Chapter 246-945 WAC - Frequently Asked Questions
The commission staff has worked closely with the National Association Board of Pharmacy (NABP) to update the Washington State Multistate Pharmacy Jurisprudence Exam (MPJE) to reflect the new rules, chapter 246-945 WAC. Due to NABP's extensive review and vetting process, new and re-written questions will not be added until after July 2021. Please read next bullet points carefully.
What you need to know:
- After June 30, 2020, questions that are in contradiction with chapter 246-945 WAC will not be included on the WA MPJE. Everything else will remain unchanged. (no new questions added.
- After July 2021, new and re-written questions related to chapter WAC 246-945, will be added to the exam.
Part 1 – General Provisions
- What do the terms ‘pharmaceutical firms' and ‘facility' mean in the new rules?
The commission's new rules chapter (chapter 246-945 WAC) references pharmaceutical firms in the following rules:
- WAC 246-945-005 (Commission inspections and investigations);
- WAC 246-945-020 (Records retention period and commission access to records); and
- WAC 246-945-040(4)-(6) (Uniform Controlled Substance Act).
The commission has defined pharmaceutical firms as “business[es] engaged in the dispensing, delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within or into Washington state” (WAC 246-945-001(61)). This includes pharmacies (including hospital pharmacies), health care entities (HCEs), hospital pharmacy associated clinics (HPACs), wholesalers (including virtual wholesalers), manufacturers (including virtual manufacturers), remote dispensing sites, and nonresident pharmacies.
The Commission defined “facility” in two places within chapter 246-945 WAC. Each definition applies to a discrete set of rules contained within chapter 246-945 WAC:
- For the purposes of WAC 246-945-230 through WAC 246-945-247 (Part 2 – General Licensing; Subpart C – Pharmaceutical Firm Licensing) facility means “pharmacies, nonresident pharmacies, health care entities, hospital pharmacy associated clinics, wholesalers, and manufacturers” (WAC 246-945-230(1)(b)).
- For the purposes of WAC 246-945-405 through WAC 246-945-600 (Part 4 – Operational Standards) facility means pharmacies, health care entities, and hospital pharmacy associated clinics unless otherwise specified (WAC 246-945-405).
For Part 4 – Operational Standards (WAC 246-945-405 through WAC 246-945-600) that include the word “facility” apply to pharmacies, health care entities, and hospital pharmacy associated clinics. For example, pharmacies, health care entities, and hospital pharmacy associated clinics must comply with WAC 246-945-410. In contrast, if a rule specifies a facility type e.g. a pharmacy, then only that facility type is subject to the provisions of that rule. For example, WAC 246-945-417 specifically requires pharmacies to use an electronic recordkeeping system, but WAC 246-945-418 allows HPACs and HCEs to maintain a paper recordkeeping procedure.
There are also situations in Part 4 – Operational Standards when the word “facility” is used but the rules otherwise specify this does not include pharmacies, health care entities, and hospital pharmacy associated clinics. This includes when the commission is referencing a wholesaler, manufacturer, or outsourcing facility (see e.g. WAC 246-945-550(2), WAC 246-945-560, WAC 246-945-590(2)). This also includes when the Commission is referencing an “institutional facility” (see WAC 246-945-340(2)(b), WAC 246-945-340(3)(a), WAC 246-945-445(1), WAC 246-945-455(1), and WAC 246-945-485(1)(a)). An institutional facility is defined as “any organization whose primary purpose is to provide a physical environment for patients to obtain health care services including, but not limited to, services in a hospital, long-term care facility, hospice program, mental health facility, drug abuse treatment center, residential habilitation center, or a local, state, or federal correction facility” (RCW 18.64.011(17)).
Subpart A Commission Operations
Subpart B Prescription Labeling, Records, and Advertising
Subpart C Legend Drugs and Controlled Substances
Easy-open Cap Authorizations. Is there any documentation required for easy-open, not child-resistant container authorizations?
The Pharmacy Quality Assurance Commission would recommend as a best practice that a pharmacist obtain a request in writing from a patient who requests their medication be dispensed in a container that is not child-resistant to assist during inspections.
Subpart D Home Dialysis
Subpart E Compounding minimum standards
- How can the holder of a “Drug Other Controlled Substance Registration” comply with the requirement to perform an inventory every two years on the anniversary of the issuance of the registration, as required by WAC 246-945-060(4), if the holder is not aware of the anniversary date for their registration or is otherwise unable to complete the inventory on the anniversary date?
The Pharmacy Quality Assurance Commission (Commission) will not find a holder of a “Drug Other Controlled Substance Registration” deficient or in violation of the requirement to perform an inventory on the anniversary of the issuance of their registration in WAC 246-945-060(4) so long as the registrant ensures that each inventory is taken within two years of the previous inventory. The registrant should also ensure that all other provisions of WAC 246-945-060(4) are complied with, such as maintaining the inventory list for two years.
