All Pharmacy Law Waivers

In light of Governor Gavin Newsom’s declaration of emergency and the national declaration of emergency, and consistent with Business and Professions Code (BPC) section 4062, the California State Board of Pharmacy (Board) or the Board president through delegated authority has issued the following waivers.

The Board will make every effort to send a notice via a subscriber alert when the declaration of emergency has been lifted to signal the expiration of any waivers. The Board urges interested parties to sign up to receive subscriber alerts for the most up-to-date information.

Expired Waivers

Remote Processing (BPC section 4071.1(a))

Pharmacist Remote Processing Waiver on Behalf of a Health Care Facility Licensed Pursuant to Health and Safety Code Section 1250

Pharmacists are permitted to verify medication chart order reviews for appropriateness before administration consistent with federal requirements as permitted by this waiver if in compliance with the following conditions:

The pharmacist must be a California-licensed pharmacist located in California.
The health care facility has established policies and procedures detailing provisions for remote verification of medication chart orders
The health care facility maintains a record of the pharmacist’s verification of medication chart order.
The health care facility must maintain records consistent with the requirements in Business and Professions Code sections 4081 and 4105.

Effective: April 19, 2023

Expires: August 9, 2023

Prescriber Dispensing Medication to Emergency Room Patient (BPC 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, beta-agonist inhalation products.

Reissued: December 5, 2022

Expiration: May 28, 2023

Prescriber Dispensing of COVID-19 Antiviral Medication to an Emergency Room Patient (including BPC sections 4068(a)(1), 4068(a)(5), 4068(a)(6), 4076.5, and 4427.2(a))

Waives the following provisions, including any regulation, related to the prohibition against a prescriber dispensing medications to an emergency room patient under the following conditions. All other provisions of Business and Professions Code (BPC) 4068 that are not explicitly waived (not listed below) are in effect.

BPC 4068(a)(1) – The hospital pharmacy is closed and there is no pharmacist.
BPC 4068(a)(5) – The prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.
BPC 4068(a)(6) – The quantity of drugs dispensed to any patient … shall not exceed a 72-hour supply.
BPC 4076.5 and CCR 1707.5 – Standardized patient-centered, prescription drug label
BPC 4427.2(a) – Licensure requirement for ADDS

The conditions of the waiver are as follows:

The medication is a Food and Drug Administration (FDA) authorized or approved COVID-19 antiviral therapeutic medication, with the FDA label for the treatment of COVID-19, and is prescribed consistent with the conditions or limitations on use established in the FDA’s approval or authorization, including any applicable conditions specified in any Emergency Use Authorization (EUA).
If the antiviral medication is packaged by the manufacturer in a ready to dispense container, the antiviral medication shall be dispensed in the original manufacturer’s container.
Prior to prescribing and dispensing the medication, the prescriber reviews the patient’s medication history to determine any drug interactions, contraindications, or potential for severe side effects.
The medication is labeled to include the patient’s name; the drug name, strength, and manufacturer; directions for use; date of issuance; name of the prescriber; and hospital information.
Verbal consultation is provided by an authorized health care provider as specified in the conditions detailed in the FDA’s approval or authorization for the drug that includes, at a minimum, information on directions for use, proper storage, the importance of compliance with directions, precautions, relevant warnings, common and severe side effects or adverse effects, and therapeutic contraindications.
The patient is advised that the COVID-19 antiviral medication is not packaged in a child-resistant container, when applicable.
Hospital inpatient pharmacies that are not closed and operate an automated unit dose system (AUDS) in the emergency room will not be required to license the AUDS in the emergency room, provided the medications dispensed are limited to the COVID-19 antiviral therapeutic medications included in this waiver. The AUDS shall comply with all other requirements for an ADDS.

Amended and Reissue Effective: January 26, 2022

Expires: May 28, 2023

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: May 28, 2023

Staffing Ratio of Pharmacists to Intern Pharmacists and General Supervision and Interprofessional Supervision - Immunizations - BPC section 4114

Ratio for Pharmacists not Solely Engaged in Immunization-Related Activities

The ratio of pharmacists to intern pharmacists may increase to allow for one additional intern pharmacist for each supervising pharmacist under the following conditions:

The additional intern pharmacist is administering immunizations consistent with the provisions of Pharmacy Law.
The pharmacy maintains a readily retrievable record documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver and the staff operating under the waiver. Records must be maintained for one year following the end of the declared emergency.

