Journal of Pharmaceutical Care in Pain & Symptom Control
Vol. 5: 47-57 (Volume publication date: 1997)
ABSTRACT
There are three categories of compounded drugs. Extemporaneously compounded drugs are prepared by pharmacists for a unique patient need, regulated by the state board of pharmacy in most states. No product standards exist, and problems are not required to be reported. Manufacturing is commercial compounding which is regulated by the FDA which controls product quality and manufacturing process. Large scale extemporaneous compounding in anticipation of need for the dosage forms, or compounding and promoting those dosage forms to replace commercial products is defined as “substitution compounding.” Some individuals may interpret such actions as being outside FDA regulations. Most state laws neither define nor regulate large scale compounding, which explains why several unsuccessful legislative attempts have been made to shift regulation from the FDA to the State Board of Pharmacy, essentially removing all controls. Compounded drugs add the risk of impurity, erratic drug delivery, instability, and uncertain potency. Examples are provided which demonstrate the harm which can result from the use of compounded drugs. Questions pertaining to legality and liability depend on the interpretation of vague laws, but deal primarily with the issue of the motive of the compounding pharmacist. Are they interested primarily in improving patient care, or in the extreme profits which can result from large scale compounding? This article should enable patients, physicians, nurses, and other healthcare practitioners to make more informed decisions when they are considering use of an extemporaneously compounded dosage form or a pharmacist suggests substitution of a compounded drug for a commercially available product.
KEYWORDS: Extemporaneous compounding – drugs – dosage forms – large scale compounding – substitution compounding – manufacturing – legal – boards of pharmacy – FDA – CGMP
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