Members-only Site   |   Print Page   |   Contact Us   |   Sign In   |   Register
Differences between Calif Hazardous Drug Regulations and USP 800 Standards
Share |

 

Hazardous Drug  Compounding


CA SBOP Regs

Non-Sterile

Sterile

USP<800> Standards

Non-Sterile

Sterile

Implementation date

January 1, 2017

X

X

Implementation date

July 1st, 2018

X

X

CPEC must be vented outside

X

X

CPEC with redundant hepa filters can be recirculated back into CSEC

X

 

Hazardous drug definition: All anti-neoplastic drugs as defined by the NIOSH list and any other chemical the PIC deems hazardous*.

X

X

All hazardous drugs are defined by what appears on the NIOSH HD list

X

X

“Personal protective equipment” (PPE) means clothing or devices that protect the employee from exposure to compounding ingredients and/or potential toxins and minimize the contamination of compounded preparations. These include shoe covers, head and facial hair covers, face masks, gowns, and gloves.

 

X

X

Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and nonsterile HDs.

Chemotherapy gloves must be powder-free.

Disposable PPE must not be re-used.

Gowns must be disposable and shown to resist permeability by HDs, Gowns must close in the back (i.e., no open front), be long sleeved, and have closed cuffs that are elastic or knit. Gowns must not have seams or closures. Gowns must be changed per the manufacturer's information for permeation of the gown. If no permeation information is available for the gowns used, change them every 2–3 hours or immediately after a spill or splash. Gowns worn in HD handling areas must not be worn to other areas.

 

A second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC.

 

Appropriate eye and face protection must be worn when there is a risk for spills or splashes of HDs or HD waste materials when working outside of a C-PEC.

Goggles must be used when eye protection is needed.

For all other activities, the entity's SOP must describe the appropriate PPE to be worn based on its occupational safety plan and assessment of risk (if used). The entity must develop SOPs for PPE based on the risk of exposure (see Types of Exposure) and activities performed

 

X

X

ISO Class 7 or better air quality is required for ante-areas providing air to a negative pressure room.

 

X

ISO Class 7 ante-room (preferred) or an unclassified containment segregated compounding area (C-SCA)

 

X

PEC Requirements:

Each PEC in the room shall be externally vented

 

X

 

CPEC Requirements:

Externally vented (preferred) or redundant–HEPA filtered in series

X

 

Where hazardous drugs are prepared, the exhaust air from the CPEC shall be appropriately removed by properly designed external building ventilation. This external venting should be dedicated to one BSC or CACI

 

 

X

ISO Class 7 buffer room with an ISO Class 7 ante-room

• Externally vented

• Examples: Class II BSC or

CACI

 

Unclassified C-SCA

• Externally vented

• Examples: Class II BSC or CACI

 

X

Sterile HD Gloving:

Unclear

 

X

When compounding sterile HDs the 2nd outer chemotherapy glove must be sterile.

 

X

All hazardous agents shall bear a special label which states “Chemotherapy -Dispose of Properly” or “Hazardous – Dispose of Properly.”

 

X

X

Labeling: HDs identified by the entity as requiring special HD handling precautions must be clearly labeled at all times during their transport.

X

X

Any pharmacy engaged in any hazardous drug compounding shall maintain written documentation regarding appropriate cleaning of facilities and equipment to prevent cross-contamination with non-hazardous drugs.

 

X

X

USP<800> Section 15: Deactivation, Decontamination, Clean

 

Sterile compounding adds Disinfecting

X

X

                                                           

 

 

 

 

Association Management Software Powered by YourMembership  ::  Legal