WSR 25-10-089
PROPOSED RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed May 6, 2025, 2:30 p.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 24-15-057.
Title of Rule and Other Identifying Information: Uniform facility enforcement framework for pharmacy. The pharmacy quality assurance commission (commission) is proposing to implement a uniform process for fining pharmaceutical firms in new WAC 246-945-007 Civil fines for pharmaceutical firms. The proposed rules implement ESSB 5271 (chapter 121, Laws of 2024).
Hearing Location(s): On June 26, 2025, at 1:00 p.m., at Capital Region ESD 113, 6005 Tyee Drive S.W., Tumwater, WA 98512; or virtually at https://us02web.zoom.us/j/86309299195 or https://zoom.us/join, Webinar ID 863 0929 9195; or One-tap mobile +12532158782,,86309299195# US (Tacoma), +12532050468,,86309299195# US; or telephone: Dial (for higher quality, dial a number based on your current location): +1 253 215 8782 US (Tacoma), +1 253 205 0468 US.
Date of Intended Adoption: June 26, 2025.
Submit Written Comments to: Julia Katz, P.O. Box 47852, Olympia, WA 98504-7852, fax 360-236-2260, https://fortress.wa.gov/doh/policyreview/, beginning the date and time of this filing, by June 12, 2025, at 11:59 p.m.
Assistance for Persons with Disabilities: Contact Julia Katz, phone 360-236-4946, fax 360-236-2260, TTY 711, email PharmacyRules@doh.wa.gov, by June 12, 2025.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission is proposing to implement a fine matrix for pharmaceutical firms as part of a uniform facility enforcement framework in new WAC 246-945-007 Civil fines for pharmaceutical firms. The enforcement framework delineates how the commission will impose civil fines upon pharmaceutical firm licensees, registrants, permit holders, or other pharmaceutical firm credential holders when the commission determines the licensee has previously been subject to an enforcement action for the same or similar type of violation of the same or similar statute or rule, or has been given any previous statement of deficiency that included the same or similar type of violation of the same or similar statute or rule, or when a licensee failed to correct noncompliance with a statute or rule by a date established or agreed to by the commission. The proposed rule establishes civil fines in relation to the severity and scope of the noncompliance and operation size of the licensee. The anticipated effect is to increase patient safety by ensuring that pharmaceutical firms licensed in Washington state comply with regulations.
Reasons Supporting Proposal: The proposed rule is necessary to implement ESSB 5271 as it pertains to pharmaceutical firms, codified in RCW
18.64.024 and
18.64.026. ESSB 5271 was enacted during the 2024 regular legislative session with an effective date of June 6, 2024. ESSB 5271 directed the commission to adopt rules to establish specific fine amounts. On May 2, 2024, the commission authorized rule making to establish a fine severity framework and related mechanisms permitted by ESSB 5271.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting and Implementation: Julia Katz, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4946; Enforcement: Marlee B. O'Neill, 111 Israel Road S.E., Tumwater, WA 98501, 360-480-9108.
A school district fiscal impact statement is not required under RCW
28A.305.135.
A cost-benefit analysis is required under RCW
34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Julia Katz, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4946, fax 360-236-2260, TTY 711, email
PharmacyRules@doh.wa.gov.
Scope of exemption for rule proposal from Regulatory Fairness Act requirements:
Is not exempt.
The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. There are no costs imposed by the proposed rule; the cost is less than the minor cost threshold ($19,161.74 for pharmacies and drug stores, $10,305.83 for drugs and druggists' sundries merchant wholesalers).
The minor cost analysis demonstrated that there is no estimated cost to pharmaceutical firms. Using the governor's office for regulatory innovation and assistance's minor cost threshold calculator with the North American Industry Classification System (NAICS) code titles 446110 Pharmacies and Drug Stores and 424210 Drugs and Druggists' Sundries Merchant Wholesalers, the minor cost threshold is not met per RCW
19.85.020. A full small business economic impact statement (SBEIS) may not be required since the minor cost threshold is not met.
