WSR 20-16-045
EXPEDITED RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed July 27, 2020, 1:26 p.m.]
Title of Rule and Other Identifying Information: Chapters 246-856, 246-858, 246-860, 246-863, 246-865, 246-867, 246-869, 246-870, 246-871, 246-873, 246-874, 246-875, 246-877, 246-878, 246-879, 246-881, 246-883, 246-885, 246-886, 246-887, 246-888, 246-889, 246-891, 246-895, 246-897, 246-899, 246-901 (except for WAC 246-901-061), 246-903, 246-904, and 246-905 WAC. The pharmacy quality assurance commission (commission) consolidated multiple chapters of rules into one chapter, chapter 246-945 WAC, that covers the practice of pharmacy. The commission is proposing to repeal the old chapters relating to the practice of pharmacy.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission recently completed a two and a half year process to consolidate its thirty-three separate chapters of WAC into one new chapter, chapter 246-945 WAC. The proposal repeals the chapters of rules relating to pharmacy that were replaced by chapter 246-945 WAC, with the exception of the continuing education (CE) sections (chapter 246-861 WAC and WAC 246-901-061), which have a delayed effective date in the new chapter to align with rule making currently in progress regarding fees collected by the commission.
When the commission began its rules rewrite project, the commission created four separate rule-making packages to divide the rule-making process into four parts. The repeal language was going to be filed in each of the four separate rule-making packages so that there would be no gaps in implementation of rules for the practice of pharmacy. However, the commission decided to combine all four parts into the same rule rewrite process. When the four parts were rolled up into one rule-making package, the repeal language was not added in at that point. Therefore, although it was the commission's intention to repeal the old WAC when they adopted chapter 246-945 WAC, the old rules must be repealed separately. The proposal simply repeals the thirty-three [thirty] chapters of rule that the new WAC replaced, adding clarity for licensees and the public.
Reasons Supporting Proposal: Without repealing the WAC chapters replaced by chapter 246-945 WAC, both sets of rules will be codified at the same time and could lead to confusion. The commission issued a policy statement to help clarify, but the repeal of the old WAC chapters replaced by chapter 246-945 WAC is necessary to avoid confusion and complete the goal of simplifying and streamlining regulations relating to the practice of pharmacy.
Statutory Authority for Adoption: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043, 18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310, 18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253, 18.64.410, 18.64.500, 18.64.590.
Statute Being Implemented: RCW 18.64.005.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Washington state pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Lindsay Trant, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2932.
This notice meets the following criteria to use the expedited repeal process for these rules:
Other rules of the agency or of another agency govern the same activity as the rule, making the rule redundant.
Explanation of the Reason the Agency Believes the Expedited Rule-Making Process is Appropriate: The commission has adopted a new chapter that consolidates the old chapters making the old chapters redundant. Other rules of the agency govern the same activity as the chapters this package proposes to repeal.
NOTICE
THIS RULE IS BEING PROPOSED UNDER AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THIS USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Lindsay Trant, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504, phone 360-236-2932, fax 360-236-2321, email https://fortress.wa.gov/doh/policyreview, AND RECEIVED BY October 5, 2020.
May 29, 2020
Tim Lynch, PharmD, MS, Chair
Pharmacy Quality Assurance Commission
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-856-001
Purpose.
WAC 246-856-020
Adjudicative proceedings—Procedural rules for the board of pharmacy.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-858-020
General requirements.
WAC 246-858-030
Registration of interns.
WAC 246-858-040
Rules for the pharmacy intern.
WAC 246-858-050
Intern training reports.
WAC 246-858-060
Requirements for preceptor certification.
WAC 246-858-070
Rules for preceptors.
WAC 246-858-080
Special internship approval.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-860-010
Purpose of chapter.
WAC 246-860-020
Definitions.
WAC 246-860-100
Sexual misconduct.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-863-020
Examinations.
WAC 246-863-030
Applicants—Reciprocity applicants.
WAC 246-863-035
Temporary permits.
WAC 246-863-040
Foreign-trained applicants.
WAC 246-863-060
Licensed pharmacists—Employed as responsible managers—Duty to notify board.
WAC 246-863-070
Inactive credential.
WAC 246-863-080
Retired pharmacist license.
WAC 246-863-090
Expired license.
WAC 246-863-095
Pharmacist's professional responsibilities.
WAC 246-863-100
Pharmacist prescriptive authority—Prior board notification of written guideline or protocol required.
