# WAC 246-945-007: WAC 246-945-007. Civil fines for pharmaceutical firms

> Washington · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_007

## Section

- **Citation:** WAC 246-945-007
- **Heading:** WAC 246-945-007. Civil fines for pharmaceutical firms
- **Jurisdiction:** Washington
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Washington Administrative Code / Title 246 / Chapter 246-945 / Section 246-945-007

## Text

(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
$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
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, 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 $
00 - $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, 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
Fine Amounts in Relation to the Severity of the Violation for Drug Other Controlled Substances Registrant, 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
Wides
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
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 admin
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" under Table 2:
(A) Animal control/humane society registrants;
(B) Drug dog handlers registrants;
(C) Drug controlled substance researcher registrants;
(D) Drug itinerant vendor registrants;
(E) 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.
e 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
t 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 patients, visitors, 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, visitors, 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.
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 .

## Nearby sections

- [WAC 246-945-001 WAC 246-945-001. Definitions](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_001.md)
- [WAC 246-945-002 WAC 246-945-002. Administrative proceedings and appeals](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_002.md)
- [WAC 246-945-003 WAC 246-945-003. Drug Supply Chain Security Act](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_003.md)
- [WAC 246-945-005 WAC 246-945-005. Commission inspections and investigations](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_005.md)
- [WAC 246-945-007 WAC 246-945-007. Civil fines for pharmaceutical firms](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_007.md)
- [WAC 246-945-010 WAC 246-945-010. Prescription and chart order — Minimum requirements](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_010.md)
- [WAC 246-945-011 WAC 246-945-011. Prescription validity](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_011.md)
- [WAC 246-945-012 WAC 246-945-012. Prescription refills](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_012.md)
- [WAC 246-945-013 WAC 246-945-013. Partial filling of prescriptions](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_013.md)
- [WAC 246-945-014 WAC 246-945-014. Electronic prescribing mandate waiver](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_014.md)
- [WAC 246-945-015 WAC 246-945-015. Minimum requirements for dispensing practitioners](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_015.md)
- [WAC 246-945-016 WAC 246-945-016. Prescriptions — Outpatient labels — Minimum requirements](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_016.md)
- [WAC 246-945-017 WAC 246-945-017. Prescriptions — Hospital inpatient labels — Minimum requirements](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_017.md)
- [WAC 246-945-018 WAC 246-945-018. Prescriptions — Labeling — Prepackage medications](https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_018.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_WA_ADC_246_945_007. Check the current official text before relying on it. Not legal advice.