South Dakota News: Compounding or Manufacturing

July 1, 2006 4:59 pm Topics: Compounding

Published in the July 2006 South Dakota State Board of Pharmacy Newsletter

The question of whether a practice is compounding or manufacturing is best answered by whether or not you are preparing a medication pursuant to a legal prescription for a particular patient versus making a product for someone else who is selling the compounded product to the patient’s prescriber or another business.

If you are making compounded products not pursuant to an individual patient prescription and in large quantities for future sales, you will garner the attention of FDA. Do not compound over-the-counter products – this is definitely wrong. Pharmacists may not realize they have crossed the line until regulators appear on their doorstep.

First, you should survey your compounding practices. Second, review with your state board of pharmacy or pharmacy regulations.

Third, check with your insurance carrier such as Pharmacists Mutual, or the Pharmacy Compounding Accreditation Board for advice at www.pcab.info.