Intern pharmacists providing immunizations under the provisions of this waiver may do so under the general supervision of a pharmacist at the discretion of the supervising pharmacist.

Ratio for Pharmacists Solely Engaged in Immunization-Related Activities

Alternatively, the ratio of pharmacists to intern pharmacists may increase to allow for two additional intern pharmacists for each supervising pharmacist under the following conditions:

The supervising pharmacist is solely engaged in immunization-related activities.
The additional intern pharmacists are administering immunizations consistent with the provisions of Pharmacy Law.
The pharmacy maintains a readily retrievable record documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver and the staff operating under the waiver. Records must be maintained for one year following the end of the declared emergency.

Intern pharmacists providing immunizations under the provisions of this waiver may do so under the general supervision of a pharmacist at the discretion of the supervising pharmacist.

Supervision of Pharmacist Interns Performing Solely COVID-19 and/or Influenza Vaccine-Related Functions in Connection with State, Local, Federal or Institutional Vaccination Efforts

In connection with state, local, federal or institutional vaccination efforts, an intern pharmacist may perform authorized COVID-19 and influenza vaccination-related functions consistent with the provisions of Pharmacy Law, including COVID-19 and/or Influenza vaccine administration, at the direction of and under the supervision of a pharmacist, or other California-licensed physician and surgeon, nurse practitioner or physician assistant who are experienced in administering intramuscular injections, who are statutorily authorized to order and administer vaccines, supervise the performance of vaccinations, perform such vaccination duties as a part of their statutorily authorized scope of practice, and whose license is in good standing with the respective regulatory board.

The vaccine sponsoring entity at such sites shall determine whether other healthcare professionals are experienced in administering intramuscular injections such that they may appropriately supervise pharmacist interns at such sites.

For pharmacist interns operating within the scope of this waiver, the designated vaccination provider organization (i.e., pharmacy, clinic, health department, or other applicable entity) shall maintain a record that identifies the supervising health care professional under whose supervision the intern pharmacist performed vaccination-related functions. The record must be maintained and readily available for three years following the end of the declared emergency and provided to the Board upon request.

Amended and reissued: October 14, 2021

Expiration: May 28, 2023

Remote Processing (BPC section 4071.1(a))

For the purposes of this waiver, "remote processing" means the entering of an order or prescription into a computer from outside of the pharmacy or hospital for a licensed pharmacy as defined in Business and Professions Code (BPC) sections 4029 and 4037.

In addition to the provisions of BPC section 4071.1(a), pharmacists performing remote processing may also receive, interpret, evaluate, clarify, and approve medication orders and prescriptions, including medication orders and prescriptions for controlled substances classified in Schedule II, III, IV or V. Under this waiver, remote processing may also include order entry, other data entry, performing prospective drug utilization review, interpreting clinical data, insurance processing, performing therapeutic interventions, providing drug information services, and authorizing release of medication for administration. The waiver does not include the dispensing of a drug or final product verification by remote processing.

Further, this waiver expands the provisions of BPC section 4071.1(a) to allow for remote processing by pharmacy technicians and pharmacy interns to include nondiscretionary tasks, including prescription or order entry, other data entry, and insurance processing of prescriptions and medication orders for which supervision by a pharmacist is provided using remote supervision via technology that, at a minimum, ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verify the work performed by the pharmacy intern or pharmacy technician.

Pharmacy and Pharmacist Remote Processing Waiver Conditions

Pharmacists are permitted to conduct remote processing as permitted by this waiver if in compliance with the following:

The pharmacist must be a California-licensed pharmacist who either processes medication orders or prescriptions from a remote site or on the premises of a California licensed-pharmacy.
A California-licensed pharmacy may allow a staff pharmacist 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. Such policies must be readily retrievable and provided to the Board upon request (i.e. be able to be produced within three business days of request).
A pharmacy utilizing remote processing shall ensure that all pharmacists providing such services have been trained on the pharmacy's policies and procedures relating to medication order, prescription processing, and remote supervision via technology that, at a minimum, ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verify the work performed by the pharmacy intern or pharmacy technician.
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.
A pharmacy utilizing remote processing is responsible for maintaining records of all medication orders and prescriptions entered into the pharmacy’s information system.

