
Medical Disclaimer
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.