WAC 246-863-110
Monitoring of drug therapy by pharmacists.
WAC 246-863-120
AIDS prevention and information education requirements.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-865-010
Definitions.
WAC 246-865-020
Promulgation.
WAC 246-865-030
Emergency kit.
WAC 246-865-040
Supplemental dose kits.
WAC 246-865-050
Drug facilities.
WAC 246-865-060
Pharmaceutical services.
WAC 246-865-070
Provision for continuity of drug therapy for residents.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-867-001
Purpose and scope.
WAC 246-867-010
Definitions.
WAC 246-867-020
Applicability.
WAC 246-867-030
Reporting and freedom from liability.
WAC 246-867-040
Approval of substance abuse monitoring programs.
WAC 246-867-050
Participation in approved substance abuse monitoring program.
WAC 246-867-060
Confidentiality.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-869-010
Pharmacies' responsibilities.
WAC 246-869-020
Pharmacies and differential hours.
WAC 246-869-030
Pharmacy license notice requirements.
WAC 246-869-040
New pharmacy registration.
WAC 246-869-060
Employers to require evidence of pharmacist's qualifications.
WAC 246-869-070
Responsible manager—Appointment.
WAC 246-869-080
Clinic dispensaries.
WAC 246-869-090
Prescription transfers.
WAC 246-869-100
Prescription record requirements.
WAC 246-869-105
Continuity of care refills in proclaimed emergencies.
WAC 246-869-110
Refusal to permit inspection.
WAC 246-869-130
Return or exchange of drugs.
WAC 246-869-140
Prescription department—Conversing with pharmacist prohibited.
WAC 246-869-150
Physical standards for pharmacies—Adequate stock.
WAC 246-869-160
Physical standards for pharmacies—Adequate facilities.
WAC 246-869-170
Physical standards for pharmacies—Sanitary conditions.
WAC 246-869-180
Physical standards for pharmacies—Adequate equipment.
WAC 246-869-190
Pharmacy inspections and self-inspection worksheets.
WAC 246-869-200
Poison control.
WAC 246-869-210
Prescription labeling.
WAC 246-869-220
Patient counseling required.
WAC 246-869-230
Child-resistant containers.
WAC 246-869-235
Prescription drug repackaging—Definitions.
WAC 246-869-250
Closing a pharmacy.
WAC 246-869-255
Customized patient medication packages.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-870-010
Purpose.
WAC 246-870-020
What definitions do I need to know to understand these rules?
WAC 246-870-030
What is included in the electronic transmission and transfer of prescription information?
WAC 246-870-040
Can all prescriptions be transmitted electronically?
WAC 246-870-050
What are the requirements for fax machines?
WAC 246-870-060
What are the board requirements for electronic prescription transmission systems?
WAC 246-870-070
What are the board requirements for pharmacies using electronic prescription transmission systems?
WAC 246-870-080
Can prescription records be stored electronically?
WAC 246-870-090
Can electronic mail systems be used to transmit patient information?
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-871-001
Scope and purpose.
WAC 246-871-010
Definitions.
WAC 246-871-020
Policy and procedure manual.
WAC 246-871-030
Physical requirements.
WAC 246-871-040
Personnel.
WAC 246-871-050
Drug distribution and control.
WAC 246-871-060
Antineoplastic medications.
WAC 246-871-070
Clinical services.
WAC 246-871-080
Quality assurance.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-873-010
Definitions.
WAC 246-873-020
Applicability.
WAC 246-873-030
Licensure.
WAC 246-873-040
Personnel.
WAC 246-873-050
Absence of a pharmacist.
WAC 246-873-060
Provision of emergency department discharge medications when pharmacy services are unavailable.
WAC 246-873-070
Physical requirements.
WAC 246-873-080
Drug procurement, distribution and control.
WAC 246-873-090
Administration of drugs.
WAC 246-873-100
Investigational drugs.
WAC 246-873-110
Additional responsibilities of pharmacy service.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-874-010
Definitions.
WAC 246-874-020
General applicability.
WAC 246-874-025
Responsible manager designation requirement for an ADDD.
WAC 246-874-030
General requirements for an ADDD.
WAC 246-874-040
Security and safety requirements for ADDD.
WAC 246-874-050
Accountability requirements for an ADDD.
WAC 246-874-060
Quality assurance process requirements for ADDD.
WAC 246-874-070
Nursing students ADDD access.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-875-001
Purpose.
WAC 246-875-010
Definitions.
WAC 246-875-020
Minimum required information in an automated patient medication record system.
