In the United States, compounding pharmacies are regulated by multiple entities at the federal and state levels to ensure patient safety and the quality of compounded medications. The primary regulatory bodies involved in overseeing compounding pharmacies are:
- Food and Drug Administration (FDA): The FDA is responsible for regulating the safety, effectiveness, and quality of drugs in the United States. While compounding falls under the practice of pharmacy and is primarily regulated by state boards of pharmacy, the FDA provides oversight for certain aspects of compounding. They establish guidelines and regulations regarding the ingredients used in compounding, good manufacturing practices, and the distribution of compounded medications. The FDA also inspects and monitors compounding facilities to ensure compliance with regulations.
- State Boards of Pharmacy: Each state has its own Board of Pharmacy that governs the practice of pharmacy within its jurisdiction. State boards of pharmacy are responsible for licensing and regulating compounding pharmacies within their respective states. They set specific rules and regulations for compounding practices, including compounding standards, record-keeping requirements, and quality control measures. State boards of pharmacy also conduct inspections and investigations to ensure compliance with state regulations.
- United States Pharmacopeia (USP): The USP is a nonprofit organization that establishes standards for the quality, purity, strength, and consistency of medications. Their standards, outlined in the USP-NF (United States Pharmacopeia-National Formulary), provide guidance for compounding practices and help ensure the integrity and safety of compounded medications. Compliance with USP standards is considered a best practice for compounding pharmacies.
It's worth noting that individual states may have additional regulations and requirements beyond the federal standards to ensure patient safety and quality control. These regulations can vary from state to state.
Overall, compounding pharmacies are subject to regulatory oversight at both the federal and state levels, with the FDA, state boards of pharmacy, and USP playing key roles in establishing and enforcing standards for compounding practices and the safety of compounded medications.