Duty to Consult Exemption

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: 

1. The patient or patient’s agent receives a verbal and prominently written notice of his or her right to request consultation by telephone.
2. 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.
3. 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.
4. A pharmacist may provide oral consultation to the patient or patient’s agent prior to the sale or delivery of a prescription.
5. The pharmacy has policies and procedures in place to ensure compliance with the requirements of this waiver prior to implementation. 
6. A pharmacist may consult with patients or patients’ agents using telephone, video chat or other method as acceptable to the patient.
7. 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.
8. 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: August 31, 2021, or until 30 days after the emergency declaration is lifted, whichever is sooner.

Use of PPE in Compounding Isolators Exemption

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:

1. 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.
2. 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.
3. A policy is developed that details the revised conditions for use of PPE for compounding pursuant to this waiver.
4. Applicable pharmacy staff are trained on the policy and the training is documented prior to implementation.
5. Master formulas are evaluated to determine if changes are necessary to the criteria for establishing beyond-use dating.
6. Surface sampling schedule will be reviewed for the possible need to increase the frequency.
7. 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.

Use of PPE During Covid-19 Pandemic

USP Requirements Related to Use of Personal Protective Equipment (BPC section 4126.8)

Waive USP 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 .
• 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.

CA BOP – State of Emergency

In the summer of 2019 devastating fires in Northern California prompted this notice from the California Board of Pharmacy:

Governor Gavin Newsom has declared a state of emergency related to earthquakes in Kern and San Bernardino counties.

During an emergency, the Board of Pharmacy encourages efforts by licensees to continue providing health care to impacted residents and communities. The board also reminds pharmacies of state laws intended to help pharmacists provide prescription drugs for residents displaced by disaster.

Pursuant to California Business and Professions Code (BPC) section 4062(b), the board allows pharmacies to waive requirements that may be impossible to meet during an emergency – including requirements for prescription forms, record-keeping, labeling, and other standard pharmacy practices and duties. Pharmacists should write “dispensed pursuant to BPC 4062(b)” on the prescription form in case of audit by the board or an insurance company.

In addition, BPC section 4064 authorizes pharmacists to use their professional judgment to refill a prescription for a dangerous drug or device without a prescriber’s authorization if failure to refill the prescription might interrupt ongoing care or have a significant adverse impact on the patient’s well-being.

The board’s formal policy for filling prescriptions during an emergency is spelled out in its “Disaster Response Policy Statement.” The statement can be found by entering “policy statements” in the search box at the board’s website, www.pharmacy.ca.gov; and on Page 5 in the January 2007 issue of The Script.

Additional resources: