Formulation Disclaimer

The information provided in Fagron's sample formulation is a suggested formulation and is NOT an FDA-approved drug label. The suggested formulation is provided for reference only and is based on formulations that have historically been ordered by duly licensed professionals, and is intended for use by pharmacy professionals engaged in compounding practice ONLY.

When compounding, use only USP Chapter <795> or Chapter <797> guidelines (as applicable) to achieve strength, quality and purity with appropriate packaging and labeling in accordance with professional pharmacy practice, using USP grade ingredients. The compounded formulations must meet the requirements of all applicable compendia monographs.

The information provided is intended as a “suggested formulation” for traditional compounding using certain active pharmaceutical ingredients (APIs) and/or excipients. This information is provided solely to supplement, not to substitute the professional expertise and judgment of a licensed physician or licensed pharmacist or professional authorized to conduct drug compounding to meet the specific clinical needs of a patient with a prescription. Administration of the formulations must be based upon the professional judgment of the licensed health care provider after considering the patient’s unique medical conditions and factors including body weight, size and overall health status. No liability attaches if suggested formulation is used beyond the scope of pharmacy compounding by a licensed pharmacist or licensed physician.

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. Licensed pharmacist and/or licensed physician is also responsible for ensuring that none of the ingredients used in compounding are substances that are on an exclusion list maintained by the FDA, and that all of the ingredients may be lawfully used in pharmacy compounding. Outsourcing facilities, as applicable, are responsible for ensuring compliance with Section 503B of the Food, Drug and Cosmetic Act, including registration, reporting requirements and Current Good Manufacturing Practices (CGMPs). Outsourcing facility is also responsible for ensuring that each of the ingredients appear on an inclusion list maintained by the FDA of bulk drug products, and that all of the ingredients may be lawfully used in pharmacy compounding. Fagron makes no representation as to the inclusion of any ingredient on such list maintained by the FDA. Distribution of this information is limited to licensed professionals engaged in the practice of pharmacy compounding or the ordering of prescription compounded medication. This information is NOT intended to be disseminated to the public, and Fagron bears no liability for the use of these formulations in marketing or promotion by pharmacies, outsourcing facilities, and/or physicians.

Subject to and protected by U.S. Copyright laws and not intended for copying or duplication.

For additional information, visit www.fagron.us.