The information contained herein is NOT intended to be the label for a finished drug product. No claims are made as to the uses, safety, efficacy or bioavailability of the compounded products contained therein. The compounded products are not intended to replace the independent judgment of the prescriber or the licensed pharmacist.
The information provided regarding Elite’s compound offerings are for compounded formulations and are NOT an FDA-approved drug label. The suggested formulations are provided for reference only and are based on formulations that have historically been ordered by duly licensed professionals. Compounded products are exempt from FDA approval and no claims are made to the safety and efficacy of any compounded product for any indication or specific use.
Prescribing of the compounds must be based upon the professional judgment of the licensed health care provider after considering the patient’s unique medical condition and factors including body weight, size and overall health status. No liability attaches in any way to any actual or alleged injury to any person or any damage to any tangible property if the compounded product is used beyond the scope as prescribed by your physician.
The licensed pharmacist and/or licensed physician maintains the responsibility to ensure compliance with Section 503A of the Food, Drug and Cosmetic Act, including the requirement that a compound be dispensed pursuant to a valid prescription, from a licensed prescriber, for an identified individual patient. The licensed pharmacist and/or licensed physician is also responsible for ensuring that none of the ingredients appear on an exclusion list maintained by the FDA, and that all of the ingredients may be lawfully used in pharmacy compounding.
