OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

OMB 0910-0139 ยท HHS/FDA.

OMB 0910-0139

This information collection supports FDA regulations for finished pharmaceuticals, as well as medical gas containers and closures and active pharmaceutical ingredients (APIs). The regulations mandate recordkeeping responsibilities that ensure covered articles are produced in accordance with current good manufacturing practice (CGMP). Products not in compliance with CGMP may be deemed adulterated and subject to agency enforcement action. We are revising the collection to provide for pharmaceutical voluntary consensus standard recognition.

The latest form for Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients) expires 2026-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
All Historical Document Collections
Approved without change
 No material or nonsubstantive change to a currently approved collection 2023-09-28
Approved without change
 Revision of a currently approved collection 2023-04-26
Approved without change
 Extension without change of a currently approved collection 2021-06-23
Approved without change
 Revision of a currently approved collection 2018-04-16
Approved without change
 Extension without change of a currently approved collection 2015-03-06
Approved without change
 Extension without change of a currently approved collection 2011-09-29
Approved without change
 Extension without change of a currently approved collection 2008-09-30
Approved without change
 No material or nonsubstantive change to a currently approved collection 2005-12-22
Approved without change
 Extension without change of a currently approved collection 2005-07-27
Approved without change
 Extension without change of a currently approved collection 2002-06-11
Approved without change
 Reinstatement with change of a previously approved collection 1999-04-22
Approved without change
 No material or nonsubstantive change to a currently approved collection 1995-09-30
Approved without change
 Reinstatement with change of a previously approved collection 1992-09-15
Approved without change
 Reinstatement with change of a previously approved collection 1988-01-04
Approved without change
 Revision of a currently approved collection 1985-02-12
Approved with change
 No material or nonsubstantive change to a currently approved collection 1983-09-08
Approved without change
 Revision of a currently approved collection 1982-12-29
Approved with change
 No material or nonsubstantive change to a currently approved collection 1982-07-16
Approved without change
 New collection (Request for a new OMB Control Number) 1981-10-30
OMB Details

Recordkeeping CGMP for Finished Pharmaceuticals

Federal Enterprise Architecture: Health - Public Health Monitoring