Oversight of Compounding Pharmacies
Myth: All pharmacies can provide compounded medications.
Fact: Not all pharmacies are equipped or licensed to provide compounding services. Compounding requires specialized equipment, facilities, and specially trained staff. Pharmacies that offer compounding services must comply with specific regulatory standards and may need to obtain additional licensure or certification.
Myth: Compounded medications are not regulated.
Fact: Compounded medications are highly regulated by both federal and state authorities. In the United States, the Food and Drug Administration (FDA) oversees certain aspects of compounding, particularly for large-scale compounding pharmacies. Additionally, state boards of pharmacy regulate compounding practices within their jurisdictions to ensure safety and compliance with standards. Lastly, compounding pharmacies, especially large-scale facilities and outsourcing pharmacies (503B facilities), must adhere to rigorous Good Manufacturing Practices (GMPs) similar to those required for pharmaceutical manufacturing.
Myth: Compounded medications do not require a prescription.
Fact: In the United States, compounded medications require a prescription from a licensed healthcare provider. This ensures that the medication is tailored specifically to the patient’s medical needs and that its use is medically supervised.
Myth: Compounding pharmacists do not need special training.
Fact: Compounding pharmacists require specialized training and expertise to safely prepare customized medications. This includes knowledge of pharmaceutical chemistry, sterile compounding techniques, and an understanding of regulatory requirements.