{"product_id":"2940149310845","title":"Veterinary Products Regulation","description":"Did you know that one of the signers of the Declaration of Independence was a leader in Veterinary medicine? Benjamin Rush, a physician, held a vision for veterinary science. That vision eventually led to the founding of the University of Pennsylvania Veterinary School. Fast forward from the 1800s to the 1900s for the FDA appointment of the first veterinarian.  \u003cbr\u003eThe historical evolution of FDA’s Center of Veterinary Medicine (CVM) is detailed in this volume. Additionally, this volume focuses on issues concerning animal drugs, feeds, foods and animal health products that are regulated through (CVM). Animal drugs are regulated under specific sections of the Food Drug and Cosmetic Act. They are regulated as either new animal drugs under 21 U.S.C. § 360b or as antibiotics and, if used in feed or drinking water for food producing animals, they are regulated as food additives. The terms “new animal drug and “animal feed” are defined under 21 U.S.C. § 321(v) and (w). A “new animal drug“ is “any drug intended for use in animals or in animal feed”. Similar to the drug approval process for human drugs, new animal drugs must also go through the drug approval process to establish safety and efficacy. Before a new animal drug can be marketed, it must be approved by CVM using quality, safety and efficacy as a basis. Section 512 of the FDCA or 21 U.S.C. § 352, applies to misbranded animal drugs and devices. \u003cbr\u003eThe concept of new animal drugs is detailed in the decision of United States v. Articles of Drug for Veterinary Use. A new animal drug is deemed unsafe unless the drug received FDA approval. Further, the new animal drug must be used in conformity to the approved labeling. Drugs used in food-producing animals must be safe for animals as well as for the food-product derived from the treated animal. CVM conducts product monitoring through surveillance and compliance programs. The Food Safety Modernization Act has impacted as well. \u003cbr\u003eThe FDCA does not contain a preapproval provision for pet food. However, pet food can nevertheless be deemed “adulterated” and “misbranded” under the FDCA as illustrated in the decision of United States v. Strauss. Pet foods are prohibited from containing poisonous or deleterious substances or pesticide residues in excess of established tolerances.  Recalls do occur and the largest in United States history was the nationwide pet food recall due to tainted imported wheat gluten. Pharmacy compounding is also explored. \u003cbr\u003eFinally, the hotly contested issue of the use of antimicrobials in food producing animals was addressed in late 2013. The outcome was the issuance of a final guidance pertaining to a voluntary phase out program in animals for food production purposes. A companion veterinary feed directive involves the “switch” from over-the-counter to prescription drug product necessitating a veterinary feed directive. Each chapter contains critical analysis issues to explore.","brand":"Forti Publications","offers":[{"title":"Default Title","offer_id":47101119987952,"sku":"2940149310845","price":32.85,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0737\/7593\/9824\/files\/2940149310845_p0.jpg?v=1763715040","url":"https:\/\/shop-qa.barnesandnoble.com\/products\/2940149310845","provider":"Barnes \u0026 Noble (DEV)","version":"1.0","type":"link"}