it’s not your grandfather’s pharmacy anymore . . .
Upstate HomeCare Maintaints 797 Compliant Pharmacy To Ensure The Highest Level Of Safety In Our Compounded Drugs.
During the 1960s, the practice of pharmacy began growing and evolving. In response to an increasing number of patient injuries due to medication delivery and sterile compounding, the industry began calling attention to safety.
The United States Pharmacopeia (USP) drafted a revision of the general information chapter 1206, which was proposed as a guideline and detailed the procedures for preparing sterile drugs intended for home use. The FDA committee wanted an enforceable entity and, by changing chapter 1206 to chapter 797 and moving it into the General Tests and Assays portion of the USP, they established a legal base by which the FDA could determine whether a drug has been adulterated. The revision of the chapter ensures that medications are compounded accurately and appropriately, protecting patients from microbially contaminated preparations.
USP 797 enlists quality controls for technique, method, and validation, building quality and safety into the entire compounding process. CSPs must be accurately identified, measured, diluted, and mixed. They must then be appropriately purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. And all this must be accomplished in an environment that ensures less than 352,001 particles per cubic meter (0.5 μm or larger), called a cleanroom. To give perspective to this requirement, realize that ambient air outside in a typical urban environment might contain as many as 35,000,000 particles per cubic meter (0.5 μm or larger).
Upstate’s cleanroom meets this ISO7 requirement by having the air entering our cleanroom filtered to exclude dust. Then the air inside is constantly recirculated through high efficiency particulate air HEPA and ultra low penetration air filters to remove internally generated contaminants.
Static controls are maintained through sticky mats on entrance and exit, a controlled anti room in which special cleanroom garments must be put on, such as gloves, gowns, hoods, and shoe covers.
