Bioidentical Hormones

Are Compounding Pharmacies Safe?

by Magnolia on April 1, 2015

Post image for Are Compounding Pharmacies Safe?

Thanks to the recent outbreak of fungal meningitis in the United States, which is now responsible for 25 deaths across the country, compounding pharmacies are now in the cross-hairs of federal regulators, and questions are being raised about their safety.

The New England Compounding Center, (NECC), located in Massachusetts, shipped thousands of vials of a contaminated steroid injection medication used to treat back pain, to 23 states and 76 medical facilities across the country, exposing over 14,000 people to the potentially fatal disease.

As a woman who has suffered with serious back pain her entire adult life, and who has used steroid injections to manage the pain, this story definitely caught my attention. It also caught my attention because it is a compounding pharmacy at the center of the scandal.

Who Uses Compounding Pharmacies?

Millions of patients use compounding pharmacies every day for their prescription medications. Many of those patients are women in perimenopause and menopause who use compounding pharmacies to provide bioidentical hormones to help them treat and manage their symptoms. Unfortunately, it is also a decision these women (and their physicians) often have to defend as well.

There has been a longstanding divide and disagreement among physicians over the safety and effectiveness of bioidentical hormones for decades now. A disagreement which pharmaceutical companies, who would rather that we all use the medications they manufacture and market to women, is happy to support, defend, and finance.

If calling into question the safety of compounding pharmacies or claiming that they are a threat to public health because they do not fall under the federal regulatory oversight of the FDA will bolster their position, you can be certain they will. All is fair in asymmetrical warfare, especially when billions of dollars of profit are at stake.

Since the outbreak, the New England Compounding Center has suspended all of its operations and recalled all of their products. However, none of this has stopped the federal government from getting involved. As anticipated, members of congress are now calling for federal regulations of compounding pharmacies.

Compounding Pharmacies Are Already Regulated

On its face, calling for regulation of compounding pharmacies to insure the safety of public health is not unreasonable; and I am certainly not suggesting that NECC’s negligence is not a cause for serious concern – it is, and it should be.

What bothers me is the suggestion that because the FDA does not have regulatory oversight of compounding pharmacies, that they are not regulated or subject to any oversight whatsoever, because this is just not the case. Compounding pharmacies, along with all pharmacies have been regulated for decades by state regulatory boards, and are also subject to local regulation and oversight as well.

According to Dr. Paul Savage, MD¹, the problems occur because  “more often than not, the regulations tend to be enforced retroactively. That is, after an event such as the contamination of the steroid medication in the NECC case has occurred.  Pro-active policing of the regulations do not occur with enough regularity”

In fact, that has been exactly the problem in the NECC case.  More information has recently surfaced about the failure of regulators to adequately investigate known safety violations with the NECC as far back as 1999.  So clearly, the problem is not that there is a lack of regulation of compounding pharmacies which makes them unsafe.  The problem is the negligence of the employees to adhere to already established safety policies and procedures, and the failure of regulators to enforce known violations.

What Can You Do?

If you use compounding pharmacies or are interested in using them, it is important to seek the advice of a healthcare provider that you know and trust. “A quality health care provider” says Dr. Savage¹, “should have recommendations for compounding pharmacies, and be able to provide you with answers regarding the safety and quality required.”

It’s also important that you ask your practitioner if you are receiving any compounding products.  If you are, it is important to determine the quality and safety of the compounder.  This is especially important if you are using IV therapy, injections, or implanted medications.

Remember ladies, while it’s always a good idea to remain vigilant, it’s also a good idea to not allow mass hysteria to negatively affect or cloud your judgment!  If you have been using compounding pharmacies for your bioidentical hormone prescriptions safely up until now, there is no reason to believe that you can’t continue to do so!


¹Dr. Paul Savage MD FACEP, is the CEO of Ageology physicians group in Chicago, Illinois.  Dr. Savage is an acknowledged expert in the field of bioidentical hormones, anti-aging and regenerative medicine and metabolic medicine and is nationally known and recognized as a leader in this field.


