Inaccurate Testosterone Products

[James]

I've been meaning to mention this for some time and finally found the time to do so. We've got a lot of smart guys on this site and I'm curious what your take is on this. I know many doctors, pharmacists, and many here will probably say "testosterone is testosterone and the molecule is the same so it should all be consistent." I'm of the belief that the testosterone concentrations in some compounded testosterone is not very accurate. My lab numbers and symptoms are all over the board despite the fact my dose and injection schedule has remained the same. I'm taking compounding cypionate from a pharmacy in Utah. The clinic I go to orders a ton of it and there are supposedly many thousands of guys going to this clinic nationwide. I understand my body can metabolize the drug differently from week to week, but the numbers (and my symptoms), whether TT, FT, or E2, are all over the board. Interestingly, SHBG remains farily consistent as do most other labs. I looked online and only found 1 study that showed inacurate concentrations from compounding pharmacies and only then it was with gels and creams and not injections. The study reported 'significant variability both within and between compounding pharmacies with respect to the measured concentration of testosterone in the compounded products. However the concentration of testosterone with Androgel & Testim was always consistent and accurate. Only 50% of a batch from one compounding pharmacy provided a product with a testosterone concentration within +/- 20% of the prescribed dose. Two pharmacies actually compounded products with greater than 20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone.' In the conclusion it said, ' Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.' I know this was gels and creams and injections are a different beast, but I think there's something to this guys. I'm not smart enough to figure it out but maybe a rush to jump on the testosterone bandwagan and cut costs to big men's health clinics that buy a crap load of this stuff. Not sure what oversight there is with these kinds of things. I know there are probably regulations, facility and preparation standards blah, blah, blah, that compounding pharmacies 'must' adhere to, but when the human element is involved and if profit is placed above accuracy, who knows how correct these products are. The doc at my clinic decided to write me a prescription for brand name testosterone and is allowing me to self inject. It will be interesting to see if I can get some consistency with my numbers. What do you guys think?

 

[maxadvance]

Interesting, what study are you referencing?

 

[Vince]

[h=5]Conclusions[/b]Poor quality compounded drugs are a serious public health concern, as improperly compounded products have been linked to grave adverse events, including deaths. The results of the FY 2006 compounded drug survey suggest a problem with the quality of certain compounded drug products. All of the API samples passed analytical testing, suggesting that the analytical failures of the finished drug products were likely related to the compounding processes at the pharmacies. Thirty-three percent of compounded finished product samples did not conform to product labeling in terms of potency and/or content uniformity. The majority of the finished compounded product samples analyzed in this survey were hormone therapy products. These products appear to be popular, commonly compounded, and available at many pharmacies. Given the wide use of these products, the fact that nearly one-third failed analytical testing raises public health concerns. The potencies of the compounded finished drug products that failed analysis were highly variable and, in the case of content uniformity, both sub- and super-potent active components were found in the same product samples. The wide range in potency and uniformity of dosage observed in this survey can, in a clinical setting, lead to uncertainty in the amount of drug that a patient receives. Such uncertainty can lead to medication errors that pose a health risk for patients who rely on compounded drugs.http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm204237.htm

 

[Vince]

So far I've only used APS compounding pharmacy, I've been very happy with all of their products...... https://www.excelmale.com/forum/showthread.php?3836-APS-vs-EMPOWER-Pharmacy

 

[Vince Carter]

I think its easy to infer that there's some variance, and I'm sure that there is, some. I know that there's a general malaise from buig Pharma towards compounding pharmacies so it has be taken with some awareness of any agenda. Until you take vials from every big Pharma and multiple compounding pharmacies, you'll never know.
Me personally my SHBG is so low that a variance of injection of just a couple of hours, moves my TT by a 100 points.
I inject EOD...say I inject Saturday morning @ 0500, have a blood draw on Monday @ 0800, and result a TT of 900. In that same paradigm I've seen me inject @ 0700 (two hours later) on a Saturday, same draw on Monday @ 0800, and hit a TT of 1000.
Far too many variables in the individual and how they use the drug to try and draw a conclusion to the strength of medication on that alone.

 

[Nelson Vergel]

Even with perfect quality control from suppliers and your perfect adherence to your program there are variations in T blood levels of 20-30 %. Are you expecting a straight line?

Even with Androgel, a pharma grade product, there are variations.

Large Testosterone Blood Level Variations Found with the Use of Androgel


Of course, you could try another compounding pharmacy and see what happens.

 

[James]

Vince - good read. It would be good if there was something more recent. Powerful stuff though. The majority of compounded samples analyzed were for Hormone Replacement products! That says a lot. Like V. Carter said, I will never know for sure if this is what I'm experiencing unless I analyze vials from big pharma and vials from the compounding pharmacy I currently go to. My script for big pharma test will be ready tonight. Don't know price yet. If the price is too high, will take Nelson's advice and seek another compounding pharmacy, one that seems to get a lot of good feedback. I've got a couple in mind, leaning toward Empower.