|California Non-Sterile and Sterile Compounding Regulations Effective January 1, 2017|
IACP California Member Alert
New California State Board of Pharmacy (CA SBOP) Non-Sterile and Sterile Compounding Regulations effective January 1, 2017 - SUBMIT QUESTIONS NOW!
The CA SBOP has implemented new regulations for non-sterile and sterile compounding which include compounding of hazardous drugs. We strongly urge you to download the regulations and read the document completely to become compliant by 1/1/2017.
PLEASE NOTE: these regulations have significant differences from USP <800>. The Board has not adopted USP <800> in its entirety but have implemented their own requirements for the handling and compounding of hazardous drugs. To find out more about these regulations, please refer to the following items and pages in the regulations linked above:
- Definition of “hazardous” – page 4
o Download a copy of the current National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs
- Labeling of hazardous drugs – page 13
- Policy & Procedures for compounding of hazardous drugs – page 15
- Compounding Facilities & Equipment for hazardous drugs – page 16
- Sterile Compounding Labeling Requirements – page 21
- Sterile Compounding Policy & Procedures – page 23
- Facility and Equipment Standards for Sterile Compounding – page 26
- Sterile Compounding Attire – page 28
- Sterile Compounding Consultation; Training of Sterile Compounding Staff – page 29
In addition, there is a waiver process that the SBOP has included in the regulations for pharmacies to apply for if they are unable to complete implementation by the effective date. The SBOP will be providing additional information about this process once it is finalized.
FOR REFERENCE: Please click here to view the Differences between California Hazardous Drug Regulations and USP <800> Standards.
We highly encourage you to submit questions on how to implement these regulations to the CA SBOP Inspector hotline below.
- Email: email@example.com - if sending an email, include your name, organization, contact phone number and best time to contact you.
- Fax: (916) 574-8618
- Phone: (916) 574-7900 (Tuesday and Thursday from 8:00 a.m. – 4:30 p.m.)
International Academy of Compounding Pharmacists
4638 Riverstone Blvd.
Tell us how compounded pharmaceuticals have helped you, someone you know, or how you have helped someone as a practicing compounding pharmacist. Help us protect your continued access to pharmacy compounding!
Share the P3 community and the value and necessity of personalized prescriptions with your friends.