Compounded preparations are not FDA-approved. FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed. References to manufacturing, analytical testing, Certificates of Analysis or professional availability do not constitute or imply FDA approval.
A professional business-development website
Unvari.com is a corporate website intended to provide general information about the Unvari brand and invite qualified medical practices to discuss potential professional relationships.
The website does not process product purchases, prescriptions, pharmacy orders, patient registrations, medical records or insurance transactions.
Product names and formulation information are presented for professional business inquiries and do not constitute a consumer offer, patient recommendation or guarantee of access.
Compounded preparations are not FDA-approved
Compounded preparations referenced through the Unvari professional network are not reviewed or approved by FDA through the new-drug approval process.
FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed.
The Unvari name, packaging, manufacturer identity, third-party testing, production-lot documentation or Certificate of Analysis does not represent or imply that FDA has approved a compounded preparation.
Practitioner authorization is required
Applicable preparations require a valid patient-specific prescription or order issued by an appropriately licensed practitioner following an evaluation of an identified patient.
A website inquiry, business meeting, professional account discussion or request for information is not a prescription and does not authorize dispensing.
Patient-specific information must be submitted only through the practitioner and pharmacy systems designated for prescription and dispensing activities.
Distinct responsibilities within the network
Owns and manages the Unvari brand, brand standards and Unvari.com.
Performs the applicable manufacturing functions associated with Unvari products.
Supports distribution, professional-practice relationships and applicable business communications.
Independently review prescriptions and perform applicable compounding and dispensing activities.
May provide logistics or shipping support under the applicable pharmacy or fulfillment arrangement.
The exact parties and functions involved may vary by formulation, prescription, state, dispensing pharmacy and fulfillment arrangement. The dispensing pharmacy responsible for a patient-specific preparation is identified through the applicable label and pharmacy documentation.
Manufactured in the United States
Unvari products are manufactured in the United States by Alpha BioMed Labs.
Manufacturing statements refer to the manufacturing activities and products supported by Unvari’s records and applicable production documentation.
A United States manufacturing statement does not by itself represent FDA approval, pharmacy approval, clinical suitability or availability in every jurisdiction.
Quality claims are production-lot specific
Each released Unvari production lot is supported by third-party analytical testing and a corresponding Certificate of Analysis.
A Certificate of Analysis applies to the production lot, sample, analytical methods and results identified in that document.
A COA does not independently establish that a preparation is appropriate for a particular patient, guarantee clinical outcomes, eliminate all risk, replace pharmacy review, replace practitioner judgment or constitute regulatory approval.
Qualified professional partners may request available production-lot documentation through the applicable business relationship.
Nationwide capability does not guarantee universal availability
The Unvari network supports professional partnership and fulfillment capabilities across the United States.
Actual access or fulfillment may depend on:
Website references to nationwide capabilities do not mean that every formulation is available to every practitioner or patient in every state at all times.
Product information is not clinical guidance
Nothing on Unvari.com is intended to provide medical advice, diagnosis, treatment recommendations, dosing instructions, prescribing guidance, pharmacy advice or patient counseling.
Practitioners remain independently responsible for evaluating patients, determining medical appropriateness, obtaining applicable consent, issuing lawful prescriptions and providing appropriate monitoring and follow-up.
Participating pharmacies independently determine whether a prescription may lawfully and appropriately be compounded and dispensed.
Unvari.com is not a patient system
Unvari.com does not request or intentionally collect patient information, prescription information, medical records, diagnoses, treatment details or other patient-specific health data.
Patient names, dates of birth, addresses, photographs, diagnoses, medical histories, prescriptions, treatment information, laboratory results, insurance information, medical records or other patient identifiers.
Patient information associated with prescribing and dispensing must be transmitted only through the authorized practitioner or pharmacy systems established for that purpose.
Product and regulatory information may change
Unvari may revise this page to reflect changes in products, formulations, participating organizations, pharmacy arrangements, testing programs, availability or applicable requirements.
The updated version will become effective when posted with a revised effective date. Product-specific documents and executed agreements may contain additional or more specific terms.
Product and regulatory questions
Qualified medical practices may contact Unvari to request professional partnership information or available quality documentation. Do not send patient, medical or prescription information.
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