PostScription: Changing Pharmacy Regulations Could Affect US Compounders

Author(s):  Downing Pat, Roberson Kim

Issue:  Nov/Dec 2003 - Compounding for Investigational Studies
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Abstract:  The authors discuss changes in regulations affecting pharmacists licensed in Texas that could set a precedent to affect pharmaceutical compounding throughout the United States. According to the authors, many of the proposed new regulations have been written as best practices rather than as minimum standards of practice, and some may inhibit the pharmacist’s professional judgment. Required documentation and additional testing of some preparations will also increase pharmacists’ operating costs. The most important proposed changes involve replacing state pharmacy-practice regulations with federal regulations from the US Food and Drug Administration and guidelines from the United States Pharmacopeia and using a percentage of compounds prepared for medical office use to differentiate manufacturing from compounding (the 5% rule). The authors discuss both of these proposed changes, ending with a call to action for pharmacists to make their views known.

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