Compounded hormone therapy is a topic that has both strong supporters and fierce critics. Here is some background, history, and resources to help you better understand the debate.
What is compounding?
Compounding is the customization of a drug tailored to a specific patient based on a physician’s prescription. Compounding is used when a patient is allergic to one or more of the excipients — or additives — used in a more traditional formulation (such as peanut oil). Additionally, when the dosages provided by FDA-approved products are too high, a physician may write a prescription for a compounded lower dosage. Although we most hear about compounded therapies with respect to hormone therapy, many other types of therapies are also compounded.
What caused the rise in compounded hormone therapy?
When the Women’s Health Initiative (WHI) study was halted, many health care providers stopped prescribing — and women stopped using — the hormone therapy products that had been used in the trial to relieve menopausal symptoms because of safety concerns. With few options to help women manage symptoms, many health care providers turned to compounded products made from bioidentical versions of estrogen and progesterone (find definitions here).
This led to a rise in the use of compounded hormone therapy, also referred to as either bioidentical hormone therapy (BHT) or compounded bioidentical hormone therapy (CBHT).
Pros & Cons of Compounding
PROS
CUSTOM DOSING
Allows for alternate dosing to what is offered commercially. For example, a provider might want to start a patient on a dose that is lower than the lowest commercially available dose.
ALLERGY AVOIDANCE
Some patients are allergic to or don’t tolerate an ingredient in an FDA-approved drug. The active ingredient can be mixed (“formulated”) with other, better-tolerated ingredients (“excipients”).
CONTINUAL DOSE OPTIMIZATION
With a compounded product, a patient works with her healthcare provider and the compounding pharmacist as a team to continually adjust and reformulate the medication so that it’s working optimally with minimal side effects.
CONS
DOSE ACCURACY AND VARIABILITY
Some studies have shown variability in the amount of the active ingredients, such as estrogen and progesterone, in compounding capsules.
NOT FDA-APPROVED
FDA approval requires that both the active pharmaceutical ingredients and other ingredients in a drug go through trials that prove safety and efficacy. They must also have the exact same mix of ingredients in each batch and a verified manufacturing process, and be stable for designated periods of time.
In compounding, while the active ingredient and other ingredients it is mixed with (excipients) are all FDA-approved as individual components, the proportions they are mixed in and the process under which they are combined is not FDA-approved.
NO PACKAGE WARNINGS
Unlike FDA-approved drugs, compounded products are not required to have a package insert that details all of the safety information and possible side effects.
How is compounding regulated?
A fungal meningitis outbreak from contaminated steroid preparations in 2012 led to the passage of the US Drug Quality and Security Act in November of 2013. That law created two options for a compounding pharmacy in terms of regulation. A pharmacy can choose to register as an “outsourcing facility,” which allows them to make bulk (large quantities of) compounded drugs under the regulation of the FDA. It’s usually the larger pharmacies that can afford to comply with this type of regulation. Smaller compounding pharmacies who don’t go this route are regulated by their State Boards of Pharmacy.
In September 2018 The agency (FDA) entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs. Article here.
On July 1, 2020, the Board on Health Sciences Policy within the National Academies of Sciences, Engineering, and Medicine released a new report The Clinical Utility of Compounded Bioidentical Hormone Therapy (cBHT): A Review of Safety, Effectiveness, and Use.
Their overarching recommendation was: Given the paucity of data on safety and effectiveness of cBHT, the committee concluded that there is insufficient evidence to support the overall clinical utility of cBHT.
The full report can be downloaded here.
How would I find a pharmacy that is safe?
If you and your healthcare provider decide to use a compounded product, they will likely suggest a compounding pharmacy they are used to working with. You can check to see if that pharmacy is a member of The Pharmacy Compounding Accreditation Board (PCAB) — an oversight body that ensures compliance with the highest industry standards. Use this link to find a member pharmacy near you.
COMPOUNDED PRODUCTS ARE NOT INHERENTLY SAFER THAN FDA-APPROVED PRODUCTS
Some people believe that compounded products are safer than FDA-approved products because they are bioidentical — that is, molecularly identical to those that are made by our bodies. However, many others believe just the opposite — that they are less safe because their production is not overseen by the FDA’s stringent approval process and regulations.
BIOIDENTICAL FDA-APPROVED PRODUCTS DO EXIST
It took us a long time to realize this. In the beginning, we thought that you had to use compounding to get bioidentical products. But there are several bioidentical products on the market that are also approved by the FDA. Please refer to our hormone therapy product chart for more information. As you’ll see, there are many bioidentical estrogen products but only two bioidentical progesterone products (one oral, one gel).
FAQs about Pharmaceutical Compounding by the American Pharmacists Association
Consumer and Health Care Professional Information on Compounding from the USFDA
Are Bioidentical Hormones Better? by Dr. Andrew Weil
American College of Gynecologists Position Statement, 2012 “Not only is evidence lacking to support superiority claims of compounded bioidentical hormones over conventional menopausal hormone therapy, but these claims also pose the additional risks of variable purity and potency and lack efficacy and safety data.”
MenoPause blog post on the use of compounded hormones by the North American Menopause Society, 2015