| (C) All convector or HVAC enclosures exposed in the
room shall be constructed with rounded corners and shall have enclosures
fastened with tamper-resistant fasteners.
(4) Plumbing fixtures and piping systems. Plumbing
fixtures and piping systems shall be in accordance with subsection
(t)(4) of this section.
(5) Electrical requirements. Electrical requirements
shall be in accordance with §133.162(d)(5) of this title and
this paragraph. The nurse call shall be in accordance with §133.162(d)(5)(L)
and Table 7 of §133.169(g) of this title.
(x) Pharmacy suite.
(1) Architectural requirements.
(A) General. The pharmacy room or suite shall be located
for convenient access, staff control, and security for drugs and personnel.
(B) Dispensing area. The pharmacy room or suite shall
include the following functional spaces and facilities:
(i) area(s) for pickup, receiving, reviewing and recording;
(ii) extemporaneous compounding area with sufficient
counter space for drug preparation and sink with hands-free operable
controls;
(iii) work counter space for automated and manual dispensing
activities;
(iv) storage or areas for temporary storage, exchange,
and restocking of carts; and
(v) security provisions for drugs and personnel in
the dispensing counter area.
(C) Manufacturing. The pharmacy room or suite shall
provide the following functional spaces and facilities for the manufacturing
area(s):
(i) bulk compounding area with work space and counters;
and
(ii) area(s) for packaging, labeling and quality control.
(D) Storage. The following spaces shall be provided
in cabinets, shelves, and/or separate rooms or closets:
(i) space for bulk storage, active storage, and refrigerated
storage;
(ii) storage in a fire safety cabinet or storage room
that is constructed under the requirements for protection from hazardous
areas in accordance with NFPA 101, Chapter 12, for alcohol or other
volatile fluids, when used;
(iii) storage in a secure vault, safe, or double locking
wall cabinet for narcotics and controlled drugs; and
(iv) storage space for general supplies and equipment
not in use.
(E) 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 TAC §291.26 (relating to Pharmacies
Compounding Sterile Pharmaceuticals) and the United States Pharmacopoeia,
Chapter 797, Pharmaceutical Compounding-Sterile Preparations.
(i) 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.
(ii) The preparation room shall contain a work counter,
gowning area and shelving.
(iii) 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.
(iv) Laminar-flow hoods/work stations shall be located
inside the hood room.
(F) 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.
(i) 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.
(ii) 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.
(iii) 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).
(G) Administrative area(s). The following functional
spaces and facilities shall be included for the administrative area(s):
(i) office area for the chief pharmacist and any other
offices areas required for records, reports, accounting activities,
and patients profiles;
(ii) poison control center with storage facilities
for reaction data and drug information centers; and
(iii) a room or area for counseling and instruction
when individual medication pick-up is available for inpatients or
outpatients.
(H) Satellite pharmacy facilities. When provided, the
room(s) shall include a work counter, a sink with hands-free operable
controls, storage facilities, and refrigerator for medications. As
applicable, items required in subparagraphs (B) and (C) of this paragraph
may be incorporated into the satellite pharmacy.
(I) Service areas and facilities. The following service
areas and facilities shall be provided.
(i) Hand washing facilities. A hand washing fixture
with hands-free operable controls shall be located in each room where
open medication is handled except for IV prepared chemo-hood rooms.
(ii) Staff facilities. Toilet rooms with hand washing
fixture with hands-free operable controls may be outside the suite
but shall be convenient for staff use.
(2) Details and finishes. Details and finishes shall
be in accordance with §133.162(d)(2) of this title and this paragraph.
(A) Flooring in the IV solutions area for the preparation
room, hood room and chemo-hood room shall be seamless and coved to
the wall.
(B) 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.
(C) All penetrations in the walls and ceilings shall
be sealed.
(D) 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 pharmacy.
(3) Mechanical Requirements. Mechanical requirements
shall be in accordance with §133.162(d)(3) of this title and
this paragraph.
(A) When IV solutions are prepared, the required laminar-flow
system shall include a nonhygroscopic filter rated at 99.97% (HEPA).
A pressure gauge shall be installed for detection of filter leaks
or defects.
(B) When fume hoods are used for chemotherapy, 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.
(C) When fume hoods are used, the design should consider
the placement and types of air distribution devices to avoid the disturbance
of a uniform velocity across the face of the hood.
(D) All air entering the IV solutions area for the
preparation room, hood room and chemo-hood room shall be HEPA filtered.
(E) 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.
(4) Piping systems and plumbing fixtures. Piping systems
and plumbing fixtures shall be in accordance with §133.162(d)(4)
of this title and this paragraph.
(A) Material used for plumbing fixtures shall be nonabsorptive
and acid-resistant.
(B) Water spouts used at lavatories and sinks shall
have clearances adequate to avoid contaminating utensils and the contents
of carafes, etc.
(5) Electrical requirements. Electrical requirements
shall be in accordance with §133.162(d)(5) of this title and
this paragraph.
(A) Under-counter receptacles and conduits shall be
arranged (raised) to not interfere with cleaning of the floor below
or of the equipment.
(B) Exhaust hoods shall have an indicator light indicating
that the exhaust fan is in operation.
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