1250.4 Compounding area for parenteral solutions

The pharmacy shall have a designated area for the preparation of sterile products for dispensing which shall:

1. In accordance with Federal Standard 209 (b), Clean Room and Work Station Requirements, Controlled Environment as approved by the Commission, Federal Supply Service, General Service Administration meet standards for Class 100 HEPA (high efficiency particulate air) filtered air such as laminar airflow hood or clean room.
2. Have nonporous and cleanable surfaces, ceilings and ceiling tiles, walls, floors and floor coverings.

3. The pharmacy shall be arranged in such a manner that the laminar-flow hood is located in an area which is exposed to minimal traffic flow, and is separate from any area used for bulk storage of items not related to the compounding of parenteral solutions.

   There shall be sufficient space, well separated from the laminar-flow hood area for the storage of bulk materials, equipment and waste materials.

4. A sink with hot and cold running water must be within the parenteral solution compounding area or adjacent to it.

5. Any pharmacy that compounds sterile injectable products from one or more nonsterile ingredients must compound the medication in one of the following environments:

   1. 5.1 An ISO class 5 laminar airflow hood within an ISO class 7 cleanroom. The cleanroom must have a positive air pressure differential relative adjacent areas.
   2. 5.2 An ISO class 5 cleanroom.

   3. 5.3 A barrier isolator that provides an ISO class 5 environment for compounding.

      Note: For additional pharmacy mechanical standard requirements, see Chapter 5, California Mechanical Code.