So far, the California State Board of Pharmacy has issued the following waivers relaxing some requirements due to the coronavirus outbreak:

  1. Sterile compounding renewal requirements for facilities located within a hospital

This waiver provides that a sterile compounding pharmacy whose license expires on or before May 1, 2020, may have its license renewed without being subject to the renewal requirements. The sterile compounding facility must be located within a hospital or satellite location regulated by the California Department of Public Health and issued a General Acute Care Hospital License and be in good standing with the Board of Pharmacy.

  1. Drug acquisition from an unlicensed supplier

This waiver provides that a California-licensed pharmacy may receive dangerous drugs and dangerous devices from an unlicensed pharmacy, wholesaler, or third-party logistics provider located in another state to alleviate a temporary shortage of a dangerous drug or device that could result in the denial of health care as long as:

  • The unlicensed location is appropriately licensed in its home state, and documentation of the license verification is maintained by the California pharmacy.
  • The pharmacy maintains documentation of the temporary shortage of any dangerous drug or device received from any pharmacy, wholesaler, or third-party logistics provider not licensed in California.
  • The pharmacy complies with all record-keeping requirements for each dangerous drug and device received from any pharmacy, wholesaler, or third-party logistics provider not licensed in California.
  • All documentation and records required above shall be maintained and readily retrievable for three years following the end of the declared emergency.
  • The dangerous drug or device was produced by an authorized FDA registered drug manufacturer.

3.     Staffing Ratio of Pharmacists to Intern Pharmacists and Technicians

The ratio of pharmacists to intern pharmacists and to technicians may increase to allow for one additional pharmacy intern or technician for each supervising pharmacist as long as the pharmacy documents the need for the ratio modification due to the COVID-19 public health emergency. Examples of documentation may include, but are not limited to, an increased prescription volume or limitation on staff availability because of quarantine.

4.     Remote Processing

Pharmacists are permitted to conduct remote processing. Pharmacy interns and pharmacy technicians are also permitted to conduct nondiscretionary tasks related to remote processing.

The waiver provides that:

  • a California-licensed pharmacy may allow staff to engage in remote processing provided the pharmacy has policies and procedures that outline the authorized functions to be performed.
  • Policies and procedures must include methods for protecting the confidentiality and integrity of patient information and must expressly prohibit the printing or storage of protected health information on a device that is outside of the licensed pharmacy.
  • A pharmacy must ensure that any pharmacist performing remote processing shall have secure electronic access to the pharmacy’s patient information system and to other electronic systems that an on-site pharmacist has access to when the pharmacy is open.
  • Each remote entry record must comply with all record keeping requirements for pharmacies, including capturing the positive identification of the pharmacist involved in the remote review and verification of a medication order or prescription.
  1.     Signature requirement for receipt of delivery of drugs

This waiver applies only to the signature requirement for the pharmacist accepting delivery. It waives the signature requirement for the receipt of the delivery of drugs as required by California law 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.

6.     Requirement for consulting pharmacist to make quarterly visits to clinic

It waives 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 satisfaction, that the corrections outlined in the findings of the audit have been made.
  1.    Reuse of personal protective equipment (PPE)

The waiver allows masks and gowns to 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.
  1.    Provision related to use of alcohol sanitizer before donning sterile gloves

This waiver allows for hand cleaning with the use of non-persistent activity alcohol sanitizer prior to donning sterile gloves.

The waivers could be found on the California Board of Pharmacy website.