New Jersey Administrative Code
Title 13 - LAW AND PUBLIC SAFETY
Chapter 39 - STATE BOARD OF PHARMACY
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- Section 13:39-11.9 - Compounding of antineoplastic agents and other hazardous substances (Repealed)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
Disclaimer: These regulations may not be the most recent version. New Jersey may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
