A compounded medicine needs a reason and a named source.

Why a custom drug

Compounding means making or mixing a drug for a patient instead of supplying a ready-made product. A licensed pharmacist or doctor can prepare it.

Larger medicine-making sites registered with FDA can also compound drugs.

For compounded medicine, FDA does not check before sale whether it is safe, made well or works as intended.

Ask why an approved drug cannot meet your need. Then ask for the medicine maker’s name and find out who would send it.

Which part of the law applies

For a patient’s prescription

A pharmacist or doctor usually prepares the drug for the patient named on a valid prescription. This part of federal law is called 503A.

Other conditions in that law also apply.

For batches made at a larger site

Sterile means free of living germs.

A larger site can register with FDA to make batches of sterile drugs, often for clinics and hospitals. Its legal name is a “503B outsourcing facility”; 503B names the part of federal law it follows.

Under 503B, the medicine maker does not need a prescription with each patient’s name.

For the larger 503B sites, federal rules set standards for the quality of medicine-making, and FDA inspects the sites. The 503A route for named patients is exempt from those factory rules. State pharmacy rules and standards for preparing medicines still apply.

Neither compounding route gives the resulting medicine FDA approval.

Price alone does not create permission

When an approved medicine is available to buy, federal law restricts making compounded copies on a routine basis.

For the patient named on the prescription, the prescriber must judge whether changing the medicine makes a significant difference. A cheaper price cannot serve as that reason.

FDA gives the example of preparing medicine without a dye the patient is allergic to.

At the September 26, 2026 check, semaglutide and tirzepatide injections were off FDA’s shortage list.

An empty shelf at a pharmacy does not amount to inclusion on FDA’s national shortage list.

Bring the pharmacy question back to Utah

Utah pharmacy rules checked September 28, 2026.

Utah requires a Class D license for an out-of-state pharmacy serving Utah residents.

An out-of-state pharmacy that compounds must give Utah an accepted inspection report from the past two years when it applies.

Ask for the pharmacy’s name and check its Utah record. Ask its pharmacist to explain anything on the medicine label that you do not understand. Keep asking until the answer is clear.