Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products 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
CompoundingandRepackagingofRadiopharmaceuticalsbyOF (2024).pdf Other-Agency Guidance
Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities (2024).pdf Other-Agency Guidance
Mixing--Diluting--or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application (2024).pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products GFI,	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	CompoundingandRepackagingofRadiopharmaceuticalsbyOF (2024).pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities (2024).pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	Mixing--Diluting--or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application (2024).pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 28	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,801	1,801
Annual IC Time Burden (Hours)	1,009	1,009
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.