Know which medicine is offered

Separate preparation from approval

A licensed pharmacist or physician can prepare a compounded drug. A registered outsourcing facility can also prepare it.

An outsourcing facility makes sterile batches of medicine. A sterile preparation has no living germs in it.

For compounded drugs, the Food and Drug Administration (FDA) conducts no approval review before sale. Before sale, the agency does not verify those preparations’ performance, quality, or safety. That is the position recorded September 26, 2026.

FDA describes compounding as potentially appropriate when an approved medicine cannot address the person’s medical need or is unavailable commercially.

Ask the prescriber to name the need being addressed by this preparation. Ask why the finished approved option does not meet it. Keep that explanation tied to the proposed product and your assessment rather than a broad claim that everything in a program is personalized.

A clear answer makes later questions easier. A vague answer is a reason to request the missing product information before comparing costs.

Read the copying rule with its limits

As of September 26, 2026, the law limited routine compounding of copies of drugs already on the market.

Under the rule for a pharmacy preparing medicine for a named person, the prescriber can decide that the change is medically important for that particular person. Cost savings by themselves do not satisfy that requirement.

FDA’s explanation of compounding gives the example of leaving out a dye that a person is allergic to. Ask the prescriber whether a proposed change addresses your own medical need.

What the individual change means

Essentially a copy is the law’s term for a closely matching preparation. The individual explanation matters. Have the prescriber describe the proposed change and its importance for your own care. Do not write the medical reason yourself to make a preferred order fit.

In its April 1, 2026 update, FDA said semaglutide with added vitamin B12 could still count as essentially a copy, depending on the product and individual determination.

In the same April 1, 2026 update, FDA said semaglutide and tirzepatide were on neither its national shortage list nor its allowed raw-ingredient list for larger batch-making facilities, called outsourcing facilities. Both absences were rechecked September 26, 2026.

A larger facility therefore could not rely on the national-shortage exception to make these medicines from raw ingredients. The allowed-ingredient-list route was unavailable too.

A bulk list concerns raw ingredients used in compounding. A shortage list concerns national supply. Ask which rule is being relied on for the exact preparation. A local stock problem and a national shortage listing are different questions.

Do not read a withdrawn request as permission

FDA’s page about raw drug ingredients includes a table of requests that people or groups withdrew after asking the agency to allow those ingredients for compounding. Those requests are called nominations. The date printed for the page’s content is April 22, 2026. It does not tell us when each request was withdrawn.

A withdrawn nomination does not by itself authorize compounding with that ingredient or move it into Category 1, FDA’s temporary policy of holding off on enforcement when its conditions are met. The separate draft from the Department of Health and Human Services (HHS) was announced October 30, 2026; this update was checked November 3, 2026. That draft describes HHS’s intent to hold off on enforcement against state-licensed pharmacies and physicians that meet all its conditions. It covers compounding epitalon, BPC-157, KPV, semax, MOTS-c or TB-500 for an individual patient’s prescription. The draft covers single-ingredient preparations and excludes blends. It also excludes the larger batch-making facilities known as 503B outsourcing facilities. This draft is nonbinding and is not FDA approval. None of the six is on FDA’s 503A bulks list, the official raw-ingredient list for this type of compounding.

FDA keeps its safety concerns beside those withdrawn entries and provides no withdrawal date for each substance.

A nomination is a request to have an ingredient considered. Taking that request back is not an approval decision. Ask for the actual record behind a claim that a peptide’s status has changed, with the product and route named.

Route means how a product enters or is applied to the body. Keep that detail in the description. The same name in a different context does not answer the question about the proposed preparation.

Read the linked FDA material with the prescriber’s explanation beside it. Ask how the proposed prescription meets the conditions that apply to it. Keep the product question open until the actual care service can explain its basis.