FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs - DISCUSSION

This thread is for the purpose to discuss the Press Release found here .

And another press release by the International Academy of Compounding Pharmacists found here .

Please remember that all discussions should be civil and contain a tone of kindness.

THank you for your expected cooperation.

The way I read this (and I hope I'm correct) is that they are not talking about Tri-Est prescribed by my physician as long as the pharmacy is NOT advertising it as a "cure-all" of sorts? I hope I'm correct, because I can't use "straight" estradiol. This is the first thing that works for me. Am I interpreting this correctly?
Thanks for your ideas...

Its very difficult to understand, isn't it?

From what I understand, FDA is going after pharmacies who advertise (online specifically according to their actual letters) that BHRT is safer and who claim estriol is safer.

I believe the violations are about the advertising claims. But we will keep an ear out for any clarification!

If someone would only do long term research for estriol and all other compounded HRT, we would have more to understand.

What's interesting is that I can tolerate estriol, but not estradiol on its own. I did my own research and in Europe there are apparently quite a few doctors who use solely estriol. That's why, I guess, the tri-est is so good for me. Ughh. Let's just hope they'll let us keep using what works.
Thanks for your update

Yes, it looks like the compounding pharmacies that are saying their hormones are bio-identical or natural, or cure or prevent certain diseases are the one's in trouble.

I would check with my compounding pharmacy though if they compound estriol because the FDA says this:

"Estriol, however, is not a component of an FDA-approved drug and, consistent with FDA policy, pharmacies may not compound drugs containing estriol unless they have a valid investigational new drug application."


I so wish there was more research on estriol and compounding hormones for women.

This article makes it sound as if the FDA wants to halt compounds containing estriol. My insurance company has recently send me a letter saying it will no longer pay for compounded hormones. It seems Wyeth, the makers of Premarin, want the FDA to limit our choices. I really hope I am interpreting this wrong.


http://www.foxbusiness.com/markets/i...trict-womens-a

Your link doesn't work but that's okay. There is no need to link to the article as I have linked to the official press release of FDA in the first post.

This is from the article
4. What is estriol and why is FDA concerned about “BHRT” drugs that contain it?

Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.

5. Will compounded hormone therapy drugs still be available to patients?

FDA believes that pharmacists engaging in traditional compounding provide a valuable medical service, and the Agency respects and takes seriously a licensed practitioner’s decision that an FDA-approved drug may not be appropriate for his or her patient’s medical needs. When a licensed practitioner decides that his or her patient’s specific medical needs will be best served by a compounded hormone therapy drug, FDA would expect to exercise enforcement discretion towards the compounding of that drug, consistent with FDA’s policy described in the Compounding CPG.

Estriol, however, is not a component of an FDA-approved drug and, consistent with FDA policy, pharmacies may not compound drugs containing estriol unless they have a valid investigational new drug application.

The FDA seems to be saying that pharmacies can use estriol if they seek an investigational new drug application. Does anyone know if pharmacies have already sought a new drug application for estriol. Kathy, do you know what Bellevue Pharmacy is saying about this?

I haven't talked to Bellevue, but I have found this information on the website for International Academy of Compounding Pharmacy:

http://www.iacprx.org/site/DocServer...pdf?docID=3281

FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones

Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone
Treatments, Use the Term “Bio-identical”

MISSOURI CITY, Texas – In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, substituting its judgment for that of doctors. Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to do so in October 2005. More than 70,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth’s petition, the vast majority of whom opposed the petition.

“Under this policy, patients will suffer while Wyeth profits,” said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP). “Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth’s products are found to be ineffective or produce side effects. This is a decision that should be left to doctors.”

In the letters, the FDA states that it will “halt” compounding of medications containing estriol, an estrogen produced by the human body. Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors’ prescriptions for women suffering from symptoms of menopause.

Like many commonly prescribed drugs (e.g, Phenobarbital, quinine, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDAapproved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.

The FDA also stated in its letters that pharmacies may not use the term “bio-identical” to characterize compounded hormone therapies, even though the chemicals used in such compounds are chemically identical to what is produced by the human body. Furthermore, manufacturers of drugs containing the same bio-identical hormones commonly use the term to characterize their products.

The chemical structure of these drugs is indisputable. Pharmacy compounding is a long-standing, state-regulated and medically vital practice. Millions of Americans have unique health needs that off-the-shelf prescription medicines
cannot meet. For them, customized, compounded medications prescribed or ordered by licensed physicians or veterinarians and mixed safely by trained, licensed compounding pharmacists are the only way to better health.

About IACP
The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.
# #

ok I'm totally confused--who is rite and who is wrong? Is Tri-est bad? If my pharm. has a white board behind the counter showing side effects of menapause and offering bio's is that what they mean by advertising? I picked up a week's worth of my tri-est to hold me over till meeting a new dr, since my newest one wants me just on anti depressives instead of hormones (I'm 40 my body needs hormones!) It was quiet at the pharm but no one said anything and my pharm gave me my hormones for free since neither he or I know if this doc will let me continue either. I have felt this hormone replacement has worked well for me, now I'm confused is it bad for me? Is it just the big pharmicitucal companies trying to kill off competition? what about progesterone and testosterone?