CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover

Description

Drug carryover generally occurs when a drug used in the manufacture of a batch of medicated feed, for which the drug is approved, gets inadvertently included in a subsequent batch of: (1) a non-medicated feed, (2) a different medicated feed for which the drug is not approved (e.g., medicated feed for another species), or (3) a medicated feed that contains the same drug that can result in a higher drug level than is stated on the labeling.  Drug carryover can occur for various reasons, including, for example, the use of the same equipment to manufacture both medicated and non-medicated feed; the design, construction, or inadequate maintenance of feed manufacturing equipment; poor dust control in a feed mill; inadequate cleanout practices for manufacturing and distribution equipment between sequential batches of animal feed; or human error.

Scope & Applicability

Regulatory Context

• 21CFR558.3§ 558.3 Definitions and general considerations applicable to this part.

  (a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is noRead full regulation →

• 21CFR225.65§ 225.65 Equipment cleanout procedures.

  (a) Adequate cleanout procedures for all equipment used in the manufacture and distribution of medicated feeds are essential to maintain proper drug potency and avoid unsafe contamination of feeds with drugs. Such procedures may consist of cleaning by physical means, e.g., vacuuming, sweeping, washiRead 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 →

• CGMP/Animal Food/Adulterated

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  2025-12-23

• CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

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  2025-07-08

• CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

  Lystn LLC dba Answers Pet Food

  2025-07-08

• CGMP/Non-Medicated Feed/Adulterated

  Livestock Nutrition Center

  2025-04-22

• CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

  Mid America Pet Food LLC

  2024-12-10

• CGMP/Medicated Feeds/Adulterated

  Hi-Pro Feeds, LLC

  2024-04-30

• CGMP/Medicated Feeds/Adulterated

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  2024-04-16

• CGMP/Medicated Feeds/Adulterated

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  2024-03-19

• CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated

  Agila Corporation dba Woody’s Pet Food Deli

  2024-03-05

• CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated

  Battle Creek Co-op/CHS, LLC dba Progressive Nutrition

  2024-02-13

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