Missouri News: Compounded Drug Testing Report for Fiscal Year 2007

February 1, 2008 3:56 PM Topics: Compounding

Published in the February 2008 Missouri Board of Pharmacy Newsletter

As part of a program initiated in 2003, the Board continues to test drug preparations compounded by pharmacies. Inspectors collect prepa¬rations and send them to certified laboratories for potency testing and if applicable, for sterility testing and presence of endotoxins. The tables below summarize the dosage forms and number of tests performed on the various compounds, the failure rates, and compounds that failed testing. Potency of compounds that failed testing ranged from 21.2% to 450.4%. 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. When the Board is notified of unsatisfactory results, pharmacies are asked to complete a quality assurance review detailing their compounding practices and provide a corrective action plan.

Dosage Form (Tests Performed)
Capsule (37)
Injection (7)
IV solution (12)
Oral solution (2)
Oral suspension (140)
Suppository (5)
Tablet (2)
Topical cream/ointment (1)
Transdermal (6)
Troche (1)

Test Results – Tests Performed (Percentage)
Satisfactory – 162 (76.1%)
Unsatisfactory – 51 (23.9%)

Compounds with Unsatisfactory Test Results
Azathioprine oral suspension
Baclofen suppositories
Biest/Progesterone capsules
Biest/Progesterone/DHEA capsules
Biest/Progesterone/Testosterone capsules
Boric Acid capsules
Captopril oral suspension
Carboplatin IV solution
Cisplatin IV solution
Clonidine injection
DHEA capsules
Diethylstilbestrol capsules
Enalapril oral suspension
Enalapril tablets
Histamine Diphosphate injection
Histamine injection
Ketoprofen transdermal
Lansoprazole oral suspension
Metronidazole oral suspension
Omeprazole oral suspension
Piroxicam capsules
Progesterone capsules
Progesterone suppositories
Progesterone troches
Progesterone/Melatonin/Hydroxytryptophan capsules
Rifampin oral suspension
Spironolactone/HCTZ oral suspension
Testosterone transdermal
Triest/DHEA capsules
Triest/Progesterone capsules
Triest/Progesterone/DHEA/Testosterone capsules