Compounding pharmacies have drawn increasing public attention, especially as some have begun offering in-demand medications like semaglutide (commonly branded as Wegovy) for weight loss. While there are valid reasons to consider using a compounding pharmacy, it’s important to do thorough research before proceeding, advises Dr. Robert Shmerling, Senior Faculty Editor at Harvard Health Publishing. Below is a comprehensive overview to help guide your decision.
What Exactly Is a Compounding Pharmacy?
The term “compounding pharmacy” refers to a facility that creates customized medications that aren’t available in standard commercial formulations. “Any pharmacy that mixes medications on-site to meet an individual’s specific requirements falls into this category,” says Dr. Shmerling. These custom-made medications make up approximately 3% of all prescriptions in the U.S.
There are roughly 56,000 retail or community pharmacies nationwide, and about 7,500 of them offer compounding services, according to the American Pharmacists Association.
When Might You Need a Compounding Pharmacy?
Several scenarios could lead someone to seek out a compounding pharmacy. Common reasons include:
- Needing a specific dosage or strength not available commercially
- Requiring a different drug format, such as a liquid instead of a pill
- Eliminating certain allergens like lactose or gluten from a medication
- Adding flavors to medications to make them more palatable for children
Another instance where compounding might be necessary is during drug shortages. For example, recent supply issues involving medications like semaglutide and tirzepatide (Zepbound) have pushed people toward compounded alternatives. In such cases, compounding pharmacies obtain the active pharmaceutical ingredients directly and create the medication on-site.
Understanding the Risks Involved
Although compounded drugs should only include FDA-approved ingredients, the final formulation is not reviewed by the FDA for safety, efficacy, or quality. This lack of oversight means there’s a possibility that the product may not meet the expected standards, cautions Dr. Shmerling.
In 2023, for instance, the FDA received complaints about some pharmacies using non-approved salt forms of semaglutide—such as semaglutide sodium and semaglutide acetate—which lack official safety and efficacy validation.
Compounded medications also present dosing challenges. Unlike FDA-approved semaglutide injections, which are pre-filled to reduce user error, compounded versions may require manual handling by either healthcare providers or patients. This increases the risk of incorrect dosages, which can result in side effects ranging from nausea and vomiting to more severe issues like acute pancreatitis. In some cases, patients have required hospitalization.
“There are reports of patients accidentally administering doses 20 times higher than recommended due to unclear instructions from the compounding pharmacy,” Dr. Shmerling warns.
Additionally, the absence of FDA oversight raises the risk of contamination. A tragic example occurred in 2012 when contaminated steroid injections from a compounding pharmacy led to a fungal meningitis outbreak that affected nearly 800 people and resulted in 64 deaths.
Due to these concerns, Dr. Shmerling advises turning to compounding pharmacies only when absolutely necessary—specifically, when no commercially available alternatives exist.
Can You Be Sure a Compounded Drug Is Safe?
Unfortunately, determining the safety and potency of a compounded medication isn’t always straightforward. “There’s a significant element of buyer beware,” says Dr. Shmerling. Since compounded drugs aren’t FDA-approved, there’s no formal guarantee of their effectiveness or purity.
That said, there are some regulatory safeguards in place. Compounding pharmacies are subject to state pharmacy board regulations, and if they handle controlled substances like hydrocodone or amphetamines, they must also comply with DEA rules. Additionally, these pharmacies must adhere to standards developed by the U.S. Pharmacopeia (USP), an independent organization that collaborates with the FDA on medication quality benchmarks.
How to Identify a Reputable Compounding Pharmacy
Finding a trustworthy compounding pharmacy can be challenging. Your healthcare provider might be able to refer you to a reliable facility they’ve worked with. If not, you can locate compounding pharmacies through the Alliance for Pharmacy Compounding’s website.
When evaluating a pharmacy, consider asking the following questions:
- Are you licensed to operate or ship medications to my state?
- What are the qualifications of your pharmacists? (Look for board-certified sterile compounding pharmacists, or BCSCPs.)
- Do you use third-party laboratories to test your compounded products?
- What accreditations does your pharmacy hold? (The Pharmacy Compounding Accreditation Board (PCAB) accreditation is a good sign.)
If you’re located in New York, particularly the Bronx, Mediserv Pharmacy is worth considering. As Your Local Bronx Pharmacy, they are a full-service independent provider offering not only conventional prescriptions and medical supplies but also flu and strep testing, compounded medications, and more. Their commitment to community health and personalized service makes them a strong option for those seeking quality care and reliable compounded treatments.
You should also be wary of buying compounded drugs online, whether it’s through an online pharmacy or a telehealth platform. This has become a particularly popular option for weight loss drugs. According to the FDA, when buying drugs online, you may not know whether the drug was produced by a compounder whose drugs meet appropriate quality standards, or whether the compounder is appropriately licensed and regulated.
