An Objective Look at Compounding Pharmacies and their Role in Menopausal Medicine
What you need to know about the mainstream and compounding pharmaceutical industries.
My Friends... with so much information swirling over mainstream and social media about compounding pharmacies, I thought it was time to do a little "fact-checking". I hope you enjoy this piece! Cheers! Carla
Navigating the menopausal transition can be challenging when considering treatment decisions. There is a scarcity of providers with expertise in menopausal medicine and the available FDA-approved products may not offer options for treatment of some symptoms. For this reason, women and their providers have turned to compounding pharmacies to prepare customized combination therapies that may not be available in the FDA-approved pharmaceutical marketplace.
Arguments ensue over the use of compounding pharmacies and their products because “they are not regulated by the FDA” and thus “not subject to the scientific scrutiny of the FDA regulatory process”. The truth is that compounding pharmacies are indeed subject to oversight.
Regulation of compounding pharmacies is done at the state, rather than the federal level. State pharmacy boards have mechanisms for ensuring that compounding pharmacies are in compliance with state regulations.
The Pharmacy Compounding Accreditation Board (PCAB) offers accreditation to pharmacies that adhere to rigid requirements and voluntarily undergo strict inspections.
The FDA has the authority to intervene and conduct surveillance of a compounding pharmacy if there is suspicion of unsanitary practices or making false claims about their products.
Compounding pharmacies have also endured criticism because the medications they formulate “have not been subject to the same vigorous study of safety and efficacy as their FDA approved counterparts”. Although this may be true, an argument can be made that there are other avenues of rigorous scientific study independent of the FDA regulatory process. An example can be seen in the off-label use of FDA-approved medications.
Off-label use of medications is a very common and legal practice where the prescriber uses an FDA-approved medication for a purpose other than what the medication was approved for initially. An example is the use of Letrozole for ovulation induction therapy in women trying to conceive. Letrozole was originally FDA approved for the treatment of advanced breast cancer in postmenopausal women in 1998. However, Letrozole was later discovered to be a very effective medication for stimulating ovulation in women with ovulatory dysfunction disorders such as polycystic ovarian syndrome (PCOS). Through the decades, a wealth of studies have been published in the peer-reviewed medical literature on the safety and efficacy of letrozole for the use of ovulation induction in patients with PCOS - some studies suggest that letrozole is even MORE effective in certain women than its FDA approved counterpart, clomiphene citrate.
Because of the extensive, peer-reviewed study and favorable findings, Letrozole is just one of many excellent examples of a therapy that has been accepted as an option within the standard of care - despite lacking official FDA approval for this purpose.
An objective look at the compounding industry would not be complete without a discussion of the 2012 meningitis outbreak originating at the New England Compounding Center (NECC) in Framingham, Massachusetts. A fungal contaminant found in their widely distributed methylprednisolone acetate (MPA) steroid injection resulted in 793 infections and 64 deaths due to fungal meningitis. Those involved at NECC were convicted of racketeering, racketeering conspiracy, mail fraud, and the introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead by a federal jury. NECC was not a PCAB-certified compounding pharmacy (2,3).
Likewise, fraud and abuse can also be found in the “mainstream” pharmaceutical industry that supplies FDA-approved products. Opioid manufacturer, Purdue Pharma plead guilty in a Federal court in New Jersey in 2020 to conspiracies to defraud the United States and violate the anti-kickback statute. Purdue admitted that it marketed and sold its opioid products to healthcare providers, despite their suspicion that those providers were diverting their opioid products to abusers. They also lied to the Drug Enforcement Administration about steps it had taken to prevent such diversion, fraudulently increasing the number of products it was permitted to sell. Purdue also paid kickbacks to providers to encourage them to prescribe even more of its products (4). Fortunately, in both of these instances, the parties were held to account in the Federal court system.
So the lesson here is that there is bad behavior in both the mainstream pharmaceutical industry and in the compounding industry. Arguably, the larger problem is the criminal behavior that seems to elude federal and non-federal oversight.
At the end of the day - no matter where your therapies come from - the best outcome results from doing our homework, being informed, and seeking providers who appreciate our concerns and experiences with the following points in mind:
The FDA is not the only avenue for overseeing the safe practices of pharmacies, nor is it the only avenue of research scrutiny for the safety and efficacy of medications.
For women seeking treatment with non-FDA-approved products - do your homework! Use only PCAB-approved compounding pharmacies and research your potential pharmacy thoroughly.
Research your provider to be sure they do not receive any financial incentive for prescribing a particular product.
Have an open and educated conversation with your provider about what the research evidence shows about the safety and efficacy of your potential therapy for your menopausal experience.
As a provider, my first choice continues to be FDA-approved formulations as a FIRST LINE in the treatment of my patients because the FDA approval process indeed requires extensive and highly scrutinized medical research and long-term, phased studies of safety and efficacy. However, when there are no viable FDA-approved options (as is the case with Testosterone therapy for women) a reputable PCAB-accredited compounding pharmacy that can formulate a safe and appropriate dose and delivery system is my next consideration.
Together, using all the tools and information available to us, providers and patients can navigate this difficult and imperfect landscape of menopausal medicine effectively and successfully.