What is CompoundingCompounding is the Art and Science of Creating Personalized Medications
Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are “made from scratch” – individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.
A Brief History of Compounding
At one time, nearly all prescriptions were compounded. With the advent of mass drug manufacturing in the 1950s and ‘60s, compounding rapidly declined. The pharmacist’s role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms, and most pharmacists no longer were trained to compound medications. However, the “one-size-fits-all” nature of many mass-produced medications meant that some patients’ needs were not being met.
Innovative Compounding Technology & Techniques Meet Patient Needs
Fortunately, compounding has experienced a resurgence as modern technology and innovative techniques and research have allowed more pharmacists to customize medications to meet specific patient needs.
- Trained compounding pharmacists now can personalize medicine for patients who need specific:
- Dosage forms
- Ingredients excluded from medications due to allergies or other sensitivities
Do Compounded Medications Require FDA Approval?
The FDA approval process is intended for mass-produced drugs made by large manufacturers. Because compounded medications are personalized for individual patients, it is not possible for each formulation to go through the FDA’s drug approval process, which takes years to complete and is prohibitively expensive, often costing hundreds of millions of dollars.
However, every compounding pharmacy must comply with the regulations set by the State Board of Pharmacy of the state in which the pharmacy is located. Each State Board of Pharmacy has the power to set and enforce regulations for compounding in its state, just as traditional pharmacies are regulated. The ingredients used by compounding pharmacies to make compounds come from FDA-registered and inspected facilities.