WSR 18-16-075
PROPOSED RULES
DEPARTMENT OF HEALTH
[Filed July 30, 2018, 10:49 a.m.]
Original Notice.
Title of Rule and Other Identifying Information: WAC 246-907-030 Pharmaceutical licensing periods—Fees and renewal cycle, 246-907-0301 Pharmacy assistant licensing periods and fees—Fees and renewal cycle and 246-907-0302 Hospital pharmacy associated clinics licensing periods and fees—Fees 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.
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:
(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:
(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 fees—Fees and renewal cycle. |