As you approach the idea of starting body-identical hormone (bio-identical) replacement, you will undoubtedly be exposed to the concept of pharmaceutical compounding. You may have read about concerns with the compounding of some body-identical hormones that the FDA does not regulate. We are here to put your mind at ease and explain compounding and its value in administering hormones specific to your needs.
What is compounding, and why is it necessary?
Compounding is a pharmaceutical preparation of a drug by a licensed pharmacist to meet the unique needs of an individual patient. A patient may not be able to tolerate a commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued.
The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device per a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”
Following are a few examples of how a compounding pharmacist can customize medications based on a doctor’s prescription to meet a patient’s needs:
Customize strength or dosage.
Flavor a medication (to make it more palatable for a child or a pet).
Reformulate the drug to exclude an unwanted, nonessential ingredient, such as lactose, gluten, or a dye to which a patient is allergic.
Change the form of the medication for patients who, for example, have difficulty swallowing or experience stomach upset when taking oral medication.
Compounding pharmacists can put drugs into specially flavored liquids, topical creams, transdermal gels, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not include making copies of commercially available drug products, as the law does not allow this.
How is pharmaceutical compounding different from drug manufacturing?
Traditional compounding is the preparation of a medication to meet the prescriber’s exact specifications and to be dispensed directly to the patient, following a valid prescription for that patient. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy.
Manufacturing is the mass production of drug products approved by the Food and Drug Administration (FDA). These products are sold to pharmacies, health care practitioners, or others authorized under state and federal law to resell them.
What is a compounding pharmacy?
While most pharmacies offer some level of compounding, most are done in pharmacies that have invested in equipment and training to do so safely and efficiently. The preparations offered by these compounding pharmacies can be nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for the eye or injection into body tissues or the blood).
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work.
Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Compounding also takes place in hospital pharmacies and at other healthcare facilities.
What Are Compounded Body Identical (Bio-Identical) Hormones?
Body-identical hormones are plant-derived hormones that are chemically similar or structurally identical to those produced by the body. Body identical hormones include commercially available products approved by the U.S. Food and Drug Administration (FDA), such as micronized progesterone and estradiol, and compounded preparations that the FDA does not regulate.
There is evidence to support the efficacy of bio-identical hormones vs. synthetic hormones. This study found that using the natural steroids estradiol or progesterone resulted in greater risk reduction than synthetic hormones. Oral hormone therapies resulted in a reduced risk for combined neurodegenerative diseases, while hormone therapies administered through the skin reduced the risk of developing dementia.
When discussing body-identical hormones, this is usually about compounded hormones. Compounded bioidentical hormones are made just for you by a compounding pharmacy. They can be made into various dosage forms, like vaginal suppositories, oral capsules, and topical creams. And their strengths and ingredients can be customized to meet your individual needs, usually based on lab results.
Body-identical hormones are processed hormones designed to mimic the hormones made by your body’s glands. Drug companies premake some prescription forms of bioidentical hormones. The U.S. Food and Drug Administration (FDA) has approved certain types of bioidentical hormones.
Examples of compounded bioidentical hormones include:
Estrogens (estriol, estradiol, and estrone)
Progesterone
Testosterone
Dehydroepiandrosterone (DHEA; prasterone)
A compounded hormone product may contain one or a combination of a few different hormones. For example, some healthcare providers will combine more than one type of estrogen. And they may add progesterone, too.
FDA-approved bioidentical hormones
Several FDA-approved hormone products meet the definition of “bioidentical.” These include a variety of tablets, creams, inserts, and more to help relieve specific menopause symptoms.
Examples of FDA-approved bio-identical hormones include:
Route | Type | Brand Name |
Oral | Estradiol tablet | Estrace |
| Estradiol/progesterone capsule | Bijuva |
Vaginal | Estradiol vaginal cream | Estrace |
| Estradiol vaginal ring | Femring, Estring |
| Estradiol vaginal insert | Vagifem, Yuvafem, Imvexxy |
| DHEA vaginal insert | Intrarosa |
Topical | Estradiol patch | Climara, Alora, Vivelle, Vivelle-dot, Dotti |
| Estradiol gel | Divigel, Elestrin, EstroGel |
| Estradiol spray | Evamist |
Injection | Estradiol injection | Depo-Estradiol |
Progesterone is also available. Some healthcare providers may prescribe itto treat menopause symptoms. But one of its FDA-approved uses is to protect the uterus if you’re also taking estrogen.
Are Compounded Hormones Safe?
Safety is the primary concern for most consumers regarding compounded pharmaceuticals. We spoke with the owner of a compounding pharmacy in Utah to get the skinny on these questions. This is what we learned.
The FDA allows up to 20% deviation from the name-brand drug for generic drugs. In this particular compounding pharmacy, any deviation over 10% is discarded. Most compounding pharmaceuticals have variations of closer to 5%.
All ingredients that go into compounded drugs are FDA approved.
The state monitors compounded pharmacies. Utah has a strict monitoring system with random inspections. Each state will have individual monitoring systems for compounded pharmacies.
In summary, compounded hormones are regulated by the state, and reputable compounding pharmacies provide safe, effective doses of the hormones your provider recommends.