Food as Medicine: Omega-3s & Zinc For Itchy Skin and Scalp in Perimenopause

Thumbnail image for Food as Medicine: Omega-3s & Zinc For Itchy Skin and Scalp in Perimenopause

This is the first post in a new series I’m entitling “Food as Medicine.”  After several years of reading and writing about perimenopause, I’ve come to the conclusion that food is as important in managing the symptoms of perimenopause, as I believe bioidentical hormones are. In fact, I would likely say that food is even more important. Now, […]

March 3, 2015 CONTINUE READING →

Looking for Resources for Perimenopause? Look No Further!

Thumbnail image for Looking for Resources for Perimenopause? Look No Further!

A lot of my readers ask for help in locating physicians, pharmacies, and recommendations for bioidentical progesterone (which I promote a lot here).  I almost always forget to direct them to my  Resources Page.  And unless you take the time to click through on some of my pages, you might not locate it either, though […]

February 15, 2015 CONTINUE READING →

Estrogen, Uterine Polyps & Me

Thumbnail image for Estrogen, Uterine Polyps & Me

UPDATE: A reader left a comment pointing out that this article wasn’t entirely accurate.  She herself had undergone a procedure to have uterine polyps removed and informed me that hers were so deeply embedded in her uterus, that there was no possible way for a routine gynecological exam to discover them. She also noted there […]

January 30, 2015 CONTINUE READING →

Bioidentical Progesterone for Insomnia: It Works for Me!

Thumbnail image for Bioidentical Progesterone for Insomnia: It Works for Me!

I’ve been taking Prometrium, an FDA approved bioidentical progesterone, for the past month to help me with sleep, and to help with my night sweats and hot flashes. I told you all I would share my experience with you, and the jury is in: it works. I am taking 200 milligrams about 2 hours before […]

November 18, 2014 CONTINUE READING →

So Exactly “WHAT” are Bioidentical Hormones?

Thumbnail image for So Exactly “WHAT” are Bioidentical Hormones?

I’m going to come clean and tell you that until the last couple of years, I really didn’t understand the difference between bioidentical hormones and what we call synthetic hormones. I also didn’t know that bioidentical hormones have actually been around for a very long time – like, nearly 100 years. Surprised?  I was too. […]

October 22, 2014 CONTINUE READING →

FDA Approved Bioidentical Hormones……Really?

Thumbnail image for FDA Approved Bioidentical Hormones……Really?

It does seem like an oxymoron to have the words “bioidentical” and “FDA approved” in the same sentence, I know.  If you’re like me, you’ve probably always associated anything that is FDA approved with pharmaceutical companies. You’ve probably also thought that anything produced by a pharmaceutical company couldn’t be bioidentical or natural either – and […]

October 22, 2014 CONTINUE READING →

Prometrium: An Oral FDA Approved Bioidentical Progesterone

Thumbnail image for Prometrium: An Oral FDA Approved Bioidentical Progesterone

It is no secret that I personally prefer bioidentical hormones for the treatment of symptoms of perimenopause as opposed to synthetic hormones and drugs. In fact, I sincerely believe that most women prefer natural, healthier, and less intrusive treatments as well. However, most bioidentical hormones are not FDA approved, and therefore, are not covered by most health insurance plans. Unfortunately, this […]

October 22, 2014 CONTINUE READING →

Premarin, Prempro & Bioidentical Hormones

Thumbnail image for Premarin, Prempro & Bioidentical Hormones

If you are confused about the difference between synthetic hormones and bioidentical hormones, you are certainly not alone. The difference between the two is a hotly contested issue among medical professionals, and unfortunately, it is women suffering with hormone imbalance who are always caught in the middle. Some physicians will tell you flatly bioidentical hormones […]

October 16, 2014 CONTINUE READING →

Dear Magnolia…….Bioidentical Hormones Have Worked for Me!

Thumbnail image for Dear Magnolia…….Bioidentical Hormones Have Worked for Me!

