WSR 21-18-102
PERMANENT RULES
DEPARTMENT OF HEALTH
[Filed August 31, 2021, 11:32 a.m., effective December 1, 2021]
Effective Date of Rule: December 1, 2021.
Purpose: WAC 246-945-990 Pharmaceutical licensing fees and renewal cycle, 246-945-991 Hospital pharmacy associated clinics fees and renewal cycle, and 246-945-992 Fee payment. The department of health (department), in consultation with the pharmacy quality assurance commission (commission), has adopted changes and recodified three sections of rule to move fees for all license types collected by the commission into the recently created chapter 246-945 WAC. The adopted rules also change professional licenses to a two-year renewal cycle and adds a new fee for the registration of a remote dispensing site created by the passage of SSB 6086.
Citation of Rules Affected by this Order: New WAC 246-945-990, 246-945-991 and 246-945-992; and repealing WAC 246-907-030, 246-907-0302, and 246-907-040.
Statutory Authority for Adoption: RCW
43.70.110,
43.70.250; and SSB 6086 (chapter 244, Laws of 2020).
Adopted under notice filed as WSR 21-12-074 on May 28, 2021.
Changes Other than Editing from Proposed to Adopted Version: The following technical, nonsubstantive changes were made to the proposed rules upon adoption:
WAC 246-945-990 (5)(b) removed fees listed under "with differential hours." The pharmacy license with differential hours no longer exists, so that was removed for accuracy.
WAC 246-945-992(1) had a typo. "A licensed pharmacist" should have read "A licensed pharmacy." That typo has been corrected in the adopted version of the rules.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 1, Amended 0, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 2, Amended 0, Repealed 3.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 3, Amended 0, Repealed 3.
Date Adopted: August 31, 2021.
Kristin Peterson, JD
Deputy Secretary
for Policy and Planning
for Umair A. Shah, MD, MPH
Secretary
OTS-2987.5
AMENDATORY SECTION(Amending WSR 18-21-123, filed 10/18/18, effective 1/1/19)
WAC 246-907-030Pharmaceutical licensing fees and renewal cycle.
(1) Pharmacist, pharmacy technician, pharmacy intern, and pharmacy assistant credentials must be renewed every two years on the practitioner's birthday as provided in chapter 246-12 WAC((, Part 2)).
(2) Pharmacy location credentials, controlled substance researcher registration, drug dog handler K9 registration, and other Controlled Substances Act registrations will expire on June 1st of each year.
(3) All other credentials, including health care entity, 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 professionals:
(a) All pharmacy professionals:
Title of fee | Fee |
Verification of credential | $25.00 |
Duplicate credential | 10.00 |
(b) Pharmacist:
((Original))Initial credential | (($200.00)) $400.00 |
Renewal | ((265.00)) 530.00 |
Late renewal penalty | ((135.00)) 265.00 |
Expired credential reissuance | 265.00 |
Inactive credential renewal | 265.00 |
Retired active credential status application | ((25.00)) 50.00 |
Retired active credential status renewal | ((25.00)) 50.00 |
Temporary practice permit | 100.00 |
Reciprocity (license by license transfer) | 465.00 |
(c) Pharmacy technician:
((Original))Initial credential | (($70.00)) $140.00 |
Renewal | ((70.00)) 140.00 |
Late renewal penalty | ((50.00)) 70.00 |
Expired credential reissuance | 70.00 |
(d) Pharmacy intern:
((Original))Initial credential | (($45.00)) $90.00 |
Renewal | ((45.00)) 90.00 |
Late renewal penalty | ((45.00)) 50.00 |
Verification of internship hours | 25.00 |
Expired credential reissuance | 45.00 |
(e) Pharmacy assistant:
((Original))Initial credential | (($35.00)) $70.00 |
Renewal | ((35.00)) 70.00 |
Late renewal penalty | ((35.00)) 50.00 |
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))246-945-991) |
| ((Original))Initial credential | $540.00 |
| Renewal | 540.00 |
| Late renewal penalty | 270.00 |
Pharmacy technician utilization |
| ((Original))Initial utilization | 100.00 |
| Renewal | 100.00 |
Controlled substances authority |
| ((Original))Initial credential | 150.00 |
| Renewal | 150.00 |
((With differential hours |
| Original credential | 55.00 |
| Renewal | 55.00)) |
(c) Nonresident pharmacy:
Pharmacy credential |
| ((Original))Initial credential | $540.00 |
| Renewal | 540.00 |
| Late renewal penalty | 270.00 |
