Pharmaceutical Firms Laws and Rules

New Rules adopted by Commission


Chapter 246-945 WAC - Pharmacy Quality Assurance Commission

Chapter 246-11 WAC - Model procedural rules for boards

Chapter 246-12 WAC - Administrative Procedures and Requirements for Credentialed Health Care Providers

Chapter 246-15 WAC - Whistleblower Complaints in Health Care Settings

Chapter 246-16 WAC - Standards of professional conduct

Chapter 246-470 WAC - Prescription Monitoring Program

Chapter 246-907 WAC - License Periods and Fees

Chapter 246-978 WAC - Death With Dignity Act Requirements

MPJE Study Guide (PDF)

Rules in Progress webpage

Former WAC Chapters

Revised Codes of Washington

Recent Rule and Law Changes

Federal Regulation and Codified Controlled Substance Act - Title 21 CFR, Part 1300 - 1399

List of Interchangeable Biological Products, including biosimilar products licensed by the Federal Drug Administration under the Public Health Service Act.

Dextromethorphan product list over the counter products for which a retailer must verify the age of purchasers unless their outward appearance is reasonably presumed to be 25 years of age or older. List updated by the U.S. Food and Drug Administration (FDA) daily.

RCWs/WACs Search

Revised Code of Washington (RCW) or statute is current laws enacted by the Washington State Legislature, and signed by the governor, or enacted via the initiative process.

Washington Administrative Code (WAC) or rules are adopted by an agency or regulatory body (Pharmacy Quality Assurance Commission) with specific authority granted by the legislature (in statute) to engage in rule making. Similar to legislation and the Constitution, rules are a source of primary law in Washington state.

MPJE - How will Multistate Pharmacy Jurisprudence Examination (MPJE) exam be updated based on the implementation of chapter 246-945 WAC?

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, subpart C - Easy-open Cap Authorizations. Is there any documentation required for easy-open, not child-resistant container authorizations?

No, neither WAC 246-945-032 or 16 C.F.R. Part 1700 require pharmacies to obtain documentation that a patient wishes to receive their medication in a container that is not child-resistant.

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.

Part 2, subpart A 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.

Part 2, subpart A & B Continuing Education – With the change in rules, how many continuing pharmacy education (CPE) credit hours must I complete to renew my pharmacist 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 March 1, 2021 as the effective date of the fee rules. At that time the CPE rules will align with the two-year renewal cycles.

Pharmacists whose licenses expire on or after March 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. Pharmacists whose licenses expire before March 1, 2022 must complete the equivalent of 1.5 continuing education units (CEU) to be eligible for license renewal pursuant to WAC 246-861-090(1).

Pharmacy technicians whose certifications expire on or after March 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 March 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).

Part 2, subpart C 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.

Part 3 Pharmacy Technicians – Specialized Functions - 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; and". Additionally, 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).

Part 3 WAC 246-945-345 Prescription Transfers FAQ

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 noncontrolled 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.

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?

No, a transfer via fax that is uploaded or scanned to the PMR is not considered an electronic prescription (21 CFR Sec 1306.25(5) and RCW 69.41.055(1)).

Part 4 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.

Part 4 Pharmacies without a pharmacist on-site and drugs outside of a pharmacy: WAC 246-945-430 vs -455

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) and application form.

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?