Every day, compounding pharmacists compound the joy of living for their patients by helping them get back to health—and to the people and things they love.
In traditional pharmacy compounding, a pharmacist creates a customized medication, most often from pure ingredients, for an individual patient. Pharmacists’ ability to compound medications is authorized in federal law for good reason: While manufactured drugs are the standard, those don’t come in strengths and dosage forms that are right for everyone, and healthcare practitioners need to be able to prescribe customized medications when, in their judgment, a manufactured drug is not the best course of therapy for a human or animal patient.
A 2020 FDA-funded report on compounded hormones from the National Academies of Science, Engineering and Medicine recommends across-the-board restrictions on compounded hormones. These restrictions would undermine physicians’ professional judgment and interfere with the practice of medicine, and could prove catastrophic for millions of patients who benefit from those therapies. But that NASEM report is compromised by potential bias, conflicts of interest, and bad science.
Most, if not all, of the NASEM committee members lacked any real-world experience prescribing and dispensing compounded hormones to patients. In essence, the committee was asked to develop recommendations on a topic in which they had little or no expertise.
Explore the NASEM Report's Flaws
Compounding pharmacies routinely create custom medicines for both human and animal patients. They collaborate with physicians, veterinarians and other prescribers to ensure that each patient gets the precise medicine that, in the prescriber’s judgment, the patient needs.
Some people may think compounding pharmacies are affiliated with the big pharmaceutical companies, but they’re not.
According to the 2021 National Compounding Demographics Study, the typical compounding pharmacy is a small business with roots in the local economy. In fact, 84% of compounding pharmacies have only one location. They are committed to the health and safety of their patients, they support the local tax base, and they serve a wide range of patients, both human and animal
Compounding pharmacies adhere to high standards of quality, safety and compliance—including the rigorous compounding standards of the US Pharmacopeia. They are licensed by state boards of pharmacy. Every one of the active ingredients that compounding pharmacies use must come from FDA-registered facilities and manufacturers. Compounding labs and the equipment in them are subject to exacting regulation and are inspected by state boards of pharmacy and sometimes by FDA.
A compounding pharmacy makes customized prescriptions from ‘scratch’ in the lab based on a prescriber’s order. Regular pharmacies dispense drugs that are prepared and packaged by pharmaceutical companies. These medications are not customized for each patient like medications from compounding pharmacies.
Contrary to some unfortunate misconceptions, compounding pharmacies do not have anything to do with illicit, counterfeit or ‘black-market’ drugs or medications. Compounding pharmacies simply create personalized, customized medications and treatments based on qualified prescriber’s orders.
Compounding pharmacies are regulated by state boards of pharmacy, FDA, DEA, NABP and some are also Accredited. These specialized pharmacies follow very strict guidelines and training procedures to guarantee patients are receiving the highest possible quality compound.
Compounded prescriptions have to be compounded by hand for individual patients. Most compounding pharmacies keep some of the frequently used compounds made in advance so patients can get their medications as quickly as possible. However, some compounds can only be made when a prescriber’s order is placed, which can take longer than simply grabbing pills off a shelf.
It depends. Generally compounding pharmacies have been excluded from insurance networks, which means they typically don’t file your insurance claim directly. In most cases, compounding pharmacies can provide you the information you need to file a claim with your insurance company. The good news is many times compounded medications are in the same price range of a typical insurance copay or generic drug.
The FDA is responsible for approving individual medications, not overseeing pharmacies. Traditional pharmacies and compounding pharmacies are overseen by State Boards of Pharmacy and compounding pharmacies are governed and overseen by all the same boards and bodies as traditional pharmacies.
These medications are carefully designed and created for each individual patient, which typically provides an even more targeted therapy for the patient. Another benefit of compounding pharmacies is that if the medication doesn’t work as originally prescribed, we can work closely with the patient and prescriber to find the right formulation of their customized medication.
Yes, again, compounding pharmacies are regulated by all the same agencies and bodies as traditional pharmacies and therefore must meet the same standards. That said, most compounding pharmacies have state-of-the-art sterile rooms and follow strict USP 797 rules.