BILL ANALYSIS
Senate Research Center S.B. 1274
By: Van de Putte
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
Current law does not address the issue of flavoring medicine. However, current interpretation by the Texas State Board of Pharmacy (board) considers flavoring to be compounding.
The 79th Legislature, Regular Session, 2005, enacted S.B. 492, relating to prescription drug compounding. This was the first time in many years that the Texas Legislature took a comprehensive look at compounding, reflecting the advances in technology related to this pharmaceutical practice. While it addressed the more global issue of compounding, S.B. 492 did not address the distinction between flavoring and compounding and did not officially divide flavoring rules from compounding rules.
Generally speaking, compounding is the process of a pharmacist mixing together one or more raw ingredients to create a drug that is then dispensed to a patient pursuant to a prescription. Flavoring is the practice of adding a few drops of flavor to an existing commercially manufactured drug to make that medication more palatable to the patient. Flavoring of medications has been shown to increase patient compliance.
The major distinction between flavoring and standard compounding is that flavoring does not change the dose or composition of the medication. Compounding is a sterile, invasive process that focuses on several complex elements while flavoring is a simple, medically tested process that only requires a few drops of liquid into a liquid prescription or over-the-counter medicine.
As proposed, S.B. 1274 exempts the reconstitution of commercial products or the addition of flavoring from being considered as compounding.
RULEMAKING AUTHORITY
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Subdivision (9), Section 551.003, Occupations Code, to redefine "compounding."
SECTION 2. Effective date: September 1, 2007.