Okla. Admin. Code § 535:15-10-55

Current through Vol. 42, No. 8, January 2, 2025

Section 535:15-10-55 - Drug compounding facilities

(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.

Okla. Admin. Code § 535:15-10-55

Added at 26 Ok Reg 2276, eff 7-1-09

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021

Amended by Oklahoma Register, Volume 39, Issue 24, September 1, 2022, eff. 9/11/2022

Amended by Oklahoma Register, Volume 40, Issue 22, August 1, 2023, eff. 9/1/2023