Key Takeaways
- A compounded medicine is mixed for you by a licensed pharmacy, at the strength and in the form your provider prescribes.
- Compounding exists because some people need a strength, a form or an ingredient change that no manufactured product offers.
- An FDA-approved product is one standard product made for everyone. A compounded preparation is made specifically for one person.
- Your pharmacy label lists your strength and directions.
If you've seen "compounded" on a prescription or a treatment page, you might wonder what it means. It's about how the medicine is made: prepared by a pharmacy for one person, rather than made the same way for everyone.
What Is Compounding?
It's when a licensed pharmacist or physician combines, mixes or alters the ingredients of a drug to make a medicine suited to one person's needs, as the FDA describes it.
Why It Exists
Because people's needs vary and manufactured products come in set forms. You might need a strength that isn't made, a liquid because you can't swallow a tablet, or a version without an ingredient that doesn't agree with you. Compounding fills the gap between what's manufactured and what you need.
How Is It Different From an FDA-Approved Product?
The difference is who the medicine is made for, and how it's checked before it reaches you.
An FDA-approved product is reviewed by the FDA before it's sold. The manufacturer submits trial data, and the FDA approves the product's labeling: what it treats, at what doses and with which warnings. Every batch made under that approval is the same product.
A compounded preparation is made by a licensed pharmacy for one person's prescription, at the strength and in the form your provider chooses. Compounded medicines aren't FDA-approved, and the FDA doesn't review them before they're marketed, so they don't come with approved labeling of their own.†
Both start with a prescription, and your provider can help you weigh which one fits your situation.
TWO ARRANGEMENTS
Made for everyone, or made for you.
| Manufactured | Compounded | |
|---|---|---|
| What it is | One standard product | Prepared for one person |
| Who checks it first | Reviewed by the FDA before it is sold | Reviewed by the prescriber and the pharmacist |
| Where instructions come from | Labeling set by the FDA | Your prescription and your own label |
A prescription either way.
How Do Your Provider and Pharmacy Work Together?
Your provider prescribes, and a licensed pharmacy prepares your medicine to that prescription. First, a provider licensed in your state reviews your health history and the medicines you take, and decides whether a compounded preparation fits. If it does, your provider writes your prescription, including the strength.
Your pharmacy label tells you what's in your medicine, at what strength, and how to take it. Follow those directions, and ask your provider or pharmacist about anything that's unclear. Because the pharmacy prepares it for your prescription, compounding can add time to delivery.
Before each refill, your provider reviews your care, and your care team is available between refills.
Who Oversees a Compounding Pharmacy?
It depends on the kind of pharmacy. State boards generally lead oversight of pharmacies that compound on prescription, and the FDA can inspect them too. Federal law sets out two kinds of compounders, each named for the section of the law that covers it.
- Pharmacies under section 503A: a licensed pharmacist in a state-licensed pharmacy prepares your medicine, and federal law requires it to be compounded on a valid prescription for an individual patient. State boards of pharmacy generally handle day-to-day oversight, and the FDA also carries out some inspections.
- Outsourcing facilities under section 503B: these register with the FDA, which primarily oversees them and inspects them on a risk-based schedule. They must meet federal manufacturing quality standards, known as current good manufacturing practice (CGMP). They can fill a prescription for one person or supply a provider's office.
What Should You Ask?
Four questions are worth asking your provider or pharmacist.
- What's in it, and at what strength? Your prescription and pharmacy label tell you.
- Who prepares it? A licensed pharmacy, and your provider can tell you which one.
- What is it meant to help with? Your provider explains how it fits your goals and how your progress will be reviewed.
- Is there an FDA-approved option? For some medicines, there is. Your provider can tell you whether one exists for yours and how the two compare.
Safety Information for Your Medicine
Before prescribing, your provider checks the safety information on the FDA-approved label for the same active ingredient. Share your health history, the medicines you take and any side effects you notice. Check with your provider before changing how much you take or how often.
Our guides to compounded semaglutide and compounded tirzepatide cover side effects and who should be careful with those medicines.
Start With an Evaluation
Whether a compounded preparation fits you is a decision you make with a licensed provider who knows your history. When you're ready, the next step is an evaluation.
Frequently Asked Questions
Is a compounded medication safe?
Is compounded the same as generic?
Why would a provider prescribe something compounded?
How can I check the pharmacy that fills my prescription?
Why do compounded versions of some medicines come and go?
Can you take a compounded medicine and the approved version together?
What does the boxed warning on Ozempic and Zepbound say?
References
References
Before You Go…
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