Pharmacy compounders have a lot of factors to consider when making the decision to go into the business of mixing individual prescriptions, particularly those considered “hazardous.” It can be a lucrative operation, but one which is closely overseen. For good reason, though: mistakes in the recent past have taught us that sloppy procedures, partly resulting from a lack of regulations, can have deadly consequences.
In order for a pharmacy compounder to safely and properly mix prescriptions according to legal regulations, a compounding cleanroom is required. The cleanroom, also referred to as a secondary engineering control (SEC) room, is where you will use and house specific equipment such as a laminar air flow workstation (LAFW) and a compounding aseptic isolator (CAI).
Pharmacies are governed under Section 503A of the Compounding Quality Act and must meet minimum cleanliness requirements in order to pass regulation and ensure sterile conditions for compounding. Following and adhering to these requirements is pertinent to providing safe conditions both for you and for the recipients of the prescriptions, especially when compounding prescriptions that are considered hazardous.
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