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Monday, February 25, 2013

REGULATING THROUGH RULES: SUGGESTED CHANGES IN THE FEDERAL REGULATION OF VETERINARY COMPOUNDING


13 Hous. J. Health L. & Policy 129
Copyright © 2012 David Hrncir
Houston Journal of Health Law & Policy
I SSN 1534-7907

David Hrncir*
TABLE OF CONTENTS
INTRODUCTION .......................................................................................... 129
DEFINITION OF COMPOUNDING .................................................... 132
HISTORY OF VETERINARY COMPOUNDING AND ITS
REGULATION .................................................................................. 133
WHY THE FDA SHOULD PREFER NOTICE-AND-COMMENT
RULEMAKING ............................................................................................. 138
CHEVRON DEFERENCE ................................................................... 138
AUER DEFERENCE .......................................................................... 141
SIMILARITIES IN PROMULGATING CPGS AND RULES ................... 142
THE U.S. SUPREME COURT’S SUGGESTIONS ................................. 145
THE FDA WILL BE DRIVING THE INITIATIVE ............................... 145
BENEFITS TO THE COMPOUNDING PROFESSION ....................................... 146
THE ABILITY TO COMMENT ........................................................... 146
A MORE CERTAIN REGULATORY ENVIRONMENT ........................ 147
THE STATUTORY BASIS FOR A PROPOSED RULE ....................................... 148
POLICY BASES FOR A PROPOSED RULE AND SUGGESTED CONTENT ....... 153
SOME FINAL REBUTTALS TO FDA HESITATION OVER THE ABOVE

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