503B Initial Reporting

Guidance for Industry (GFI): Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0827 can be found here:

Documents and Forms

Document Name Document Type
praCompoundingProductReportingFGuidance.May2016.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	503B Initial Reporting	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-Agency Guidance			praCompoundingProductReportingFGuidance.May2016.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: 55	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	12,101	12,101
Annual IC Time Burden (Hours)	24,201	24,201
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.