WSR 18-16-075
PROPOSED RULES
DEPARTMENT OF HEALTH
[Filed July 30, 2018, 10:49 a.m.]
Original Notice.
Proposal is exempt under RCW 34.05.310(4) or 34.05.330(1).
Title of Rule and Other Identifying Information: WAC 246-907-030 Pharmaceutical licensing periodsFees and renewal cycle, 246-907-0301 Pharmacy assistant licensing periods and feesFees and renewal cycle and 246-907-0302 Hospital pharmacy associated clinics licensing periods and feesFees and renewal cycle; the department is proposing fee increases for many of the pharmacy program fees, including pharmacy professions and pharmaceutical firms. The department is also proposing a few fee decreases to simplify the fee schedule, and changes to duplicate credential, verification of credential, and late renewal penalties to align them with standards for all health professions. The proposal includes repeal of WAC 246-907-0301 and moving fees for pharmacy assistants to WAC 246-907-030.
Hearing Location(s): On September 4, 2018, at 1:00 p.m., at the Department of Health (DOH), Town Center 2, 111 Israel Road S.E., Room 158, Tumwater, WA 98501.
Date of Intended Adoption: September 14, 2018.
Submit Written Comments to: Sherry Thomas, Policy Coordinator, P.O. Box 47850, Olympia, WA 98504-7850, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2901, by September 4, 2018.
Assistance for Persons with Disabilities: Contact Sherry Thomas, phone 360-236-4612, TTY 360-833-6388 or 711, email sherry.thomas@doh.wa.gov, by August 27, 2018.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Current fees are not generating sufficient revenue to keep the program self-supporting as required in the law. The pharmacy program budget is currently in a $1 million deficit that is anticipated to grow to $12 million by 2025 if fees are not increased. This deficit is caused by a number of factors that included a large increase in complaint volume and multiple legislative changes that increased inspection and enforcement activities, created newly regulated facilities, and converted the pharmacy board from a seven member board to a fifteen member commission, all of which have contributed to the need for more investigators and other staff. In addition, the pharmacy program must increase staffing to address the current and projected workload of the commission, which includes substantial revision and consolidation of thirty current WAC chapters and related procedures to address changes in technology and the health care system. Section 219(16), chapter 1, Laws of 2017, provided additional spending authority to the commission that has been pending adoption of these proposed fee rules.
The department is proposing increases to initial credential and renewal fees for many of the pharmacy credentials to include pharmacy professions and pharmaceutical firms. The fees for controlled substances researcher are not changing because they were substantially increased in 2016. The department anticipates these changes will best help the program recover from the current large deficit and reach the desired fund balance of fifteen percent over an eight year period. The department is also proposing adjustments to standardize fees for late renewal, verification of credentials, and duplicate credentials, a few small fee decreases to simplify the fee schedule, and formatting changes to help credential holders determine which fees they are required to pay. In addition, the department is proposing including the pharmacy assistant fees in WAC 246-907-030 and repealing WAC 246-907-0301.
Reasons Supporting Proposal: RCW 43.70.250 requires the cost of each licensing program to be fully borne by the profession's/program's members and licensing fees to be based on licensure costs. Increasing fees to the proposed levels will allow this program's revenues to align with current and projected expenses and avoid the anticipated $12 million budget deficit over an eight year period. The other fee adjustments and formatting changes will simplify the fee schedule and create consistency in the fees for functions that require similar staff time to complete across all health professions/programs.
The commission and the department will continue to monitor the budget and identify efficiencies where possible to attempt to lower the expenditure growth rate of seven percent down to 3.5 percent. The process to identify potential efficiencies is anticipated to begin in August 2018.
Statutory Authority for Adoption: RCW 43.70.250.
Statute Being Implemented: RCW 43.70.250, 43.70.280, chapters 18.64 and 18.64A RCW.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: DOH, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Sherry Thomas, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4612.
A school district fiscal impact statement is not required under RCW 28A.305.135.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(vi) exempts rules that set or adjust fees or rates pursuant to legislative standards.
This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:
Is exempt under RCW 19.85.025(3) as the rules set or adjust fees under the authority of RCW 19.02.075 or that set or adjust fees or rates pursuant to legislative standards, including fees set or adjusted under the authority of RCW 19.80.045.
July 27, 2108 [2018]
John Wiesman, DrPH, MPH
Secretary
AMENDATORY SECTION(Amending WSR 16-18-087, filed 9/6/16, effective 10/7/16)
WAC 246-907-030Pharmaceutical licensing ((periods and fees))fees and renewal cycle.
(1) Pharmacist, pharmacy technician, ((and)) pharmacy intern ((licenses)), and pharmacy assistant credentials must be renewed every year on the practitioner's birthday as provided in chapter 246-12 WAC, Part 2.
(2) Pharmacy location((, controlled substance registration (pharmacy)))credentials, controlled ((Substances Act))substance researcher registration, ((pharmacy technician utilization, and shopkeepers differential hours licenses))drug dog handler K9 registration, and other Controlled Substances Act registrations will expire on June 1st of each year.
(3) All other ((licenses))credentials, including health care entity ((licenses, registrations, permits, or certifications)) will expire on October 1st of each year, except the shopkeeper endorsement which expires annually associated with a business license issued by the department of revenue.
(4) The following nonrefundable fees will be charged for pharmacy ((location))professionals:
((Title of fee
Fee
Original pharmacy fee
$370.00
Original pharmacy technician
utilization fee
65.00
Renewal pharmacy fee
405.00
Renewal pharmacy technician
utilization fee
75.00
Penalty pharmacy fee
205.00
(5) The following nonrefundable fees will be charged for vendor:
Original fee
75.00
Renewal fee
75.00
Penalty fee
50.00
(6) The following nonrefundable fees will be charged for pharmacist:
Original license fee
145.00
Renewal fee, active and inactive license
190.00
Renewal fee, retired license
25.00
Penalty fee
100.00
Expired license reissuance (active and inactive)
90.00
Reciprocity fee
335.00
Certification of license status to other states
30.00
Retired license
25.00
Temporary permit
65.00
(7) The following nonrefundable fees will be charged for shopkeeper:
Original fee
40.00
Renewal fee
40.00
Penalty fee
40.00
Shopkeeper - With differential hours:
Original fee
35.00
Renewal fee
35.00
Penalty fee
35.00
(8) The following nonrefundable fees will be charged for drug manufacturer:
Original fee
590.00
Renewal fee
590.00
Penalty fee
295.00
(9) The following nonrefundable fees will be charged for drug wholesaler - Full line:
Original fee
590.00
Renewal fee
590.00
Penalty fee
295.00
(10) The following nonrefundable fees will be charged for drug wholesaler - OTC only:
Original fee
330.00
Renewal fee
330.00
Penalty fee
165.00
(11) The following nonrefundable fees will be charged for drug wholesaler - Export:
Original fee
590.00
Renewal fee
590.00
Penalty
295.00
(12) The following nonrefundable fees will be charged for drug wholesaler - Export nonprofit humanitarian organization.
Original fee
25.00
Renewal fee
25.00
Penalty
25.00
(13) The following nonrefundable fees will be charged for pharmacy technician:
Original fee
60.00
Renewal fee
50.00
Penalty fee
50.00
Expired license reissuance
50.00
(14) The following nonrefundable fees will be charged for pharmacy intern:
Original registration fee
30.00
Renewal registration fee
30.00
(15) The following nonrefundable fees will be charged for Controlled Substances Act (CSA):
Registrations
Dispensing registration fee (i.e., pharmacies and health care entities)
80.00
Dispensing renewal fee (i.e., pharmacies and health care entities)
65.00
Distributors registration fee (i.e., wholesalers)
115.00
Distributors renewal fee (i.e., wholesalers)
115.00
Manufacturers registration fee
115.00
Manufacturers renewal fee
115.00
Sodium pentobarbital for animal euthanization registration fee
40.00
Sodium pentobarbital for animal euthanization renewal fee
40.00
Researchers registration fee
400.00
Researchers renewal fee
400.00
Other CSA registrations
40.00
(16) The following nonrefundable fees will be charged for legend drug sample - Distributor:
Registration fees
Original fee
365.00
Renewal fee
265.00
Penalty fee
135.00
(17) The following nonrefundable fees will be charged for poison manufacturer/seller - License fees:
Original fee
40.00
Renewal fee
40.00
(18) The following nonrefundable fees will be charged for facility inspection fee:
 
