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CHAPTER 20:51:31

 

STERILE COMPOUNDING PRACTICES

Section

20:51:31:01        Definitions.

20:51:31:02        Standards and procedures.

20:51:31:03        Manual required.

20:51:31:04        Physical environment requirements for sterile products.

20:51:31:05        Requirement for primary engineering control device or room.

20:51:31:06        Placement of primary engineering control device.

20:51:31:07        Compounding aseptic isolator (CAI).

20:51:31:08        Exception for placement of CAI.

20:51:31:09        Ante area requirements.

20:51:31:10        Delayed implementation.

20:51:31:11        Cleaning, maintenance, and supplies.

20:51:31:12        Additional records required.

20:51:31:13        Quality assurance.

20:51:31:14        Pharmacist responsibilities.

20:51:31:15        Training documentation.

20:51:31:16        Reference requirements.

20:51:31:17        Labeling requirements.

20:51:31:18        Microbial contamination risk levels.

20:51:31:19        Low-risk preparations.

20:51:31:20        Medium-risk preparations.

20:51:31:21        High-risk preparations.

20:51:31:22        Immediate-use preparations.

20:51:31:23        Utilization of single-dose and multiple-dose containers.

20:51:31:24        Utilization of proprietary bag and vial systems.

20:51:31:25        Sterilization methods.

20:51:31:26        Media-fill testing by personnel.

20:51:31:27        Environmental monitoring requirements.

20:51:31:28        Storage and delivery of sterile preparations.

20:51:31:29        Additional requirements for preparation of hazardous drugs.

20:51:31:30        Responsibilities for patient care.

20:51:31:31        Patient or caregiver education and training.


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