Pharma-Grade Enclomiphene now available

#22
Our use of clomiphene is off-label anyway. Would that be considered "not FDA approved?"
These are two separate things. FDA approval means that a drug has been shown to be safe and effective in treating a particular condition, and it may be manufactured and marketed. The approval process is long, difficult and expensive.

Off-label prescribing refers to an unapproved use of an approved drug. Once a drug is approved then healthcare providers are given discretion in prescribing it for purposes other than what was used to gain approval: "... when they judge that it is medically appropriate for their patient."

Ostensibly, unapproved drugs such as enclomiphene and ipamorelin can be prescribed when they are compounded, thus falling less under the FDA's jurisdiction:
The public tends to think that unapproved drugs are “illegal” and that only FDA approved drugs are legal to use in the U.S. This is simply not true. FDA approval is required for drugs that are going to be manufactured and marketed by a manufacturing facility in the U.S. and distributed through interstate commerce. Compounded preparations are prepared pursuant to a prescription issued by a prescriber (legally authorized to prescribe by the state) for a specific patient and compounded by a pharmacist (legally authorized by the state to practice pharmacy). The FDA is generally not involved in pharmacy compounding since it is regulated by the individual states.
[1]
There has been new regulation subsequent to these remarks, which created a new category of compounding pharmacies, still not quite manufacturers, but now subject to FDA inspections and quality standards. Some details here.
  • 503B: This is the new category of compounders that operate according to heightened stator requirements relative to the 503A facilities.
Drugs that are produced by the outsourcing facilities must be compounded in compliance with current good manufacturing practice requirements and performed in an FDA-approved facility subject to risk-based inspections. It is also important for the outsourcing facilities to provide information on the compounded products to the FDA.
...
Traditional compounders (i.e. 503A) are allowed to compound drugs in accordance with the FC&C Act using bulk drug substances that comply with the existing United States Pharmacopeia or National Formulary monograph standards. Meanwhile, outsourcing facilities (i.e 503B) may use bulk drug substances to compound a drug that complies similarly with the FD&C Act, if the FDA has determined that there is a clinical need to compound the drugs.
I won't claim this clears everything up, but it at least gives a sense of the regulatory environment.
 
Thread starter #23
On this point, it's hard to envision someone arguing successfully that he was harmed by enclomiphene, but would not have been harmed by Clomid.
In those whose E2 is already low or low normal, I would be concerned that enclomiphene (being a pure estrogen receptor antagonist) might push them over the edge, further reducing E2 to unhealthy levels. Therefore, what about cycling low dose clomiphene concurrently to effectively keep the E2 levels from further supression? Thoughts?
 
#24
Maybe taking DHEA to raise E2 if necessary and therefore avoid introduction of zuclomiphene isomer back into the mix? However, contra this thought, see Castaneda's post on High estrogen / SHBG. He says his experience with taking DHEA results in no E2 increase, but higher E1, carrying SHBG higher, and therefore binding more E2.
 
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#26
In those whose E2 is already low or low normal, I would be concerned that enclomiphene (being a pure estrogen receptor antagonist) might push them over the edge, further reducing E2 to unhealthy levels. Therefore, what about cycling low dose clomiphene concurrently to effectively keep the E2 levels from further supression? Thoughts?
The usual problem with Clomid is too much estrogenic action, not to little. I'd expect enclomiphene alone to stimulate plenty of intratesticular aromatization via the increase in LH. But if not, isn't zuclomiphene a rather poor choice for an estrogen replacement? The long half-life is grossly mismatched with the 10-hour half-life of enclomiphene. If a guy's estradiol is that low wouldn't it make more sense to take estradiol directly? However, boosting estrogen exogenously works against the enclomiphene, at least to some extent.
 
#27
I am very interested in Enclomiphene, and a patient of Defy. If this medication does come available I would be on this in a heart beat. I truly believe this medication will help my conditions.

If Defy finds a way to bypass any legal rights and start clinical trials I will volunteer and take this medicine lol.
 
#31
Has anyone been successful with using this pharmacy yet? I can provide this information to my doctor, but I do not want to waste his time or pose any risk his license.
Yes, see this post by Steve78 over at PeakT:
Steve78 said:
Yes, tailor made, 25 mg po daily. Cost was about 130 I believe for 90 tabs including shipping. Got my old trt doc to write it. He wrote clomid before and I brought him the literature on enclomiphene. The reason why my restarts with clomid didn’t work was because of fatigue and intense brain fog which made daily living a pain. I’m hoping enclomiphene bumps my LH without the feeling like crap feeling.
 
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