Your Compounded Hormones and USP 800

Want to see your compounded testosterone creams, gels and injectables go away? Well, neither do I. And many people are concerned, because a recent regulation, USP 800, threw testosterone into a hazarous drug category that in times past was only reserved for medications such as radiopharmaceuticals (radioactive drugs) and highly toxic antineoplastics (chemotherapy drugs).  Isn't it just a bit coincidental that they placed testosterone into this bucket where the large pharmaceutical companies have competing products?!

Oh, and guess what?  They just happened to throw estradiol and progesterone into the same general hazardous material bucket!  Women hate the synthetics and are fleeing them en masse. And why wouldn't they? Why not just use the bioidentical molecule that your body has been using since the dawn of mammalian time? These synthetic hormones are rife with side effects as well. And proving that fact was a big news story from earlier in this year (2015), where pharmaceutical represenatives were lamenting the fact that women's bioidentical prescriptions now equaled those of the Big Pharma synthetics:

"Almost half of all prescriptions for menopausal hormone therapy (HT) in the U.S. are for compounded "bioidentical" hormones, researchers reported here. Estimates from a survey of compounding pharmacists revealed about 26 to 33 million prescriptions each year for compounded HT -- about the same number written for FDA-approved HT, JoAnn Pinkerton, MD, of the University of Virginia Health System, and colleagues reported at the Endocrine Society meeting here." [2]

Does that make the pharmaceutical industry angry? Well, I don't know if corporations get angry, but I just know what I see: compounders being suddenly forced to act like estrogen, progesterone and testosterone are plastic explosives!  

Just look at the title of the CDC's regulations that testosterone now falls under:  "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014." [1] Really?!  Since when is testosterone hazardous if is breathed in the air?  Compound pharmacists are always gloved and work in a sterile environment.  There is no way for them to physicially come in contact with the testosterone unless they are violating existing safety codes.  Thus, there is no point in USP 800 as far as hormones are concerned

NOTE:  You may find this so unbelievable, as I did, that you want to look it up for yourself.  Simply go to this CDC link and check out the Group 2 and Group 3 drugs:  NIOSH 2014.

What makes it particularly alarming is that compounded testosterones, again in my opinion, are extremely critical to an ever-growing percentage of men who want to manage their own testosterone replacement therapy with an anti-aging physician or TRT clinic, or who simply are not covered by traditional insurance.  Think about this:  with the FDA's warning labels on testosterone products and class action lawsuits brewing behind the scenes, traditional doctors are going to be less likely to write prescription for testosterone on an ongoing basis.  And this is where having affordable compounded testosterone gels, creams and injectables is critical.  These two options are very reasonable and are still in the $50 to $100 per month range, something that most guys can pull off with a little grit and determination.

SO HOW BAD IS USP 800?  Is there any good news in all of this?  Well, yes and no.  The situation is actually a little less alarming when one consider that they put testosterone into the least hazardous of the three categories of Hazardous Drugs: [1]

1.  Group 1.  Antioneoplastic drugs.  (Antitumor chemotherapy medications)

2.  Group 2.  Non-antineoplastic drubs that meet one or more of the NIOSH criteria for a hazardous drug.

3.  Group 3.  Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding.

Tricky, eh?  They put the testosterone into this Group 3 because it is supposedly reproductively dangerous to the workers who are handling it.  For example, even compounders who stick to topical testosterone only will be required to install new hoods that will vent away all fumes.  Since when does minute amounts of testosterone in the air pose imminent danger to anyone, even a pregnant woman?!  On what science is this based on?!  Again, this is just ridiciulous in the case of testosterone.  It is simply not this kind of a hazardous drug.  

So who is the FDA tryinig to protect? The only clear motivation that I can see is to protect the interests of the large pharmaceutical companies who produce competing overpriced testosterone products.  Their entire business model is in trouble and they are trying desperately to hold onto it.  Androgel currently costs around $300 per month and a compounded cream around, say, $75.  Yes, you can probably get a compounded cream with a much greater efficacy for the cost of your copay.  The clear intent in my opinion is to drive up the costs of the compounded products to try to level the playing field.

Tell your wife and girlfriend that they have thrown her bioidentical progesterone and estradiol into the Group 2 category!  In other words, it is considered even more "radioactive and toxic" than testosterone.  All is fair except in love, war and pharmaceuticals I guess!

The bottom line is that the brand name testosterones are horrendously expensive and will cost the typical male about $300 per month if he had to pay cash here in the U.S.  Three questions come to mind with these high prices:  "1. Why? 2. Why? 3. Why?"  Testosterone is cheap to manufacture and compounders have put out effective, quality products for decades before the pharmaceutical companies even got involved.

However, there is one potentially legimate objection that may come to the mind of some of you:  injectable testosterone needs to have tighter standards and compounders need more regulatory oversight in this area to avoid another "Massachesetts Incident."  For those who don't know, a large Massachusetts compounding pharmacy killed 63 patients with an injectible product a few years back that was contaminated with a fungus.  Yes, this was a horrific incident, and there some bad compounders out there cutting safety corners.  So let's say that the industry does need more oversight and consumers need more protection from injectable products.  Well, this is governed by USP 797

USP 800 has nothing to do with injectable or non-injectable designations.  It basically is just saying, "This is a hazardous drug and needs extra oversight by the FDA because it is so toxic."  Really?  Do we really need help from the FDA when it comes to testosterone?  I don't think so.  I'll bet half the guys on the Peak Testosterone Forum know ten times more than the typical FDA bureaucrat making politically motivated decisions.

So I will cover USP 797 at a later date, which is a mixture of good and evil, but I highly encourage you to call your senator and write the FDA and let them know that you object to testosterone being called "hazardous."  Remember:  with this new regulatiion, the gun is loaded.  They can pull the trigger any time they want to.

NOTE:  I had read that progesterones and estrogens would be in Group 3 but did not see them in there.  Strangely enough, Retin-A (tretinoin) and cabergoline are.