The following is a brief description of the proposed rule including the current situation/rule, followed by the history of the issue and why the proposed rule is needed. A description of the probable compliance requirements and the kinds of professional services that a small business is likely to need in order to comply with the proposed rule: The commission is proposing to implement a uniform process for fining pharmaceutical firms in new WAC 246-945-007 Civil fines. The proposed rule is necessary to implement ESSB 5271 in chapter 246-945 WAC.
ESSB 5271 was enacted during the 2024 regular legislative session with an effective date of June 6, 2024. Codified in RCW
18.64.024 and
18.64.026, the statute allows the commission to impose conditions and civil fines upon pharmaceutical firm licensees, registrants, permit holders, or other pharmaceutical firm credential holders when the commission determines the licensee has previously been subject to an enforcement action for the same or similar type of violation of the same or similar statute or rule, or has been given any previous statement of deficiency that included the same or similar type of violation of the same or similar statute or rule, or when a licensee failed to correct noncompliance with a statute or rule by a date established or agreed to by the commission. The statutes also authorizes the commission to impose a limited stop service for statute or rule violations, if the commission finds that the violation results in immediate jeopardy.
RCW
18.64.024 requires the commission to adopt a civil fine severity matrix in rule. The matrix must establish specific fine amounts in relation to the severity of the pharmaceutical firm licensee's noncompliance, operation size of the licensee, and at an adequate level to be a deterrence for future noncompliance. Civil fines may be assessed by the commission up to $10,000 per violation, not to exceed a total amount of $1,000,000, for repeat violations of the same or similar statute or rule.
The proposed rule establishes a process for the commission to assess civil fines on pharmaceutical firm licensees, registrants, permit holders, or other pharmaceutical firm credential holders issued by the commission who are subject to a repeat violation or fail to comply with statute or rule. Civil fines will be determined in relation to the severity, scope, and operation size of the licensee with established laws and rules by pharmaceutical firms. The proposed rule defines and categorizes scope, severity, and operation size metrics, and establishes the fine amounts.
The proposed rule does not impose new compliance requirements nor professional services of small businesses in order to be compliant.
Identification and summary of which businesses are required to comply with the proposed rule using NAICS.
SBEIS Table 1. Summary of Businesses Required to Comply to the Proposed Rule
| NAICS Code (4, 5, or 6 digit) | NAICS Business Description | Number of businesses in Washington State | Minor Cost Threshold | |
| 325412 | Pharmaceutical Preparation Manufacturing | 101* | $10,463.92 | |
| 446110 | Pharmacies and Drug Stores | 267** | $19,161.74 | |
| 424210 | Drugs and Druggists' Sundries Merchant Wholesalers | 388*** | $10,305.83**** | |
*The employment security department (ESD) reported 101 businesses categorized as pharmaceutical preparation manufacturing, but department of health (department) staff reported the number of pharmaceutical manufacturers as of October 2024 as 38 manufacturers.
**The ESD reported 267 businesses categorized as Pharmacies and Drug Stores, but department staff reported the number of pharmacies as of April 2024, with 1,283 facilities being standalone pharmacies and 110 facilities being hospital pharmacies.
***The ESD reported 388 businesses categorized as Drugs and Druggists' Sundries Merchant Wholesalers, but department staff reported the number of pharmaceutical wholesalers as of October 2024 with 1,434 facilities.
****No codes were found for the remaining pharmaceutical firm licensees, registrants, permit holders, and credential holders issued by the commission, but department staff reported them as of October 2024 as Drug Animal Control/Humane Society Registration Sodium Pentobarbital as 32 registrants, Drug Controlled Substance Researcher Registration as 343 registrants, Drug Dog Handlers K9 Registration as 13 registrants, Drug Itinerant Vendor Registration as one registrant, Drug Other Controlled Substances Registration as 88 registrants, Drug Precursor Chemicals Registration as five registrants, Drug Sample Distributor Registration as 155 registrants, Hospital Pharmacy Associated Clinic as 435 licensees, Pharmacy Health Care Entity License as 692 licensees, Pharmacy Non Resident License as 9,456 licensees, Poison Distributor License as three licensees, Pharmacy Technician Formal Training Program as 17 permit holders, Training Program Pharmacy as 940 permit holders, and Wildlife Chemical Capture Drug Registration as 15 registrants.
