EnovaRX™ Single Component Cream Kits

EnovaRX Traditional Compounds
Manufactured in a FDA registered facility which must follows cGMP regulations and guidelines where applicable Compounded in a licensed retail pharmacy or physician office; Governed by the FDA and with oversight and inspection by the local state boards of pharmacy, a compound is generally exempt from requirements applicable to manufactured products
Products are listed in national pharmaceutical publications such as First Data Bank, Redbook and Medi-Span Completed compounds are prepared based on patient specific individualized prescriptions, they are not products listed in national pharmaceutical publications
All manufacturing of kits must adhere to CGMP guidelines Compounds must comply with federal and state regulations
Active Pharmaceutical ingredients must be the same each and every time Pharmacists tailor each batch of product based on patient need, as well as historical dispensing records, as opposed to creating non-patient specific standardized products. The pharmacist can utilize a different manufactured brand of active ingredient with each batch if so desired according to the professional judgement of the pharmacist
Non-patient specific products are delivered to licensed pharmacies, or other health care providers and registered facilities with a manufacturer published AWP Active raw bulk ingredients do not always have an AWP, do not always have a NDC, and are priced by the manufacturer
CGMP regulations and processes must be followed each time for kit manufacturing and assembly of topical cream kits Formulations may differ from pharmacy to pharmacy and physician practice to practice, as most compounds are prepared on a patient-specific basis ONLY
Final preparation and dispensing of product can be from any licensed pharmacy or physician practice, or other authorized health care provider Final formulation of a particular product is not universally available, and not all pharmacies or physician offices compound medications
EnovaRX are manufactured with Single Component Active Ingredients A compound is generally defined as the mixing of TWO or more components
EnovaRX products come with directions for pharmacy or in-office final preparation of cream. Final percentage may or may not be altered or determined by the prescribing physician A compound is generally defined as being completed according to a formulation created by the pharmacist or other health care provider, and does not follow “manufacturer instruction for preparation”

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