Missouri News: Compounded Drug Testing Report for Fiscal Year 2008

May 1, 2009 3:51 pm Topics: Compounding

Published in the May 2009 Missouri Board of Pharmacy Newsletter

As part of a program initiated in 2003, the Board continues to test drug preparations compounded by pharmacies. Preparations are collected by inspectors and sent to certified laboratories for potency testing and if applicable, sterility/endotoxin testing. The following tables summarize the dosage forms, number of tests performed on the various compounds, and failure rates. Complete fiscal year 2008 results can be found at http://pr.mo.gov/pharmacists-compounding.asp. Potency of compounds that failed testing ranged from 21.3% to 373.7%. An acceptable potency range is considered +/- 10% of the expected potency, unless a United States Pharmacopeia monograph states a different range for a specific preparation. Pharmacies with unsatisfactory results are asked to complete a quality assurance review detailing their compounding practices and to provide a corrective action plan.

Dosage Form (Tests Performed)
Capsule (56)
Injection (2)
Inhalation solution (1)
IV solution (12)
Ophthalmic solution (1)
Oral Solution (1)
Oral suspension (87)
Powder (7)
Suppository (14)
Transdermal (1)
Troche (4)

Test Results – Tests Performed (Percentage)
Satisfactory – 140 (75.3)
Unsatisfactory – 46 (24.7)