New Pharmacy Rules Effective July 1, 2020

Purpose

The purpose of this bulletin is to inform hospitals about the new pharmacy rules that took effect July 1, 2020. This bulletin contains an overview of the substantive changes and recommended next steps.

The key changes are:

All rules governing pharmacies and pharmacy practice are consolidated into the new chapter 246-945 WAC.
The new rules in chapter 246-945 WAC are generally effective July 1, 2020, with two sections that are delayed until March 1, 2021 (see below).
The rules are modernized to reflect current pharmacy practices without changing significant portions of existing rules.
Several new rule sections may require hospital actions.
New self-inspection forms are available for public comment.

All sections in the new chapter 246-945 WAC supersede the previous WAC sections governing pharmacies and pharmacy practice.

Applicability/Scope

The new rules apply to all pharmacies, pharmacists, pharmacy technicians, and pharmacy interns in the state of Washington.

Recommendation

Use this bulletin as a guide for reviewing chapter 246-945 WAC in its entirety to ensure understanding and compliance with the new rules.
Review the new rules that may require action by hospitals. These sections impact outpatient prescriptions, recordkeeping, facility standards, inventory, shared services, and external drug storage. They are listed in Part 1 of the Overview.
Review the new rules that change current practices. These sections impact prescription standards, pharmacy tasks, licensing for individuals and facilities, and continuing professional education. They are listed in Part 2 of the Overview.
Refer to the Significant Legislative Rule Analysis issued by Pharmacy Quality Assurance Commission (PQAC) to read learn where previous WACs were condensed or relocated.
Review PQAC’s new General Self-Inspection Worksheet and Hospital/HPAC Self-Inspection Addendum and share questions and comments with David Streeter on the new forms.

Overview

Much of the content in the new chapter 246-945 is the same as the previous rules. However, there are important changes for hospitals to note. This bulletin contains an overview of the substantive changes.

1. New rules that may require hospitals to update processes and procedures.

Below are new rules that may require action by hospitals. These new rules impact outpatient prescriptions, recordkeeping, facility standards, inventory, shared services, and external drug storage. Hospitals should review these rules to ensure compliance.

Prescriptions- Outpatient labels- Minimum Requirements (WAC 246-945-016)
This new rule requires the number of refills to be included on outpatient prescriptions, in addition to the information required under the previous rules.

Records retention period and commission access to records (WAC 246-945-020)
This new rule consolidates previous recordkeeping rules into a uniform standard that applies across all pharmacy settings. The new rule states:

(1) Unless an alternative standard for a specified record type, form, or format is expressly stated a pharmaceutical firm must maintain and retain records required as evidence of compliance with statutes and rules enforced by the commission in a readily retrievable form and location for at least two years from the date the record was created or received, whichever date is later.
(2) A pharmaceutical firm must allow the commission, or its designee, access to the pharmaceutical firm’s records upon request for the purposes of monitoring compliance with statutes and rules enforced by the commission.

Facility Standards (WAC 246-945-410)
This new rule contains the minimum uniform standards for pharmacy facilities. The substance is the same as the previous rules with two major changes. The first change is that all facility standards are condensed into the new WAC section. The second change is that the standards are now uniform across facilities, regardless of their function. Please review WAC 246-945-410 to ensure compliance with the new uniform facility standards.

Dispensing and delivery of prescription drugs (WAC 246-945-415)
This new rule consolidates the previous rules for dispensing prescription drugs. The only new requirement in this rule is subsection (6), which permits afterhours deliveries and returns. Subsection (6) states:

(6) Filled prescriptions may be picked up or returned for delivery by authorized personnel when the pharmacy is closed for business if the prescriptions are placed in a secured delivery area outside of the drug storage area. The secured delivery area must be a part of a licensed pharmacy, and equipped with adequate security, including an alarm or comparable monitoring system, to prevent unauthorized entry, theft, or diversion. Access to the secured delivery area must be addressed by the policies and procedures developed by the responsible pharmacy manager.

Please see new WAC 246-945-415 for the full new rule.