WAC 246-875-030
Minimum required information in a manual patient medication record system.
WAC 246-875-040
Minimum procedures for utilization of a patient medication record system.
WAC 246-875-050
Auxiliary recordkeeping procedure.
WAC 246-875-060
Retrieval of information from an automated system.
WAC 246-875-070
Confidentiality and security of data.
WAC 246-875-080
Extension of time for compliance.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-877-020
Drug sample prohibitions.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-878-010
Definitions.
WAC 246-878-020
Compounded drug products—Pharmacist.
WAC 246-878-030
Organization and personnel.
WAC 246-878-040
Facilities.
WAC 246-878-050
Sterile pharmaceutical.
WAC 246-878-060
Radiopharmaceuticals.
WAC 246-878-070
Special precaution products.
WAC 246-878-080
Equipment.
WAC 246-878-090
Control of components and drug product containers and closures.
WAC 246-878-100
Drug compounding controls.
WAC 246-878-110
Labeling control of excess products.
WAC 246-878-120
Records and reports.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-879-010
Definitions.
WAC 246-879-020
Minimum standards for wholesalers.
WAC 246-879-030
Inspections.
WAC 246-879-040
Records.
WAC 246-879-050
Security.
WAC 246-879-060
Unauthorized sales.
WAC 246-879-070
Application for full line wholesaler license and over-the-counter only wholesaler license.
WAC 246-879-080
Application for controlled substance wholesaler license.
WAC 246-879-090
Export wholesaler.
WAC 246-879-100
Salvaging and reprocessing companies.
WAC 246-879-110
Violations and penalties.
WAC 246-879-120
Reciprocity.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-881-010
Drug price advertising defined.
WAC 246-881-020
Drug price advertising conditions.
WAC 246-881-030
Prohibition on advertising controlled substances.
WAC 246-881-040
Drug price disclosure—Required.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-883-020
Identification of legend drugs for purposes of chapter 69.41 RCW.
WAC 246-883-025
Introductory trade or stock packages.
WAC 246-883-030
Ephedrine prescription restrictions.
WAC 246-883-040
Regulated steroids.
WAC 246-883-050
Theophylline prescription restrictions.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-885-020
Drug imprint information provided by manufacturers and distributors.
WAC 246-885-030
Over-the-counter (OTC) drug imprint regulation.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-886-001
Purpose.
WAC 246-886-010
Definitions.
WAC 246-886-020
Registration.
WAC 246-886-030
Approved legend drugs.
WAC 246-886-035
Sodium pentobarbital—Approved controlled substance.
WAC 246-886-040
Training of personnel.
WAC 246-886-050
Legend drug administration.
WAC 246-886-060
Responsible individuals.
WAC 246-886-080
Recordkeeping and reports.
WAC 246-886-090
Drug storage and field use.
WAC 246-886-100
Violations.
WAC 246-886-150
Chemical capture programs.
WAC 246-886-160
Registration requirements.
WAC 246-886-170
Authorized individuals.
WAC 246-886-180
Approved legend drugs.
WAC 246-886-190
Controlled substances training.
WAC 246-886-200
Storage requirements.
WAC 246-886-210
Controlled substances records and reports.
WAC 246-886-220
Approved controlled substances.
WAC 246-886-230
Controlled substances registration disciplinary actions.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-887-020
Uniform Controlled Substances Act.
WAC 246-887-040
Designation of nonnarcotic stimulant drugs for purposes of RCW 69.50.402 (1)(c).
WAC 246-887-045
Prescribing, dispensing, or administering of Schedule II nonnarcotic stimulants.
WAC 246-887-080
Sodium pentobarbital registration disciplinary action.
WAC 246-887-090
Authority to control.
WAC 246-887-100
Schedule I.
WAC 246-887-140
Schedule II.
WAC 246-887-150
Schedule II immediate precursors.
WAC 246-887-160
Schedule III.
WAC 246-887-170
Schedule IV.
WAC 246-887-180
Schedule V.
WAC 246-887-200
Other controlled substance registrants—Requirements.
WAC 246-887-210
Standards for transmission of controlled substances sample distribution reports.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-888-010
Purpose.
WAC 246-888-020
What is self-administration with assistance and how is it different from independent self-administration or medication administration?
WAC 246-888-030
How is self-administration with assistance initiated in a community-based care setting or an in-home setting?
WAC 246-888-045
What is an enabler?
WAC 246-888-050
How can medications be altered to assist with self-administration?
