Consent to compounded medication

A compounded medication is prepared for you by a licensed pharmacy under section 503A of the Federal Food, Drug, and Cosmetic Act. It is made to your prescription, for you specifically.

Compounded drugs are not reviewed or approved by the FDA. The FDA does not verify their safety, effectiveness or quality before they are sold. The pharmacy is licensed and inspected by its state board and subject to FDA inspection, but that is not the same thing as approval.

The law does not permit a pharmacy to compound a drug that is essentially a copy of a commercially available FDA-approved product. Where an approved product exists, your clinician must document a specific clinical reason you need something different — a documented intolerance to an inactive ingredient, or a dose the commercial product does not make.

That reason is written in your chart and you can read it in your account. Cost is not, on its own, a legally sufficient reason, and we will not record it as one.

Strength, appearance and expiry may differ from the branded product. Beyond-use dates are shorter. Storage instructions are specific and matter.

Report any reaction to us immediately. We report adverse events associated with compounded preparations to the FDA’s MedWatch programme.

You can always ask for the FDA-approved product instead, and we will help you pursue coverage for it, even where that means you pay us less. If you would rather not use a compounded preparation, say so — it changes nothing about how we treat you.