Is it Safe to Use a Compounding Pharmacy? Whether it’s the ongoing drug shortages or the need for a specialty product, the use of compounding pharmacies, specifically outsourcing facilities, is often convenient, if not a necessity. How safe is a compounding pharmacy/outsourcing facility? Is there a way to screen the good from the bad ones? In this post I discuss the safety of compounded medications and what you can do to enhance patient safety and reduce your liability.
As a pharmacy consultant, I get asked about compounding pharmacies almost daily. (To be clear for the remainder of this post, when I refer to compounding pharmacies, I am referring to outsourcing facilities which fall under the jurisdiction of the FDA, as opposed to your local pharmacy that is regulated by your State Board of Pharmacy.) As is the case in many areas of my practice, guidance is ever evolving, and the landscape constantly changes. I spend a significant amount of time reviewing guidance and news from the United States Pharmacopeia (USP), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). If your facility is using compounded medications or if the need should arise in the future, your consultant pharmacist can be an invaluable resource to help you navigate this challenging environment. If you’re not currently working with a consultant pharmacist, you can read more about how to find one who is highly qualified.
According to the FDA, “Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient”. Compounding helps many providers meet the special needs of specific patients and can be a lifesaver. This can be a great benefit for some patients, but it’s important to recognize that it also presents risks that must be weighed against the potential benefit.
You may have recently heard the FDA issued a warning letter to Professional Compounding Centers of America Inc.(PCCA) after an inspection revealed PCCA was receiving and distributing adulterated and misbranded active pharmaceutical ingredients (APIs). The warning letter includes details about failure to follow current good manufacturing practice (CGMP) as well as misbranded products which include fentanyl and morphine.
The FDA has specific standards for compounding facilities to ensure the quality of the drugs being distributed. Most compounding pharmacies adhere to FDA requirements and are compliant with CGMP. Routine FDA inspections can reveal failure to meet the standards and it is at this time that it the FDA takes action against the compounder. Warning letters are one of many potential actions the FDA can take to help ensure the quality of our drug supply chain.
Does your facility use compounded drugs?
If so, take steps to protect your patients and let a consultant pharmacist help you do a proper assessment of any outsourcing facility prior to ordering products. Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility? According to a 2019 report from the U.S. Department of Health and Human Services Office of Inspector General, about 11% of hospitals get compounded drugs from sources that are not registered with the FDA. This leads to increased risks to your patients and liability for your facility and staff. Your consultant pharmacist can help you determine if the compounder is licensed in your state, as well as determine registration as a 503B outsourcing facility.
Compounding pharmacies have more guidance from the FDA:
The FDA, like the rest of us, had to make adjustments based on the day-to-day changes the pandemic has caused. Among those changes have been emergency use authorizations for some medications and medical supplies. If you’re wondering what an EUA is, read our post “What is an Emergency Use Authorization by the FDA?” Additionally, the FDA has provided more guidance and eased some restrictions for compounding pharmacies. This could allow these facilities to make available medications that would otherwise be on the shortage list and unavailable.
Facilities can consider using compounding pharmacies — not just to mitigate some of these shortages, but also as another resource for other products that may be available in different dosage forms and may provide convenience and even cost savings. Before you engage a compounding pharmacy, however, be sure to perform due diligence. Not all compounding pharmacies are alike: determining if one is a good fit for your operation requires a bit of legwork (it’s an area where your consultant pharmacist should excel). If you haven’t, engage the services of an expert consultant pharmacist to ensure a proper vetting process is followed.
We routinely assess compounding pharmacies and provide guidance for our facilities. Whether you’re already using a compounder or plan on using one in the future, now is a good time to do your due diligence. Doing so will not only enhance patient safety, but it will also likely save you a lot of money by reducing your risk and liability. If you still have questions or need help, don’t hesitate to contact us.
More about the FDA:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies. We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.
