Animal food manufacturing facilities that produce medicated feed must register for additional licenses with the Food Drug Administration. The first, a Drug Establishment Registration (DER), is required annually for animal food manufacturing facilities wishing to purchase Category II, Type A medicated articles (i.e., animal drug premixes).
The second type of registration that medicated feed facilities must obtain is a medicated feed mill license. In years past, animal food manufacturers registered each animal drug they intended to use in the production of medicated feed. In 1996, Congress changed this by passing the Animal Drug Availability Act, making it possible for manufacturers to simply obtain a single license for their facility to use any medicated feed. Today, slightly more than 1,000 U.S. feed mills hold these never-expiring medicated feed mill licenses.
Given the medicated feed mill license provides the FDA with the information it needs to conduct inspections and enforce regulations, the American Feed Industry Association has called for the agency to eliminate the duplicative DER requirement for medicated feed facilities. While the requirement remains in place, the AFIA works with the FDA for continual improvement of the registration system to ease the regulatory strain on the industry.