21 CFR Part 225 · Current Good Manufacturing Practice for Medicated Feeds

§ 225.142 Components

Subpart G - Product Quality Assurance Official text on eCFR Amendment history

Adequate procedures shall be established and maintained for the identification, storage, and inventory control (receipt and use) of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality, and purity of these drug sources. Packaged Type A medicated articles and Type B medicated feeds shall be stored in designated areas in their original closed containers. Bulk Type A medicated articles and bulk Type B medicated feeds shall be identified and stored in a manner such that their identity, strength, quality, and purity will be maintained. All Type A medicated articles and Type B medicated feeds shall be used in accordance with their labeled mixing directions.

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What FDA inspectors cite under § 225.142

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Veterinary Medicine).

  • Adequate procedures for Type A and Type B articles 68
  • Drug Components 21
  • Use in accord with directions 17
  • Bulk Type A and Type B storage 9

Warning letters citing § 225.142

8 FDA warning letters since 2017 cite this section :

Amendment history

Federal Register documents that created or amended this section.