For example, the holder of a “Drug Other Controlled Substance Registration” would not be found to be in violation of WAC 246-945-060(4) if they completed an inventory on 6/1/2018 and then completed a second inventory on 6/1/2020, even if the anniversary of the issuance of the registration was 1/1/2020. This is because the inventory on 6/1/2020 was taken within two years of the inventory on 6/1/2018.
This position is consistent with the inventory requirements of the United States Drug Enforcement Administration (DEA) for each location registered with the DEA (21 C.F.R. §§ 1304.04 and 1304.11). Additionally, the Commission believes this position protects the public health and will not undermine efforts to reduce diversion of controlled substances.
Part 2 – General Licensing
Subpart A –Pharmacy Interns and Pharmacist
- Pharmacist Preceptor – My preceptor certification status shows profession discontinued, what does this mean?
In adopting chapter 246-945 WAC, the Commission has discontinued issuing preceptor certification. The rule chapter, effective July 1, 2020, replaces all previous rules with except for the continuing education ruled under chapter 246-861 WAC and CE rules regarding pharmacy technician requirements.
There is no longer a requirement for a pharmacist to hold a preceptor certification to supervise interns gaining experiential hours for licensure or training pharmacy technician in an approved technician-training program. All qualifying internship hours are accumulated under the direction of an ACPE accredited school or college of pharmacy.
On the other hand, for foreign-trained pharmacists earning pharmacy practice experience for licensure must earn hours under the supervision of a licensed pharmacist practicing in the U.S.
- Continuing Education – With the change in rules, how many continuing pharmacy education (CPE) credit hours must I complete to renew my pharmacist credential?
Pharmacists whose license expires on or after December 1, 2022, must complete the equivalent of 3.0 continuing pharmacy education (CPE) administered by an ACPE accredited provider to be eligible for license renewal pursuant to WAC 246-945-178. If a pharmacist's license expires before December 1, 2022, the equivalent of 1.5 continuing education units (CEU) must be completed to be eligible for license renewal pursuant to WAC 246-861-090(1).
Subpart B Pharmacy Assistants and Technicians
- Continuing Education – With the change in rules, how many continuing pharmacy education (CPE) credit hours must I complete to renew my pharmacy technician credential?
Currently, the requirements for CPE is unchanged pending rule adoption by the Secretary of Health setting fees and updating pharmacy persons' credentialing to a two-year renewal cycle. We anticipate December 1, 2021 as the effective date of the fee rules. At that time the CPE rules will align with the two-year renewal cycles.
Pharmacy technicians whose certifications expire on or after December 1, 2022, must complete the equivalent of 2.0 CPE administered by an ACPE accredited program to be eligible for certification renewal pursuant to WAC 246-945-220. Pharmacy technicians whose certifications expire before December 1, 2022 must complete the equivalent of 1.0 CEU to be eligible for certification renewal. The 1.0 CEU shall include at least one (1) hour of course work in pharmacy law and nine (9) hours in any course work that relates to the practice of pharmacy pursuant to WAC 246-901-061(1).
Subpart C Pharmaceutical Firm Licensing
- Differential Hours - Is it still required to report changes in differential hours?
No, this is no longer a requirement to report ‘differential hours' under chapter 246-945 WAC for a pharmacy located within another establishment. Therefore, a pharmacy does not need to submit an application when its hours of operation changes. However, pharmacies are encouraged to post its hours of operation at the entrance when located within another mercantile establishment.
- Are there any commission-recognized third-party inspection programs for out-of-state wholesalers?
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.
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.
Part 3 – Professional Standards
- Do tech-check-tech training programs or other specialized functions performed by technicians require commission approval under the new rules?
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.
- What is a prescription transfer?
A prescription transfer is a transfer of a prescription between pharmacies. The commission requirements addressing prescription transfers are found in WAC 246-945-345.
- Do all prescription transfers need to be transferred by electronic means?
All prescription transfers for non-controlled drugs need to be transferred by electronic means, including facsimile, except in emergencies. Controlled drug prescription transfers must conform to 21 C.F.R. Sec. 1306.25.
- Can an unfilled original electronic prescription of a Schedule II controlled substance be transferred?
On August 27, 2020, the commission reaffirmed its position (PDF), consistent with the DEA, of permitting the transfer of an unfilled original electronic prescription for a Schedule II controlled substance from one DEA-registered pharmacy to another DEA-registered pharmacy. The commission encourages pharmacies that engage in the transfer of an unfilled original electronic prescription of a Schedule II controlled substance to maintain an audit trail as defined in WAC 246-945-001(6).
- What qualifies as an emergent situation as it relates to noncontrolled prescription transfers in WAC 246-945-345(5)?
Whether a situation is “emergent” should be dependent on the pharmacist's professional judgment and the best interest of the patient. The Pharmacy Commission encourages pharmacists to contact their pharmacist inspector with questions about specific situations.
While not a requirement, the Pharmacy Commission does consider it a best practice to document the decision to transfer a prescription verbally.
- How does the commission define “verbal prescription” in WAC 246-945-320(1)(a)?
At the August 27th, 2020 commission meeting, the commission stated that the term “verbal prescription” used in WAC 246-945-320(1)(a) is synonymous with the term “oral prescription” used elsewhere in chapter 246-945 WAC. WAC 246-945-010(7) and (8) state that an “oral prescription… must be promptly reduced to a written or electronic prescription that complies with WAC 246-945-011.”
- Can transferring a prescription by electronic means be delegated to a pharmacy technician?
Yes, a pharmacy technician may transfer a noncontrolled prescription under the immediate supervision of a pharmacist by electronic means (including facsimile). The commission considers the function of transferring a noncontrolled prescription by electronic means (including facsimile) to be a nondiscretionary function associated with the practice of pharmacy that is delegable to a pharmacy technician pursuant to WAC 246-945-315. The commission understands this is a change from the previous rules, but acknowledges the direction of the new WAC chapter in adapting to the future advancement in pharmacy practice and patient care services.
However, the transfer of verbal (or oral) prescriptions to another pharmacy cannot be delegated to a pharmacy technician. Further, pharmacy technicians are NOT permitted at any time to transfer verbal or non-verbal controlled substance prescriptions according the DEA and the commission's promulgated rules.
- Is a prescription transferred to a pharmacy by fax and uploaded to the patient medical record (PMR) an electronic prescription?
- Are transfers of noncontrolled drug prescriptions to out-of-state pharmacies required to be completed via electronic means or facsimile?
Resident pharmacies must transfer prescription information for noncontrolled drugs by electronic means or facsimile, except in emergent situations (WAC 246-945-345). Electronic means is defined as “an electronic device used to send, receive, and/or store prescription information, including computers, facsimile machines, etc” (WAC 246-945-001(30)). This requirement applies to transfers of noncontrolled drug prescriptions to other resident and out-of-state pharmacies.
An out-of-state pharmacy must comply with the applicable law in their home state when transferring noncontrolled drug prescriptions to a resident pharmacy licensed by the commission.
- I live outside of Washington state, do I need a Washington state pharmacist license to provide pharmacy services to individuals in Washington state?
It depends. Per WAC 246-945-145, “An individual providing pharmacy services to individuals located in Washington is required to be credentialed by the commission unless the individual is providing pharmacy services within the scope of their employment, or affiliation, with a Washington licensed nonresident pharmacy or the law otherwise permits the practice.”
Part 4 – Operational Standards
- Are policies and procedures required under the new rules?
Yes. Please review chapter 246-945 WAC to see which policies and procedures apply to your facility.
- Which facilities need to have policies and procedures in place and for what?
The new chapter (chapter 246-945 WAC) went into effect on July 1, 2020. The overall goals of this chapter rewrite was to streamline and update the rules that regulate the practice of pharmacy while making them less prescriptive. The new rules rely much more on the professional judgement of the pharmacist or facility manager. This leads to a stronger reliance on creating and implementing policies and procedures in all facilities.
For example, WAC 246-945-410(6) states that all facilities must create and implement policies and procedures related to “Purchasing, ordering, storing, compounding, delivering, dispensing, and administering legend drugs, including controlled substances.”
Pharmacy inspectors will emphasize relevant policies and procedures during inspections. Additional guidelines can be found on the self-inspection worksheets and a breakdown of required policies and procedures are on our website (PDF).
Subpart A Pharmacies, HCEs, and HPQACs
- What rules apply to pharmacies storing, dispensing, and delivering drugs to patients without a pharmacist on-site?
In addition to the generally applicable pharmacy laws and rules that apply to pharmacies, WAC 246-945-430 contains specific requirements for pharmacists storing, dispensing, and delivering drugs to patients without a pharmacist on-site. Further, WAC 246-945-420(4) requires pharmacies that exclusively store, dispense, and deliver drugs to patients without a pharmacist on-site shall maintain a perpetual inventory.
While the Pharmacy Commission does not evaluate an individual pharmacy's model, examples of such situations which would require compliance with WAC 246-945-430 and WAC 246-945-420(4) would include, but are not limited to, pharmacies that dispense and deliver medications via a pharmacy technician without a pharmacist physically on-site, or pharmacies that dispense and deliver medications via technological means without pharmacy personnel physically on-site.
- Can a pharmacist supervise ancillary personnel or interns remotely?
Yes, but pharmacists should ensure ancillary personnel or interns are supervised in a manner that meets the Pharmacy Commission's definition of “immediate supervision”. Immediate supervision is defined in WAC 246-945-001(44). This includes the ability of pharmacists to employ technological means for supervision of ancillary personnel or interns remotely. Pharmacists are encouraged to review WAC 246-945-001(44) in its entirety when remotely supervising ancillary personnel or interns.
- How does a pharmacy register a remote dispensing site for storage and dispensing of medications approved by the FDA for treatment of opioid use disorder?
Pharmacies interested in registering a remote dispensing site should review the pharmacy commission's policy statement (Regulatory Standards Applicable to Remote Dispensing Sites – Opioid Use Disorder (PDF) and application form (PDF).
- Do licensed health care entities (HCE) who have medications stored on-site that are supplied and remain under the control of a pharmacy have to comply with WAC 246-945-455?