Electronic Systems for Patient Medication Records, Prescriptions, Chart Orders, and Controlled Substance Records (WAC 246-945-417)
Current rules provides pharmacies the option of using an electronic recordkeeping system. However, this new WAC section mandates pharmacies to use an electronic recordkeeping system. The system must be used to “establish and store patient medication records, including patient allergies, idiosyncrasies or chronic conditions, and prescription, refill, transfer information, and other information necessary to provide safe and appropriate patient care.” The new electronic system must be confidential, secure and “capable of real-time retrieval of information.” Pharmacies using electronic record systems are also required to develop policies and procedures for situations in which the system is offline. Hospital Pharmacy Associated Clinics (HPACs) and Health Care Entities (HCEs) must follow these standards if they use electronic record systems. If HPACs and HCEs choose not to use an electronic record system, then they must follow the process in new WAC 246-945-418 (Paper Recordkeeping Procedure). Please review WAC 246-945-217 to ensure compliance.

Facility Inventory requirements (WAC 246-945-420)
This new rule condenses existing inventory rules into a single rule and adds a new provision that applies to pharmacies without onsite staff. The new rule requires pharmacies operating without a pharmacist or ancillary personnel onsite to maintain a perpetual inventory record. The new rule states in its entirety:

(1) A facility shall conduct its own separate inventory of prescription drugs when it closes in accordance WAC 246-945-480.
(2) A facility shall conduct an inventory of controlled substances every two years.
(3) A facility shall conduct its own separate inventory of controlled substances in the following situations:

(a) Within thirty days of designating a responsible pharmacy manager. The incoming responsible pharmacy manager, or designee, shall conduct a complete controlled substance inventory.
(b) On the effective date of an addition of a substance to a schedule of controlled substances. Each facility that possesses the substance shall take an inventory of the substance on hand, and thereafter, include the substance in each inventory.

(4) A pharmacy that exclusively stores, dispenses or delivers legend drugs, including controlled substances, without a pharmacist on-site shall maintain a perpetual inventory.
(5) A pharmacy that exclusively stores, dispenses or delivers prescription drugs without pharmacy ancillary personnel physically on-site shall maintain a perpetual inventory.

Shared Pharmacy Services (WAC 246-945-425)
This new rule establishes the criteria for a pharmacy to provided services at multiple off-site locations. When the services are related to prescription fulfillment or processing, they must be done in compliance with long-term care pharmacy services specified in RCW 18.64.570 or the central fill pharmacy conditions specified in WAC 246-945-425 (2). The central fill conditions are:

(a) The originating pharmacy shall have written policies and procedures outlining the off-site pharmacy services to be provided by the central fill pharmacy, or the off-site pharmacist or pharmacy technician, and the responsibilities of each party;
(b) The parties shall share a secure real-time database or utilize other secure technology, including a private, encrypted connection that allows access by the central pharmacy or off-site pharmacist or pharmacy technician to the information necessary to perform off-site pharmacy services; and
(c) A single prescription may be shared by an originating pharmacy and a central fill pharmacy or off-site pharmacist or pharmacy technician. The fulfillment, processing and delivery of a prescription by one pharmacy for another pursuant to this section will not be construed as the fulfillment of a transferred prescription or as a wholesale distribution.

Please review WAC 246-945-425 to ensure policies comply with the new rule.

Pharmacies storing, dispensing and delivering drugs to patients without a pharmacist on-site (WAC 246-945-430)
This new rule establishes the requirements for pharmacies to follow if they store, dispense, and deliver drugs without an onsite pharmacist. The rule states:

(1) The following requirements apply to pharmacies storing, dispensing and delivering drugs to patients without a pharmacist on-site and are in addition to applicable state and federal laws applying to pharmacies.
(2) The pharmacy is required to have adequate visual surveillance of the full pharmacy and retain a high quality recording for a minimum of thirty calendar days.
(3) Access to a pharmacy by individuals must be limited, authorized, and regularly monitored.
(4) A visual and audio communication system used to counsel and interact with each patient or patient’s caregiver, must be clear, secure, and HIPAA compliant.
(5) The responsible pharmacy manager, or designee, shall complete and retain, in accordance with WAC 246-945-005 a monthly in-person inspection of the pharmacy.
(6) A pharmacist must be capable of being on-site at the pharmacy within three hours if an emergency arises.
(7) The pharmacy must be closed to the public if any component of the surveillance or visual and audio communication system is malfunctioning, and remain closed until system corrections or repairs are completed or a pharmacist is on-site to oversee pharmacy operations.

Drugs Stored Outside the Pharmacy (WAC 246-945-455)
This new rule establishes the requirements for drugs stored outside of a pharmacy’s physical space. The rules states:

(1) In order for drugs to be stored in a designated area outside the pharmacy including, but not limited to, floor stock, in an emergency cabinet, in an emergency kit, or as emergency outpatient drug delivery from an emergency department at a registered institutional facility, the following conditions must be met:

(a) Drugs stored in such a manner shall remain under the control of, and be routinely monitored by, the supplying pharmacy;
(b) The supplying pharmacy shall develop and implement policies and procedures to prevent and detect unauthorized access, document drugs used, returned and wasted, and regular inventory procedures;
(c) Access must be limited to health care professionals licensed under the chapters specified in RCW 18.130.040 acting within their scope, and nursing students as provided in WAC 246-945-450;
(d) The area is appropriately equipped to ensure security and protection from diversion or tampering; and
(e) The facility is able to possess and store drugs.

(2) For nursing homes and hospice programs an emergency kit or supplemental dose kit must comply with RCW 18.64.560.

2. New rules that are changes from current practice or law

Below are new rules that change current practice. These rules impact several areas, including prescription standards, pharmacy tasks, licensing for individuals and facilities, and continuing professional education. Pharmacy staff should review these new rules to understand the changes to their roles and professional responsibilities.

Prescription and Chart Order- Minimum Standards (WAC 246-945-010)
This new rule consolidates the previous rules for prescription and chart orders in different settings into a single rule. The result is a uniform standard that applies across all pharmacy settings. Please see new WAC 246-945-010 for the full rule.

Prescription Validity (WAC 246-945-011)
This new rule consolidates and clarifies existing prescription validity requirements. The new rule states:

(1) Prior to dispensing and delivering a prescription, a pharmacist shall verify its validity.
(2) A prescription shall be considered invalid if:

(a) At the time of presentation, the prescription shows evidence of alteration, erasure, or addition by any person other than the person who wrote it;
(b) The prescription does not contain the required information as provided in WAC 246-945-010;
(c) The prescription is expired; or
(d) The prescription is for a controlled substance and does not comply with the requirements in RCW 69.50.308.

(3) A prescription is considered expired when:

(a) The prescription is for a controlled substance listed in Schedule II through V and the date of dispensing is more than six months after the prescription’s date of issue.
(b) The prescription is for a noncontrolled legend drug or OTC’s and the date of dispensing is more than twelve months after the prescription’s date of issue.

Partial Filling of Prescriptions (WAC 246-945-013)
This new rule allows pharmacists to partially fill prescriptions for noncontrolled legend drugs and Schedule III-V substances if certain conditions are met. The conditions are:

(a) The partial fill is requested by the patient or the prescriber;
(b) The partial filling is recorded in the same manner as a refilling;
(c) The total quantity dispensed and delivered in all partial fillings must not exceed the total quantity prescribed; and
(d) Partial fills for controlled substances listed in Schedule III through V comply with 21 C.F.R. Sec. 1306.23.
(e) Additionally, pharmacist may partially fill a prescription for Schedule II substance in accordance with RCW 18.64.265, 21 U.S.C. Sec. 829, and 21 C.F.R. Sec. 1306.13.

Child-Resistant Containers (WAC 246-945-032)
In general, prescriptions must be dispensed in child-resistant containers. This new rule establishes an exemption for that requirement. Under the rule, prescribers, patients or patient representatives may request an exemption to receive prescriptions in containers that are not child-resistant. Please see WAC 246-945-032 for the full exemption criteria.

