Which FDA Guidance for Industry addressed voluntary withdrawal of production uses and changed labeling from OTC to VFD for medicated feed products?

• A. FDA Guidance for Industry #209
• B. FDA Guidance for Industry #213
• C. FDA Guidance for Industry #210
• D. FDA Guidance for Industry #214

Answer: (B)

The main idea here is understanding how FDA guides industry through converting medicated feeds from over-the-counter use to a system that requires veterinary oversight under a Veterinary Feed Directive, including the voluntary withdrawal of production uses and the labeling changes that go with it.

Guidance for Industry #213 specifically addresses implementing the Veterinary Feed Directive for medicated feeds. It explains the shift from OTC labeling to VFD labeling, the role of a licensed veterinarian in issuing VFD orders, and how production uses that were formerly allowed OTC are voluntarily withdrawn or reclassified to require veterinary oversight. The guidance also outlines what must appear on VFD labeling and in the accompanying paperwork, along with recordkeeping and compliance expectations. This directly matches the scenario of voluntary withdrawal of production uses and labeling changes from OTC to VFD.

Other FDA guidance documents cover related topics like antimicrobial stewardship or general drug labeling practices, but they do not address this specific transition to the VFD framework for medicated feeds.