Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES
- Section 13:39-11.1 - Purpose and scope
- Section 13:39-11.2 - Definitions
- Section 13:39-11.3 - Application and pre-approval requirements for compounding sterile preparations
- Section 13:39-11.4 - Cleanroom: use, access, location; temperature; air pressure
- Section 13:39-11.5 - Cleanroom requirements
- Section 13:39-11.6 - Ante area requirements
- Section 13:39-11.7 - Buffer area requirements
- Section 13:39-11.8 - Use of compounding aseptic isolators and compounding aseptic containment isolators located outside of a cleanroom
- Section 13:39-11.9 - Compounding of antineoplastic agents and other hazardous substances (Repealed)
- Section 13:39-11.10 - Institutional pharmacy use of airflow workbenches not in a buffer area for low-risk level compounded sterile preparations
- Section 13:39-11.11 - Compounding immediate use compounded sterile preparations in an institutional pharmacy
- Section 13:39-11.12 - Pharmacist-in-charge responsibilities
- Section 13:39-11.13 - Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision
- Section 13:39-11.14 - Personnel cleansing and garbing requirements
- Section 13:39-11.15 - Cleaning and disinfection requirements for cleanroom, buffer area, and ante area
- Section 13:39-11.16 - Training and evaluation requirements
- Section 13:39-11.17 - Batch preparation
- Section 13:39-11.18 - Compounded sterile preparations for prescriber practice use
- Section 13:39-11.19 - Stability and sterility criteria and beyond-use dating
- Section 13:39-11.20 - Documentation; audit trail
- Section 13:39-11.21 - Information required to appear on prescription label
- Section 13:39-11.22 - Handling, packaging, and delivery
- Section 13:39-11.23 - Policy and procedures manual
- Section 13:39-11.24 - Quality assurance program
- Section 13:39-11.25 - Prohibited compounding
- Section 13:39-11.26 - Security
- Section 13:39-11.27 - Reserved