Pharmacy Intern and Pharmacy Technician Remote Processing Waiver Conditions

Pharmacy interns and pharmacy technicians are permitted to conduct nondiscretionary tasks related to remote processing as permitted by the waiver if in compliance with the following:

The pharmacy intern or pharmacy technician who either enters medication orders or prescriptions from a remote site or on the premises of a California-licensed pharmacy must be licensed by the Board.
A pharmacy utilizing remote processing shall ensure that all pharmacy interns and pharmacy technicians providing such services have been trained on the pharmacy's policies and procedures relating to medication order or prescription processing and remote supervision via technology that, at a minimum, ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verify the work performed by the pharmacy intern or pharmacy technician.
A pharmacy shall ensure that any pharmacy intern or pharmacy technician performing remote processing shall have secure electronic access to the pharmacy's patient information system and to other electronic systems to which an on-site pharmacy intern or pharmacy technician has access when the pharmacy is open.
Each remote entry record must comply with all record keeping requirements for pharmacies.
A pharmacy utilizing remote processing is responsible for maintaining records of all medication orders and prescriptions entered into the pharmacy’s information system.

Reinstated: September 3, 2021

Expiration: May 28, 2023

Pharmacists Initiating and Administering Vaccines [(CCR section 1746.4(d)]

A pharmacist shall not be required to notify each patient’s primary care provider of a COVID-19 vaccine administration under the provisions of 16 CCR Section 1746.4(d), under the following conditions:

The patient receives a copy of a CDC immunization card or printout that documents what COVID vaccination was administered, the date and where the vaccination was received.
The patient is advised that the primary care provider will not be provided with such notification.
If a pharmacist has access to a shared patient record system, the pharmacist must comply with the reporting requirement.

All other documentation and reporting requirements remain in effect, including reporting to the immunization registry.

Effective: December 17, 2020

Expiration: Ninety days after the emergency declaration is lifted.

Restoration of Retired or Canceled Pharmacist License – Related to Retired Licensees [BPC section 4200.5(d)]; Related to Canceled Pharmacist Licenses [BPC section 4402(b)]; and Related to Payment of Fees for Reissuance or Renewal of License (BPC section 4403)

To allow for the restoration of a previously retired or canceled pharmacist license, the Board waives the provisions of Business and Professions Code sections 4200.5(d), 4402(b), and 4403 under the following conditions:

At the time of cancellation or transition to a retired status, the license was not subject to any disciplinary conditions or subject to any disciplinary proceeding.
The license has been in such a status no longer than five years.
The individual applies for restoration by completing the required form Application to Restore Your License located on the Board’s website under “COVID-19 Information.”

Upon processing of the application for restoring the license, the individual will receive email notification from the Board.

The Board has issued restored or reactivated pharmacist licenses for a maximum of six months. On September 17, 2020, the Department of Consumer Affairs (DCA) issued a waiver regarding license reactivation or restoration requirements subject to certain conditions. The September 17, 2020, DCA Waiver provides that a reactivated or restored license is valid until January 1, 2021, or when the State of Emergency ceases to exist, whichever is sooner. More recently, the December 15, 2020, DCA Waiver provides that a reactivated or restored license is valid until July 1, 2021, or when the State of Emergency ceases to exist, whichever is soon. To align the validity dates of all restored or reactivated licenses required under pharmacy law with the December 15, 2020, DCA waiver, all restored or reactivated pharmacist licenses under the Board waiver will be valid until July 1, 2021, or until the State of Emergency ceases to exist, whichever is sooner.

Information about DCA waivers can be found at DCA Waivers and Guidance.

Effective: April 3, 2020

Expiration: January 1, 2022, subject to the proviso if the DCA waiver is extended, the Board’s waiver will extend to coincide with the same time limits.

