Radiopharmaceutical Compounding GFI

Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0858

IC ID: 232156

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Statutory Authority
Other-Statutory Authority
Information Collection (IC) Details

View Information Collection (IC)

Radiopharmaceutical Compounding GFI
 
No Removed
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance CDER NEW Compound Radiopharms GFI 2018.pdf No   Printable Only
Other-Statutory Authority 21 USC 353a Pharmacy compounding.pdf Yes Yes Fillable Fileable
Other-Statutory Authority 21 USC 353b Outsourcing Facilities.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

10 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Requested Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 0 0 0 -250 0 250
Annual IC Time Burden (Hours) 0 0 0 -13 0 13
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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