A compounded medication is prepared by a pharmacist from scratch using raw materials to customize a medication per a physician's written prescription. The resulting medication is referred to as a "compound". Due to the individualized nature of this medication, we can eliminate the "one size fits all" pitfall for patients who have not responded to commercially available medication. Making the ideal compound requires a close relationship between the patient, doctor and pharmacist. Quality control is crucial when compounding medications. Professional Village Pharmacy (PVP) meets or exceeds standards for providing accurate compounded medications.
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.
Contact us at www.ProfessionalVillageRX.com
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