Description
A most important responsibility of an animal feed manufacturer is to assure that the feed produced--whether medicated or non-medicated--meets the intended specifications and is not adulterated. All feed mixing operations, regardless of size or drugs used, share this responsibility. Medicated feeds must be proper with respect to drug content to have their intended effect. Medicated and non-medicated feeds that are adulterated with undesired drugs may cause violative drug residues in meat, milk or eggs, or injury to consuming animals. Everyone associated with food animal agriculture must work to avoid these risks to the public and animal health, and the potential loss of consumer confidence in animal-derived food products.
Scope & Applicability
Product Classes
8manufactured using Type A medicated article
Specific category of animal drug products
Assay limits for Type B and Type C medicated feeds are specified as a range.
used to manufacture medicated feed; A concentrated form of a drug used to manufacture medicated feed.; Concentrated drug form used to manufacture medicated feed; single ingredient component for medicated feed; Medicated feed mill license is required to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.; Concentrated drug form for manufacturing medicated feed; Concentrated form of animal drug used to manufacture medicated feed; Type A medicated articles fo
intermediate medicated feed; A medicated feed intended for further manufacture of another medicated feed.; Intermediate medicated feed; Intermediate medicated feed product; medicated feed intended for further mixing; Intermediate medicated feed used to manufacture Type C feed
Final medicated feed intended for consumption; Medicated feed intended for consumption as a complete feed; medicated feed intended for direct consumption by animals; Medicated feed intended for direct consumption by animals
classification of drugs relevance to VFD drugs; Drugs requiring no withdrawal period at lowest use level
classification of drugs relevance to VFD drugs; Drugs requiring withdrawal periods or regulated on no-residue basis; A list of Category II drugs is located in 21 CFR 558.4(d).; Drug category requiring a medicated feed mill license
Stakeholders
2Entities responsible for complying with CGMP regulations
Entity manufacturing feed from Type A medicated articles
Regulatory Context
Attributes
1Requirement for equipment capability
Identified Hazards
Hazards
1Potential risk in meat, milk, or eggs from adulterated feed
Related CFR Sections (8)
- 21CFR225.120§ 225.120 Buildings and grounds.
Buildings used for production of medicated feed shall provide adequate space for equipment, processing, and orderly receipt and storage of medicated feed. Areas shall include access for routine maintenance and cleaning of equipment. Buildings and grounds shall be constructed and maintained in a mannRead full regulation →
- 21CFR225.202§ 225.202 Formula, production, and distribution records.
Records shall be maintained identifying the formulation, date of mixing, and if not for own use, date of shipment. The records shall be adequate to facilitate the recall of specific batches of medicated feed that have been distributed. Such records shall be retained on the premises for 1 year followRead full regulation →
- 21CFR225.130§ 225.130 Equipment.
Equipment shall be capable of producing a medicated feed of intended potency and purity, and shall be maintained in a reasonably clean and orderly manner. Scales and liquid metering devices shall be accurate and of suitable size, design, construction, precision, and accuracy for their intended purpoRead full regulation →
- 21CFR225.135§ 225.135 Work and storage areas.
Work areas and equipment used for the production or storage of medicated feeds or components thereof shall not be used for, and shall be physically separated from, work areas and equipment used for the manufacture and storage of fertilizers, herbicides, insecticides, fungicides, rodenticides, and otRead full regulation →
- 21CFR225.142§ 225.142 Components.
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 Read full regulation →
- 21CFR225.158§ 225.158 Laboratory assays.
Where the results of laboratory assays of drug components, including assays by State feed control officials, indicate that the medicated feed is not in accord with the permissible limits specified in this chapter, investigation and corrective action shall be implemented immediately by the firm and sRead full regulation →
- 21CFR225.165§ 225.165 Equipment cleanout procedures.
Adequate procedures shall be established and used for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and nonmedicated feeds.Read full regulation →
- 21CFR225.180§ 225.180 Labeling.
Labels shall be received, handled, and stored in a manner that prevents label mixups and assures that the correct labels are used for the medicated feed. All deliveries of medicated feeds, whether bagged or in bulk, shall be adequately labeled to assure that the feed can be properly used.Read full regulation →
Related Warning Letters (10)
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC
- 2024-04-16
CGMP/Medicated Feeds/Adulterated
Appleton City Feed Service LLC
- 2024-03-19
CGMP/Medicated Feeds/Adulterated
Furst-McNess Company
- 2024-02-13
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Battle Creek Co-op/CHS, LLC dba Progressive Nutrition
- 2023-12-12
CGMP/Medicated Feeds/Adulterated
Nutra Blend, LLC subsidiary of Land O’Lakes
- 2023-10-24
CGMP/Medicated Feeds/Adulterated
Suther Feeds, Inc.
- 2022-12-27
CGMP/Medicated Feeds/Adulterated
Land View, Inc.
- 2022-12-20
CGMP/Medicated Feeds/Adulterated
CHS Inc./CHS River Plains
- 2022-11-22
CGMP/Medicated Feeds/Adulterated
Effingham Equity
- 2022-08-02
CGMP/Animal Food/Adulterated
Dairy Feeds, Inc.
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover (Status: Final)
- CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Status: Final)
- Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)
- CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (Status: Draft)
- CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)