WAC 246-888-060
Can all medications be altered to facilitate self-administration?
WAC 246-888-070
What other type of assistance can a nonpractitioner provide?
WAC 246-888-080
Is oxygen covered under this rule?
WAC 246-888-090
If a individual/resident is able to administer his or her own oral medication through a gastrostomy or "g-tube," can a nonpractitioner provide assistance as outlined in these rules?
WAC 246-888-100
Are there any other requirements I need to be aware of?
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-889-010
Definitions.
WAC 246-889-020
Precursor substance defined.
WAC 246-889-030
Reports of precursor receipt.
WAC 246-889-040
Monthly reporting option.
WAC 246-889-050
Suspicious transactions and reporting requirements.
WAC 246-889-070
Retail sales of nonprescription ephedrine, pseudoephedrine, and phenylpropanolamine products.
WAC 246-889-085
Requirements for the sale of restricted product.
WAC 246-889-090
Acceptable forms of photo identification.
WAC 246-889-095
Record of sales—Electronic methamphetamine precursor tracking.
WAC 246-889-110
Maintenance of and access to retail sales records of restricted products.
WAC 246-889-115
Exemptions from electronic reporting.
WAC 246-889-120
Denial of sale—Override.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-891-010
Definitions.
WAC 246-891-020
Conditions for the sale of condoms.
WAC 246-891-030
Condom standards.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-895-010
Definitions.
WAC 246-895-020
Finished pharmaceuticals—Manufacturing practice.
WAC 246-895-030
Personnel.
WAC 246-895-040
Buildings or facilities.
WAC 246-895-050
Equipment.
WAC 246-895-060
Production and control procedures.
WAC 246-895-070
Components.
WAC 246-895-080
Component and drug product containers and closures.
WAC 246-895-090
Reuse of teat dip containers and closures.
WAC 246-895-100
Laboratory controls.
WAC 246-895-110
Stability.
WAC 246-895-120
Expiration dating.
WAC 246-895-130
Packaging and labeling.
WAC 246-895-140
Master production and control records—Batch production and control records.
WAC 246-895-150
Distribution records.
WAC 246-895-160
Complaint files.
WAC 246-895-170
Variance and procedure.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-897-020
Availability.
WAC 246-897-060
Identity.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-899-020
Dispensing responsibilities.
WAC 246-899-030
Product selection responsibilities.
WAC 246-899-040
Manufacturers, wholesalers, distributors, pharmacy location, requirement that drug products offered for sale comply with 21 U.S.C. 355—Immediate suspension and subsequent revocation of licenses authorized for violation.
WAC 246-899-050
Out-of-state prescriptions.
REPEALER
The following sections of the Washington Administrative Code are repealed:
WAC 246-901-010
Definitions.
WAC 246-901-020
Pharmacy ancillary personnel utilization.
WAC 246-901-030
Technician education and training.
WAC 246-901-035
Pharmacy technician specialized functions.
WAC 246-901-040
Limitations, trainees.
WAC 246-901-050
Technician program approval.
WAC 246-901-060
Technician certification.
WAC 246-901-065
Expired technician license.
WAC 246-901-070
Pharmacy assistant utilization.
WAC 246-901-080
Pharmacy assistant registration.
WAC 246-901-090
Identification.
WAC 246-901-100
Board approval of pharmacies utilizing pharmacy ancillary personnel and specialized functions.
WAC 246-901-120
AIDS prevention and information education requirements.
WAC 246-901-130
Pharmacist to pharmacy technician ratio.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-903-001
Purpose and scope.
WAC 246-903-010
Definitions.
WAC 246-903-020
Nuclear pharmacies.
WAC 246-903-030
Nuclear pharmacists.
WAC 246-903-040
Minimum equipment requirements.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-904-010
Definition.
WAC 246-904-020
New health care entity licensing.
WAC 246-904-030
Pharmacist in charge.
WAC 246-904-040
Drug procurement, distribution and control.
WAC 246-904-050
Dispensing of prescription medications from health care entities.
WAC 246-904-060
Labeling.
WAC 246-904-070
Records.
WAC 246-904-080
Absence of a pharmacist.
WAC 246-904-090
Administration.
WAC 246-904-100
Closing.
REPEALER
The following chapter of the Washington Administrative Code is repealed:
WAC 246-905-020
Home dialysis program—Legend drugs.
WAC 246-905-030
Pharmacist consultant.
WAC 246-905-040
Records.
WAC 246-905-050
Quality assurance.