200.00
(19) The following nonrefundable fees will be charged for precursor control permit:
Original fee
65.00
Renewal fee
65.00
(20) The following nonrefundable fees will be charged for license reissue:
Reissue fee
30.00
(21) The following nonrefundable fees will be charged for health care entity:
Original fee
365.00
Renewal
265.00
Penalty
))
(a) All pharmacy professionals:
Title of fee
Fee
Verification of credential
$25.00
Duplicate credential
10.00
(b) Pharmacist:
Original credential
$200.00
Renewal
265.00
Late renewal penalty
135.00
Expired credential reissuance
265.00
Inactive credential renewal
265.00
Retired credential application
25.00
Retired credential renewal
25.00
Temporary permit
100.00
Reciprocity
465.00
(c) Pharmacy technician:
Original credential
$70.00
Renewal
70.00
Late renewal penalty
50.00
Expired credential reissuance
70.00
(d) Pharmacy intern:
Original credential
$45.00
Renewal
45.00
Late renewal penalty
45.00
Verification of internship hours
25.00
Expired credential reissuance
45.00
(e) Pharmacy assistant:
Original credential
$35.00
Renewal
35.00
Late renewal penalty
35.00
Expired credential reissuance
35.00
(5) The following nonrefundable fees will be charged for pharmaceutical firms:
(a) All pharmaceutical firms:
Verification of credential
$25.00
Duplicate credential
10.00
Facility inspection
400.00
(b) Pharmacy (includes hospital pharmacies):
Pharmacy credential (for hospital pharmacy associated clinics, see WAC 246-907-0302)
 
