What is Compounding?
According to the U.S. Federal Food and Drug Administration (FDA), “pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient. Pharmacy compounding, if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.”
Compounding pharmacists and the specially trained compounding pharmacy technicians whom they supervise customize medications to fit individual human and veterinary patient needs when patients cannot or will not take the practitioner’s preferred pharmaceutical therapy in its commercially available form. Compounding hearkens back to the roots of historic pharmacy practice. Before pharmaceutical manufacturing arose, prescription medications were typically made by a pharmacist in response to a prescription order. Even with the rise of drug manufacturing, some patients could not or would not take medications in their manufactured form due to palatability issues, difficulties with route of administration, unavailability of the drug due to back-order or discontinuation, strength-patient size mismatch, and or the presence of allergenic or irritating inactive ingredients.
Not every pharmacy has compounding capabilities. Those that do engage in compounding should have specially trained staff and equipment to accommodate the preparation of customized medications by prescription order. They should follow best-practice standard operating procedures promulgated by state and federal governments and by applicable certification boards. They should also adhere strictly to laws and regulations that govern the practice of compounding. Furthermore, they should use industry-recognized references to ensure potency and stability of the customized medications that they prepare.