Do Compounded Medications Require FDA Approval?
The FDA approval process is intended for mass-produced drugs made by manufacturers. Because compounded medications are personalized for individual patients, the federal government has approved the use of compounded medications for those individuals who have received a prescription for that specific compounded medication.
What is Compounding?
Compounding is the Art and Science of Creating Personalized Medications
Find out more about compounded medications:
- Specialty Compounding: Compounding is a useful tool in varied areas of medicine
- Alternative Medication Forms: Making medications more effective and easier to take
- Compounding Answers: Answers to common compounding questions
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
Trained, PCCA member pharmacists can now personalize medicine for patients who need specific:
- Dosage forms
- Ingredients excluded from medications due to allergies or other sensitivities