Results of the Board’s Implementation and Inspections of California Sterile Compounding Facilities : 137 violations found in 58 pharmacies!!

. FOR INFORMATION:  Results of the Board’s Implementation and Inspections of
California Sterile Compounding Facilities
Attachment 13
Presentation at the Committee Meeting
During the meeting,  Dr. Ratcliff highlighted the top ten violations found during
compounding inspections which included lack of compounding self‐assessment, quality
assurance issues, facility issues, adequate compounding attire, general compounding quality
assurance issues, process validations issues, insufficient or nonexistent policies and
procedures, substandard equipment used, and lack of training.
Attachment 13 includes the data found as a result of compounding inspections in California
and Out‐of‐State Facilities.
c. FOR INFORMATION:  Data on Violations Found During Out‐of‐State Compounding
Inspections
d. FOR INFORMATION:  Recalls of Compounded Drugs Throughout the United States
Attachment 14
Between November 8, 2013 and September 11, 2014, the board posted seven subscriber
alerts related to compounding drug recalls.  
Attachment 14 includes copies of the subscriber alerts.
During the meeting, the committee reviewed the attachments and Dr. Gutierrez noted that
there was still quite a bit of recalls going on

Attachment 13

Inspection Findings
(6/26/14 – 9/5/14)
140 Sterile Compounding Inspections
66 Hospital/LSC
63 Annual/new inspections of current
licensed sterile compounders
11 Non‐resident Inspections
________________________________________
137 violations were found in 58 of these
pharmacies

Inspection Outcomes
(6/27/14 – 9/5/14)
137 non‐compliance issues were recorded
in 57 pharmacies
Violations
Hospital/LSC (28) 55 40.1%
PHY/LSC (21) 48 35.0%
NRP/NSC (8) 34 24.8%
Top Violations in HSP/LSC (N=55)
(6/26/14 – 9/5/14)
 Compounding records incomplete 13 23.6%
 Ceiling, walls, surfaces not disinfected weekly 11 20.0%
 Compounding self‐assessment not completed 4 7.3%

Top Violations in PHY/LSC (N=48)
(6/26/14 – 9/5/14)
 Master formula incomplete 4 33.3%
 Ceiling, walls, surfaces not disinfected weekly 3 25.0%
 Compounding self‐assessment not completed 3 25.0%
Top Violations in NRP/NSC (N=34)
(6/26/14 – 9/5/14)
 Compounding self‐assessment not completed 6 17.6%
 Ceiling, walls, surfaces not disinfected weekly 3 8.8%
 P&P’s not reviewed annually by PIC 3 8.8%

Inspections to be Completed
(9/1/14 – 12/31/14)
In CA
9/1/14 expiration = 46 (completed)
10/1/14 expiration = 43
11/1/14 expiration = 273
12/1/14 expiration = 49
Non‐resident
9/1/14 expiration = 11 (completed)
10/1/14 expiration = 7 (scheduled)
11/1/14 expiration = 10
12/1/14 expiration = 7

quoted from here