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Press Release Background FDA 3.5.2014
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IACP Seeks FDA Approval of Bulk Drug Substances List For Compounding Pharmacists, 3.5.14


 

BACKGROUND

Please click on the links below to access the requests that the IACP has filed with the U.S. Food and Drug Administration (FDA).

 

IACP's 503A Comments to FDA Regarding Bulk Drug Substances 

 

IACP Nominations on 2,403 Bulk Ingredients - 503A   

IACP Nominations on Bulk Ingredients 503A Non USP Non Approved Drug Substances - List

Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding for 503A - En Bloc Submission of The Homeopathic Pharmacopeia of the United States. 

Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding as Defined by 503A - En Bloc Submission of The British Pharmacopeia (BP), The European Pharmacopeia (EP) and The Japanese Pharmacopeia (JP).   

Bulk Drug Nominations for Substances that may be used in Pharmacy Compounding as Defined by 503A - En Bloc Submission of The Food Chemicals Codex (FCC) and The USP Dietary Supplements Compendium (DSC).

 

 

IACP's 503B Comments to FDA Regarding Bulk Drug Substances 

 

IACP Nominations on 2,403 Bulk Ingredients - 503B 

IACP Nominations on Bulk Ingredients 503B Non USP Non Approved Drug Substances - List

Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B - En Bloc Submission of The Homeopathic Pharmacopeia of the United States.   

Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B - En Bloc Submission of The British Pharmacopeia (BP), The European Pharmacopeia (EP) and The Japanese Pharmacopeia (JP). 

Bulk Drug Nominations for Substances that may be used in Compounding by Outsourcing Facilities as Defined by 503B - En Bloc Submission of The Food Chemicals Codex (FCC) and The USP Dietary Supplements Compendium (DSC). 

IACP Nominations on Bulk Ingredients 503B USP Mongraphed Drugs

 

 



 


 

 

 

 

 

 

 

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