FDA Issues Draft Guidance on Practices to Prevent Contamination of Animal Food From Unsafe Drug Carryover

The U.S. Food and Drug Administration (FDA) on May 9 issued a draft guidance on established practices medicated feed manufacturers can use to prevent contamination of animal food from unsafe drug carryover into other batches of medicated feed or non-medicated animal food.

Information in the draft guidance for industry (GFI) #272, “Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover,” includes:

  • Background: The draft guidance states that drug carryover usually happens when an approved drug used in a batch of medicated feed is inadvertently included in a subsequent manufactured batch of animal food and that drug carryover can occur for various reasons, including: 1) the use of the same equipment to manufacture both medicated feed and non-medicated animal food; 2) the design, construction, or inadequate maintenance of manufacturing equipment; 3) poor dust control in a feed mill; 4) inadequate cleanout practices for manufacturing and distribution equipment between sequential manufactured batches of animal food; or 5) human error.
  • Regulatory Requirements: The draft guidance provides an overview of FDA’s regulatory requirements that pertain to the safety of mediated feed and animal food, including the Current Good Manufacturing Practice (CGMP) for Medicated Feed regulation (21 Code of Federal Regulations (CFR) Part 225), drug residue limits for human food (21 CFR Part 514.1(b)(7) and Part 556), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation (21 CFR Part 507), and Sanitary Transportation of Human and Animal Food regulation (21 CFR Part 1, Subpart O).
  • Practices to Prevent Unsafe Contamination from Drug Carryover: The draft guidance describes commonly used practices to prevent unsafe drug carryover, including physical cleanout, flushing, and sequencing. The draft also lists factors to consider when designing sequencing procedures to prevent unsafe contamination of from drug carryover and to protect human and animal health.

FDA states that when finalized, draft GFI #272 will not change the substance of existing policies or introduce new policies. Rather, it will consolidate much of the information found in two outdated Compliance Policy Guides and include current animal food regulatory information and updated examples of factors to consider when designing sequencing practices.

FDA will accept public comments on the draft guidance through Aug. 8. After the comment period ends, FDA will consider feedback submitted and begin work on the final version of the guidance.

Source: NGFA