Analysis of probable costs of businesses in the industry to comply with the proposed rule and includes the cost of equipment, supplies, labor, professional services, and administrative costs. The analysis considers if compliance with the proposed rule will cause businesses in the industry to lose sales or revenue:
WAC 246-945-007 CIVIL FINES FOR PHARMACEUTICAL FIRMS.
Description: The proposed rule establishes a process for the commission to assess civil fines on pharmaceutical firm licensees, registrants, permit holders, or other pharmaceutical firm credential holders issued by the commission who are subject to a repeat violation or fail to comply with statute or rule. Civil fines will be determined in relation to the severity, scope, and operation size of the licensee with established laws and rules by pharmaceutical firms. The proposed rule defines and categorizes scope, severity, and operation size metrics, and establishes the fine amounts.
Cost(s): This rule does not require a licensed pharmaceutical firm to implement any new requirements or make changes to their policies or procedures. No new costs will be imposed on licensed pharmaceutical firms unless they violate established laws and rules, and the commission has determined:
| |
| • | The licensed pharmaceutical firm has previously been subject to an enforcement action for the same or similar type of violation of the same statute or rule; |
| • | The licensed pharmaceutical firm has been given any previous statement of deficiency that included the same or similar type of violation of the same statute or rule; or |
| • | The licensed pharmaceutical firm failed to correct noncompliance with a statute or rule by a date established or agreed to by the department. |
Summary of all Cost(s):
SBEIS Table 2. Summary of Section 3 Probable Cost(s)
| WAC Section and Title | Probable Cost(s) | |
| WAC 246-945-007 Civil Fines | $0 | |
Analysis on if the proposed rule may impose more-than-minor costs for businesses in the industry. Includes a summary of how the costs were calculated: No, since there are no costs imposed by the proposed rule, the cost is less than the minor cost threshold ($10,463.92 for pharmaceutical preparation manufacturing, $19,161.74 for pharmacies and drug stores, $10,305.83 for drugs and druggists' sundries merchant wholesalers).
Summary of how the costs were calculated: The proposed rule does not require a licensed pharmaceutical firm to implement any new requirements or make changes to their policies or procedures. The proposed rules outline fines that may be imposed on licensed pharmaceutical firms if they violate established laws and rules, and the commission has determined fines are necessary to deter future noncompliance.
A copy of the detailed cost calculations may be obtained by contacting Julia Katz, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4946, fax 360-236-2260, TTY 711, email PharmacyRules@doh.wa.gov.
May 5, 2025
Hawkins DeFrance, PharmD, Chair
Pharmacy Quality Assurance Commission
RDS-6272.1
NEW SECTION
WAC 246-945-007Civil fines for pharmaceutical firms.
(1) This section does not govern actions taken under chapter
18.130 RCW.
(2) The commission may assess civil fines on pharmaceutical firm licensees pursuant to RCW
18.64.024 and
18.64.026, and these rules.
(a) The commission may assess a civil fine of up to $10,000 per violation, not to exceed a total fine of $1,000,000, on a licensee when:
(i) The licensee has previously been subject to an enforcement action for the same or similar type of violation of the same or similar statute or rule;
(ii) The licensee has been given any previous statement of deficiency that included the same or similar type of violation of the same or similar statute or rule; or
(iii) The licensee has failed to correct noncompliance with a statute or rule by a date established or agreed to by the commission.
