Repackaging 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
Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities JAN 2017.pdf Other-Agency Guidance
21 USC 353a Pharmacy compounding.pdf Other-Statutory Authority
21 USC 353b Outsourcing Facilities.pdf Other-Statutory Authority

Information Collection (IC) Details

IC Title:	Repackaging GFI	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities JAN 2017.pdf	Yes	Yes	Fillable Fileable
Other-Statutory Authority	21 USC 353a Pharmacy compounding.pdf	Yes	Yes	Fillable Fileable
Other-Statutory Authority	21 USC 353b Outsourcing Facilities.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: 6	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-138	138
Annual IC Time Burden (Hours)	-150	150
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.