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 w…
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Individual pharmacies that compound testosterone operate without direct FDA oversight and approval, resulting in considerable variation in potency and quality, even between samples from the same pharmacy.
“While testosterone gels and creams are the most commonly used forms of compounded testosterone therapies and are routinely less expensive than branded forms of testosterone, individual pharmacies operate without direct FDA oversight and approval, resulting in considerable variation in potency and quality, even between samples from the same pharmacy.”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [50]
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Evaluation and Management of Testosterone Deficiency: AUA Guideline
Mulhall, J. P., Trost, L. W., Brannigan, R. E., Kurtz, E. G., Redmon, J. B., Chiles, K. A., Lightner, D. J., Miner, M. M., Murad, M. H., Nelson, C. J., et al. (2018) · Journal of Urology · doi:10.1016/j.juro.2018.03.115 · Cited by 766 · see citing works
- Authors
- Grober, E. D., Garbens, A., Božović, A., Kulasingam, V., Fanipour, M., & Diamandis, E. P.
- Affiliations
- Mount Sinai Hospital (CA)
- University Health Network (CA)
- Corresponding author
- Grober, Ethan D.
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-06-01
- Volume
- 12
- Issue
- 6
- Pages
- 1381-1388
- ISSN
- 1743-6095 (ISSN-L)
- 1743-6109
- OpenAlex
- W1636718264
- Cited by
- 27
- References
- 7
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 4 · 2020: 3 · 2019: 3 · 2018: 2 · 2017: 1 · 2016: 1
- FWCI
- 1.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- The Journal of Sexual Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Paladin Labs
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- testosterone gel, compounding pharmacies, testosterone replacement therapy, liquid chromatography-tandem mass spectrometry, product variation
- MeSH terms
- Canada, Drug Compounding, Gels, Humans, Pharmacies, Testosterone
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