(b) The commission may assess a civil fine that is higher than the maximum fine amounts in Table 1, Table 2, or Table 3, not to exceed $10,000 per violation, if it determines that the maximum fine amounts would not be sufficient to deter future noncompliance.
(c) The commission shall determine the amount of a civil fine in accordance with Table 1, Table 2, Table 3, or (d)(i) of this subsection:
Table 1
Fine Amounts in Relation to the Severity of the Violation for Remote Opioid Use Disorder (OUD) Dispensing Sites and Pharmacies (including HPACs, Nuclear Pharmacies, and Nonresident Pharmacies) |
Operation Size - Small | <30,000 prescriptions dispensed annually |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $100 - $500 | $1,750 - $2,750 | $3,000 - $6,000 |
Pattern | $500 - $1,500 | $2,750 - $3,750 | $4,000 - $7,000 |
Widespread | $1,500 - $2,500 | $3,750 - $4,750 | $5,000 - $8,000 |
Operation Size - Medium | 30,000 - 69,999 prescriptions dispensed annually |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $250 - $750 | $1,125 - $3,125 | $4,000 - $7,000 |
Pattern | $750 - $1,750 | $2,125 - $4,125 | $5,000 - $8,000 |
Widespread | $1,750 - $2,750 | $3,125 - $5,125 | $6,000 - $9,000 |
Operation Size - Large | 70,000+ prescriptions dispensed annually |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $500 - $1,000 | $1,500 - $3,500 | $5,000 - $8,000 |
Pattern | $1,000 - $2,000 | $2,400 - $4,500 | $6,000 - $9,000 |
Widespread | $2,000 - $3,000 | $3,500 - $5,500 | $7,000 - $10,000 |
Table 2
Fine Amounts in Relation to the Severity of the Violation for Drug Other Controlled Substances Registrant (Opioid Treatment Programs and Precursor Chemical Registrants), Drug Sample Distributor Registrant, Pharmaceutical Manufacturers, Pharmaceutical Wholesaler, Shopkeeper Registrants and Poison Distributors |
Operation Size - Small | <10 FTEs |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $100 - $500 | $1,750 - $2,750 | $3,000 - $6,000 |
Pattern | $500 - $1,500 | $2,750 - $3,750 | $4,000 - $7,000 |
Widespread | $1,500 - $2,500 | $3,750 - $4,750 | $5,000 - $8,000 |
Operation Size - Medium | 10 - 24 FTEs |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $250 - $750 | $1,125 - $3,125 | $4,000 - $7,000 |
Pattern | $750 - $1,750 | $2,125 - $4,125 | $5,000 - $8,000 |
Widespread | $1,750 - $2,750 | $3,125 - $5,125 | $6,000 - $9,000 |
Operation Size - Large | 25+ FTEs |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $500 - $1,000 | $1,500 - $3,500 | $5,000 - $8,000 |
Pattern | $1,000 - $2,000 | $2,400 - $4,500 | $6,000 - $9,000 |
Widespread | $2,000 - $3,000 | $3,500 - $5,500 | $7,000 - $10,000 |
Table 3
Fine Amounts in Relation to the Severity of the Violation for Health Care Entities (HCEs) |
Operation Size - Small | <5,000 drug orders dispensed and administered or delivered to the patient annually |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $100 - $500 | $1,750 - $2,750 | $3,000 - $6,000 |
Pattern | $500 - $1,500 | $2,750 - $3,750 | $4,000 - $7,000 |
Widespread | $1,500 - $2,500 | $3,750 - $4,750 | $5,000 - $8,000 |
Operation Size - Medium | 5,000 - 19,999 drug orders dispensed and administered or delivered to the patient annually |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $250 - $750 | $1,125 - $3,125 | $4,000 - $7,000 |
Pattern | $750 - $1,750 | $2,125 - $4,125 | $5,000 - $8,000 |
Widespread | $1,750 - $2,750 | $3,125 - $5,125 | $6,000 - $9,000 |
Operation Size - Large | 20,000+ drug orders dispensed and administered or delivered to the patient annually |
| Impact of Potential or Actual Harm |
Scope | Low | Moderate | High |
Limited | $500 - $1,000 | $1,500 - $3,500 | $5,000 - $8,000 |
Pattern | $1,000 - $2,000 | $2,400 - $4,500 | $6,000 - $9,000 |
Widespread | $2,000 - $3,000 | $3,500 - $5,500 | $7,000 - $10,000 |
(d) The "operation size" of a licensee will be considered when calculating fine amounts. Licensee operation sizes are categorized as small, medium, and large.
