Compounding medications: Just what the doctor ordered
- by Revan Health & Revan Rx
There is a lot of discussion online right now regarding compounded medications, driven largely by the boom in telehealth prescribing for weight-loss and longevity drugs.
Compounding medications is the process in which a licensed pharmacist or doctor mixes, changes, or combines ingredients to create a custom medicine for a specific patient. People need compounded drugs due to possible allergies, for easier dosing, drugs that are in shortage, and for adjusted strengths of medication.
Compounding lets a licensed pharmacist prepare a medication tailored to an individual patient when their prescription and clinical circumstances call for it.
But compounded medications are not FDA-approved products.
“Traditional compounding pharmacies (503A facilities) operate under state pharmacy board oversight rather than FDA approval processes,” said Dr. Jason Revel, PharmD., Founder and Director of Pharmacy Services at Revan Health and Revan Rx. “Following the 2012 fungal meningitis outbreak from contaminated steroid injections, Congress passed the Drug Quality and Security Act (DQSA), creating an additional category—503B outsourcing facilities—that may voluntarily register with FDA and produce larger quantities under quality standards resembling Good Manufacturing Practices.”
Revel is a compounding pharmacist. He also said that the lack of FDA approval means compounded products do not undergo premarket review for safety, efficacy, or manufacturing quality.
“FDA testing of compounded products has revealed concerning quality issues: potency variations ranging from 59% to 268% of labeled strength, sterility failures, and contamination,” Revel said. However, when reputable pharmacies prepare compounded medications to USP standards, they serve legitimate medical needs that manufactured products cannot meet.”
Compounding pharmacies do prepare medications following standards established by the United States Pharmacopeia (USP).
“Pharmaceutical compounding creates customized medications by combining, mixing, or altering ingredients to meet specific patient needs that commercially available products cannot meet,” said Revel, adding that two main categories exist: sterile compounding (for injections, infusions, and eye preparations) and nonsterile compounding (creams, ointments, oral liquids, capsules).
These standards require specific environmental controls, equipment, personnel training, and quality testing to prevent contamination and ensure potency.
“Compounding proves especially valuable in pediatric care, where many medications lack child-friendly formulations,” Revel added. “Liquid preparations can incorporate flavoring agents to improve flavor and compliance in young patients. Similarly, veterinary patients often require compounded medications when FDA-approved veterinary products remain unavailable, or when dosing must be tailored to species-specific needs.”
Revan Rx does non-sterile and hazardous drug compounding, which requires strict adherence to safety standards, including negative-pressure rooms and specialized protective gear, to protect workers and patients from toxic exposure.
Revan is a certified veterinary compounding pharmacy.
The primary therapies treated with compounded drugs are hormone therapy, dermatologic use, pain management, and specialized nutrition therapy.
Revel said compounded medications typically cost more than mass-manufactured equivalents because of individualized preparation, specialized equipment, and smaller batch sizes.
“Insurance coverage varies widely by plan, therapeutic indication, and whether FDA-approved alternatives exist,” he said. “Many insurers require prior authorization or impose quantity limits, while some compounded formulations—particularly topical pain creams with multiple ingredients—may not be covered at all.”
Patients should discuss coverage specifics with both their prescriber and pharmacy, as out-of-pocket costs can range from modest to substantial depending on formulation complexity. Still, most medical/pharmacy insurance plans do not cover compounded preparations.
Revan works with wellness centers and their prescribers on a variety of customized compounded medications. Remember, Revan Rx specializes in nonsterile compounding, so they can’t compound sterile medications.
“What this means is that we do not prepare injectable products, including tirzepatide vials or other sterile formulations,” Revel said. “If you’re looking for nonsterile compounded options, we’d be happy to discuss what may be available and how we can help.
For your compounded medication needs, including gender-affirming hormone therapy, call (405) 896-7975 or (888) 773-8267, or visit revanrx.com.