(Shared from the Board of Pharmacy)
In light of the Governor’s declaration of emergency and the national declaration of emergency, and consistent with Business and Professions Code section 4062, Greg Lippe, President of the California State Board of Pharmacy, has authorized the following waivers of specific provisions of Pharmacy Law. Under the Board’s policy, a waiver granted by the Board President is limited to 30 days.
Waivers to General Pharmacy Law
Business and Professions Code section 4059.5 Waive the signature requirement for the receipt of the delivery of drugs as required in BPC 4059.5 under the following conditions:
- The delivery personnel confirm that the employee accepting the delivery is a pharmacist.
- The delivery personnel input the pharmacist’s name and license number conveyed to them by the pharmacist directly into their signature capture device in lieu of the pharmacist physically signing the tablet as part of the delivery process.
Note: This waiver applies only to the signature requirement for the pharmacist accepting delivery. Business and Professions Code sections 4068(a)(1), 4068(a)(5), and 4068(a)(6) Waive provisions related to the prohibition against a prescriber to dispensing medications to an emergency room patient if the medication dispensed is a short-acting or long-acting bronchodilator. Business and Professions Code sections 4182(a) & (b)/BPC 4192(a) & (b) Waive the requirement for a consulting pharmacist to perform quarterly visits to a clinic under the following conditions:
- The consulting pharmacist, using his or her professional judgment, determines that the quarterly inspection is not required during the declared emergency. When making such a determination, it may be appropriate to consider prior consultation report findings, potential impact to patients receiving care in the clinic, etc.
- A consulting pharmacist performs a desk audit of the clinic’s procedures and records in lieu of the visit.
- A consulting pharmacist generates a report outlining any findings resulting from the desk audit and provides that report to the professional director or his or her designee.
- The consultant receives confirmation to his or her satisfactio, that the corrections outlined in the findings of the audit have been made.
Waivers Related Specifically to Compounding
Business and Professions Code section 4126.8 Waive USP <797> requirements related to the use of personal protective equipment (PPE) as related to Business and Professions Code section 4126.8, in that a PPE masks and gowns may be reused by staff performing sterile compounding under the following conditions:
- The pharmacist-in-charge has made a determination that the current and potential stock of PPE on hand is insufficient to maintain the single-use provisions established in USP 797.
- The pharmacy has developed a policy that details the conditions under which PPE may be reused. Such policies shall be consistent with standards of practice used during emergency situations.
- Documented training on the policy is provided to all staff.
- Master formulas are evaluated to determine if changes are necessary to the criteria for establishing beyond-use dating.
- Surface sampling schedule was reviewed for the possible need to increase the frequency.
- Documentation is maintained indicating the duration of time the pharmacy is operating under the waiver approval.
Title 16, California Code of Regulations, section 1751.5(a)(5) Waive 16 CCR section 1751.5(a)(5) to allow for hand cleaning with the use of non-persistent activity alcohol sanitizer prior to donning sterile gloves.
This blog is meant to provide information on current news and general information. It is not intended to constitute legal advice, nor is any attorney-client relationship established by its posting on this website. If you are facing a situation that involves your professional license, consult with a licensed attorney.
About Adam Brown
Mr. Brown joined the firm of Brown & Brown after receiving his Juris Doctor from Whittier Law School in Costa Mesa, California. He is also a graduate of the University of California at Irvine, where he received his B.A. degree in English.