Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

OMB 0910-0606

This information collection provides for documenting procedures and maintaining records pertaining to the production of dietary supplements. Products that do not meet CGMP requirements may be deemed to be in violation of the Federal Food, Drug, and Cosmetic Act. The information collection also covers regulations pertaining to exemptions from testing requirements applicable to these products and how petitions should be filed with FDA.

The latest form for Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements expires 2023-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0606 Supporting Statement_2023.docx Supporting Statement A
Dietary Supplements CGMP; Reporting
Dietary Supplements CGMP; Recordkeeping

All Historical Document Collections

202209-0910-007 Approved without change	Extension without change of a currently approved collection	2023-05-11
202004-0910-003 Approved without change	Revision of a currently approved collection	2020-04-27
201703-0910-016 Approved without change	Extension without change of a currently approved collection	2017-04-25
201402-0910-005 Approved without change	Extension without change of a currently approved collection	2014-02-27
201009-0910-006 Approved without change	Extension without change of a currently approved collection	2010-09-30
200707-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	2007-07-10

OMB Details

Dietary Supplements CGMP; Recordkeeping

Federal Enterprise Architecture: Health - Consumer Health and Safety