Need, ingredient and permission
A reason for compounding is not product approval
FDA means the US medicines agency.
Compounding may address a patient’s unmet medical need when approved medicines cannot, according to FDA guidance checked on September 26, 2026.
That may also apply when the approved drug is not available.
FDA does not check a compounded drug for safety, quality or benefit before it is sold.
- Ask what need this change would address.
- Ask what finished product will actually be supplied.
- Ask who prepares it and who will answer questions about it.
The ingredient has to qualify too
The law limits which raw ingredients a regular pharmacy may use to make a medicine; these rules were checked on September 26, 2026.
An official ingredient standard is a written set of requirements for what the substance is and its quality.
If one exists, the pharmacy’s ingredient must meet those requirements.
The pharmacy must also follow the standard for preparing compounded medicines.
An ingredient standard is different from approval for a finished medicine.
If no ingredient standard exists, an ingredient already used in an approved drug can qualify.
Otherwise it has to appear on the 503A Bulks List, which names the additional ingredients permitted for regular pharmacies.
Epitalon is a man-made peptide.
Epitalon was absent from that formal list and from FDA’s temporary ingredient categories as of September 28, 2026.
FDA also has a temporary policy for certain ingredients still being reviewed, as checked on September 26, 2026.
For those ingredients, FDA plans to hold off on action against pharmacies that follow the policy’s conditions.
That pause in action is not legal permission to use the ingredient.
For epitalon, FDA found no applicable official ingredient standard, and it is not an ingredient in an approved drug; this was checked on September 28, 2026.
- Ask which ingredient rule the proposed preparation relies on.
- Request the actual record rather than a general claim about personalised care.
Taking back a request does not grant permission
The people who asked FDA to consider epitalon for pharmacy use had taken their request back by the September 2026 check.
The reason for taking it back is not given in the source notes used here.
The withdrawn request left the pharmacy ingredient rules unchanged in September 2026; it granted no permission to use epitalon.
Epitalon did not meet any of those legal ingredient conditions for regular pharmacy compounding as of September 2026.
These are rules about which ingredients may be used, rather than results of laboratory tests on a batch of medicine.
- Ask what changed in the rule itself.
- Compare the claimed permission with the ingredient records before committing.
Sources for this page
Sources checked through September 28, 2026.