What “FDA-approved” means
An FDA-approved drug has been reviewed by the FDA for safety and effectiveness for a specific use, and the way it is made is checked for quality. Approval is for that product and that use. A peptide being approved for one condition does not make a similar-sounding product, or a different use, approved.
“FDA-registered” or “made in an FDA-registered facility” is not the same as FDA-approved.
What compounding means
Compounding is when a pharmacy mixes or changes a drug for a specific patient’s needs, for example when a person needs a different strength or can’t take an ingredient in the approved product. Compounding has a real place in medicine.
Compounded drugs are not FDA-approved. The FDA does not review them for safety, effectiveness or quality before they are sold. The FDA says compounded drugs should be used only when a patient’s medical needs cannot be met by an FDA-approved drug.
Why some peptides are restricted
When pharmacies ask to use certain substances in compounding, the FDA reviews them. It has placed some peptide substances on a list of substances that may present significant safety risks, for reasons such as impurities that can form during manufacturing and the risk of immune reactions. The list changes over time.
Products sold as “research chemicals” or “not for human use” have no approval for use in people at all.
How to protect yourself
- Ask what the exact product is and whether it is FDA-approved for your situation.
- If it is compounded, ask which pharmacy makes it and why an approved drug can’t be used.
- Be cautious about products bought online without a prescription.
- Tell every clinician you see about any peptide or supplement you use.
- Don’t start, stop or change a product based on an article; talk with the clinician who prescribes it.
Talk with our Frisco team
At a peptide consultation, your provider discusses which peptide options, if any, may be appropriate for your goals and health history, what evidence is available for them, the potential risks, and what ongoing care involves. Learn more about peptide consultations in Frisco and what peptide therapy is, or call 214-618-9600 or request a consultation.