Texas Department of State Health Services Pharmacy §133.163(x)

Objectives ● “797 Rule” Spatial Requirements for Pharmacy ● Chapter 22 of Texas Administrative Code, §291.26 (relating to Pharmacies Compounding Sterile Pharmaceuticals). ● The United States Pharmacopoeia, Chapter 797, Pharmaceutical Compounding-Sterile Preparations. (January 1, 2004) ● Questions ???

Review of the New Hospital Spatial Req. - Pharmacy Pharmacy suite - §133.163(x) (New) Intravenous (IV) solutions area. When IV solutions are prepared in a pharmacy, a sterile work area shall be provided and be in compliance with 22 Texas Administrative Code, §291.26 (relating to Pharmacies Compounding Sterile Pharmaceuticals) and the United States Pharmacopoeia, Chapter 797, Pharmaceutical Compounding-Sterile Preparations. The IV work area shall consist of a preparation room, hood room and, if provided, a separate chemo-hood room. Access to the preparation room shall be through the pharmacy only, access to the hood room or chemo-hood room shall be through the preparation room only.

Review of the New Hospital Spatial Req. - Pharmacy Pharmacy suite (Cont) The preparation room shall contain a work counter, gowning area and shelving. A hand washing fixture with hands-free operable controls shall be in the preparation room and within five feet of each entrance to the hood room or chemo-hood room. Hand washing fixtures and floor drains are not allowed inside the hood room or chemo-hood room. Laminar-flow hoods/work stations shall be located inside the hood room.

Review of the New Hospital Spatial Req. - Pharmacy Pharmacy suite (cont.) Compounding aseptic isolator (CAI). When a CAI is used for compounding, in lieu of the IV solutions area, it may be done within the pharmacy provided it complies with the following. The CAI shall provide isolation from the room and maintain the International Organization for Standardization (ISO) Class 5 (100 particles greater than or equal to 0.5 microns per cubic foot) levels during dynamic operating conditions including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations.

Review of the New Hospital Spatial Req. - Pharmacy Pharmacy suite (cont.) The particle counts sampled shall be 6 to 12 inches upstream of the critical exposure site within the CAI and maintain ISO Class 5 levels during compounding operations. The facility shall obtain documentation from the manufacturer that the CAI will meet this standard when located in worse than ISO Class 7 (10,000 particles greater than or equal to 0.5 microns per cubic foot environments. The door from hood room shall swing into the preparation room. The door from preparation room shall swing into the chemo room. The door from preparation room shall swing into the pharmacy.

Review of the New Hospital Spatial Req. - Pharmacy Pharmacy suite (cont.) When fume hoods are used for Chemo, the air/fumes shall be exhausted directly to the exterior. The hood exhaust shall not use the building exhaust system. When more than one fume hood is in the same hood room and the work stations face each other, at least six feet must separate work area openings. In the IV solutions area the air pressure in the preparation room shall be positive to the pharmacy, the hood room shall be positive to the preparation room and the chemo-hood room shall be negative to the preparation room.

Review of the New Hospital Spatial Req. - Pharmacy Pharmacy suite (cont.) Flooring in the IV solutions area for the preparation room, hood room and chemo-hood room shall be seamless and coved to the wall. IV solutions area ceiling and wall finishes for the preparation room, hood room and chemo-hood room shall be interlocking monolithic panels and sealed together or monolithic epoxy-painted gypsum board. The ceiling shall be coved to the wall. All penetrations in the walls and ceilings shall be sealed.

Hospital Licensing Rules Title 25 TAC - Chapter 133 Pharmacy