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HR 3204: Food and Drug Administration Proposed Rules 12.3.13
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HR 3204: Food and Drug Administration Proposed Rules

 

Bulk Drug Substances that May be Used to Compound Drug Products, etc., Concerning Outsourcing Facilities:
Request for Nominations

2013-28978 
[Docket No. FDA-2013-N-1524; Filed: 12/02/13 at 11:15am;  Publication Date: 12/4/2013]
   
Drug Products that Present Demonstrable Difficulties for Compounding:
 2013-28980 
[Docket No. FDA-2013-N-1523; Filed: 12/02/13 at 11:15am;  Publication Date: 12/4/2013]
 
List of Bulk Drug Substances that May be Used in Pharmacy Compounding; Withdrawal
 2013-28979 
[Docket No. FDA-2013-N-1525; Filed: 12/02/13 at 11:15am;  Publication Date: 12/4/2013]
 
NOTICES
Draft Guidance for Industry; Availability:
Interim Product Reporting for Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act

 2013-28960 
[Docket No. FDA-2013-N-1428; Filed: 12/02/13 at 11:15am;  Publication Date: 12/4/2013]
 
Registration for Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
 2013-28962 

[Docket No. FDA-2013-N-1429; Filed: 12/02/13 at 11:15am;  Publication Date: 12/4/2013]
 
Draft Guidance; Withdrawal:
Pharmacy Compounding of Human Drug Products under Section 503A of the Federal Food, Drug, and Cosmetic Act

 2013-28963 
[Docket No. FDA-2013-D-1444; Filed: 12/02/13 at 11:15am;  Publication Date: 12/4/2013]

 
Posted 12.3.13  
 
 
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