Duty to Consult (Title 16, California Code of Regulations, section 1707.2(a))

If the pharmacist-in-charge makes the determination that oral consultation, as required under Title 16, California Code of Regulations, section 1707.2(a), places the public and/or personnel at risk for exposure to COVID-19, in-person oral consultation may be waived under the following conditions:

The patient or patient’s agent receives a verbal and prominently written notice of his or her right to request consultation by telephone.
The written notice includes the telephone number to call and the hours of availability during which the patient may obtain oral consultation from a pharmacist who has ready access to the patient’s records.
A pharmacist is readily available to speak to the patient or patient’s agent during any regular hours of operation, unless additional hours of availability are provided and a return call is scheduled to occur within that time in the same business day, if acceptable to the patient. The pharmacist must make two good faith attempts to contact the patient by telephone and document the attempts or consultation. Documentation shall include the name of patient or prescription number, date, time and identification of pharmacist who provided consultation.
A pharmacist may provide oral consultation to the patient or patient’s agent prior to the sale or delivery of a prescription.
The pharmacy has policies and procedures in place to ensure compliance with the requirements of this waiver prior to implementation.
A pharmacist may consult with patients or patients’ agents using telephone, video chat or other method as acceptable to the patient.
If a pharmacist deems consultation is warranted in the exercise of his or her professional judgment or if there is an adverse drug therapy warning deemed necessary after the review as required by Title 16, California Code of Regulations, section 1707.3, consultation must occur prior to the patient or the patient’s agent receiving the prescription.
Documentation required by this waiver shall be maintained and readily retrievable for one year following the end of the declared emergency.

Effective: January 14, 2022

Expiration: February 28, 2022

Prelicensure Inspection at Proposed Location of an Automated Drug Delivery System (ADDS) - Business and Professions Code sections 4119.11(a)(9) and BPC 4427.2(e)

A California licensed pharmacy applying for an ADDS license for a proposed location or relocation of an ADDS will not be subject to the required prelicensure inspection at the proposed location provided the pharmacy submits the following:

A description of the proposed ADDS location with pictures, video and/or a floor plan with the surrounding areas labeled and how the ADDS is secured.
A copy of the pharmacy’s policies and procedures to operate the ADDS regarding security, safety, accuracy, accountability, patient confidentiality, maintenance, maintaining the quality, potency and purity of the dangerous drugs and devices, restocking, record keeping and quality assurance.
Proof of training or plans for training pharmacy staff and personnel at the pharmacy applying for the proposed ADDS location on the policies and procedures.
A statement that a copy of the policies and procedures will be maintained as required by BPC section 4427.3(c).

If the ADDS is an Automated Patient Dispensing System (APDS), the pharmacy must also provide the following with its application (see BCP section 4427.6):

Policies and procedures that include all of the following: criteria used to determine which drugs are placed in the APDS; methods of ensuring patients are aware that consultation is available; a description of assignments of responsibility; training on using the APDS; plans for orienting participating patients; plans for ensuring delivery of drugs when the APDS is disabled or malfunctioning; and plans for handling of complaints, errors, omissions and other incidents with the use of the APDS.
A statement explaining how a written consent from participating patients is obtained and what means are used to identify the patient or patient’s agent before releasing the drug.
A statement confirming the APDS has a two-way audio and video for consultation; records are maintained for all transactions; child resistant containers are used; drug warning labels are used for drugs causing risk of overdose, addiction, impairment while operating a vehicle, and risk if alcohol is consumed; a sign is prominently posted on the APDS with the pharmacy’s name, address and phone number; the prescription label meets the patient-centered labeling requirements; and translation and interpretive services are available.

Effective: January 14, 2022

Expiration: February 28, 2022

Signature Requirement for Receipt of Delivery of Drugs (BPC section 4059.5)

Waive the signature requirement for the receipt of the delivery of drugs as required in BPC section 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.

Effective: January 14, 2022

Expiration: February 28, 2022

Requirement for Consulting Pharmacist to Make Quarterly Visits to Clinic (BPC 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 satisfaction, that the corrections outlined in the findings of the audit have been made.

Effective: January 14, 2022

Expiration: February 28, 2022

Prelicensure Inspection at Proposed Location of an Automated Drug Delivery System (ADDS) - Business and Professions Code sections 4119.11(a)(9) and BPC 4427.2(e)

A description of the proposed ADDS location with pictures, video and/or a floor plan with the surrounding areas labeled and how the ADDS is secured.
A copy of the pharmacy’s policies and procedures to operate the ADDS regarding security, safety, accuracy, accountability, patient confidentiality, maintenance, maintaining the quality, potency and purity of the dangerous drugs and devices, restocking, record keeping and quality assurance.
Proof of training or plans for training pharmacy staff and personnel at the pharmacy applying for the proposed ADDS location on the policies and procedures.
A statement that a copy of the policies and procedures will be maintained as required by BPC section 4427.3(c).

