Mass Vaccination Sites – AMENDED AND REISSUED
In response to the Governor’s emergency declaration and consistent with the authority of the Board to waive Pharmacy Law or the regulations adopted pursuant to it, the Board president, through his delegated authority, approves the below waiver related to mass vaccination sites.
The federal Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUA) for COVID-19 vaccinations. The federal government, through partnerships with state governments, contemplates that vaccines must be sent through a closed system of distribution, either directly from the manufacturer or through pre-determined licensed drug distributors for facility distribution to emergency response providers that include public health agencies with legal responsibility and authority to respond to a public health incident.
Emergency Response Providers were required to identify vaccination sites and to ensure vaccination providers were aware of any applicable EUA. The Centers for Disease Control and Prevention (CDC) requires vaccination providers to sign a COVID-19 Vaccination Program Vaccine Provider Participation Agreement (Provider Agreement) to receive free vaccines under the CDC COVID-19 Vaccination Program. The CDC requires that program providers may redistribute vaccines to other sites if the provider has signed a Supplemental COVID-19 Vaccine Redistribution Agreement that has been approved by the jurisdiction’s immunization program. The California Department of Public Health is overseeing redistribution plans by program providers that receive COVID-19 vaccines.
In response to the Governor’s emergency proclamation, and to facilitate the distribution, storage, mixing, and administration of FDA-authorized COVID-19 vaccine to California- or federally-approved facilities or providers that will administer the vaccines, and consistent with the authority of the Board to waive Pharmacy Law (Business and Professions Code section 4000, et seq.) and the regulations adopted pursuant to it (California Code of Regulations, title 16, section 1700, et seq.), the Board President through his delegated authority, issues the following waiver as detailed below:
Storage and Redistribution of FDA-Authorized COVID-19 Vaccinations in Compliance with California Department of Public Health and CDC Guidance Related to Mass Vaccination Sites
Public health agencies or authorities, or other vaccination providers, are granted a limited waiver from complying with any statutory or regulatory restriction or licensing requirement under Pharmacy Law and the implementing regulations related to the storage or redistribution of COVID-19 vaccinations, consistent with the COVID-19 Redistribution Guidance issued by the California Department of Public Health (CDPH), under the following conditions:
- The public health agency or authority, or other provider, has executed a Provider Agreement or similar agreement with the CDC to operate a mass vaccination site at the request of, or in concert with, the California Department of Public Health, or a local health authority.
- The public health agency or authority, or other provider, has executed a CDC Supplemental COVID-19 Vaccine Redistribution Agreement.
- The public health agency or authority, or other provider has received approval of its redistribution plan by the CDPH.
- The public health agency or authority, or other provider complies with the redistribution reporting requirements in the CDPH COVID-19 Redistribution Guidance.
- Redistribution activities are limited to appropriately trained personnel and performed consistent with the approved redistribution plan, CDC guidelines, and any applicable provision of an Emergency Use Authorization issued by the FDA.
- Records of redistribution, including a copy of the approval, Supplemental COVID-19 Vaccine Redistribution Agreement and any required reporting under the COVID-19 Redistribution Guidance, shall be maintained for a period of three years and maintained in a readily retrievable manner.
Use of Pharmacy Technicians as part of the Vaccination Team at Mass Vaccination Sites Sponsored by State or Local Authorities Directly or Through Contractual Arrangements with Third Parties
Public health agencies or authorities, or other vaccination providers under contract with public health agencies or authorities are granted a limited waiver of Business and Professions Code section 4038, subdivision (a), to the extent it restricts a pharmacy technician to working only in a pharmacy, subject to the following conditions:
- The pharmacy technician is appropriately trained in aseptic technique, if the pharmacy technician is mixing or reconstituting a vaccine, and documentation of such training is providing to the supervising pharmacist upon request.
- The pharmacy technician is appropriately trained to administer vaccines as required under DCA 20-103, Order Waiving Restrictions on Pharmacy Technicians Relating to Administering COVID-19 Vaccines (DCA Waiver), and documentation of the pharmacy technician’s training and qualifications to administer vaccines is provided to the supervising pharmacist.
- The pharmacy technician is performing authorized duties under the direct supervision and control of a supervising pharmacist at a mass vaccination site approved by the State of California or a local health department.
- The pharmacy technician’s duties are limited to (a) the preparation of individual doses of a COVID-19 vaccine as specified in an applicable Emergency Use Authorization(s) issued by the United States Food and Drug Administration, or (b) the administration of a COVID-19 vaccine pursuant to the DCA Waiver.
- Documentation showing compliance with the terms of this waiver is maintained for a period of three years from the date of each use of the waiver.
In addition to the foregoing conditions for utilizing pharmacy technicians at mass vaccination sites, the Department of Consumer Affairs recently issued DCA Waiver-21-142, Order Waiving Staffing Ratio of Pharmacists to Pharmacy Technicians Relating to Administering COVID-19 Vaccines (DCA Waiver). The DCA Waiver waived the restriction in Business & Professions Code section 4115, subdivision (f)(1) that limits pharmacies with only one pharmacist to no more than one pharmacist technician. The DCA Waiver permits pharmacists in pharmacies engaged exclusively in initiating and administering COVID-19 vaccines to supervise two pharmacy technicians, provided that the pharmacy technicians are solely engaged in administering COVID-19 vaccines.
Because mass vaccination sites may not be operating as mobile pharmacies and take advantage of the DCA Waiver, a pharmacist engaged exclusively in initiating and administering COVID-19 vaccines at a mass vaccination site as described in this waiver, may supervise two pharmacy technicians subject to the following conditions:
- The staffing ratio increase is consistent with the mass vaccination site’s operating procedures and conditions.
- The pharmacy technicians are engaged exclusively in preparing and administering COVID-19 vaccines.
- The pharmacy technicians’ COVID-19-related activities are under the direct supervision and control of a supervising pharmacist.
Amended and Reissued: April 21, 2021
Expiration: December 31, 2022, or until 30 days following the declared disaster, whichever is sooner.