Compounded vs. Manufactured Medications: What the Difference Means for You

You will see the word "compounded" all over GetMyIVM, along with a footnote that compounded preparations are not FDA-approved. Neither is a formality. Understanding the difference between a compounded and a manufactured medication tells you what you are receiving, who is responsible for it, and why some of our policies are the way they are.

What a manufactured medication is

A manufactured medication is a specific product, made at scale by a pharmaceutical company, that the FDA has reviewed and approved. Approval covers that exact product, its strength, its form, and the uses listed on its label. When our pricing cards list "FDA-approved uses" for ivermectin, mebendazole, or hydroxychloroquine, those are the labeled uses of the manufactured version of the active ingredient.

On GetMyIVM, hydroxychloroquine 200 mg tablets are a manufactured, FDA-approved product.

What a compounded medication is

A compounded medication is prepared by a licensed compounding pharmacy for one specific patient, under a prescription from that patient's physician. Pharmacists combine or alter ingredients to produce a strength, combination, or form that is not available as a manufactured product. Compounding is a long-standing, legal part of pharmacy practice, regulated by state boards of pharmacy and by federal law.

Our compounded ivermectin 12 mg capsules, the ivermectin 25 mg plus mebendazole 250 mg combination capsules, and the compounded mebendazole 250 mg capsules are compounded preparations.

What "not FDA-approved" means here

The FDA approves products, not individual pharmacy preparations. A compounded preparation has not been through the FDA's approval process, and the FDA does not review each preparation before it is dispensed. This is true of every compounded medication from every pharmacy; it is a statement about the regulatory pathway, not about a particular batch. Oversight of a compounding pharmacy comes from its state board of pharmacy, and quality rests with that licensed pharmacy.

Because the preparations themselves are not approved, the FDA-approved uses shown on our site always refer to the manufactured version of each active ingredient, and we make no claims about any non-FDA-approved use of any medication.

Why the difference changes our policies

• Returns. A compounded medication is made for you after the prescription arrives. By law it cannot be returned to the pharmacy or resold, which is why a dispensed order cannot be refunded.
• Timing. Preparation happens after approval, so allow time for compounding before shipping.
• Pharmacy choice. Most of our medications must be prepared by a compounding pharmacy equipped to make them, which is why our partner pharmacy is the default. You may still send any prescription to a pharmacy of your choice.
• Physician judgment. Whether a compounded or manufactured medication is appropriate for you is decided by a licensed physician, with your informed consent, after reviewing your individual history.

Frequently asked questions

Is "compounded" the same as "generic"? No. A generic is a manufactured, FDA-approved product that is equivalent to a brand-name product. A compounded preparation is made by a pharmacy for an individual prescription and is not FDA-approved.

Is compounding legal? Yes, when a licensed pharmacy prepares a medication under a valid prescription for a specific patient, in compliance with state and federal rules.

Why not just prescribe the manufactured version? That is the physician's decision. Some strengths and combinations on our site do not exist as manufactured products. If a manufactured medication is appropriate, your physician can prescribe it, and you can use any pharmacy you choose.

Does "not FDA-approved" mean unsafe? It means that specific preparation has not gone through FDA approval. It does not, by itself, describe how a medication will affect you. That assessment is exactly what your physician makes before deciding whether any prescription is appropriate for you.

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We make no claim that any medication treats, cures, or prevents any disease. A licensed physician determines whether any prescription is appropriate and safe for you based on your individual health information and your informed consent. GetMyIVM makes no claims regarding any non-FDA-approved use. Compounded preparations are not FDA-approved.