Under provisions of the American Medicinal Drug Use Clarification Act (AMDUCA) and 21 CFR part 530, FDA can prohibit use of an entire class of drugs in selected animal species if FDA determines that: (I) an acceptable analytical method needs to be established and such a method has not or cannot be established; or (II) the extra-label use of the drug or drug class presents a public health risk. FDA can also limit the prohibition on extra-label use to specific species, indications, dosage forms, routes of administration, or a combination of these.
|Based upon recommendations by the National Conference on Interstate Milk Shipments (NCIMS), the FDA publishes a set of minimum standards and requirements for the production of Grade "A" milk. These standards, which are published collectively as the Grade A Pasteurized Milk Ordinance (Grade "A" PMO), provide applicable CFR references and can be used as an inspectional guide to cover specific operations in the dairy industry, including pasteurization equipment, packaging, quality control and record keeping requirements. Although the PMO does not have the force of regulations, it provides procedures and standards of general applicability that are acceptable to FDA. Owing to human food safety concerns, certain drugs are not to be used or not to be stored on dairy operations or fed to lactating dairy cattle. These restrictions include:|