Active Moiety Name FDA Established Pharmacologic Class (EPC) Text

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Active Moiety Name FDA Established Pharmacologic Class (EPC) Text

FDA Established Pharmacologic Class (EPC) Text Phrase PLR regulations require that the following statement is included in the Highlights Indications and Usage heading if a drug is a member of an EPC [see 21 CFR 201.57(a)(6)]: Active Moiety Name “(Drug) is a (FDA EPC Text Phrase) indicated for [indication(s)].” For each listed active moiety, the associated FDA EPC text phrase is included in this document. For more information about how FDA determines the EPC Text Phrase, see the 2009 "Determining EPC for Use in the Highlights" guidance and 2013 "Determining EPC for Use in the Highlights" MAPP 7400.13.

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List of Covered Drugs
List of Covered Drugs Effective July 1, 2016 INTRODUCTION We are pleased to provide the 2011 Gold Coast Health Plan List of Covered Drugs as a useful reference and informational tool. The GCHP List of Covered Drugs can assist practitioners in selecting clinically appropriate and cost effective products for their patients. The information contained in the GCHP List of Covered Drugs is provided solely for the convenience of medical providers. We do not warrant or assure accuracy of such information nor is it intended to be comprehensive in nature. This List of Covered Drugs is not intended to be a substitute for the knowledge, expertise, skill and judgment of the medical provider in his or her choice of prescription drugs. All the information in this List of Covered Drugs is provided as a reference for drug therapy selection. Specific drug selection for an individual patient rests solely with the prescriber. We assume no responsibility for the actions or omissions of any medical provider based upon reliance, in whole or in part, on the information contained herein. The medical provider should consult the drug manufacturer's product literature or standard references for more detailed information. National guidelines can be found on the National Guideline Clearinghouse site at http://www.guideline.gov PREFACE The GCHP List of Covered Drugs is organized by sections. Each section is divided by therapeutic drug class primarily defined by mechanism of action. Unless exceptions are noted, generally all applicable dosage forms and strengths of the drug cited are included in the GCHP List of Covered Drugs. Generics should be considered the first line of prescribing.
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