Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-55 - Drug compounding facilities

Current through Vol. 41, No. 20, July 1, 2024
(a) Pharmacies
				  engaging in compounding shall have a specifically designated and adequate space
				  for the orderly compounding of prescriptions, including the placement and
				  storage of equipment and materials.
(b) The aseptic processing for sterile
				  preparations shall be in an area separate and distinct from the area used for
				  the compounding of non-sterile drug preparations. A primary engineering control
				  (PEC), (laminar airflow workbench (LAFW), biological safety cabinet (BSC),
				  compounding aseptic isolator (CAI) or compounding aseptic containment isolator
				  (CACI)) will be used to prepare all sterile preparations, except those
				  compounded for Immediate Use.
(c)
				  The area(s) used for the compounding of drugs shall be maintained in a good
				  state of repair. These area(s) shall also be maintained in a clean and sanitary
				  condition. Adequate washing facilities are to be provided and sewage, trash and
				  other refuse in the compounding area is to be disposed of in a safe, sanitary,
				  and timely manner.
(d) Bulk drugs
				  and other chemicals or materials used in the compounding of drugs must be
				  stored as directed by the manufacturer, in a clean, dry area under appropriate
				  temperature conditions (controlled room temperature, refrigerator, or freezer
				  in adequately labeled containers.) Bulk drugs shall also be stored such that
				  they are protected from contamination.
(e) Adequate lighting and ventilation shall
				  be provided in all compounding areas.
(f) Potable water shall be supplied under
				  continuous positive pressure in a plumbing system free of defects that could
				  contribute contamination to any compounded drug preparation.
(g) Work area and equipment. Any pharmacy
				  dispensing compounded sterile preparations shall meet or exceed the following
				  requirements:
(1) A transition area from the
				  general pharmacy (also called ante area or ante room) shall have a certified
				  and inspected ISO Class 8 or better area which may contain a sink. All
				  personnel hand hygiene and garbing procedures, staging of components, order
				  entry, CSP labeling, and other high-particulate-generating activities are
				  performed in the ante area. Drugs and other materials, taken into the
				  transition area shall be removed from corrugated cardboard and other
				  particle-generating materials before being taken into the area.
(2) A separate controlled limited access area
				  (also called a buffer area or buffer room) shall have a certified and inspected
				  ISO Class 7 or better environment for compounding sterile solutions. The buffer
				  room shall be of adequate space. Cleanliness of the area is of critical
				  importance.
(3) A separate
				  controlled limited access area (also called a buffer area or buffer room) for
				  compounding sterile solutions, which shall be of adequate space for
				  compounding, labeling, dispensing, and sterile preparation of the medication.
				  This area shall have controlled temperature. Cleanliness of the area is of
				  critical importance. Drugs and other materials, taken into the limited access
				  area, shall be removed from cardboard and other particle generating materials
				  before being taken into the area.
(4) The controlled limited access area shall
				  have a certified and inspected ISO Class 5 environment. Such an environment
				  exists inside a certified laminar airflow hood (clean room, biological safety
				  cabinet or other barrier isolator meeting ISO Class 5 requirements) used for
				  the preparation of all compounded sterile products. The ISO Class 5 environment
				  device or area is to be inspected and certified semiannually. Barrier isolator
				  workstations are closed systems and are not as sensitive to their external
				  environment as laminar airflow equipment. It is recommended to place them in a
				  limited access area with cleaning and sanitizing in the surrounding area on a
				  routine basis.
(5) A pressure gauge
				  or velocity meter shall be installed to monitor the pressure differential or
				  airflow between the clean room and the general environment outside the
				  compounding area. The results shall be reviewed and documented on a log at
				  least every work shift (minimum frequency shall be at least daily) or by a
				  continuous recording device. The pressure between the ISO Class 7 and the
				  general pharmacy area shall not be less than 5 Pa (0.02 inch water column). In
				  facilities where low and medium risk level CSPs are prepared, differential
				  airflow shall maintain a minimum velocity of 0.2 meters per second (40 feet per
				  minute) between buffer area and ante-area.
(6) Hazardous drugs shall be prepared within
				  a certified Class II, Type A (exhaust may be discharged to the outdoors) or
				  Class II, Type B (exhaust may be discharged to the outdoors) laminar flow
				  biological safety cabinet. Hazardous drug compounding shall have negative
				  pressure to adjacent positive pressure ISO Class 7 or better ante-areas, thus
				  providing inward airflow to contain any airborne drug. All vented cabinets
				  shall be vented through HEPA filtration, preferably to outside air or through
				  use of suitable technology or equipment. Ventilation exhaust shall be placed as
				  not to reenter the facility at any point.
(7) The area shall be designed to avoid
				  excessive traffic and airflow disturbances.
(8) The area shall be ventilated in a manner
				  not interfering with laminar flow hood conditions.
(9) PECs should be left on continuously. If a
				  PEC has been turned off, allow the blowers to run continuously for at least 30
				  minutes before using.
(10) Daily
				  procedures must be established for cleaning the compounding area. The pharmacy
				  must keep cleaning logs consistent with the minimum cleaning frequency. Logs
				  shall be kept for 2 years.
(11)
				  Minimum frequency of cleaning and disinfecting compounding areas are listed
				  below:
(A) ISO Class 5 [Primary Engineering
				  Control (e.g., LAFW, BSC, CAI, CACI)] shall be cleaned and disinfected at the
				  beginning of each shift, before each batch, not longer than 30 minutes
				  following the previous surface disinfection when ongoing compounding activities
				  occur, after spills, and when surface contamination is known or
				  suspected.
(B) Counters and easily
				  cleanable work surfaces shall be cleaned and disinfected daily.
(C) Floors shall be cleaned and disinfected
				  daily.
(D) Walls shall be cleaned
				  and disinfected monthly.
(E)
				  Ceilings shall be cleaned and disinfected monthly.
(F) Storage shelving shall be cleaned and
				  disinfected monthly.