If the ADDS is an Automated Patient Dispensing System (APDS), the pharmacy must also provide the following with its application (see BCP section 4427.6):

Policies and procedures that include all of the following: criteria used to determine which drugs are placed in the APDS; methods of ensuring patients are aware that consultation is available; a description of assignments of responsibility; training on using the APDS; plans for orienting participating patients; plans for ensuring delivery of drugs when the APDS is disabled or malfunctioning; and plans for handling of complaints, errors, omissions and other incidents with the use of the APDS.
A statement explaining how a written consent from participating patients is obtained and what means are used to identify the patient or patient’s agent before releasing the drug.
A statement confirming the APDS has a two-way audio and video for consultation; records are maintained for all transactions; child resistant containers are used; drug warning labels are used for drugs causing risk of overdose, addiction, impairment while operating a vehicle, and risk if alcohol is consumed; a sign is prominently posted on the APDS with the pharmacy’s name, address and phone number; the prescription label meets the patient-centered labeling requirements; and translation and interpretive services are available.

Effective: November 20, 2020

Expiration: October 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Duty to Consult (Title 16, California Code of Regulations, section 1707.2(a))

The patient or patient’s agent receives a verbal and prominently written notice of his or her right to request consultation by telephone.
The written notice includes the telephone number to call and the hours of availability during which the patient may obtain oral consultation from a pharmacist who has ready access to the patient’s records.
A pharmacist is readily available to speak to the patient or patient’s agent during any regular hours of operation, unless additional hours of availability are provided and a return call is scheduled to occur within that time in the same business day, if acceptable to the patient. The pharmacist must make two good faith attempts to contact the patient by telephone and document the attempts or consultation. Documentation shall include the name of patient or prescription number, date, time and identification of pharmacist who provided consultation.
A pharmacist may provide oral consultation to the patient or patient’s agent prior to the sale or delivery of a prescription.
The pharmacy has policies and procedures in place to ensure compliance with the requirements of this waiver prior to implementation.
A pharmacist may consult with patients or patients’ agents using telephone, video chat or other method as acceptable to the patient.
If a pharmacist deems consultation is warranted in the exercise of his or her professional judgment or if there is an adverse drug therapy warning deemed necessary after the review as required by Title 16, California Code of Regulations, section 1707.3, consultation must occur prior to the patient or the patient’s agent receiving the prescription.
Documentation required by this waiver shall be maintained and readily retrievable for one year following the end of the declared emergency.

Effective: April 1, 2020

Expiration: October 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Intern Pharmacists – (Business and Professions Code section 4114(a)) – AMENDED AND REISSUED

In response to Department Consumer Affairs Waiver 21-139, Order Waiving Restrictions On Healthcare Students Administering COVID-19 Vaccines In Association With State or Local Vaccination Efforts issued April 2, 2021, the Board is extending and amending its waiver issued in January 2021 to provide an alternative route to supervise pharmacy interns solely administering COVID vaccines.

Supervision of Pharmacist Interns Performing COVID Vaccine-Related Functions in Connection with State, Local, Federal or Institutional Vaccination Efforts

In connection with state, local, federal or institutional vaccination efforts, an intern pharmacist may perform authorized COVID-19 vaccination-related functions, including vaccine administration, at the direction of and under the supervision of a pharmacist, or other California-licensed physician and surgeon, nurse practitioner or physician assistant who are statutorily authorized to order and administer vaccines, supervise the performance of vaccinations, perform such vaccination duties as a part of their statutorily authorized scope of practice, and whose license is in good standing with the respective regulatory board.

Supervision of Pharmacist Interns Solely Administering COVID Vaccines

When solely administering vaccines in a pharmacy or in association with state, local, federal or institutional vaccination efforts, a pharmacist intern may be supervised by a practicing healthcare professional who is experienced in administering intramuscular injections if all of the conditions of DCA Waiver 21-139 are met. The vaccine sponsoring entity at such sites should determine whether other healthcare professionals are experienced in administering intramuscular injections such that they may appropriately supervise pharmacist interns at such sites.

