Compounding after the shortage

What compounding means

To compound a drug is to make or change it. It differs from supplying a ready-made product. A pharmacist, physician or registered facility does this work. It can address a medical need that the approved products leave unmet.

The September 26, 2026 record kept a key distinction: compounded drugs had no FDA approval. FDA had reviewed none of the compounded product’s effectiveness, quality or safety before sale. Compounding can still be lawful.

• Ask what medical need the change is intended to meet.
• Ask which approved option was considered.
• Identify the dispensing pharmacy or the facility preparing it.

Why the shortage changed the discussion

A national shortage creates an exception to restrictions on making copies of approved drugs. When the shortage ends, the copying restrictions matter again.

February 21, 2025 was the date FDA found the national semaglutide injection shortage had ended. The agency said limited local supply disruptions could still occur.

In the record checked September 26, 2026, semaglutide injections were absent from FDA’s shortage list. A bare shelf at a nearby pharmacy did not change that national finding.

So there is more to ask than whether a pharmacy can make this drug. Ask why the proposed drug is different for the person receiving it. Ask which rule allows that change.

• Is the offer relying on an old shortage claim?
• What change is being proposed, and why?
• Is the reason for the change written in the care record?

A change needs more than a new label

Under the rule limiting pharmacy-made copies, a “significant difference” means a change to the medicine that matters for the person named in the prescription. The prescriber judges that difference. Ask for a written explanation of what changed and how it addresses your care. The library checked this rule on September 26, 2026. Price alone does not count as that difference.

FDA’s April 1, 2026 policy gave semaglutide combined with vitamin B12 as an example that may still count as essentially a copy. Adding a vitamin does not automatically settle the copying question.

The words sodium and acetate name different chemical forms of semaglutide, called salts. Here, salt is a chemistry term for a form of the drug. FDA says these forms are different active ingredients from the semaglutide in approved medicines. At that September 26, 2026 review, FDA said it could identify no way to use these ingredients legally in compounded medicines.

• Ask for the full ingredient name.
• Ask how the change is meant to address the stated need.
• Ask for an explanation that concerns your circumstances rather than a menu of stock reasons.

Keep approval and registration separate

Federal compounding law has separate parts called 503A and 503B. The 503A part generally covers a pharmacy making medicine for a named person with a prescription. The 503B part covers a compounding facility that prepares batches, often for clinics and hospitals. It chooses to register with FDA and does not have to be a licensed pharmacy. This kind of place is called an outsourcing facility; it can make batches without a separate prescription for each person.

FDA registration means the facility chose to put itself on FDA’s list of outsourcing facilities. Registration alone does not mean FDA approved the place or the medicines it makes, or endorsed their quality. The same September 26, 2026 check found no generic semaglutide with final approval for U.S. marketing.

FDA calls it misleading to label a compound an approved generic. It also objects to claims that a compound is proven to work the same way as an approved drug.

• Which type of compounder is making this preparation?
• Which state board has the pharmacy’s license record?
• Who answers questions about the medicine after dispensing?

Questions before a commitment

In its semaglutide alert, FDA described dosing errors and hospital stays. Some mistakes involved measuring; others involved calculations made by health professionals.

FDA’s pharmacy lookup directs readers to the state board’s license database. A listing confirms a license record; it does not certify that every dispensing decision is appropriate.

• Ask the prescriber and dispensing pharmacist to resolve unclear instructions together.
• Keep the exact product and pharmacy names with your care records.
• Ask what follow-up is included if a problem appears.

The aim is a clear account of the proposed change. If an answer rests only on “same as the brand” or an old shortage headline, bring the question back to the prescriber before making a commitment.