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Under those regulations, compounding is considered part of the practice of pharmacy and, in most states, is governed by state law and regulation.Manufacturing is regulated by the federal government through the auspices of the Food and Drug Administration (FDA).Safe infusion, injection, and medication vial practices have been addressed by CMS Facility requirements are intended to establish a safe environment for compounding CSPs.
All compounding personnel, mainly pharmacists and pharmacy technicians, are responsible for compounding and dispensing sterile products and preparations of correct ingredient identity, purity (freedom from physical contaminants, such as precipitates, and compatibility), and sterility and for dispensing them in appropriate containers that are labeled accurately and appropriately for the end user.
In most cases, extemporaneously compounded preparations must be prepared pursuant to a prescriber’s prescription for a specific patient.
Some states have specific regulations dealing with CSPs for office use.
This area should provide adequate space for the PEC and may include a limited amount of shelving and/or carts for staging of compounding (not for storing stock).
An ante area provides space for hand washing, garbing, and product decontamination; it also serves as a way to further segregate the buffer area from other, less-clean areas of the facility.