Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

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The Food and Drug Administration (FDA) is proposing to prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants). FDA is also proposing new recordkeeping requirements for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. FDA is proposing these actions as part of its continuing efforts to strengthen defenses against the potential risk of exposure to, and spread of, bovine spongiform encephalopathy (BSE) and related human disease in the United States.