Controlled substances authority |
| ((Original))Initial credential | 150.00 |
| Renewal | 150.00 |
(d) Controlled substance researcher:
((Original))Initial credential | $400.00 |
Renewal | 400.00 |
(e) Other controlled substances act registrations (i.e., analytical laboratories, school laboratories):
((Original))Initial credential | $360.00 |
Renewal | 360.00 |
(f) Drug dog handler K9 registration:
((Original))Initial credential | $55.00 |
Renewal | 55.00 |
(g) Health care entity:
Health care entity credential |
| ((Original))Initial credential | $540.00 |
| Renewal | 540.00 |
| Late renewal penalty | 270.00 |
Controlled substances authority |
| ((Original))Initial credential | 150.00 |
| Renewal | 150.00 |
(h) Drug manufacturer:
Manufacturer credential |
| ((Original))Initial credential | $825.00 |
| Renewal | 825.00 |
| Late renewal penalty | 300.00 |
Controlled substances authority |
| ((Original))Initial credential | 150.00 |
| Renewal | 150.00 |
(i) Drug wholesaler – Full line:
Wholesaler credential |
| ((Original))Initial credential | $825.00 |
| Renewal | 825.00 |
| Late renewal penalty | 300.00 |
Controlled substances authority |
| ((Original))Initial credential | 150.00 |
| Renewal | 150.00 |
(j) Drug wholesaler – Export:
Wholesaler credential |
| ((Original))Initial credential | $825.00 |
| Renewal | 825.00 |
| Late renewal penalty | 300.00 |
(k) Drug wholesaler – OTC only:
((Original))Initial credential | $465.00 |
Renewal | 465.00 |
Late renewal penalty | 235.00 |
(l) Drug wholesaler – Export nonprofit humanitarian organization:
Wholesaler credential |
| ((Original))Initial credential | $25.00 |
| Renewal | 25.00 |
| Late renewal penalty | 25.00 |
(m) Legend drug sample distributor:
Distributor credential |
| ((Original))Initial credential | $540.00 |
| Renewal | 540.00 |
| Late renewal penalty | 270.00 |
Controlled substances authority |
| ((Original))Initial credential | 150.00 |
| Renewal | 150.00 |
(n) Poison manufacturer/seller:
((Original))Initial credential | $55.00 |
Renewal | 55.00 |
Late renewal penalty | 50.00 |
(o) Precursor chemicals:
((Original))Initial credential | $55.00 |
Renewal | 55.00 |
Late renewal penalty | 50.00 |
(p) Itinerant vendor:
((Original))Initial credential | $55.00 |
Renewal | 55.00 |
Late renewal penalty | 50.00 |
(q) Sodium pentobarbital for animal euthanization:
((Original))Initial credential | $55.00 |
Renewal | 55.00 |
Late renewal penalty | 50.00 |
(r) Shopkeeper:
((Original))Initial credential | $55.00 |
Renewal | 55.00 |
(s) Remote dispensing site for opioid use disorder medications registration:
Initial credential | $55.00 |
Renewal | 55.00 |
Late renewal penalty | 50.00 |
AMENDATORY SECTION(Amending WSR 18-21-123, filed 10/18/18, effective 1/1/19)
WAC 246-907-0302Hospital pharmacy associated clinics 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)))246-945-990(5). 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))246-945-233(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 | $895.00 | |
B | 11-50 | $2,240.00 | |
C | 51-100 | $3,125.00 | |
D | Over 100 | $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 | $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.
AMENDATORY SECTION(Amending WSR 91-19-028, filed 9/10/91, effective 10/11/91)
WAC 246-907-040Fee payment.
(1) A licensed ((pharmacist))pharmacy, wholesaler, or manufacturer shall pay a facility inspection fee in lieu of the original license fee when there is only a change of facility location within the premises identified by the license address. Any change of location to a different address shall require a new application and payment of the original license fee.
(2) An original license fee shall be paid whenever there is any change in ownership, including change in business structure or organizational structure such as a change from sole proprietorship to a corporation, or a change of more than fifty percent ownership in a corporation.
(3) All fees for pharmacy professionals are charged on ((an annual))a biennial basis and will not be prorated.
(4) All fees for pharmaceutical firms are charged on an annual basis and will not be prorated.
NEW SECTION
The following sections of the Washington Administrative Code are decodified and recodified as follows:
Old WAC Number | New WAC Number |
246-907-030 | 246-945-990 |
246-907-0302 | 246-945-991 |
246-907-040 | 246-945-992 |