Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

OMB 0910-0154

OMB 0910-0154

This ICR requests approval for recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), and product distribution. These records are subject to FDA review during an inspection. Type A medicated articles which are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

The latest form for Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226 expires 2023-08-31 and can be found here.

All Historical Document Collections
Approved without change
Extension without change of a currently approved collection 2020-07-22
Approved without change
Extension without change of a currently approved collection 2017-07-27
Approved without change
Extension without change of a currently approved collection 2014-06-30
Approved without change
Extension without change of a currently approved collection 2011-04-28
Improperly submitted and continue
Extension without change of a currently approved collection 2011-02-22
Approved without change
Extension without change of a currently approved collection 2007-12-18
Approved without change
Extension without change of a currently approved collection 2004-11-17
Approved without change
Extension without change of a currently approved collection 2001-07-20
Approved without change
Reinstatement with change of a previously approved collection 1998-07-09
Approved without change
Reinstatement with change of a previously approved collection 1993-02-01
Approved without change
Revision of a currently approved collection 1989-07-19
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-04-25
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 1986-03-07
Approved without change
New collection (Request for a new OMB Control Number) 1983-02-24
OMB Details

Recordkeeping requirements for cGMP Regulations for Type A Medicated Feeds

Federal Enterprise Architecture: Health - Consumer Health and Safety


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