Subchapter 11 - COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL PHARMACIES

  1. § 13:39-11.1 - Purpose and scope
  2. § 13:39-11.2 - Definitions
  3. § 13:39-11.3 - Application and pre-approval requirements for compounding sterile preparations
  4. § 13:39-11.4 - Cleanroom: use, access, location; temperature; air pressure
  5. § 13:39-11.5 - Cleanroom requirements
  6. § 13:39-11.6 - Ante area requirements
  7. § 13:39-11.7 - Buffer area requirements
  8. § 13:39-11.8 - Use of compounding aseptic isolators and compounding aseptic containment isolators located outside of a cleanroom
  9. § 13:39-11.9 - Compounding of antineoplastic agents and other hazardous substances (Repealed)
  10. § 13:39-11.10 - Institutional pharmacy use of airflow workbenches not in a buffer area for low-risk level compounded sterile preparations
  11. § 13:39-11.11 - Compounding immediate use compounded sterile preparations in an institutional pharmacy
  12. § 13:39-11.12 - Pharmacist-in-charge responsibilities
  13. § 13:39-11.13 - Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision
  14. § 13:39-11.14 - Personnel cleansing and garbing requirements
  15. § 13:39-11.15 - Cleaning and disinfection requirements for cleanroom, buffer area, and ante area
  16. § 13:39-11.16 - Training and evaluation requirements
  17. § 13:39-11.17 - Batch preparation
  18. § 13:39-11.18 - Compounded sterile preparations for prescriber practice use
  19. § 13:39-11.19 - Stability and sterility criteria and beyond-use dating
  20. § 13:39-11.20 - Documentation; audit trail
  21. § 13:39-11.21 - Information required to appear on prescription label
  22. § 13:39-11.22 - Handling, packaging, and delivery
  23. § 13:39-11.23 - Policy and procedures manual
  24. § 13:39-11.24 - Quality assurance program
  25. § 13:39-11.25 - Prohibited compounding
  26. § 13:39-11.26 - Security
  27. § 13:39-11.27 - Reserved

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