Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

OMB 0910-0045

OMB 0910-0045

Manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishments. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States. This information collection supports agency regulations regarding these requirements.

The latest form for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution expires 2021-12-31 and can be found here.

All Historical Document Collections
Approved with change
No material or nonsubstantive change to a currently approved collection 2020-10-08
Approved without change
Extension without change of a currently approved collection 2018-12-06
Approved without change
Revision of a currently approved collection 2016-12-16
Approved without change
Extension without change of a currently approved collection 2015-07-08
Approved without change
Revision of a currently approved collection 2014-06-23
Approved without change
Revision of a currently approved collection 2012-03-27
Approved with change
Revision of a currently approved collection 2009-01-16
Approved without change
Extension without change of a currently approved collection 2007-12-20
Approved without change
Extension without change of a currently approved collection 2004-10-25
Approved without change
Extension without change of a currently approved collection 2001-03-27
Approved without change
Reinstatement with change of a previously approved collection 1998-03-12
Approved without change
Revision of a currently approved collection 1994-06-30
Approved without change
Reinstatement with change of a previously approved collection 1992-11-20
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-04-07
Approved without change
Reinstatement with change of a previously approved collection 1986-06-06
Approved without change
Revision of a currently approved collection 1983-04-19
Approved without change
Reinstatement with change of a previously approved collection 1978-06-27
Approved with change
No material or nonsubstantive change to a currently approved collection 1977-11-15
Approved without change
Reinstatement with change of a previously approved collection 1977-08-22
OMB Details

Initial establishment registration

Federal Enterprise Architecture: Health - Consumer Health and Safety


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