Members-only Site   |   Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Breaking News

California and New Jersey State Board of Pharmacy Updates

Thursday, December 14, 2017   (0 Comments)
Posted by: IACP
Share |

 
   
   
   
 
California State Board of Pharmacy Issues Emergency Rules Addressing Beyond Use Dating and Non-sterile Compound Drug Preparations
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
 
New Jersey Board of Pharmacy Votes at Board Meeting to Delay USP Chapter <800> Implementation Until December 2019

 
The New Jersey Board of Pharmacy voted at its Board Meeting yesterday to delay implementation of USP Chapter <800> until December 2019. The Board had planned to implement the original effective date of July 2018 - despite USP's delay of 800.Please click here to view the Agenda.Please view IACP's Member Alert on this Board Meeting here.

IACP Members: Thank you to all who attended this public meeting. We greatly appreciate your participation!

Office-use Compoundingalso was on the NJ Board of Pharmacy meeting agenda. Please click here to read more about a letter IACP recently sent to all State Boards of Pharmacy and Medicine regarding patients' need for office use and access to compounded medications.The letter expressed continued concern regarding the Food & Drug Administration's (FDA)implementation of the Drug Quality & Security Act (DQSA) without following Congressional intent. The letter also emphasized that FDA's actions consequently are affecting patient access to compounded medications, and causing mass confusion for the States, providers, patients, and pharmacists.

IACP will continue to keep you aware of developments as they occur.Please email IACP at iacpinfo@iacprx.org with any questions.

Thank you for being an IACP Member and for standing up for your patients!
 

 
IACP's Compounders Stateside is amembers-only,one-stop resource for state tracking, including legislative and regulatory updates, and State Boards of Pharmacy updates.

Need to know the latest happenings in your State? IACP has the information for you! This is vital information for your practice to ensure you're operating within your state guidelines. Check this resource regularly for the latest information for your pharmacy.


 

 
 
 

Association Management Software Powered by YourMembership  ::  Legal