 Check out some things you need to know...
The CR-101 was filed on April 19th under WSR 21-09-063 initiating permanent rulemaking to allow retired pharmacists to apply for a retired active pharmacist license status and practice pharmacy under certain conditions such as in a state of emergency. For more information on the permanent rulemaking, please follow this link. For more information on the current emergency rules for the retired active pharmacist license status, please see this link.
At the March 5th business meeting, the Pharmacy Quality Assurance Commission (commission) provided clarification on WAC 246-945-230(3)(a) and the inspection requirement for modifications or remodels for facilities licensed by the commission. This guidance on inspection requirements for remodels or modifications is now available here.
The Yakima County Vaccination Site is in need of at least six individuals that are licensed, students, and/or allowed to vaccinate under the PREP Act in Washington state. Duties include: vaccine reconstitution and syringe preparation, monitoring temperature of vaccine, and ensuring safe vaccine storage and handling. The site hours are 7am to 8pm with two shifts per day and will operate until at least June 12th. The vaccination site is located at the State Fair Park, 1301 S. Fair Avenue, Yakima WA 98901. If you are interested in volunteering, email doh-podlsc@doh.wa.gov.
As a reminder, on March 11, the U.S. Department of Health and Human Services (HHS) announced that it was adding additional categories of qualified people authorized to administer COVID-19 vaccines, including certain students.
The WA State Department of Health has updated its guidance on who can administer COVID vaccines in Washington State and issued guidance related to the recent HHS announcement:
Providers authorized to administer and order COVID-19 vaccines (PDF)
Healthcare Providers Who May Administer COVID-19 Vaccines Guidance (PDF)
The above guidance can be found on the department’s website at: COVID-19 Vaccine Administration: Washington State Department of Health.
Substitute House Bill 1445 (SHB 1445) amends the definition of compounding for the practice of pharmacy in RCW 18.64.011(6) to:
(6) "Compounding" means the act of combining two or more ingredients in the preparation of a prescription. Reconstitution and mixing of (a) sterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription and administered immediately or in accordance with package labeling, and (b) nonsterile products according to federal food and drug administration-approved labeling does not constitute compounding if prepared pursuant to a prescription.
This change will align Washington State’s definition of compounding with that of the FDA and USP in their forthcoming revised chapters, and lower administrative burdens for pharmacists across the state. Governor Inslee signed SHB 1445 on April 16th and the law will go into effect 90 days after the last day of session, or July 24th, 2021.
Commission approves new third party program for out-of-state wholesalers
At the April 23rd business meeting, the commission voted to recognize the National Coalition for Drug Quality & Security as a third-party inspection program for out-of-state wholesaler applicants. Please see our updated FAQ below.
Q: Are there any commission-recognized third-party inspection programs for out-of-state wholesalers?
A: Yes, the commission recognizes the National Coalition for Drug Quality & Security (NCDQS) as well as NABP’s Drug Distributor Accreditation program (formerly known as VAWD) as a third-party inspection programs for wholesaler applicants located outside of Washington State. The commission added approval for NCDQS at the April 23rd, 2021 business meeting.
As stated in WAC 246-945-246(3)(a), wholesaler applicants located outside of Washington State need to include a site inspection report conducted by the regulatory authority in the resident U.S. jurisdiction, or third-party inspection report from a program recognized by the commission with their application.
Specialized Function FAQ Update
Q: Do tech-check-tech training programs or other specialized functions performed by technicians require commission approval under the new rules?
A: No, there are no specific training requirements for pharmacy technician specialized functions under the new rules. However, WAC 246-945-315(2)(a) states that when delegating a pharmacy function to a pharmacy technician, "A pharmacist shall consider the pharmacy technician's scope of practice, education, skill, and experience and take them into account…" Lastly, the additional function (formerly the specialized function) must be included in the AUP, which still requires Commission approval.
Note, the Commission may adopt guidance documents to define the scope of training for specialized functions as deemed necessary (e.g. pharmacy technician administration).
Follow this link for all FAQs on chapter 246-945 WAC.
Wholesalers may apply to the Pharmacy Quality Assurance Commission for an exemption from the suspicious order reporting requirements in WAC 246-945-585 if they do not distribute controlled substances or drugs of concerns. The revised version is linked below. For convenience, you may complete the form as a PDF or in MSWord.
Please note: The email to submit the exemption attestation form has been updated to hsqafc@doh.wa.gov. If you have submitted an exemption attestation previously, there is no need to submit another form to the new email address. PQAC will ensure all previous submissions are forwarded to the new location.
PDF - Current Suspicious Orders Exemption Attestation fillable PDF
WORD - Current Suspicious Orders Exemption Attestation fillable .docx
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