For pharmacy interns operating within the scope of this waiver, the designated vaccination provider organization (i.e., pharmacy, clinic, health department, or other applicable entity) shall maintain a record that identifies the supervising health care professional under whose supervision the intern pharmacist performed vaccination-related functions. The record must be maintained and readily available for three years following the end of the declared emergency and provided to the Board upon request.

Effective: April 22, 2021

Expiration: September 18, 2021

Signature Requirement for Receipt of Delivery of Drugs (BPC section 4059.5)

Waive the signature requirement for the receipt of the delivery of drugs as required in BPC section 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.

Effective: March 17, 2020

Expiration: August 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Prescriber Dispensing Medication to Emergency Room Patient (BPC 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, beta-agonist inhalation product.

Effective: March 27, 2020

Expiration: August 31, 2021, or until the 30 days after the emergency declaration is lifted, whichever is sooner.

USP <797> Requirements Related to Use of Personal Protective Equipment (BPC 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 mask and gown 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.

Effective: March 17, 2020

Expiration: May 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Use of PPE in Certain Compounding Aseptic Isolators or Compounding Aseptic Containment Isolators (Title 16, California Code of Regulations, section 1751.5)

Provisions of Title 16, California Code of Regulations, section 1751.5(a)(1)-(3) related to the requirement to don PPE garb (including masks, gowns, head, and shoe covers) when compounding in a compounding aseptic isolator or compounding aseptic containment isolator May be waived 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 garbing requirements established in the regulation.
The isolator manufacturer has provided written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. This documentation must be readily retrievable by the licensed location.
A policy is developed that details the revised conditions for use of PPE for compounding pursuant to this waiver.
Applicable pharmacy staff are trained on the policy and the training is documented prior to implementation.
Master formulas are evaluated to determine if changes are necessary to the criteria for establishing beyond-use dating.
Surface sampling schedule will be reviewed for the possible need to increase the frequency.
Documentation indicating the duration of time the pharmacy is operating under the waiver approval is maintained.

Note: This waiver not does extend to the requirements for the use of sterile gloves.

Effective: April 1, 2020

Expiration: May 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Sterile Compounding Renewal Requirements for Facilities Located Within a Hospital (BPC sections 4127.1(c) & (d) and 4127.15(b))

A sterile compounding pharmacy whose license expires on or before July 1, 2020, may have its license renewed without being subject to the renewal requirements in BPC sections 4127.1(c) and (d) and 4127.15(b) under the following conditions:

The sterile compounding facility is located within a hospital or satellite location regulated by the California Department of Public Health and issued a General Acute Care Hospital License.
The compounding facility complies with all other provisions of Pharmacy Law as applicable, unless otherwise waived by the Board during this declared emergency.

Effective: March 21, 2020, modified March 27, 2020

Mass Vaccination Sites

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

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

The pharmacy technician is appropriately trained in aseptic technique, if the pharmacist 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.

Effective Date: March 5, 2021

Expiration Date: June 3, 2021

Intern Pharmacists – (Business and Professions Code section 4114(a))

An intern pharmacist may perform authorized COVID-19 vaccination-related functions at the direction of and under the supervision of a pharmacist, or other California-licensed physician and surgeon, nurse practitioner or physician assistant who are statutorily authorized to order and administer vaccines, supervise the performance of vaccinations, perform such vaccination duties as a part of their statutorily authorized scope of practice, and whose license is in good standing with the respective regulatory board.

The vaccination provider organization (pharmacy, clinic, health department, or other applicable entity) shall maintain a record that identifies the supervising health care professional under whose supervision the intern pharmacist performed vaccination-related functions. The record must be maintained and readily available for three years following the end of the declared emergency and provided to the Board upon request.

Effective: January 27, 2021

Expires: April 26, 2021

Remote Processing (BPC section 4071.1(a))

Pharmacy and Pharmacist Remote Processing Waiver Conditions

Pharmacists are permitted to conduct remote processing as permitted by this waiver if in compliance with the following:

The pharmacist must be a California-licensed pharmacist who either processes medication orders or prescriptions from a remote site or on the premises of a California licensed-pharmacy.
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. Such policies must be readily retrievable and provided to the Board upon request (i.e. be able to be produced within three business days of request).
A pharmacy utilizing remote processing shall ensure that all pharmacists providing such services have been trained on the pharmacy's policies and procedures relating to medication order, prescription processing, and remote supervision via technology that, at a minimum, ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verify the work performed by the pharmacy intern or pharmacy technician.
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.
A pharmacy utilizing remote processing is responsible for maintaining records of all medication orders and prescriptions entered into the pharmacy’s information system.

