Expiration of COVID-19 Board of Pharmacy Waivers

Certain waivers (listed below) issued by the California State Board of Pharmacy (“Board”) in response to the COVID-19 state and national declarations of emergency expired in the month of July and have not been extended. The waivers that are still in effect are available here.

Pharmacies whose operations still require waiver of the following requirements should request a site-specific waiver immediately:

1. Pharmacist Direct Supervision of Interns Required by Cal. Bus. & Prof. Code 4114(a) (Expired  July 19, 2020)
2. Cal. Bus & Prof. Code 4169(a)(1) and 4161(b) Regarding Prohibited Acts Involving Dangerous Drugs or Device (Expired July 24, 2020)
3. Use of Alcohol Before Donning Sterile Gloves Required by 16 CCR 1751.5 (a)(5) (Expired July 24, 2020)
4. Reassessment/Revalidation/Re-evaluation Requirements for Sterile Compounding Staff Competencies under 16 CCR 1751.6(e)(2) (Expired August 12, 2020)
5. Certification in Basic Live Support Required by Cal. Bus. & Prof. Code 4052.8(b)(2) (Expired August 2, 2020)

The following blanket waivers will expire in September and October unless extended by the Board:

1. Staffing Ratio of Pharmacists and General Supervision Requirements for Immunizations Required by Cal. Bus. & Prof. Code §4114 (Expires October 20, 2020)
2. Prelicensure Inspection at Proposed Location of an Automated Drug Delivery System (ADDS) Required by Cal. Bus. & Prof. Code §§4119.11(a)(9) and 4427.2(e) (Expires October 9, 2020)
3. Restoration of Retired or Canceled Pharmacist License under Cal. Bus. & Prof. Code §§4200.5(d); 4202(b); and 4403 (Expires October 1, 2020)
4. Duty to Consult Required by 16 CCR 1707.2(a) (Expires September 29, 2020)
5. Use of PPE in Certain Compounding Aseptic Isolators or Compounding Aseptic Containment Isolators Required by 16 CCR 1751.5 (Expires August 30, 2020)
6. Remote Processing Required by Cal. Bus. & Prof. Code §4071.1(a) (Expires September 22, 2020 or under the emergency declaration is lifted, whichever is sooner)
7. Signature Requirement for Receipt of Delivery of Drugs Required by Cal. Bus. & Prof. Code § 4059.5 (Expires September 22, 2020 or under the emergency declaration is lifted, whichever is sooner)
8. Prescriber Dispensing Medication to Emergency Room Patient Required by Cal. Bus. & Prof. Code §§4068(a)(1); 4068(a)(5); and 4068(a)(6) (Expires September 22, 2020 or under the emergency declaration is lifted, whichever is sooner)
9. Requirement for Consulting Pharmacist to Make Quarterly Visits to Clinic Required by Cal. Bus. & Prof. Code §§4182(a)-(b); and 4192(a)-(b) (Expires September 22, 2020 or under the emergency declaration is lifted, whichever is sooner)

Pharmacies should be prepared to request a site specific waiver for the above waivers in the event that the Board does not extend the expiration date. Licensees may request a site-specific waiver of rules and regulations within the Board’s authority which, if granted, will last up to thirty (30) days.

All requests for waivers may be submitted to [email protected]. (Note: This email address is for any type of waiver, not just compounding.) The request should include the following information:

• License number(s) (for pharmacists and pharmacies)
• A brief statement regarding the extent of the waiver requested.
• A brief statement detailing how the declared emergency caused the need for the waiver.
• Relevant laws that the licensee is requesting be waived.
• Authorized contact person – Any owner, officer, member, pharmacist-in-charge, or other individual otherwise authorized to act on behalf of the licensee.

For questions regarding this client alert, please contact:
Lara Compton, Partner
[email protected]

Roma B. Patel, Attorney at Law
[email protected]