CHA News Article

Member Feedback Requested on Proposed Sterile Compounding Regulations
CHA will host informational call tomorrow

The California State Board of Pharmacy has produced a new draft of proposed regulations for pharmacies that compound or compound sterile preparations. The changes will be considered by the board for release for a 45-day comment period during its July 30 meeting. Many of the proposed regulations affect facility and equipment standards for sterile compounding such as ventilation, negative pressure and ante rooms. It is especially important for small, rural and critical access hospitals to review the proposed regulations. In the interest of developing the best regulations, the Board of Pharmacy has granted CHA an opportunity to submit feedback on physical plant modifications by July 9.

CHA Medication Safety Committee leaders — and others who worked together to compose extensive comments to the board’s original language in January — are analyzing the new regulations and drafting comments. In addition, CHA will host an all-member call tomorrow, July 8, offering interested hospitals an opportunity to gather information and discuss CHA’s comments on the proposed changes.

CHA encourages all members to compare the proposed physical and plant structural changes to current compounding facility and equipment standards and submit comments to CHA on the attached proposed worksheet and/or participate in the July 8 call:

Tuesday, July 8
4 p.m. – 5 p.m.
(800) 882-3610, Passcode 5968133#

Attached are CHA’s Jan. 10 comment letter, the Board of Pharmacy proposed language and a worksheet for submitting comments.