Compounding Minimum Standards (WAC 246-945-100)
This new rule adopts United States Pharmacopeia’s (USP) compliance requirements for nonsterile and sterile compounding. Please see WAC 246-945-100 for the full USP citations.

New License Required (WAC 246-945-145)
This new rule clarifies who is required to possess a license for providing pharmacy services in Washington. The new rule says in its entirety: “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.” The key change from the previous rule is the exemption for nonresident pharmacy employees is explicitly stated.

Pharmacist Licensure by License Transfer- Temporary Practice Permits (WAC 246-945-170)
This new rule is based on the previous rules but contains two minor changes that reflect PQAC’s current practice. The first change is that applicants seeking to transfer a license to Washington State must do so using the NABP eLTP process. The second change is a new, one-time 180-day extension to temporary practice permits under certain conditions. The conditions are: if the temporary permit expires before the actual license is issued; or if PQAC does not reach an approval or denial decision 180 days after the temporary practice permit is issued. Please see WAC 246-945-170 for the full transfer requirements.

Inactive Pharmacist License (WAC 246-945-173)
This new rule establishes the process through which a pharmacist may renew an inactive license. The key change between the new rule and the previous rule is that the threshold for inactivity is changed to 3 years, instead of 3-5 years. If a pharmacist license is inactive for less than three years, the individual must follow the requirements in WAC 246-12-090 through 110. If the license is inactive for more than three years, then the individual must follow the applicable process for their licensing status specified in WAC 246-945-173(4) or (5).

Pharmacist Continuing Education (WAC 246-945-178)
This new rule slightly modifies pharmacists’ continuing education requirements. The previous rules required pharmacists to complete 1.5 units of continuing education each year. The new rule requires 3 units of continuing education completed over the span of two years. Please note: this section is effective March 1, 2021.

Pharmacy technician—Continuing education (WAC 246-945-220)
This new rule slightly modifies pharmacy technicians’ continuing education requirements. The previous rules required pharmacy technicians to complete 1 unit of continuing education each year. The new rule requires 2 units of continuing education completed over the span of two years. Please note: this section is effective March 1, 2021.

General Information, Change of Location, Ownership or New Construction (WAC 246-945-230)
This new rule condenses many previous rules concerning facility licensing into a single, clarified WAC section. In order to operate, newly constructed facilities must apply for a license, pay a licensing fee, undergo an inspection and “[obtain] a controlled substances registration from the commission and … [register] with the DEA if the facility intends to possess or distribute controlled substances.”

If a licensed facility will be modified or remodeled, then the facility must notify PQAC and pay an inspection fee. According to the rule, “a modification or remodel of a pharmacy location includes changes to a previously approved area, room or pharmacy building which result in changes in the pharmacy that affects security, square footage, access to drugs, compounding or necessitates temporary relocation of pharmacy services.”

This rule also covers the licensing process in cases when the pharmacy relocates or is acquired by new ownership. Please see WAC 246-945-230 for the complete rules regarding new construction, relocation and change of ownership.

Hospital Pharmacy Associated Clinics (HPACs) (WAC 246-945-233)
This new rule codifies the emergency rules that governed HPACs, which were first enacted in September 2016. The new rule states in its entirety:

(1) A parent hospital pharmacy may add or delete a hospital pharmacy associated clinic (HPAC) to a hospital pharmacy license at any time in compliance with WAC 246-945-230 (a), (b), and (d).
(2) The HPAC must designate a responsible pharmacy manager and notify the commission of changes.
(3) HPAC locations are identified as follows:

(a) Category 1 HPAC: Receives drugs transferred from the parent hospital pharmacy to the HPAC and does not perform sterile or nonsterile compounding of drugs.
(b) Category 2 HPAC: Receives drugs transferred from the parent hospital pharmacy to the HPAC and performs sterile or nonsterile compounding of drugs.

(4) A HPAC licensed under the parent hospital pharmacy license must obtain a separate DEA registration in order to possess controlled substances.

Health Care Entity License (WAC 246-945-245)
This new section codifies PQAC’s previous practice regarding pharmacies operating within health care systems or other entities. The new section states:

(1) The commission shall issue a health care entity license to an applicant that:

(a) Is in compliance with WAC 246-945-230; and
(b) Has designated a responsible pharmacy manager.

(2) An organization (e.g., a clinic) must obtain a separate license for each of its locations. One organization occupying multiple suites in one facility is deemed to be occupying one location requiring one license. Separate organizations occupying the same location must obtain separate licenses.

Delegation of Pharmacy Functions to Ancillary Personnel (WAC 246-945-315)
This new rule contains the same substance as several previous WAC sections. The key change is that supervision via technology is defined and permitted. The rule states regarding supervision via technology:
All delegated pharmacy functions shall be performed under a pharmacist’s immediate supervision. A pharmacist, as an adjunct to assist in the immediate supervision of the pharmacy ancillary personnel or intern, may employ technological means to communicate with or observe the pharmacy ancillary personnel or intern. A pharmacist shall make certain all applicable state and federal laws including, but not limited to, confidentiality, are fully observed when employing technological means of communication and observation. If technology is being used to provide immediate supervision of pharmacy ancillary personnel or intern such technology shall be sufficient to provide the personal assistance, direction and approval required to meet the standard of practice for the delegated tasks.

Please review WAC 146-945-315 to ensure supervision arrangements are compliant with the new rule.

Nondelegable Tasks (WAC 246-945-320)
This new rule consolidates the nondelegable tasks contained in previous WACs. The key change is the inclusion of two additional tasks that may not be delegated by a pharmacist to ancillary personnel. The new nondelegable tasks are patient counseling (WAC 246-945-325) and prescription adaptation (WAC 246-945-355). Please see WAC 246-945-320 for the full list of non-delegable tasks.

Patient Counseling (WAC 246-945-325)
This new rule clarifies when pharmacists are required to offer counseling to patients. Pharmacists are required to offer counseling to patients when a prescription is initially filled or changed, or “[w]hen the pharmacist using their professional judgment determines counseling is necessary to promote safe and effective use and to facilitate an appropriate therapeutic outcome for that patient.”

Refilling Prescriptions (WAC 246-945-330)
This new rule reflects the previous rules regarding prescription refills. The key change is that pharmacists are now permitted to renew a prescription for a noncontrolled legend drug once in a six-month period if the prescriber is unable to be reached. The refill must be equal to the most recent amount dispensed or a thirty-day supply, whichever amount is less. The pharmacist must also communicate the refill to the prescriber within one business day of providing the refill.

Prescription Adaptation (WAC 246-945-335)
Under this new rule, pharmacists may alter the quantity or dosage form. According to the Significant Legislative Rule Analysis, this new rule “aligns with RCW 18.64.011 ‘Practice of Pharmacy’ by allowing the pharmacist to utilize their professional judgment in order to meet the patient’s needs.” Pharmacists may also fill in missing information on a prescription of they have “evidence to support the change.” Please see WAC 246-945-355 to review the rule in its entirety.

Prescriptions- Drug Product Substitutions (WAC 246-945-340)
This new rule clearly lists the circumstances under which a pharmacy may substitute a drug or biologic product. This is not a change from current practice; just a clarification. The rule states:

(1) A pharmacist may substitute a drug or biologic product dispensed pursuant to a prescription if in compliance with applicable laws and rules.
(2) A pharmacist may substitute a drug product or a biologic product when any of the following applies:

(a) The substitution is permitted by RCW 69.41.120;
(b) The substitution is permitted by a formulary developed by an interdisciplinary team of an institutional facility; or
(c) The substitution is otherwise permitted by law.

(3) In addition to any other applicable requirements, a pharmacist shall only substitute a drug or a biologic product pursuant to subsection (2)(b) of this section if:

(a) An employee or contractor of the institutional facility prescribed the drug or biologic product to be substituted;
(b) The interdisciplinary team was composed of a nonpharmacist prescriber listed in RCW 69.41.030 and a pharmacist; and
(c) The formulary is readily retrievable by the pharmacist.

