It is prepared for a need
A pharmacist, a doctor or a registered compounding facility can prepare a custom medicine; that process is called compounding.
Some patients need a preparation that ready-made drugs cannot provide. One example is a custom medicine without the dye that triggers their allergy.
Source AIt does not have the same review
As of September 2026, no compounded drug has FDA approval.
The FDA, or Food and Drug Administration, does not check its safety, quality or effect before it is marketed, as of September 2026.
Under September 2026 rules, compounding is lawful when its specific conditions are met; the absence of approval does not by itself make every such preparation illegal.
Source AAsk why this change is needed for you
Federal rules in September 2026 limit making copies of ready-made medicines repeatedly or in large amounts.
A change to the medicine may avoid counting as a copy if the prescriber records why it makes an important medical difference for you.
Have the prescriber explain the alteration to the medicine and the health reason you need it. A change on paper alone does not explain your need.
Paying less is not a qualifying medical difference under the September 2026 rules.
Source BIllinois adds its own conditions
Illinois law in September 2026 allows a pharmacy to make its own version only if the ready-made medicine cannot be obtained in time through usual suppliers.
The prescriber must also request the made-to-order medicine, under that Illinois rule.
Ask the pharmacy whether usual suppliers can provide it in time for your need, rather than looking only at one shop’s shelf.
Federal copying limits apply as well; that Illinois wording is not a substitute for them, as of September 2026.
Ask the prescriber why you need this change and how the proposed medicine meets both sets of rules.
Source CNotes behind the answers
- Source A — FDA: Preparation and reviewFDA compounding explanationFDA on compounding qualityBack to answer A
- Source B — FDA: When a made-to-order drug counts as a copyFDA copying-policy explanationBack to answer B
- Source C — Illinois law: Compounding an available productIllinois compounding definitionBack to answer C