503A; Recordkeeping

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

Documents and Forms

Document Name Document Type
0800 503A final std MOU FDA Cleared.pdf Other-Memorandum of Understanding
0800 503A final std MOU FDA Cleared.pdf Other-Memorandum of Understanding
0800 503A GFI 2016.pdf Other-Agency Guidance Document
0800 503A GFI 2016.pdf Other-Agency Guidance Document

Information Collection (IC) Details

IC Title:	503A; Recordkeeping	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

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-Memorandum of Understanding			0800 503A final std MOU FDA Cleared.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance Document			0800 503A GFI 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: 45	Number of Respondents for Small Entity: 0

Affected Public: State, Local, and Tribal Governments

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	90	90
Annual IC Time Burden (Hours)	90	90
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.