(i) The following licensees are categorized as "small":
(A) Animal control/humane society registrants;
(B) Drug other controlled substance registrants (drug dog handlers K9 registrants;
(C) Drug controlled substance researcher registrants;
(D) Analytical laboratories;
(E) Drug itinerant vendor registrants;
(F) Wildlife chemical capture drug registrants;
(F) Ancillary utilization pharmacies; and
(G) Technician training programs.
(ii) "Prescriptions" in Table 1 and "drug orders" in Table 3 includes prescriptions and drug orders for "legend drugs" as defined in RCW
69.41.010 and "controlled substances" as defined in RCW
69.50.101.
(e) The licensee shall assist the commission with determining their operation size, including providing information necessary to determine a licensee's operation size. A licensee who fails to assist the commission will be deemed a large operation size.
(f) The "severity of the violation" will be considered when determining fines. Levels of severity are categorized as low, moderate, or high, and defined as:
(i) "Low" means harm could happen but would be rare. The violation undermines safety or quality or contributes to an unsafe environment but is very unlikely to directly contribute to harm;
(ii) "Moderate" means harm could happen occasionally. The violation could cause harm directly, but is more likely to cause harm as a continuing factor in the presence of special circumstances or additional failures. If the deficient practice continues, it would be possible that harm could occur but only in certain situations or patients;
(iii) "High" means harm could happen at any time or did happen. The violation could directly lead to harm without the need for other significant circumstances or failures. If the deficient practice continues, it would be likely that harm could happen at any time to any patient.
(g) Factors the commission will consider when determining the severity of the violation include, but are not limited to:
(i) Whether harm to the patient has occurred, or could occur including, but not limited to, a violation of patient's rights;
(ii) The impact of the actual or potential harm on the patient;
(iii) The degree to which the licensee failed to meet the patient's highest practicable physical, mental, and psychosocial well-being;
(iv) Whether a fine at a lower severity has been levied and the condition or deficiency related to the violation has not been adequately resolved; and
(v) Whether the licensee has been offered, or requested, and received and implemented technical assistance from the commission.
(h) The scope of the violation is the frequency, incidence, or extent of the occurrence of the violation(s). The levels of scope are defined as follows:
(i) "Limited" means a unique occurrence of the deficient practice that is not representative of routine or regular practice and has the potential to impact only one or a very limited number of patient or staff. It is an outlier. The scope of the violation is limited when one or a very limited number of patients are affected or one or a very limited number of staff are involved, or the deficient practice occurs in a very limited number of locations.
(ii) "Pattern" means multiple occurrences of the deficient practice, or a single occurrence that has the potential to impact more than a limited number of patients or staff. It is a process variation. The scope of the violation becomes a pattern when more than a very limited number of patients are affected, or more than a very limited number of staff are involved, or the situation has occurred in several locations, or the same patient(s) have been affected by repeated occurrences of the same deficient practice.
(iii) "Widespread" means the deficient practice is pervasive in the facility or represents a systemic failure or has the potential to impact most or all patients, visitors, or staff. It is a process failure. Widespread scope refers to the entire organization, not just a subset of patients or one unit.
(i) When determining the scope of the violation, the commission will also consider the duration of time that has passed between violations that relate to the same or similar circumstances.
(j) A licensee may appeal the commission's action of assessing civil fines under RCW
18.64.024.