Rule 480-11-.02 Compounded Drug Preparations
Public comments were received from Coy Privette, Regional Manager for Roadrunner Pharmacy. Mr.
Privette stated that he is speaking for the veterinary profession and wholeheartedly supports what the
Board is requiring; however, there are some areas of concern for Roadrunner Pharmacy. He requested
the Board consider the veterinary needs for compounding and how they differ from human
compounding when making some of these changes. Mr. Prather responded by stating that he feels the
Georgia Board of Veterinary Medicine should express its concerns to the Board as to what changes
should be made to this rule.
Public comments were received from Robert Stannard. Mr. Stannard stated he would like to address
480-11-.02(2)(a), which states that only a pharmacy licensed or registered by the Board may distribute compounded preparations to practitioners licensed in this state for administration to their patients in the course of their professional practice, either personally or by an authorized person under their direct and immediate supervision. He stated that there have been many questions raised by pharmacies about the interpretation of this. Ms. Wray responded that if a pharmacy distributes more than five percent of its total compounded preparations to practitioners for office use, it would need to be a 503b facility. If they are filling patient specific prescriptions, they can compound and ship out of state if they are compliant in that state. If they are doing office stock, they would be a 503b facility under federal law.
Written comments were received from the following:
Roadrunner Pharmacy
Todd A. Hughes
Dr. Gerald Skees, Family Pet Hospital
Jim Bracewell made a motion to adopt Rule 480-11-.02 Compounded Drug Preparations. Laird Miller
seconded and the Board voted unanimously in favor of the motion.
Public comments were received from Coy Privette, Regional Manager for Roadrunner Pharmacy. Mr.
Privette stated that he is speaking for the veterinary profession and wholeheartedly supports what the
Board is requiring; however, there are some areas of concern for Roadrunner Pharmacy. He requested
the Board consider the veterinary needs for compounding and how they differ from human
compounding when making some of these changes. Mr. Prather responded by stating that he feels the
Georgia Board of Veterinary Medicine should express its concerns to the Board as to what changes
should be made to this rule.
Public comments were received from Robert Stannard. Mr. Stannard stated he would like to address
480-11-.02(2)(a), which states that only a pharmacy licensed or registered by the Board may distribute compounded preparations to practitioners licensed in this state for administration to their patients in the course of their professional practice, either personally or by an authorized person under their direct and immediate supervision. He stated that there have been many questions raised by pharmacies about the interpretation of this. Ms. Wray responded that if a pharmacy distributes more than five percent of its total compounded preparations to practitioners for office use, it would need to be a 503b facility. If they are filling patient specific prescriptions, they can compound and ship out of state if they are compliant in that state. If they are doing office stock, they would be a 503b facility under federal law.
Written comments were received from the following:
Roadrunner Pharmacy
Todd A. Hughes
Dr. Gerald Skees, Family Pet Hospital
Jim Bracewell made a motion to adopt Rule 480-11-.02 Compounded Drug Preparations. Laird Miller
seconded and the Board voted unanimously in favor of the motion.
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