KansasPrescribed does not mean approved

A little clarity before care.

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Approved or made to order

Approved and made to order mean different things.

Compounded means made to order. The useful question is why a finished, approved medicine cannot meet your need and what is different about the proposed preparation.

Start with the short answer
Follow the question.
  1. PrescriptionA treatment decision
  2. CompoundingA preparation process
  3. Product approvalA separate product review

Reconsider the care assumption

The prescription and the product review are separate.

Federal compounding rules as of September 26, 2026.

FDA, the Food and Drug Administration, does not grant approval to drugs made to order. It does not check them for quality, safety or effects before they reach a patient.

A made-to-order drug can fill a medical need that an approved drug cannot meet.

Take this with you

Words to start the conversation

  • Why does an approved product not meet my need?
  • Who will make this preparation?
  • What change matters for me, and who has documented it?

Follow the preparation from need to oversight

Ask why the change matters for you

Federal law limits when a pharmacy can keep making copies of drugs that are already available.

For a particular named patient, the prescriber must decide that changing the medicine makes an important difference for that patient. A lower price does not count.

FDA gives examples of needs an approved medicine may not meet: an allergy to a dye, or being unable to swallow a tablet. These examples do not automatically permit every made-to-order medicine; the other compounding rules still apply.

Ask what exactly would change in your medicine, why that matters for your health, and where the reason is written down.

What made to order means

The drug is prepared by a pharmacist or doctor instead of coming from a factory as a finished product.

For the usual pharmacy route, a named patient needs a valid prescription.

FDA also records larger makers on its register. They are called outsourcing facilities. They make batches of sterile drugs and can supply them without a prescription for each patient.

Sterile means free of living germs. USP, a standards organisation, sets minimum standards for preparing sterile medicines.

Who checks the making of the medicine

State pharmacy boards oversee the usual pharmacy route. FDA has the main oversight role for registered batch makers.

The batch makers follow federal factory quality rules. Pharmacies making drugs for one named patient do not have to follow those factory rules. They still answer to state pharmacy boards and follow USP standards for preparing medicines that must be free of germs.

FDA registration, being recorded with the agency, does not approve the medicines a facility makes.

Poor compounding can leave germs in a drug. The amount of the ingredient that produces the drug’s effect—the active ingredient—can also be wrong.

Chapter notes

Evidence for this chapter

  1. A
    FDA: compounding questions and oversight

    For how these preparations are made and regulated.

  2. B
    FDA: quality concerns with compounded drugs

    For the limits of review and problems in preparation.

  3. C
    FDA: making medicine for a named patient

    For the ordinary pharmacy route.

  4. D
    FDA: outsourcing facilities

    For the batch-making route.

  5. E
    FDA: limits on copying available medicines

    For the copy restriction and changes for a named patient.

  6. F
    USP: standards for making medicines free of germs

    This public summary describes what the standard covers; it does not show whether your pharmacy follows it.