Prescription Transfers (WAC 246-945-345)
This new rule clarifies the previous rules regarding prescription transfers. The key change is that “[s]ufficient information needs to be exchanged in the transfer of a prescription to maintain an auditable trail, and all elements of a valid prescription.” Please see WAC 246-945-345 for the full prescription transfer requirements.

Monitoring of Drug Therapy by Pharmacist (WAC 246-945-355)
This new WAC section codifies existing practice into rule. The rule states:
In the absence of a CDTA, the term ‘monitoring drug therapy’ used in RCW 18.64.011 shall mean a review of the drug therapy regimen of patients by a pharmacist for the purpose of evaluating or rendering advice to the prescribing practitioner or patient regarding the patients drug therapy. Monitoring of drug therapy includes, but is not limited to, the evaluation of the patient through history taking, physical examination, ordering, administering or reviewing laboratory tests, imaging, and social evaluation related to an existing diagnosis and drug therapies for optimization of drug therapy.

Administration of Patient Owned Medications (WAC 246-945-440)
This new rule states all “[f]acilities shall develop written policies and procedures for the administration of patient owned medications.” This is a change from the previous rule, which only specified this requirement for patient owned drugs brought into hospitals.

Facility Reporting Requirements (WAC 246-945-480)
This new section consolidates existing WACs and PQAC policies for reporting in two different situations: 1) when there is a change in the designated responsible pharmacy manager and 2) when a pharmacy permanently closes. Subsection 1 states, “The outgoing and incoming responsible pharmacy manager must report in writing to the commission a change in a responsible manager designation within ten business days of the change.” Subsections 2-5 contain the reporting and notification requirements for closing a pharmacy. Please see WAC 246-945-480 for the specific closure requirements.

Destruction or Return of Drugs or Devices- Restrictions (WAC 246-945-485)
This new section specifies the conditions under which a dispensed drug or device may be returned for re-use or destruction. Please see WAC 246-945-485 for the specific conditions.
3. PQAC’s new self-inspection form

PQAC issued new General Self-Inspection Worksheet and Hospital/HPAC Self-Inspection Addendum that reflect the new rules. However, PQAC will be revising these forms based on stakeholder feedback and questions. WSHA is planning to submit a letter containing hospitals’ feedback. Please share questions and comments with David Streeter on the new forms by 5 PM on July 20, 2020. More information about the new self-inspection forms is available in PQAC’s July 1, 2020 GovDelivery message here.

Next Step

Review PQAC’s new General Self-Inspection Worksheet and Hospital/HPAC Self-Inspection Addendum and share feedback with David Streeter on the new forms by 5 PM on July 20, 2020.

WSHA’s 2020 New Law Implementation Guide

Please visit WSHA’s 2020 implementation guide online, where you will find a list of the high priority laws that WSHA is preparing resources and information on to help members implement the new laws, as well as links to resources such as this bulletin. In addition, you will find the Government Affairs team’s schedule for release of upcoming resources on other laws and additional resources for implementation.

Background and References

The new rules are the result of PQAC’s three-year rule re-write project. PQAC wrote in its CR-103 filing:

Prior to the effective date of this rule making, pharmacy rules were spread over thirty-four chapters. Many of these chapters were outdated and overly prescriptive, limiting the ability for licensees to adapt to changes in practice and technological advances. Beginning in September 2017 the commission was able to dedicate the time and resources necessary to carry out a full chapter update of their rules. The standards established in this new chapter were discussed over the course of two years with conversations between the commission members, commission staff, stakeholders, and the public to provide feedback.

WSHA actively participated in the rulemaking process and appreciates PQAC’s work to modernize the pharmacy rules. WSHA participated in the stakeholder process to ensure hospitals’ concerns were reflected in the resulting proposal. During the CR 102 phase, WSHA conveyed hospitals’ feedback to PQAC through a letter and oral testimony. WSHA will continue to remain engaged with PQAC as it implements these new rules.

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July 13, 2020

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