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| USDA/APHIS | RIN: 0579-AD66 | Publication ID: Fall 2015 |
| Title: ●Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License | |
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Abstract:
This rulemaking amends the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian-client-patient relationship. This rule is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act and to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship. |
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| Agency: Department of Agriculture(USDA) | Priority: Substantive, Nonsignificant |
| RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 9 CFR 107 | |
| Legal Authority: 21 U.S.C. 151 to 159 | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. | |
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Donna L. Malloy Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS Department of Agriculture Animal and Plant Health Inspection Service Unit 38, 4700 River Road, Unit 148, Riverdale, MD 20737-1231 Phone:301 851-3426 |
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