What changes when a medicine is compounded?

What does “compounded” mean?

Compounding means a doctor or pharmacist makes medicine to fill a specific order, rather than supplying a drug company’s finished product; the government compounding guide explains this distinction.

The Food and Drug Administration uses the short name FDA. This agency in the U.S. checks medicines for approval.

As of September 2026, compounded products had no FDA approval. FDA did not check their quality, safety, or effectiveness before marketing.

Safety means the chance of harm. Effectiveness means whether the product does the job it is meant to do.

Is every compounded medicine unlawful?

No. The FDA explanation explains that compounding can meet a person’s medical need when an approved drug cannot.

Under the rules recorded in September 2026, pharmacies could not regularly make near-copies of available approved drugs just because a copy cost less.

The prescriber must use the medical record to explain the important difference this change makes for that patient.

For example, a person may be allergic to a colouring in a ready-made medicine. Compounding may let a pharmacist prepare medicine without that colouring.

A low price and a patient-specific medical reason are different things.

Why do older shortage claims need a check?

The September 2026 FDA supply-and-copy update showed no national shortage listing for semaglutide injection or tirzepatide.

During the national shortages, pharmacies were allowed to make copies of those medicines. Once the shortages ended, that permission ended too.

The extra time FDA gave pharmacies to stop making those copies ran out in 2025.

A local pharmacy running out does not put the medicine on FDA’s national shortage list.

A change for a particular patient’s medical need is a separate question from permission to copy drugs during a shortage.

Ask whoever writes your prescription which change your medical need calls for and how it fits the compounding rules.

Does adding a vitamin settle the copy question?

FDA’s September 2026 notes treated some vitamin-added semaglutide products as copies unless the person writing the prescription recorded a meaningful difference for that patient.

The extra ingredient alone is not a clear answer. Ask what it changes for your particular need.

Is a compounded version simply a generic?

A generic is a version of a branded medicine with FDA approval of its own. A compounded preparation does not have that approval.