What Is a Compounding Pharmacy?
Compounding pharmacies make medicine when what’s commercially available doesn’t meet the unique needs of the individual patient. While commercially available medications at retail pharmacies are widely used, they may not be suitable for everyone. As a result, there has been growing awareness and renewed interest in pharmaceutical compounding.
In some cases, the exact medication a patient needs is not commercially available or is affected by a supply shortage. Other times, a patient may need a non-standard dosage, may have an ingredient allergy, or may require a different dosage form.
Example: If a pediatric or geriatric patient is unable to swallow a prescribed tablet or capsule, a doctor may prescribe the medication to be compounded as a liquid or suspension instead. This ensures that the patient can take the medication as prescribed, without the dosage form becoming a barrier to proper treatment.
Key Facts About Compounded Medications
- Compounding pharmacies can make medications for both humans and animals.
- Different formulations can be used to remove allergens for a patient.
- Compounded medications account for approximately 3–5% of all prescriptions filled in the U.S.
- Medications can be combined during compounding, so a patient doesn’t need to take multiple prescriptions.
- Compounding is not new! The modern era of compounding began around the 1800s.
503A vs 503B Compounding Pharmacies: What’s the Difference?
In the world of compounding, you may have heard the terms “503A” and “503B.” You might be thinking, “Aren’t both of those making compounded medications?”—and you’d be right. But there are a few key differences between the two:
503A Compounding
- Compounds patient-specific medications, requiring a valid prescription.
- Dispensed to individual patients for at-home use.
- Prescriptions are tailored to the individual.
- Not permitted to distribute compounds for office use.
503B Compounding
- Bulk-manufacturing facilities that create large quantities of compounded drugs.
- Sent to healthcare facilities or medical offices.
- Large batches produced in advance.
- Also referred to as an outsourcing facility.
FAQs About Compounded Prescriptions
Are compounds covered by insurance?
Depending on your insurance plan, you may be reimbursed by submitting a claim form. Many insurance companies do cover compounded prescriptions; however, we recommend contacting your provider directly to understand your specific coverage.
Do I need a prescription?
Yes, compounds require a prescription from a licensed provider. They are not available for over-the-counter (OTC) purchase.
Who can write a prescription for a compounded medication?
Prescriptions can be written by licensed healthcare providers such as doctors, dentists, naturopathic doctors, physician assistants, and nurse practitioners, depending on their training and state laws. The ability to prescribe certain medications may vary from state to state.
How long does it take to receive my compounded prescription?
Compounding pharmacies operate differently than retail pharmacies. At a retail pharmacy, most prescriptions and over-the-counter (OTC) medications are mass-produced and kept in stock for same-day pickup—sometimes in as little as 15 minutes. In contrast, compounded prescriptions are prepared specifically for a patient and only after an order is placed. Some pharmacies can prepare and ship your compound within 24–48 hours, while others may take 5–7 days or longer depending on the prescription, ingredient availability, and workflow.
What is the difference between sterile and non-sterile compounding?
In the compounding pharmacy industry, there are distinct definitions, regulations, and licensure requirements for sterile versus non-sterile compounding.
Sterile compounding: Follows strict standards and is necessary when there is a high risk of infection. Sterile medications are typically used for injections, eye drops (ophthalmic preparations), and other applications requiring a completely sterile environment. These medications must be prepared in a cleanroom—a controlled space free from viruses, bacteria, or other microorganisms—to ensure sterility and patient safety.
Valor Compounding Pharmacy offers a select catalog of sterile compounds that undergo rigorous testing, including method suitability and container closure testing. Call us at (855) 554-2889 to learn more about our sterile offerings.
Non-sterile compounding: More common. While these medications are not prepared in a sterile cleanroom, they are still made under strict guidelines in a sanitized environment. Non-sterile compounds include solutions, suspensions, ointments, creams, gels, powders, suppositories, capsules, troches, and sublingual tablets.
Learn More About Compounding
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Watch the short video below to learn about Valor Compounding Pharmacy and step inside the world of compounding!
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