1. (a) A facility shall maintain and follow written SOPs for all situations in which HDs are compounded or crushing or splitting tablets or opening capsules of antineoplastic HDs is performed.

2. (b) A facility where compounding of HDs is performed or where crushing or splitting tablets or opening capsules of antineoplastic HDs is performed shall have SOPs that include at least the following:

   1. (1) Hazard communication program
   2. (2) Occupational safety program
   3. (3) Designation of HD areas, if compounding
   4. (4) Receipt, if compounding
   5. (5) Storage, if compounding
   6. (6) Compounding, if applicable
   7. (7) Use and maintenance of proper engineering controls (e.g., C-PECs, C-SECs, and CSTDs), if applicable
   8. (8) Hand hygiene and use of PPE based on activity (e.g., receipt, transport, compounding, manipulation, administration, spill, and disposal), as applicable
   9. (9) Deactivation, decontamination, cleaning, and disinfection
   10. (10) Dispensing, if applicable
   11. (11) Transport, if compounding
   12. (12) Administering, if applicable
   13. (13) Environmental monitoring (e.g., wipe sampling), if compounding
   14. (14) Disposal, if compounding
   15. (15) Spill control, if compounding
   16. (16) Medical surveillance, if compounding
3. (c) The pharmacist-in-charge, professional director of a clinic, or designated representative-in-charge, as applicable, shall work with the facility's designated person to ensure SOPs are reviewed at least every 12 months and this review is documented. Documentation of compliance with the subdivision shall be maintained for three years.
4. (d) SOPs shall be updated whenever changes are implemented. Such changes shall be disseminated in a written format to the staff responsible for HDs prior to implementation. All notifications of such changes and the changes shall be documented in SOPs and training documents.
5. (e) Failure to follow written SOPs constitutes a basis for enforcement action.

In addition to the standards in USP Chapter 800, the following requirements apply to the compounding of HDs or where crushing or splitting tablets or opening capsules of antineoplastic HDs is performed.

Note: Authority cited: Sections 4005, 4126.8 and 4127, Business and Professions Code. Reference: Sections 4005 and 4126.8, Business and Professions Code.

History

1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).