Compounding Pharmacies: Not New, Not Sketchy, Just Misunderstood
Modern healthcare is largely built around mass-produced medication – standardized formulas manufactured at scale. But it may surprise you to learn that this is a relatively modern model of pharmacy.
Before mass-produced medicine became the norm, pharmacists routinely formulated medications for individual patients, tailoring them to a patient’s age, needs, and size. Before World War II, much of what was dispensed in this country was compounded. That’s what “pharmacy” was.
Today, compounding sometimes gets treated as the sketchy alternative or the poor cousin of pharmaceutical medicine, when individualized medication is hardly a new idea.
The two models simply answer different questions. Mass manufacturing asks how we can reliably produce medication at scale. Compounding asks what a particular patient needs when a standardized medication isn’t the right fit.
Why the Stigma?
In 2012, a compounding pharmacy called the New England Compounding Center (NECC) produced contaminated steroid injections that caused a fungal meningitis outbreak, sickening hundreds of people and ultimately contributing to more than 100 deaths.
NECC was operating far beyond the traditional model of a small, patient-specific compounding pharmacy. The tragedy exposed serious gaps in oversight and became a turning point in how compounding was regulated and perceived.
Congress responded with the Drug Quality and Security Act of 2013, which clarified federal oversight of traditional compounding pharmacies and created a new category for larger-scale compounding facilities.
Today, compounding pharmacies operate within federal and state regulatory requirements, including applicable United States Pharmacopeia (USP) standards. Pharmacies can also pursue Pharmacy Compounding Accreditation Board (PCAB) accreditation, which provides third-party verification that their compounding practices meet rigorous quality standards.
Doesn’t Veterinary Medicine Utilize Compounding?
Yes!
Compounding is standard practice in veterinary medicine because animals need an array of dosing that pharmaceutical companies don’t manufacture. A six-pound Chihuahua and a ninety-pound Lab shouldn’t necessarily take the same dose of medication.
No one considers this sketchy. If you’re the Chihuahua’s person, you’re grateful your dog isn’t being overmedicated – or, in the case of the Lab, undermedicated.
The same principle applies in human medicine. A hundred-pound woman and a two-hundred-pound man may require different doses of certain manufactured medications, including anticoagulants, chemotherapy medications, sedatives and anesthetics, and some antibiotics and steroids.
Individualized dosing isn’t considered sketchy in these instances either.
How I Use Compounded Medications in My Practice
I put many of my patients on compounded oral micronized progesterone instead of Prometrium, the standardized pharmaceutical progesterone.
While it’s bioidentical and micronized like the compounded products, Prometrium contains several additives – including peanut oil, gelatin, glycerin, lecithin, and color additives – which may not be tolerated by all users. Because many of my patients are already dealing with inflammation or ingredient sensitivities, compounded progesterone allows for greater control over what’s in their medication.
Compounding allows for more flexibility with dosing. Prometrium dosing works well for many at the options available, but some women feel best with a starting dose below the lowest standard, particularly if they’re experiencing bloating, digestive discomfort, or other side effects as they adjust to progesterone. This allows patients to gradually increase their dosage and land on an individualized formula that works best for them. Having said that, patients who tolerate the ingredients in Prometrium may elect to use it for cost savings.
Aside from hormones, I also use compounding to fine-tune dosing and ingredients for other treatments including thyroid medication, topical hormone applications, B12 injections, and more.
How Compounding supports the Estrogen Patch Shortage
My favorite form of bioidentical estradiol is still the pharmaceutical patch, as I mentioned in last week’s article. It’s not compounded, but is identical to the estrogen that’s produced by humans, and comes in multiple strengths, enabling individualized dosing.
Unfortunately, many women haven’t been happy with the patch substitutes they’ve had to use during the current shortage (such as a weekly instead of twice/weekly patch and oral products). For these patients, I may offer a low-dose compounded estradiol cream to bridge the gap. And I’ve had some patients so fed up with the shortage and the amount of time they’ve spent calling pharmacies they decided to scrap the patch altogether and use a compounded estradiol cream until the shortage is over.
While there are pharmaceutical topical estrogen preparations that come in standardized doses, including EstroGel and Divigel, I prefer compounding because it gives me more flexibility to individualize the dose and formulation for a patient’s particular needs.
None of these personalized options could exist without pharmacists who know how to formulate medications from scratch. I’m grateful for the customization I can offer my patients because compounding pharmacies exist.
Your Move
If you and your provider determine that a compounded medication is appropriate for you, ask about the pharmacy they use and its quality standards.
Look for a pharmacy that follows applicable USP compounding standards, and consider PCAB accreditation as an additional marker of quality.
Warmly,
Dr. Krista
Olive Says
I have never believed in one-size-fits-all.
Especially when it comes to treats.