title: Accuracy of testosterone concentrations in compounded testosterone products.
abstract: OBJECTIVE
  This study aims to evaluate the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies.
  
  
  METHODS
  Ten compounding pharmacies within Toronto area were included. Pharmacies were blinded as to the nature of the study. A standardized prescription for 50 mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded batches were analyzed from each pharmacy 1 month apart. Testosterone concentrations in a 5-g sachet of Androgel® 1% (Abbott) and 5-g tube of Testim®1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Laboratory Medicine Program at the University Health Network. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone.
  
  
  RESULTS
  Compounded formulations included seven gels and three creams with a volume/daily dose ranging from 0.2 mL to 1.25 mL. Product cost ranged from $57.32 to $160.71 for a 30-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products. In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within ± 20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone.
  
  
  CONCLUSIONS
  Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.
authors.affiliation: Department of Surgery, Division of Urology, Mount Sinai and Women's College Hospital, Toronto, Ontario, Canada.
authors.forename: Ethan D
authors.initials: ED
authors.lastname: Grober
authors.affiliation: Department of Surgery, Division of Urology, Mount Sinai and Women's College Hospital, Toronto, Ontario, Canada.
authors.forename: Alaina
authors.initials: A
authors.lastname: Garbens
authors.affiliation: Laboratory Medicine Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.|Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Andrea
authors.initials: A
authors.lastname: Božović
authors.affiliation: Laboratory Medicine Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.|Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Vathany
authors.initials: V
authors.lastname: Kulasingam
authors.affiliation: Department of Surgery, Division of Urology, Mount Sinai and Women's College Hospital, Toronto, Ontario, Canada.
authors.forename: Majid
authors.initials: M
authors.lastname: Fanipour
authors.affiliation: Laboratory Medicine Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.|Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.|Samuel Lunenfeld Research Institute and Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Diamandis
mesh_terms: D002170:Canada / Q000453:epidemiology; D004339:Drug Compounding / Q000592:standards*; D005782:Gels; D006801:Humans; D010594:Pharmacies; D013739:Testosterone / Q000097:blood / Q000494:pharmacology*
chemical_list: D005782:Gels; D013739:Testosterone
keywords: Compounding; Pharmacy Final Decision; Testosterone