On June 19, the Board of Pharmacy (Board) received notification from the Office of Administrative Law (OAL) that the Board's compounding regulation changes were approved. The Notice of Approval provides that the new regulations will become effective on October 1. 

As required by law, the Board conducted a comprehensive review of its compounding regulations and identified necessary changes after United States Pharmacopoeia (USP) General Chapters became compendial. These efforts resulted in the Board voting, as part of its April 2023 Board meeting, to promulgate new regulations. Since that time, and after five formal comment periods, a regulation hearing and extensive review and discussion over the course of multiple public meetings, the Board completed the formal rulemaking process. With the recent approval by the OAL of the updated compounding regulations promulgated by the Board, the Board wishes to update its stakeholders on its policy related to licensees transitioning to the updated USP General Chapters and updated regulations. 

During this intervening period, the Board encourages licensees to continue transitioning to the new standards established in USP and to take steps to establish compliance with the Board's updated regulations.

Source: View the policy statement. Revised July 28.  

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

Medi-Cal Rx shared the following information for pharmacy providers. The US Food and Drug Administration has asked the four companies that have teriparatide products (FOREO by Lilly and generics by Prasco, Teva, and Apotex) to change the package size on the label of the products. Changing package size will affect claims billing while labels with both package sizes are in distribution. Note, the product NDCs were not changed to account for the change in package size. However, the reimbursement rate was updated to account for the reduction in package size from 2.4 ml to 2.24 ml.  

The Department of Health Care Services would also like to request pharmacy providers update their POS systems to allow these claims to be submitted for 2.24 ml as this change took effect on March 29. Medi-Cal Rx also asks pharmacy providers to submit claims for 2.24 ml regardless of the package size displayed on the package. This will prevent overpayment. If the pharmacy POS system does not allow the claim to be submitted for 2.24 ml, please resubmit the claim and call Medi-Cal Rx Customer Service Center for assistance.  

Also in California, the Department of Health Care Service posted the following alerts on the Medi-Cal Rx Web Portal: 

• Claim Submission Reminders 

• Now Active: NCPDP Field 426-DQ Usual and Customary Charge Requirement 

Finally in California, the Board of Pharmacy issued the following: NOTICE OF DECISION NOT TO PROCEED - Pursuant to Government Code section 11347 

Re: Notice of Proposed Rulemaking concerning Quality Assurance Programs 

Pursuant to Government Code Section 11347, the California Board of Pharmacy (Board) hereby gives notice that it has decided not to proceed with the rulemaking action published in the California Regulatory Notice Register on August 9, 2024, Register 2024, No. 32-Z. The proposed rulemaking concerned Quality Assurance Programs (OAL Notice Z2024-0725-02). 

Any interested person with questions concerning this rulemaking should contact Lori Martinez at 916-244-6648 or by e-mail at: PharmacyRulemaking@dca.ca.gov. 

The Board will also post this Notice of Decision Not to Proceed on its website. 

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.