Pharmacy Intern and Pharmacy Technician Remote Processing Waiver Conditions

Pharmacy interns and pharmacy technicians are permitted to conduct nondiscretionary tasks related to remote processing as permitted by the waiver if in compliance with the following:

The pharmacy intern or pharmacy technician who either enters medication orders or prescriptions from a remote site or on the premises of a California-licensed pharmacy must be licensed by the Board.
A pharmacy utilizing remote processing shall ensure that all pharmacy interns and pharmacy technicians providing such services have been trained on the pharmacy's policies and procedures relating to medication order or prescription processing and remote supervision via technology that, at a minimum, ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verify the work performed by the pharmacy intern or pharmacy technician.
A pharmacy shall ensure that any pharmacy intern or pharmacy technician performing remote processing shall have secure electronic access to the pharmacy's patient information system and to other electronic systems to which an on-site pharmacy intern or pharmacy technician has access when the pharmacy is open.
Each remote entry record must comply with all record keeping requirements for pharmacies.
A pharmacy utilizing remote processing is responsible for maintaining records of all medication orders and prescriptions entered into the pharmacy’s information system.

Effective: November 19, 2020

Expiration: January 16, 2021

Staffing Ratio of Pharmacists to Intern Pharmacists and General Supervision - Immunizations - BPC section 4114

The ratio of pharmacists to intern pharmacists may increase to allow for one additional intern pharmacist for each supervising pharmacist under the following conditions:

The additional intern pharmacist is administering immunizations consistent with the provisions of Pharmacy Law.
The pharmacy maintains a readily retrievable record documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver and the staff operating under the waiver. Records must be maintained for one year following the end of the declared emergency.

Intern pharmacists providing immunizations under the provisions of this waiver may do so under the general supervision of a pharmacist at the discretion of the supervising pharmacist.

Effective: July 23, 2020

Expiration: January 18, 2021

Inventory Reconciliation Report of Controlled Substances (Title 16, California Code of Regulations, section 1715.65(c))

A pharmacy or clinic must complete the required inventory reconciliation report specified in Title 16, California Code of Regulations, section 1715.65(c) at least once every six months rather than every three months if determined to be necessary by the pharmacist-in-charge or professional director to ensure continuity of direct patient care activities that would otherwise be impacted.

Effective: December 14, 2020

Expiration: March 13, 2021

Requirement for Consulting Pharmacist to Make Quarterly Visits to Clinic (BPC 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 satisfaction that the corrections outlined in the findings of the audit have been made.

Effective: November 19, 2020

Expiration: March 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Staffing Ratio of Pharmacists to Intern Pharmacists and General Supervision - Immunizations - BPC section 4114

The ratio of pharmacists to intern pharmacists may increase to allow for one additional intern pharmacist for each supervising pharmacist under the following conditions:

The additional intern pharmacist is administering immunizations consistent with the provisions of Pharmacy Law.
The pharmacy maintains a readily retrievable record documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver and the staff operating under the waiver. Records must be maintained for one year following the end of the declared emergency.

Intern pharmacists providing immunizations under the provisions of this waiver may do so under the general supervision of a pharmacist at the discretion of the supervising pharmacist.

Effective: July 23, 2020

Expiration: January 18, 2021 - Replaced, find current version above.

Reassessment/Revalidation/Re-evaluation Requirements for Sterile Compounding Staff Competencies – Title 16, California Code of Regulations, sections 1751.6(e)(2) and 1751.7(b) and (d)

This waiver extends the reassessment, revalidation, or re-evaluation requirements in Title 16 CCR sections 1751.6(e)(2) and 1751.7(b) and (d) for up to an additional 90 days with respect to semi-annual and annual reassessment, revalidation, or re-evaluation requirements for individuals involved in sterile compounding under the following conditions:

The pharmacist-in-charge makes a determination that such a suspension in the reassessment, revalidation, or re-evaluation frequency is necessary and appropriate, balancing site-specific limitations and current staff competencies.
The pharmacist-in-charge ensures only properly trained persons are allowed to perform compounding.
Documentation is maintained identifying when reassessments, revalidations, or re-evaluations pursuant to this waiver were extended for each staff member involved in sterile compounding. Such documentation must be maintained for three years from the date of making.

