The
California State Board of Pharmacy
has issued emergency rules addressing beyond use dating and non-sterile compound drug preparations
. The Board finds that there is a significant adverse impact to patients related to the current requirements for establishing beyond use dates (BUDs) for non-sterile compounded drug preparations. "Each day that the board's existing regulations are in place, there is a significant risk that patients will be deprived access to needed medications. In addition, the board finds that it is necessary to clarify the requirements to extend the BUDs for sterile compounded drug preparations in order to allow for the BUDs of non-sterile to be emended."
This regulation will revise and specify new requirements for a pharmacist establishing beyond use dates (BUDs) for non-sterile compounded drug preparations. In addition, it clarifies that an existing provision that permits extending the BUD will only apply to sterile compounded drug preparations.
Thank You, California Pharmacists Association
The
International Academy of Compounding Pharmacists (IACP)
worked with the
California Pharmacists Association
last summer to address this important issue affecting patients. IACP applauds the California Pharmacists Association for their leadership role on this vital patient issue. IACP also recently worked with the California Pharmacists Association to submit comments on beyond use dating and sterile compound drug preparations.
California - Compounded Drug Preparations
Citation: 16 CCR Section 1735.2
Emergency Rulemaking
Agency Adopted
Summary:
The Board of Pharmacy has issued emergency rules addressing beyond use dating and compound drug preparations. The board finds that there is a significant adverse impact to patients related to the current requirements for establishing beyond use dates (BUDs) for non-sterile compounded drug preparations. Each day that the board's existing regulations are in place, there is a significant risk that patients will be deprived access to needed medications. In addition, the board finds that it is necessary to clarify the requirements to extend the BUDs for sterile compounded drug preparations in order to allow for the BUDs of non-sterile to be emended.
This regulation will revise and specify new requirements for a pharmacist establishing beyond use dates (BUDs) for non-sterile compounded drug preparations. In addition, it clarifies that an existing provision that permits extending the BUD will only apply to sterile compounded drug preparations.
History:
Emergency Regulation Review deadline 12/21/17
Emergency Regulation filed on 12/11/17
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