Recordkeeping - Radiopharmaceutical Compounding and 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
Compounding-and-Repackaging-of-Radiopharmaceuticals-by-State-Licensed-Nuclear-Pharmacies (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:	Recordkeeping - Radiopharmaceutical Compounding and 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	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			Compounding-and-Repackaging-of-Radiopharmaceuticals-by-State-Licensed-Nuclear-Pharmacies (2024).pdf		Yes	No	Printable Only
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: 15	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	400	400
Annual IC Time Burden (Hours)	25	25
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.