Effective: April 15, 2020

Expires: August 12, 2020

Certification in Basic Life Support - Business and Professions Code section 4052.8(b)(2)

Waiver of Business and Professions Code section 4052.8(b)(2), requiring certification in basic life support (BLS) in order to initiate and administer immunizations, under the following conditions:

The pharmacist held a BLS certification that expired on or after March 15, 2020.

Effective: April 6, 2020

Expiration: August 5, 2020

Use of Alcohol Sanitizer before Donning Sterile Gloves (Title 16, California Code of Regulations, section 1751.5(a)(5))

Waive Title 16, California Code of Regulations, section 1751.5(a)(5) to allow for hand cleaning with the use of non-persistent activity alcohol sanitizer prior to donning sterile gloves.

Effective: March 17, 2020

Expiration: July 24, 2020

Prohibited Acts involving Dangerous Drugs or Devices (BPC sections 4169(a)(1) and 4161(b))

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 under the following conditions:

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.

Effective: March 21, 2020

Expiration: July 24, 2020, or until the emergency declaration is lifted, whichever is sooner.

Pharmacist Direct Supervision of Interns - Business and Professions Code section 4114

Waiver of the provision of Business and Professions Code section 4114(a) to allow for general supervision of an intern pharmacist at the discretion of the supervising pharmacist under the following conditions:

The pharmacy documents the need for the supervision 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 shelter-in-place orders or quarantine.
The intern pharmacist meets one of the following criteria:
Enrolled in a recognized school of pharmacy with an anticipated graduation date in 2020; or
Graduated from a recognized school of pharmacy; or
Is certified by the Foreign Pharmacy Graduate Equivalency Committee.
The pharmacy maintains a readily retrievable record documenting the intern pharmacists operating under the general supervision of a pharmacist under the waiver and justification of the need. Records must be maintained for one year following the end of the declared emergency.
Under general supervision, the supervising pharmacist is generally aware of all activities performed by the intern pharmacist without direction from the pharmacist.

Effective: April 21, 2020

Expires: July 19, 2020

Intern Pharmacist Licenses (BPC section 4208)

The Board will automatically extend any intern pharmacist license with an expiration date on or before July 1, 2020, for an additional six months, if the intern pharmacist license is current and in good standing.

To verify your intern pharmacist license is extended, please visit the Board’s website at www.pharmacy.ca.gov and select License Search under “Quick Hits” on the homepage.

Use of Sterile Disinfectant Agents – Title 16, California Code of Regulations, section 1751.4(d)(1)

Waiver of Title 16, California Code of Regulations, section 1751.4(d)(1) to allow for the use of a non-sterile alcohol-based disinfectant after cleaning on work table surfaces, carts, and counters under the following conditions:

The pharmacist-in-charge has made a determination that the current and potential stock of sterile alcohol (sIPA) on hand is insufficient to maintain the requirements established in the regulation.
The surface or equipment is NOT contained within an ISO Class 5 environment.
Surface sampling schedule is reviewed for the possible need to increase the frequency of cleaning and disinfection.
Documentation indicating the duration of time the pharmacy is operating under this waiver is maintained.

Effective: April 3, 2020

Expiration: July 1, 2020

Staffing Ratio of Pharmacists to Pharmacy Technicians (BPC sections 4115(f)(1) and 4127.15(c)(2); and Title 16, California Code of Regulations, section 1793.7)

The ratio of pharmacists to pharmacy technicians may increase to allow for one additional pharmacy technician for each supervising pharmacist under the following conditions:

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, limitation on staff availability because of quarantine.
The supervising pharmacist, exercising their professional judgment, may refuse to supervise the additional pharmacy technician and provide the pharmacist-in-charge of their determination. When making such a determination, the supervising pharmacist must specify the circumstances of concern with respect to the pharmacy and patient care implications. Under such circumstances, the ratio may not increase.

The pharmacy must maintain a readily retrievable record, documenting the date(s) and time(s) when the ratio is increased pursuant to this waiver and the staff operating under the waiver, and justification of the need. Records must be maintained for one year following the end of the declared emergency.

Effective: March 19, 2020

Expiration: June 24, 2020, or until the emergency declaration is lifted, whichever is sooner.