevant to your condition. BPC-157 should not replace treatment known to be effective for a diagnosed condition.

Medical History Disclosure Requirements

Provide a complete and accurate medical history, including:

• Current symptoms, diagnosis, prior investigations, surgeries, and treatments tried.
• Allergies and previous reactions to medicines, injections, preservatives, or other ingredients.
• Any personal history of cancer, regardless of cancer type, stage, or time since diagnosis or treatment; precancerous changes, new lumps, unexplained weight loss, and relevant family history.
• Liver or kidney disease, diabetes, bleeding or clotting disorders, immune conditions, and infections.
• Pregnancy, breastfeeding, conception plans, and planned procedures.
• All medications, supplements, hormones, and peptides, including products obtained outside Superpower.
• Competitive sport participation and applicable anti-doping requirements.

Keep your Healthcare Provider informed of changes throughout treatment. Withholding or providing inaccurate information can lead to inappropriate treatment and serious harm.

Follow-up and Monitoring

Your treatment plan will identify a symptom or functional goal, a reassessment date, and reasons to stop. The protocol includes an asynchronous (online) check-in approximately 2 weeks after starting treatment, followed by asynchronous check-ins every 4 weeks thereafter. Your Healthcare Provider may request an earlier or additional assessment if needed. Continuing beyond the initial course is a separate decision that requires a review of your symptoms, any side effects, and the remaining uncertainties. Feeling better does not establish that continued treatment is safe.

Treatment may begin before laboratory testing is completed if your Healthcare Provider determines that starting treatment is appropriate. Required laboratory testing must be completed no later than day 60 after starting treatment. Your Healthcare Provider may require testing before treatment or sooner than day 60 if clinically indicated. Monitoring laboratory tests may be requested every 6 months, or at other times as needed, at your Healthcare Provider's discretion. Laboratory results provide information about your general health and may identify reasons to change or stop treatment. Your Healthcare Provider will determine which tests are appropriate; these may include liver enzymes, fasting glucose, triglycerides, a blood count, or other tests based on your history. Blood pressure and symptoms may also be reviewed. Additional clotting assessment may be needed for relevant medications, medical history, or planned procedures.

Normal laboratory results do not establish that BPC-157 is safe, prove that it is working, or rule out immune reactions or long-term harm. Complete the monitoring requested by your Healthcare Provider. Treatment may be held or stopped for adverse effects, significant laboratory changes, a new medical concern, missing monitoring, an unverified product or dose, or lack of meaningful benefit at the planned reassessment. Do not extend a course or increase the dose because improvement has not occurred.

Acknowledgment and Agreement to Proceed

By signing this Consent, I acknowledge the following:

• Understanding and voluntary choice: I have read and understood this information, had the opportunity to discuss my circumstances and alternatives with my Healthcare Provider, and received answers to my questions. I voluntarily consent to the proposed treatment if my Healthcare Provider determines it is appropriate and it can be lawfully provided.
• No FDA approval: I understand that BPC-157 and the compounded injectable product are not FDA-approved for any condition. This involves an unapproved drug substance, rather than simply a different use of an FDA-approved drug.
• Enforcement discretion and availability: I understand that BPC-157 is not authorized for sale, that it is provided solely in reliance on an interim HHS enforcement discretion policy that may be revised or rescinded at any time, and that continued availability is not guaranteed.
• Limited evidence and unknown risks: I understand that the potential benefits are unproven, a safe and effective dose and duration are not established, and serious or long-term risks may be unknown.
• No guarantees: No specific symptom improvement, healing, recovery time, or other result has been promised. I understand that feeling better does not prove tissue healing or make return to activity safe.
• Complete medical history: I will accurately disclose my complete medical history, including any personal history of cancer, and all products I use, and promptly report changes, symptoms, pregnancy, or plans to conceive.
• Monitoring and reassessment: I agree to complete required laboratory testing no later than day 60 after starting treatment, or earlier if directed by my Healthcare Provider, and to complete requested follow-up and monitoring tests. I understand that my Healthcare Provider may request monitoring laboratory tests every 6 months or as needed at their discretion, and that continued treatment depends on clinical reassessment, including whether there is meaningful benefit.
• Financial terms: Prescription charges, cancellation, returns, and refunds are governed by the applicable terms disclosed separately. Signing this medical Consent does not itself change those terms.
• Right to decline or stop: I may decline treatment or withdraw consent for future treatment and discuss alternatives with my Healthcare Provider. Signing this Consent does not waive my legal rights or release any party from responsibility for negligent care.

Directions for Use and Following Instructions

• I will follow the written prescription and dispensing pharmacy instructions for the exact product supplied. I will confirm the medication name, ingredients, concentration, dose, injection volume, frequency, and route before the first dose and whenever the prescription or vial changes.
• I understand that milligrams, micrograms, milliliters, and syringe "units" are not interchangeable. Syringe markings measure volume, and the amount of medication at a given marking depends on the concentration. I will not calculate or guess a dose from another product's instructions or an online example.
• I will administer this treatment only by the prescribed subcutaneous route after receiving instructions. I will not inject it into a vein, muscle, tendon, joint, or directly into an injury.
• I will not change the dose, frequency, course length, or formulation without instruction. If I miss a dose, I will follow the provided instructions or contact my Healthcare Provider or pharmacist; I will not double the next dose.
• I will wash my hands, prepare a clean area, use the instructed skin and vial-cleaning technique, rotate approved injection sites, and use a new sterile needle and syringe for each injection. I will never reuse or share injection equipment, vials, or medication.
• I will not mix BPC-157 with other medications or add a diluent unless the dispensing pharmacy specifically directs me to do so and supplies clear preparation instructions.
• I will follow the pharmacy's storage, handling, transport, and preparation instructions and keep the medication out of reach of children and pets. I will use the earlier applicable discard deadline, including the labeled beyond-use date or any shorter period after puncture or reconstitution. I will not assume a universal 28-day rule applies.
• I will not use a damaged, expired, improperly stored, unexpectedly discolored, cloudy, or visibly contaminated product. I will contact the pharmacy if I am uncertain about its appearance, storage, or shipping conditions before injecting it.
• I will dispose of used needles and syringes in an appropriate sharps container and follow local disposal instructions.
• If I inject the wrong amount or product, I will seek immediate advice from my Healthcare Provider, pharmacist, or Poison Control at 1-800-222-1222. I will seek emergency care for severe symptoms.

CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT

BY SIGNING BELOW, I PROVIDE MY INFORMED CONSENT TO THE PROPOSED TREATMENT WITH COMPOUNDED BPC-157 BY SUBCUTANEOUS INJECTION. I CERTIFY THAT I AM AT LEAST 18 YEARS OF AGE AND AM CONSENTING FOR MYSELF.

I have read this entire Informed Consent, or it has been explained to me in a language I understand. The proposed treatment, uncertainties, potential benefits, risks, and alternatives have been explained to me. I have had the opportunity to ask questions and have received answers satisfactory to me. I understand that I may request a copy of this Consent and withdraw consent for future treatment. I voluntarily elect to proceed, subject to my Healthcare Provider's assessment and applicable prescribing and dispensing requirements.

MEMBER NAME: __________________________________________________

SIGNATURE: ______________________________________________________

DATE: ___________________________________________________________