I received this comment recently from a reader who identified herself as “Found the Solution.” I was so impressed with what she had to share that I wanted to feature her comment in this month’s “Dear Magnolia” installment.  “Found the Solution” encapsulates in her comment everything I have blogged about here at The Perimenopause Blog […]

October 15, 2014 CONTINUE READING →

Hormone Replacement Therapy isn’t as Scary as You Think

Thumbnail image for Hormone Replacement Therapy isn’t as Scary as You Think

In 2002, the Women’s Health Initiative study sent the medical professionals prescribing hormone replacement therapy to their patients into a bonafide tail spin. Terrified of putting women at risk for coronary heart disease, stroke or breast cancer, physicians abandoned HRT all together, advising their patients to do the same. Few would argue the value of the study. […]

October 1, 2014 CONTINUE READING →

Are Lab Tests Accurate in Testing for Perimenopause?

Thumbnail image for Are Lab Tests Accurate in Testing for Perimenopause?

In Western medicine lab work is king. Blood work can tell you if you’re pregnant or if you’re not. You can determine if you’re diabetic or have kidney disease. If you have an infection, a high white blood cell count will tell all. And if law enforcement authorities want to determine if you are legally drunk, blood-alcohol levels can also send […]

August 11, 2014 CONTINUE READING →

DHEA: What is it & Why Should You Care?

If you’re anything like me, prior to perimenopause the only thing you knew about hormones was that you had them, and that about every 28 days or so, you had a deep and passionate longing for a luscious piece of chocolate and a high powered firearm with bulls-eye accuracy. In prior generations there wasn’t much talk about […]


Does Estrogen Cause Breast Cancer? Part III

Thumbnail image for Does Estrogen Cause Breast Cancer? Part III

This is the final post in Dr. Joseph Mazzei’s series on the relationship between estrogen therapy and breast cancer.    If you wish to contact Dr. Mazzei or any of his colleagues in the Body Logic medical group, please see his byline at the end of the post.  As always, the views expressed in this post […]


Does Estrogen Cause Breast Cancer? Part II

Thumbnail image for Does Estrogen Cause Breast Cancer? Part II

Today’s post is a continuation of  Dr. Joseph Mazzei’s post on the relationship between estrogen therapy and breast cancer.  The views expressed in this post are not necessarily the views held by The Perimenopause Blog and are for informational purposes only. Please see your physician or healthcare provider for personal medical evaluations.  Let us continue our conversation from […]

June 29, 2014 CONTINUE READING →

Does Estrogen Cause Breast Cancer? Part I

Thumbnail image for Does Estrogen Cause Breast Cancer? Part I

Today’s post is a guest post by Dr. Joseph Mazzei, a Chicago based doctor for BodyLogicMD, a medical group which sponsors The Perimenopause Blog. I asked Dr. Mazzei if he could give his opinion on estrogen therapy since it is starting to make its way back into the news once again.  In this post, Dr. Mazzei […]

June 24, 2014 CONTINUE READING →

Symptoms of Perimenopause Symptoms of Menopause

I thought it would be appropriate – and helpful – to follow up on a recent post I did on the difference between perimenopause and menopause and provide a list of the symptoms associated with each. Though the terms are often (and I’m guilty of the same) used interchangeably, they are not the same thing. Perimenopause is a transitional […]

November 17, 2013 CONTINUE READING →

Natural Therapies for Menopause & Product Giveaway!

Thumbnail image for Natural Therapies for Menopause & Product Giveaway!

Today’s post is a guest post from Dr. Rawls, co-founder of the company Vital Plan and the non-hormone product HPA Balance® to treat perimenopause and menopause symptoms.  To participate in the giveaway either leave a comment on this post in the comment section, or join us at Facebook.  Either “Like” the post, or leave a […]

October 14, 2013 CONTINUE READING →

Maggie on the Radio!

Thumbnail image for Maggie on the Radio!

I was a guest on Hotze Wellness Radio on KSEV Radio in Houston, Texas, for the full hour yesterday, to discuss my role as a women’s health blogger, and advocate for women going through perimenopause. I tried not to think about how many people might be listening, and focus only on the doctor who was […]

October 4, 2013 CONTINUE READING →