CHA News Article

CHA Comments on Proposed Changes to Compounding Regulations

CHA has submitted the attached comment letter to the California Board of Pharmacy in response to its Notice of Proposed Action regarding compounding regulations. The regulations were published after the enactment of SB 294, signed last year, to increase regulatory standards across all compounding pharmacies within and outside the state. SB 294 defines sterile compounding as compounding drug products for injection, inhalation or administration in the eyes – a broadening of current law, which focuses on compounding sterile injectable products only. Under SB 294, all pharmacies that compound sterile drug products, even if previously accredited, must now obtain an additional license from the Board. 

The Board will hold a public hearing on Jan. 16 at 10:30 a.m. in Sacramento, offering an opportunity for individuals and organizations to provide oral testimony if they did not submit written comments by the Jan. 13 deadline, or to provide additional information beyond what was provided in their written submission. However, due to rules governing the rulemaking process, no discussion will take place at the hearing. Participants may present comments, but the Board’s representative and staff will not respond to questions. All discussion, including questions for the Board, will take place at the Board’s Jan. 29-30 meeting.

CHA would like to express its thanks to members of the Medication Safety Committee for their focused work on critically necessary amendments to these regulations.

 

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