Texas Department of State Health Services

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Texas Department of State Health Services

• Pharmacy

133.163(x)
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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 ???
3
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.

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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.

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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.

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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.

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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.

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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.

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Hospital Licensing RulesTitle 25 TAC - Chapter
133
Pharmacy