Regulation & market
Compounded drug
Also known as: compounding · compounded
A medicine prepared by a pharmacy to suit an individual patient — not FDA-approved, and not reviewed for safety or effectiveness before sale.
In plain terms
Compounding exists for real clinical reasons: an allergy to a dye, a dose no manufacturer makes, a patient who cannot swallow a tablet. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness, or quality before they are marketed.
FDA has documented fraudulent compounded semaglutide and tirzepatide whose labels named compounding pharmacies that do not exist, along with unapproved salt forms and active ingredients from uninspected facilities.
Guides that use this term
BPC-157, TB-500, CJC-1295 and ipamorelin: what the FDA has actually published about each, why “removed from Category 2” does not mean cleared, and what is still unlawful to compound.
The shortages ended, and with them the enforcement discretion that allowed mass compounding of semaglutide and tirzepatide. What FDA actually said, with the dates, and what remains permitted.
Sources
Educational reference only. Pepperz does not provide medical advice, diagnosis, treatment, prescribing guidance, or dosing recommendations.