Original credential
$540.00
 
Renewal
540.00
 
Late renewal penalty
270.00
Pharmacy technician utilization
 
Original utilization
100.00
 
Renewal
100.00
Controlled substances authority
 
Original credential
150.00
 
Renewal
150.00
With differential hours
 
Original credential
55.00
 
Renewal
55.00
(c) Nonresident pharmacy:
Pharmacy credential
 
Original credential
$540.00
 
Renewal
540.00
 
Late renewal penalty
270.00
Controlled substances authority
 
Original credential
150.00
 
Renewal
150.00
(d) Controlled substance researcher:
Original credential
$400.00
Renewal
400.00
(e) Other controlled substances act registrations (i.e., analytical laboratories, school laboratories):
Original credential
$360.00
Renewal
360.00
(f) Drug dog handler K9 registration:
Original credential
$55.00
Renewal
55.00
(g) Health care entity:
Health care entity credential
 
Original credential
$540.00
 
Renewal
540.00
 
Late renewal penalty
270.00
Controlled substances authority
 
Original credential
150.00
 
Renewal
150.00
(h) Drug manufacturer:
Manufacturer credential
 
Original credential
$825.00
 
Renewal
825.00
 
Late renewal penalty
300.00
Controlled substances authority
 
Original credential
150.00
 
Renewal
150.00
(i) Drug wholesaler – Full line:
Wholesaler credential
 
Original credential
$825.00
 
Renewal
825.00
 
Late renewal penalty
300.00
Controlled substances authority
 
Original credential
150.00
 
Renewal
150.00
(j) Drug wholesaler – Export:
Wholesaler credential
 
Original credential
$825.00
 
Renewal
825.00
 
Late renewal penalty
300.00
(k) Drug wholesaler – OTC only:
Original credential
$465.00
Renewal
465.00
Late renewal penalty
235.00
(l) Drug wholesaler – Export nonprofit humanitarian organization:
Wholesaler credential
 
Original credential
$25.00
 
Renewal
25.00
 
Late renewal penalty
25.00
(m) Legend drug sample distributor:
Distributor credential
 
Original credential
$540.00
 
Renewal
540.00
 
Late renewal penalty
270.00
Controlled substances authority
 
Original credential
150.00
 
Renewal
150.00
(n) Poison manufacturer/seller:
Original credential
$55.00
Renewal
55.00
Late renewal penalty
50.00
(o) Precursor chemicals:
Original credential
$55.00
Renewal
55.00
Late renewal penalty
50.00
(p) Itinerant vendor:
Original credential
$55.00
Renewal
55.00
Late renewal penalty
50.00
(q) Sodium pentobarbital for animal euthanization:
Original credential
$55.00
Renewal
55.00
Late renewal penalty
50.00
(r) Shopkeeper:
Original credential
$55.00
Renewal
55.00
AMENDATORY SECTION(Amending WSR 16-18-069, filed 9/2/16, effective 9/8/16)
WAC 246-907-0302Hospital pharmacy associated clinics ((licensing periods and fees))fees and renewal cycle.
(1) Parent hospital pharmacy licenses with one or more hospital pharmacy associated clinics (HPAC) expire on June 1st of each year.
(2) A parent hospital pharmacy must submit fees for HPACs in addition to fees set in WAC 246-907-030(4). HPAC fees are due annually, except as provided under subsection (3)(d) of this section.
(3) A parent hospital pharmacy must submit the following nonrefundable fees based on category and number of HPACs as defined in WAC 246-873A-020(3) added to the parent hospital pharmacy license.
(a) Category 1 HPAC. A parent hospital pharmacy must submit the Category 1 HPAC fee according to the number of Category 1 HPACs under the parent hospital pharmacy license.
HPAC tier
Number of Category 1 HPACs under parent hospital pharmacy license
Total annual fee
A
1-10
$((640.00))
895.00
 
B
11-50
$((1,600.00))
2,240.00
 
C
51-100
$((2,240.00))
3,125.00
 
D
Over 100
$((2,880.00))
4,025.00
 
(b) Category 2 HPAC. A parent hospital pharmacy must submit the Category 2 HPAC fee for each Category 2 HPAC under the parent hospital pharmacy license.
Category 2 HPAC fee
$((540.00))
755.00
(c) The department charges a processing fee of fifty-five dollars for an amended license to change the number of HPACs.
(d) If at any time a parent hospital pharmacy submits an addendum increasing the number of HPACs on the parent hospital pharmacy license, which changes the applicable HPAC tier to a higher fee amount, the parent hospital pharmacy shall submit the difference in fees with the addendum.
(e) The department will not refund fees when a tier reduction occurs between renewal periods.
REPEALER
The following section of the Washington Administrative Code is repealed:
WAC 246-907-0301
Pharmacy assistant licensing periods and feesFees and renewal cycle.