What compounding means
A pharmacist or doctor can compound a medicine: prepare it for a patient rather than supply a ready-made product.
- FDA, the Food and Drug Administration, says compounding can address a patient’s need left unmet by approved medicine—for example, leaving out a dye that causes that patient an allergy.
- Compounding can be lawful when its conditions are met; a lack of FDA approval alone does not make it unlawful (September 26, 2026).
- These preparations have no FDA approval (September 26, 2026).
- Before they reach patients, FDA does not check their benefit, possible harm or quality through its usual approval review (September 26, 2026).
A made-to-order copy needs an explanation
Federal law limits routine compounding of close copies of available approved medicines (September 26, 2026).
- Under the rule for a pharmacy or doctor making medicine for a particular patient, a changed medicine may fall outside the copy restriction. The prescriber must judge the alteration to be significant for the individual patient; simply having a different product is insufficient (September 26, 2026).
- A cheaper price alone does not count as a significant difference for that patient (September 26, 2026).
- Ask what change is being made and why it matters for your health, such as removing a dye you are allergic to.
- Ask the person prescribing to explain which rule allows this medicine to be made for you.
Keep the making process visible
Ask for the name of the place making the medicine before agreeing to the plan.
- Where can I check its pharmacy licence?
- Who answers product questions?
- What written product information will I receive?
- How will I be told about storage and possible problems?