The name changes the answer.
Request a written medicine name, its intended use and how it is taken: by injection, as a tablet or some other way. Ask what approval covers that exact product.
A page lists “hormone support” but leaves out the medicine. Ask for the name in writing before treating the offer as a care plan.
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Some peptide medicines have approval
Product approval goes through a US agency. It is the Food and Drug Administration (FDA). The review concerns a specific product and proposed use.
Semaglutide (Ozempic, Wegovy) has approved uses in diabetes or weight care, depending on the product.
Somatropin is human growth hormone. Somatropin and tesamorelin (Egrifta) both have US approval.
These names are examples of medicines with approval. Ask which condition the exact product is approved to treat and why it is being proposed for you.
Ask to see the FDA approval for the exact medicine and use being discussed. A broad promise about “hormones” leaves both questions open.
Compounding changes what has been reviewed
Compounding means making a drug to order. A pharmacist or doctor prepares it to meet a patient’s needs.
Making a drug to order by compounding does not give it FDA approval. Before it is marketed, FDA does not check the finished drug’s safety, benefit or quality.
Some patient needs call for compounding because an approved drug cannot meet them. It can be lawful, with conditions; FDA approval is a different question.
Ask why the drug needs to be made to order and why an approved medicine cannot meet that need.
Hormone-related names have different histories
Sermorelin’s old brand was Geref. FDA withdrew its approvals in 2009.
In a later finding, FDA said safety or lack of benefit had not been the reasons for leaving the market.
This finding did not approve any sermorelin drug made to order today.
Biologics are medicines made using living cells; some are protein medicines. Tesamorelin and somatropin belong to this legal group.
For this group, FDA product approval is called a biologics licence. Federal law provides no way to market a version prepared outside that approval.
A research label does not establish treatment status
A “research use only” label does not settle whether a product is being offered as a medicine. FDA pointed to website claims about treating people, such as claims about weight or hormones, in letters accusing sellers of marketing drugs.
These were allegations in letters sent to specific firms, rather than court findings.
An NDC is a drug’s code in a government directory. The code identifies an entry; it gives no proof of product approval.