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FDA COMPOUNDING COMPLIANCE POLICY GUIDE UPHELD BY HOUSTON FEDERAL COURT

Executive Summary

FDA COMPOUNDING COMPLIANCE POLICY GUIDE UPHELD BY HOUSTON FEDERAL COURT in a March 31 decision by Judge David Hittner. The policy guide had been challenged in a suit brought against FDA by Professionals and Patients for Customized Care (P2C2) in May 1992. The suit alleged that the agency did not allow the public opportunity to comment on its compounding Compliance Policy Guide issued three months earlier. P2C2, a Houston-based organization made up of over 600 pharmacists, maintains that FDA's guide was a rule issued without appropriate notice-and-comment procedures. P2C2 was represented by John Simpson of Fulbright & Jaworski.
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