Missouri News: Compounded Drug Testing Report

February 1, 2007 4:02 pm Topics: Compounding

Published in the February 2007 Missouri Board of Pharmacy Newsletter

In 2003, the Board initiated a program to test drug preparations compounded by pharmacies. All preparations are tested for potency and, if applicable, sterility and endotoxin. The tables below are for the fiscal year ending June 30, 2006.

Dosage Form (Tests Performed)
Capsule (63)
IV solution (11)
Inhalation solution (4)
Injectable solution (9)
Oral solution/suspension (161)
Suppository (9)
Tablet (1)
Topical cream/ointment/liquid (3)
TPN solution (1)
Transdermal (12)

Test Results – Tests Performed (Percentage)
Satisfactory – 205 (74.8%)
Unsatisfactory – 69 (25.2%)
Total – 274 (100%)

All unsatisfactory results were related to potency failures. 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. Failing potency results ranged from 0.0% to 259.0%.

Drugs with Unsatisfactory Results
Alprostadil/Phentolamine/Papaverine
Amlodipine
Azathioprine
Baclofen
Bi-Est/Pregnenolone/Progesterone
Bi-Est/Progesterone
Bi-Est/Progesterone/Testosterone
Bi-Est/Progestrone/Testosterone/DHEA
Budesonide
Captopril
Clindamycin/Hydrocortisone
Clonazepam
Clonidine
Enalapril
Estradiol/Estriol
Estradiol/Estrone/Estriol
Hypertonic Saline
Ibuprofen
Lansoprazole
Liothyronine
Lorazepam/Diphenhydramine/Haloperidol
Magic Mouthwash™
Methimazole
Metronidazole
Omeprazole
Phenytoin
Progesterone/Melatonin/Hydroxytryptophan
Prolox™
Promethazine
Rifampin
Spironolactone
Spironolactone/Hydrochlorothiazide
Testosterone
Tri-Est/DHEA
Tri-Est/Progesterone/Testosterone
Tri-Est/Progesterone/Testosterone/DHEA
Vancomycin

Pharmacies are notified of unsatisfactory results and asked to complete a quality assurance review of their compounding practices and provide a corrective action plan.