Cal. Code Regs. Tit. 16, § 1751 - Sterile Compounding; Compounding Area; Self-Assessment

(a) Any pharmacy engaged in compounding sterile drug preparations shall conform to the parameters and requirements stated by Article 4.5 (Section 1735 et seq.), applicable to all compounding, and shall also conform to the parameters and requirements stated by this Article 7 (Section 1751 et seq.), applicable solely to sterile compounding.

(b) Any pharmacy compounding sterile drug preparations shall have a compounding area designated for the preparation of sterile drug preparations that is in a restricted location where traffic has no impact on the performance of the PEC(s). The cleanroom, including the walls, ceilings, and floors, shall be constructed in accordance with Section 1250.4 of Title 24, Part 2, Chapter 12, of the California Code of Regulations. The pharmacy shall be ventilated in a manner in accordance with Section 505.7 of Title 24, Part 4, Chapter 5 of the California Code of Regulations. The environments within the pharmacy shall meet the following standards:

(1) Each ISO environment shall be certified at least every six months by a qualified technician in accordance with Section 1751.4. Certification records must be retained in the pharmacy.

(2) Items related to the compounding of sterile drug preparations within the compounding area shall be stored in such a way as to maintain the integrity of an aseptic environment.

(3) A sink shall be included in accordance with Section 1250.4 of Title 24, Part 2, Chapter 12, of the California Code of Regulations. Sinks and drains shall not be present in any ISO Class 7 or better cleanroom, nor in a segregated sterile compounding area within three feet of an ISO Class 5 or better PEC, with the exception of emergency eye-rinsing stations. A sink may be located in an ante-area. When the PEC in the segregated sterile compounding area is a CAI or CACI and the documentation provided by the manufacturer shows it meets the requirements listed in 1751.4(f)(1)-(3) the sterile compounding area is exempt from the room requirement listed in 1751(b)(3).

(4) There shall be a refrigerator and, where appropriate, a freezer, of sufficient capacity to meet the storage requirements for all material requiring refrigeration or freezing, and a backup plan to ensure continuity of available compounded drug preparations in the event of a power outage.

Notes

Cal. Code Regs. Tit. 16, § 1751

1. New Article 8 (Sections 1751-1751.9) filed 10-6-86; effective thirtieth day thereafter (Register 86, No. 42). For history of former Article 8, see Register 85, No. 8.
2. Change without regulatory effect adding article 7 heading and amending NOTE filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
3. Amendment of article heading, section heading and section filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Amendment of section heading, section and NOTE filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading, subsection (b) and NOTE filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).
6. Amendment of article heading, section heading and section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).
7. Change without regulatory effect amending subsection (b) filed 3-20-2017 pursuant to section 100, title 1, California Code of Regulations (Register 2017, No. 12).

Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code; and Section 18944, Health and Safety Code.

1. New Article 8 (Sections 1751-1751.9) filed 10-6-86; effective thirtieth day thereafter (Register 86, No. 42). For history of former Article 8, see Register 85, No. 8.
2. Change without regulatory effect adding article 7 heading and amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
3. Amendment of article heading, section heading and section filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Amendment of section heading, section and Note filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading, subsection (b) and Note filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).
6. Amendment of article heading, section heading and section filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).
7. Change without regulatory effect amending subsection (b) filed 3-20-2017 pursuant to section 100, title 1, California Code of Regulations (Register 2017, No. 12).