Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. These 12 volumes, each as a new sixth edition, emanate from her comprehensive sixth edition food and drug regulatory law book, “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products Regulation,” available at www.fortipublications.com. Ms. Termini presents and publishes in a broad array of specialized food and drug law topics, such as corporate accountability, enforcement, health claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel University and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the committees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials.
Veterinary Products Regulationby Roseann B. Termini, Esq.
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. … See more details below
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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.
The 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.
The 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.
The 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.
Finally, 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.
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