Outsourcing Facilities: Registration and reporting of drugs under 503B(b)

Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Documents and Forms

Document Name Document Type
21 USC 353b Sec 503B FFDCA OCT 2022.pdf Other-Statutory Authority
21 USC 353b Sec 503B FFDCA OCT 2022.pdf Other-Statutory Authority
0800 GFI Outsourcing registration and reporting of drugs DEC 2016.pdf Other-Agency Guidance
0800 GFI Outsourcing registration and reporting of drugs DEC 2016.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Outsourcing Facilities: Registration and reporting of drugs under 503B(b)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Statutory Authority			21 USC 353b Sec 503B FFDCA OCT 2022.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			0800 GFI Outsourcing registration and reporting of drugs DEC 2016.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: 75	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	8,111	8,111
Annual IC Time Burden (Hours)	214	214
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.