Medical Disclaimer

Effective September 3, 2026 · Redox

Important information for practitioners about the content of this website and the regulatory status of the formulations described on it.

For licensed healthcare practitioners only

The Redox Smart Pen website is written for licensed healthcare practitioners in the United States. It is not intended for patients or the general public, and nothing on it should be read as advice to any individual about diagnosis, treatment or medication. If you are a patient, please speak with your own healthcare provider about any question relating to your health or treatment.

Not medical advice

The information on this website describes a delivery system and the formulations with which it may be prescribed. It is general in nature, is provided for informational purposes only, and does not constitute medical, pharmaceutical or legal advice. It is not a substitute for a practitioner's own training, judgement and review of the current literature, product information and applicable standards of care. Practitioners are solely responsible for deciding whether any therapy is appropriate for a particular patient, for obtaining informed consent, for prescribing, and for monitoring their patients.

Regulatory status

BPC-157 and TB-500 are not approved by the United States Food and Drug Administration (FDA) for the treatment, cure, mitigation or prevention of any disease or condition. The FDA has not evaluated statements on this website. These substances are made available only as compounded preparations, prepared by a pharmacy licensed under section 503A of the Federal Food, Drug, and Cosmetic Act, pursuant to a valid prescription for an individually identified patient. Compounded drugs are not FDA-approved and have not been evaluated by the FDA for safety, effectiveness or quality. NAD+ preparations are likewise compounded on prescription. Availability is subject to federal and state law and may change without notice.

Redox does not manufacture, compound, dispense or sell any drug, and makes no representation or warranty regarding the safety, efficacy, purity or potency of any compounded preparation. Those responsibilities rest with the dispensing pharmacy and the prescribing practitioner.

No claims of outcome

Descriptions on this website of what a formulation "supports" refer to the general category of use for which practitioners have historically considered such formulations. They are not claims that any product will produce a particular result. Individual responses to any therapy vary, and no outcome is promised or guaranteed.

The delivery system

The Redox Smart Pen is a prefilled delivery pen supplied with the compounded formulation that a practitioner has prescribed. Statements about precision dosing, cold-chain handling, batch traceability and at-home use describe the design of the delivery system and the fulfilment process. They do not alter the regulatory status of the medication inside the pen and do not replace the pharmacy's dispensing information or the practitioner's instructions to the patient.

Adverse events and emergencies

Practitioners and patients who experience or observe an adverse event, product quality problem or medication error involving a compounded preparation are encouraged to report it to the FDA MedWatch programme at fda.gov/safety/medwatch, and to the dispensing pharmacy. In a medical emergency, call 911 or your local emergency number immediately. Do not use this website or its form to report an emergency.

Testimonials and endorsements

Statements attributed to named clinicians on this website reflect that individual's professional opinion about the delivery system. They are not evidence of clinical outcomes and should not be relied on as such.

Questions

Questions about this notice can be sent to Redox Medical Group at [email protected] or (310) 421-2707. This notice forms part of our Terms of Use.

Smart delivery. Better experience. Better outcomes.

For licensed prescribers only. This site is intended solely for healthcare professionals licensed to prescribe in the United States. It is not directed to patients or the general public. Nothing on this site is patient-facing advertising.

Not FDA approved. The Redox Smart Pen is a compounded preparation. Compounded drug preparations are not FDA approved. FDA does not review compounded preparations for safety, effectiveness, or manufacturing quality. The active ingredients described here are not approved by FDA for the uses discussed, and no statement on this site should be read as a claim that any preparation is safe or effective for any condition.

Prescription and dispensing. Any preparation described here would be compounded and dispensed by an independently licensed 503A compounding pharmacy pursuant to a valid prescription for an individually identified patient, based on the prescriber's independent clinical judgment and an established prescriber-patient relationship. Availability is subject to applicable federal and state law, including the status of each ingredient under Section 503A of the Federal Food, Drug, and Cosmetic Act, and may change without notice.

Registration of interest only. Submitting this form registers your interest. It is not an order, a prescription, a purchase commitment, or an offer to sell, and it creates no obligation on either party.

Information only. Content on this site is provided for professional informational purposes and is not medical advice. Prescribers are responsible for evaluating the appropriateness of any therapy for a given patient, for informed consent, and for compliance with all applicable federal and state law, board rules, and professional standards.

Adverse events. Suspected adverse events should be reported to the dispensing pharmacy and to FDA MedWatch at 1-800-FDA-1088 or fda.gov/medwatch.

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