A plain-language guide Compounding

Compounding

Making a medicine to order.

Compounding means a doctor or pharmacist makes a medicine for one patient rather than using a product that is already made.

Some patient needs cannot be met by a ready-made medicine; compounding can help fill that gap.

Made to order does not mean approved

FDA has not approved medicines prepared through compounding.

FDA does not check each compounded medicine’s safety, effect, or quality before it reaches patients.

A doctor or another health professional with prescribing permission can write a medicine order called a prescription. The order does not mean FDA approved the named medicine.

The ingredient still matters

A bulk ingredient is the raw substance used to make the medicine.

Selank is absent from the official list of extra ingredients allowed for made-to-order medicines. It is also absent from FDA’s temporary compounding lists.

FDA uses temporary lists while it decides which ingredients to allow.

Can a pharmacy make Selank for me?

The checked rules do not show a legal route for a pharmacy to make Selank from raw powder.

This is a reading of those rules, rather than a Selank-specific FDA ruling. FDA has not clearly explained what a pharmacy may do after someone takes back a request to consider an ingredient.

Calling it “compounded” does not give permission to use the ingredient.

A practical question

Which rule allows the pharmacy to use this ingredient? Can you show me that rule and name the pharmacy?

What a withdrawn request means

Notes for this chapter