Important Notice Regarding Compounded Medications
Certain medications available through or facilitated by R3TA LLC may be compounded medications prepared by a state-licensed pharmacy or federally regulated outsourcing facility pursuant to a valid prescription issued by a licensed healthcare provider.
Compounded medications are customized preparations created to meet the specific medical needs of an individual patient when, in the professional judgment of a licensed healthcare provider, a commercially available FDA-approved product may not be appropriate or available for that patient's particular circumstances.
FDA Disclosure
Compounded medications have not been approved by the United States Food and Drug Administration ("FDA").
Compounded medications are not reviewed by the FDA for safety, effectiveness, quality, stability, potency, manufacturing consistency, or efficacy in the same manner as FDA-approved drug products. The FDA does not verify or endorse the clinical use, outcomes, or therapeutic claims associated with compounded medications.
Any statements made on this Platform regarding compounded medications have not been evaluated by the FDA unless expressly stated otherwise.
Compounded medications are not interchangeable with FDA-approved drug products. Patients and healthcare providers should not assume that a compounded medication possesses the same safety profile, efficacy, risks, benefits, ingredients, strength, quality, stability, manufacturing standards, bioavailability, clinical data, or therapeutic effects as a commercially available FDA-approved medication.
Where an FDA-approved alternative exists, the decision to prescribe or administer a compounded medication is made solely by the licensed healthcare provider exercising independent professional judgment and clinical discretion based upon the individual needs and circumstances of the patient.
The availability of a compounded medication through this Platform should not be interpreted as a representation or warranty by R3TA LLC that such medication is equivalent, superior, safer, more effective, or otherwise comparable to any FDA-approved drug product.
Clinical Discretion and Provider Responsibility
Compounded medications are prescribed solely at the independent medical judgment, discretion, and responsibility of a licensed healthcare provider.
The prescribing healthcare provider is solely responsible for determining:
- Medical necessity;
- Patient eligibility;
- Clinical appropriateness;
- Dosage and administration;
- Potential benefits and risks;
- Drug interactions;
- Monitoring requirements;
- Informed consent; and
- Ongoing patient management.
R3TA LLC does not prescribe compounded medications, determine medical necessity, make treatment recommendations, or direct patient care.
No Representation of Safety or Effectiveness
R3TA LLC makes no representations, warranties, guarantees, or assurances regarding the safety, effectiveness, suitability, quality, potency, purity, stability, or clinical outcomes associated with any compounded medication.
Individual patient responses may vary significantly, and no specific therapeutic result or medical outcome is guaranteed.
Pharmacy Responsibility
Compounded medications are prepared and dispensed by independently licensed pharmacies operating under applicable federal and state laws and regulations.
All peptide products offered or facilitated through R3TA LLC are sourced exclusively from FDA-registered 503B outsourcing facilities operating under current Good Manufacturing Practice (cGMP) standards and located within the United States. R3TA LLC does not source peptide products from foreign suppliers, research-only channels, or non-cGMP facilities.
R3TA LLC does not manufacture, compound, test, dispense, distribute, or control the preparation of compounded medications and is not responsible for the acts, omissions, products, services, representations, or regulatory compliance of any pharmacy, pharmacist, outsourcing facility, or healthcare provider.
Risk Acknowledgment
By obtaining, prescribing, dispensing, administering, or using a compounded medication, healthcare providers acknowledge and accept that compounded medications may involve risks that differ from commercially available FDA-approved medications, including but not limited to variations in formulation, potency, stability, availability of clinical data, and regulatory oversight.
Healthcare providers assume full responsibility for evaluating these risks and determining whether a compounded medication is appropriate for a particular patient.
No Medical Advice
Information provided by R3TA LLC regarding compounded medications is provided solely for informational and operational purposes and does not constitute medical advice, treatment recommendations, clinical guidance, or professional healthcare services.
All treatment decisions must be made by a licensed healthcare provider exercising independent professional judgment.
Limitation of Liability
TO THE FULLEST EXTENT PERMITTED BY LAW, R3TA LLC DISCLAIMS ALL LIABILITY ARISING FROM OR RELATED TO THE PRESCRIBING, COMPOUNDING, DISPENSING, ADMINISTRATION, USE, MISUSE, EFFECTIVENESS, SAFETY, OR CLINICAL OUTCOMES OF ANY COMPOUNDED MEDICATION.
HEALTHCARE PROVIDERS ASSUME SOLE RESPONSIBILITY FOR ALL CLINICAL DECISIONS INVOLVING COMPOUNDED MEDICATIONS AND AGREE TO HOLD HARMLESS R3TA LLC FROM ANY CLAIMS, DEMANDS, DAMAGES, LOSSES, LIABILITIES, COSTS, OR EXPENSES ARISING FROM THEIR PRESCRIPTION OR USE.
Acknowledgment
BY ACCESSING THIS PLATFORM, ORDERING PRODUCTS, OR PRESCRIBING OR ADMINISTERING ANY COMPOUNDED MEDICATION, THE USER ACKNOWLEDGES THAT THEY HAVE READ, UNDERSTOOD, AND AGREE TO THIS COMPOUNDED MEDICATION DISCLOSURE AND THAT ALL COMPOUNDED MEDICATIONS ARE UTILIZED SOLELY PURSUANT TO THE INDEPENDENT PROFESSIONAL JUDGMENT AND CLINICAL DISCRETION OF A LICENSED HEALTHCARE PROVIDER.