Texas Department of

State Health Services

Pharmacy

133.163(x)
Objectives
Chapter 22 of Texas Administrative Code,
291.26 (relating to Pharmacies Compounding
Sterile Pharmaceuticals).
797 Rule Spatial Requirements for Pharmacy
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