Compounded medicine (compounded unlicensed special)
A "compounded" medicine in the UK is one prepared by a registered pharmacy to a prescriber's specification for an individual patient. Compounded medicines are not licensed by the MHRA and are supplied as unlicensed "specials" under GPhC standards.
Full definition
In UK medicines law, a "compounded" or "extemporaneously prepared" medicine is one that does not hold a UK marketing authorisation but is prepared by a registered pharmacy under a prescriber's direction for an individual patient's needs. The legal route is described in the MHRA Blue Guide and the GPhC Standards for Registered Pharmacies. Examples in hair loss include compounded topical finasteride solutions, compounded combination finasteride and minoxidil topicals, and compounded higher-strength minoxidil solutions (e.g. 7.5 percent). All of these are unlicensed specials prescribed off-label after individual clinical assessment.
What it does not mean
"Compounded" does NOT mean clinically superior, FDA-approved, MHRA-approved, "doctor-formulated" as a clinically validated formulation, or carrying the same evidence base as a licensed product. The descriptor refers to the supply pathway, not the evidence base.
Examples in use
Honest use
"This is a compounded unlicensed special prescribed off-label after individual clinical assessment."
Common misuse
"Our compounded formulation is doctor-formulated for maximum effectiveness." (This conflates the supply pathway with an unevidenced efficacy claim.)
UK regulatory source
MHRA Blue Guide on advertising and promotion of medicines; GPhC Standards for Registered Pharmacies