Radiopharmaceutical Compounding GFI

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

Documents and Forms

Document Name Document Type
CDER NEW Compound Radiopharms GFI 2018.pdf Other-Agency Guidance
21 USC 353a Pharmacy compounding.pdf Other-Statutory Authority
21 USC 353b Outsourcing Facilities.pdf Other-Statutory Authority

Information Collection (IC) Details

IC Title:	Radiopharmaceutical Compounding GFI	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-250	250
Annual IC Time Burden (Hours)	-13	13
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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