Good Manufacturing Practice Regulations for Type A Medicated Articles

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 expires 2023-08-31 and can be found here.

Recordkeeping requirements for cGMP Regulations for Type A Medicated Feeds

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