If you have looked into prescription care online, you may have seen the word "compounded." It can be confusing, especially when it shows up next to medicines you already know by name. This guide explains what compounding means, how compounded medicines differ from FDA-approved drugs, and what you can ask before you start any new medicine.
What does "compounded" mean?
Compounding is a way of making a medicine for a specific person. According to the U.S. Food and Drug Administration (FDA), in compounding a licensed pharmacist or physician "combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient."
The FDA gives a few examples of why this can be useful. A person may have an allergy to a certain dye and need a medicine made without it. An older adult or a child who cannot swallow a tablet or capsule may need a liquid form instead. In cases like these, compounding can meet a real need when an FDA-approved medicine is not a good fit.
How FDA-approved drugs are reviewed
Before a drug is FDA-approved, the company that makes it must send the agency research showing that the drug is safe and effective for its intended use. A team of FDA experts, including medical doctors, chemists, statisticians, microbiologists and pharmacologists, reviews the evidence. The FDA looks at whether the benefits of the drug appear to outweigh its known risks.
The FDA also reviews the drug's labeling. This is the official prescribing information that explains how to use the medicine properly.
Generic drugs are FDA-approved, too. The FDA explains that generics are approved and shown to be therapeutically equivalent to the brand-name version. That makes them different from compounded drugs.
How compounded drugs are different
The most important difference is simple. In the FDA's words, "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."
That does not mean a compounded medicine is automatically unsafe. It means the medicine has not gone through the same review that an FDA-approved drug goes through. The FDA says compounded drugs can serve a medical need, and that they "also may pose risks to patients." It notes that poor compounding practices can lead to serious quality problems, such as contamination or a drug that contains too much or too little of the active ingredient.
At Talvi, we want you to know exactly what you are getting. Compounded medications are prepared by state-licensed pharmacies and are not FDA-approved.
What are 503A and 503B pharmacies?
You may see the numbers 503A and 503B. These refer to two sections of the federal Food, Drug, and Cosmetic Act that cover compounding.
503A: traditional compounding pharmacies
Section 503A covers compounding by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a physician, when certain conditions are met. State boards of pharmacy oversee these pharmacies, and the FDA also does surveillance inspections. The FDA notes that drugs made under 503A are not held to current good manufacturing practice (CGMP) standards, though all compounders must avoid insanitary conditions.
503B: outsourcing facilities
A 2013 law created a category called "outsourcing facilities" under section 503B. These facilities register with the FDA and must follow CGMP requirements, which the FDA describes as increased quality standards. Once registered, an outsourcing facility is added to the list of facilities the FDA intends to inspect on a risk-based schedule. Facilities must re-register every year. The FDA posts a public list of registered outsourcing facilities on its website.
Why the FDA has raised concerns about some products
The FDA has shared specific concerns about unapproved versions of some medicines, including GLP-1 drugs used for weight. The agency says these versions "do not undergo FDA's review for safety, effectiveness and quality before they are marketed." It has received reports of adverse events, some needing hospital care, linked to dosing mistakes with compounded semaglutide. It has also warned about counterfeit products that could contain the wrong ingredients, too little or too much active ingredient, or none at all.
The FDA's advice is to get a prescription from a licensed health care provider and to fill it at a state-licensed pharmacy.
How to spot a safe online pharmacy
Through its BeSafeRx program, the FDA lists signs of a safe online pharmacy. A safe online pharmacy:
- Always requires a doctor's prescription
- Provides a physical address and phone number in the United States
- Has a licensed pharmacist on staff to answer your questions
- Is licensed with a state board of pharmacy
The FDA also lists warning signs. These include a site that does not require a prescription, sends medicine that looks different from what you get at your local pharmacy, or offers deep discounts that seem too good to be true.
Questions to ask your clinician
Whether a medicine is compounded or FDA-approved, you deserve to understand it. Here are some questions you can bring to your visit:
- Is this medicine FDA-approved, or is it compounded?
- If it is compounded, why is it a better fit for me than an FDA-approved option?
- Which pharmacy will prepare it? Is it state-licensed, and is it a 503A pharmacy or a 503B outsourcing facility?
- How will I know the exact strength of what I receive?
- What side effects should I watch for, and who do I contact if I have them?
- How should I store this medicine?
At Talvi, a licensed clinician reviews your health history before anything is prescribed. That review is a good time to ask any of these questions.
If something does not feel right
If you have a side effect or a problem with a medicine, contact your clinician. You can also report problems to the FDA through its MedWatch program. If you have symptoms that feel severe or sudden, such as trouble breathing, call 911 or seek emergency care right away.
The bottom line
Compounded and FDA-approved medicines are not the same. FDA-approved drugs go through a review of safety, effectiveness and quality before they are sold. Compounded drugs do not. Knowing which one you have, and asking clear questions, helps you make informed choices with your clinician.