The US agency in charge of reviewing medicines is the Food and Drug Administration (FDA).
Start with the need
FDA describes compounding as a possible way to meet a medical need that a ready-made approved medicine cannot meet.
Some pharmacy-made medicines are legal under US compounding rules, as of September 2026.
Compounded medicines are sold without FDA's prior review of quality, benefit, or safety, as of September 2026.
- Which need does the ready-made product leave unmet?
- What change is being made for that need?
- What evidence supports this medicine?
Ask about a proposed copy
As of September 2026, regular pharmacies face limits on routinely copying medicines already available on the market.
Under the September 2026 copy rule, the prescriber must decide that altering the medicine makes a meaningful difference for the particular patient.
A person with a dye allergy, for example, may need medicine without that dye; a person who cannot swallow tablets may need a different form of the medicine.
Ask how the proposed change meets your own need; an example alone does not settle whether this product is lawful.
A cheaper price by itself cannot meet the copy rule recorded in September 2026.
- What need of mine does this change meet?
- How has that reason been recorded?
- Why may the pharmacy legally make this medicine for me?
Separate local stock from a national shortage
A pharmacy running out is different from a medicine appearing on FDA's national shortage list.
FDA's national shortage list did not include semaglutide injection or tirzepatide on September 26, 2026.
- Ask which exact FDA listing is being cited.
- Ask how it applies to this product.
- Ask for the current answer rather than an old headline.
Name the maker
FDA notes that people getting pharmacy-made medicines online may not know who actually made the product.
- Get the maker's full name.
- Check the pharmacy record.
- Ask for written product information and a way to reach a pharmacist.