A compounding pharmacy is a specialized pharmacy licensed to make custom drug preparations on the order of physicians. They are intended for patients that have a problem using stock medicines. For example, you might have an allergy to a particular ingredient, or the dosage may be inadequate. In such cases, your physician can turn to a compounding pharmacy, and order the drug to whatever unique specifications best suit you. These pharmacies are quite common in the HRT business. Sometimes it is for the unique products, such as high concentration compounded testosterone gels. At others, it is for the lower scrutiny, or even profit. In some states doctors can resell these medicines to you. For whatever the reason, compounded testosterone is perfectly acceptable, right? A new study suggests it might not always be!
The paper published in the Journal of Sexual Medicine concerns an investigation into pharmacies in the Toronto, Canada area. Here, researchers ordered compounded testosterone (transdermal gel) products from 10 different compounding pharmacies. In each case the product was specified to provide a “standard” dosage of 50 mg of testosterone per day. Each pharmacy received the order twice, 30 days apart. Two batches from each allowed for some examination of consistency. The testosterone level was analyzed and recorded. A wide margin of error (+/- 20%) was used to determine dosage accuracy. This actually far exceeds what is allowable by actual pharmaceutical standards. The pharmaceutical items AndroGel® 1% and Testim® 1% were used as controls.
The results in this case are alarming. For the first batch of compounded testosterone gels, approximately 50% did not meet specification. Half of the products were off-dose. If that wasn’t bad enough, it gets even worse! Only 30% of the products in the second batch contained an acceptable concentration of testosterone! A startling 7 out of 10 of the products from licensed compounding pharmacies were not suitable for use. According to the report, most of the problems involved insufficient dosing. Two pharmacies were providing gels that exceeded the prescribed amount of testosterone by more than 20%, though. Most remarkably, one pharmacy was compounding with essentially no testosterone at all. They were giving worthless creams to what they thought were legitimate patients! As expected, AndroGel and Testim tested out to be accurate and consistent.
It is a bit early to make sweeping judgments about compounded testosterone and the compounding pharmacy business, in general. This study involved a very small sample of pharmacies, only 10. These were also found specifically in the Toronto area. Obviously, we can’t take these results and relate them to the quality of testosterone products from other compounding pharmacies. Still, it does underline a potentially serious issue in the business that needs to be explored further. We are eager here at Anabolic.org to follow this issue, and will be sure to report if we find anything else of substance.
A big thanks to Dr. Scally for bringing this study to our attention. Be sure to check out his website at asih.net.
Accuracy of Testosterone Concentrations in Compounded Testosterone Products. Ethan D. Grober MD, MEd, FRCSC, Alaina Garbens MD, Andrea Božović MSc, PhD, Vathany Kulasingam PhD, Majid Fanipour MD and Eleftherios P. Diamandis MD, PhD. The Journal of Sexual Medicine. Volume 12, Issue 6, pages 1381–1388, June 2015