We are proposing to amend 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 proposed amendment is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act. The effect of the proposed amendment would be to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.
Document Subtype:
Notice of Proposed Rulemaking (NPRM)
Received Date:
July 18 2012, at 12:00 AM Eastern Daylight Time
Start-End Page:
42195 - 42197
Comment Start Date:
July 18 2012, at 12:00 AM Eastern Standard Time
Comment Due Date:
November 16 2012, at 11:59 PM Eastern Standard Time
Viruses, Serums, Toxins, and Analogous Products: Exemptions from Preparation Pursuant to an Unsuspended and Unrevoked License
Details Information
Comments
View AllSubmitter: Rodibaugh, Max Posted: 09/16/2012 ID: APHIS-2011-0048-0017
Nov 16,2012 11:59 PM ET
Submitter: Davidson, Donald Posted: 09/16/2012 ID: APHIS-2011-0048-0018
Nov 16,2012 11:59 PM ET
Submitter: Coleman, Larry Posted: 09/16/2012 ID: APHIS-2011-0048-0019
Nov 16,2012 11:59 PM ET
Submitter: Sprague, Michelle Posted: 09/16/2012 ID: APHIS-2011-0048-0020
Nov 16,2012 11:59 PM ET
Submitter: Regier, Patrick Posted: 09/16/2012 ID: APHIS-2011-0048-0021
Nov 16,2012 11:59 PM ET
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