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Compounding pharmacies come into play when medications need to be customized in some way. Whether it’s for a specific dosage, flavor, or formulation, these pharmacies prepare drugs as per the specific instructions of a healthcare provider. This process involves everything from mixing and packaging to labeling medications as outlined by the U.S Pharmacopeia Convention.
Some common examples of compounding include creating medications in unique doses, adding flavors to make a medication easier to take, removing allergens from formulas like lactose, or converting pills into liquid forms for easier consumption by patients who struggle with tablets.
Compounding pharmacies exist because standard medications don’t always meet every patient’s needs. While most pharmacies can handle some compounding, more intricate and personalized prescriptions often go to specialized compounding pharmacies, where the pharmacists are equipped with the right skills, tools, and ingredients to create custom solutions.
How to make the most of a compounding pharmacy
A compounded medication is customized specifically for a patient and requires a doctor’s prescription. Out of the roughly 56,000 pharmacies in the U.S., around 7,500 specialize in compounding. To find a compounding pharmacy nearby, you can use the locator tool on the Alliance For Pharmacy Compounding’s website. If your doctor recommends a compounded medicine, they will likely guide you to a trusted local pharmacy.
When selecting a compounding pharmacy, the Alliance For Pharmacy Compounding advises inquiring about their adherence to quality standards. This includes whether they follow United States Pharmacopoeia guidelines, the qualifications of their pharmacy team, the procedures involved in preparing your medication, especially if it’s a sterile preparation like eye drops or injections, and whether they hold accreditation from the Pharmacy Compounding Accreditation Board.
Important things to consider
There have been numerous warnings about the dangers of unsafe medications produced by compounding pharmacies, including the infamous 2012 fungal meningitis outbreak, where 753 individuals in 20 states contracted a fungal infection after receiving contaminated injections. Following this incident, the FDA has regularly issued alerts regarding contaminated products from compounding pharmacies.
Recently, the FDA issued a caution regarding compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy, which are being offered by compounding pharmacies at a lower price due to an FDA loophole allowing for compounding of patented medications during shortages.
However, the FDA has raised concerns, citing the risks involved with using compounded semaglutide. There have been adverse events reported in patients using these preparations. Since the manufacturer of semaglutide does not sell it in a form suitable for compounding, pharmacies may be using research-grade semaglutide salts. The FDA has stated they “are not aware” of any legal way to compound these drugs—suggesting that compounded versions of “Ozempic” are likely not authentic.
The FDA explains that a key distinction between commercially available and compounded medications lies in the quality standards. Commercial drugs must undergo the FDA’s rigorous approval process and are subject to strict quality control measures. In contrast, compounded medications are not FDA-approved. While they may contain FDA-approved ingredients, the compounding process itself falls outside the scope of FDA regulation.
