Are Compounded Hormone Products Safe? A Pharmacist Responds

Editor’s note:  Earlier this month, I wrote about a webinar on Bioidentical Hormone Therapy,  that was “supported” by Ascend Therapeutics, makers of an FDA-approved topical estrogen gel that competes with compounded hormone products.  There’s a companion magazine, “The Buzz on Bioidenticals,”  that is available free online and in doctors’ offices and it, too, is “supported”  by Ascend. The publication repeatedly cautions women against using compounding pharmacies and, in an article called “Why You Should Avoid Compounded Hormone Therapy” the writers suggest that doing so poses a risk to our health.

In the interest of fairness and to contribute to a balanced discussion that will help you make an informed decision about using compounded, bio-identical hormones, I contacted Christine Givant (pictured below), a pharmacist and founder of La Vita Compounding Pharmacy, in San Diego, to ask her to respond to some statements made in the “Buzz on Bioidenticals” publication.

Wendy:  First, explain what a compounding pharmacy does and why a woman on hormone therapy would choose to have her hormones “compounded.”  What does that mean exactly?

Christine:  A compounding pharmacy serves many vital purposes. To begin with, it allows the physician the opportunity to customize therapy to a patient’s individual needs. For example, Ascend Therapeutics offers a hormone product that comes in one strength, one dosage form, and one delivery device. Well, that will work for some women, but not all. A compounding pharmacy would be able to make it in the exact strength your physician determines you need and put it in a variety of dosage forms depending on your lifestyle (i.e gel, cream, suppository, lozenge, capsule, sub-lingual drop). A compounding pharmacy could also combine a daily hormone regimen into one cream, which could result in increased compliance and a lower cost to the patient.

Wendy:  In the Buzz on Bioidenticals article, “Why You should Avoid Compounded Hormone Therapy,” the writers state that “the FDA is concerned that patients may be in danger since the agency does not have oversight over compounding pharmacies and that it won’t approve compounded products because they’re not standardized.”  How are compounding pharmacies regulated, if not by the FDA?

Christine:  No pharmacy, not even the ones you find at WalMart or Walgreens, is regulated by the FDA. Its jurisdiction lies instead with commercial medications. All pharmacies, including those that offer compounding services are, in fact, highly regulated by the State Board of Pharmacy. We undergo regular inspections by the Board of Pharmacy and are required to have independent certification companies inspect and certify our clean rooms every six months.

Wendy: The article suggests that pharmacy oversight on a state-by-state level can result in problems since each state has different laws and different methods of oversight.

Christine: The Boards of Pharmacy have been regulating pharmacies since the beginning. All have stringent regulations regarding compounding. State regulations are often more stringent than the FDA regulation would be if applicable.

Wendy:  Another concern expressed in the article pertains to the possible inconsistency of compounded hormone products since “each compounding pharmacy makes hormones with various different ingredients and doses” and “batches can vary in potency.” Can you explain the compounding process?  Are you using the same FDA-approved, bio-identical Estradiol in your pharmacy that Ascend Therapeutics is using in their EstroGel product?

Christine:  The compounding process is pretty straight forward.  If a prescription calls for Estradiol 1 mg/gm cream for example, a formula is created and entered into the computer by a pharmacist and a log of the formula with a unique lot number is printed out. The log reflects the exact amount of each ingredient in the cream that needs to be weighed or measured along with detailed instructions on the proper compounding techniques.  Our scales are connected to printers that record the weight of each ingredient and we attach this printed document to the log.  This allows for a “checks and balances” system to ensure that the exact weights are weighed correctly.

The final compound and the log are checked by another pharmacist for accuracy and quality assurance. Once determined that the process used to make the compound and the weights of ingredients are accurate, the second pharmacist initials the log for approval to release to the patient.  We only utilize chemicals that are obtained from FDA approved chemical houses. We also randomly batch test our compounds and send samples into an independent lab for either potency and/or stability testing.

Of course, it is important to check out the compounding pharmacy you work with or ask your physician if they have done some investigation to ensure they are following similar practices.

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Note from Wendy: If you want to listen to the on-demand web cast of the “Buzz on Bioidenticals” presentation and read the accompanying magazine, click here.