WSR 16-12-044
PROPOSED RULES
[Filed May 25, 2016, 1:19 p.m.]
Original Notice.
Title of Rule and Other Identifying Information: WAC 246-907-030 Pharmaceutical licensing periods-Fees and renewal cycle, proposing a separate registration category and separate application and renewal fees for Controlled Substances Act (CSA) researchers. CSA researchers are under the "Other CSA registrations" fees in the current rule.
Hearing Location(s): Department of Health, Town Center 2, 111 Israel Road, Room 158, Tumwater, WA 98501, on July 6, 2016, at 1:30 p.m.
Date of Intended Adoption: July 13, 2016.
Submit Written Comments to: Sherry Thomas, P.O. Box 47850, Olympia, WA 98504-7850, e-mail https://fortress.wa.gov/doh/policyreview, fax (360) 236-4626, by July 6, 2016.
Assistance for Persons with Disabilities: Contact Sherry Thomas by June 24, 2016, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Current licensing fees do not generate sufficient revenue to cover the costs of administering the CSA researcher registration. This registration is issued to an individual, but applies to a specific lab at which other authorized individuals conduct research using controlled substances named in the application. Much of the costs are incurred through initial and ongoing inspections of the research laboratory. The department is proposing to increase application and renewal fees to cover the average costs of the inspections. In addition, we are proposing to separate the CSA researcher registration fee from the "Other CSA registrations" category because it is much more costly to administer than the other registrations in this category. This "other" category also includes registrations for dog handlers/trainers who use dogs for drug detection, analytical laboratories, and school laboratories, for which the current $40 fees are adequate.
Reasons Supporting Proposal: RCW
43.70.250 requires the cost of each licensing program to be fully borne by the profession's members and licensing fees to be based on the licensing program's costs. Revenue from the current CSA researcher registration fee does not support the cost of the unique inspections required to maintain the credential, meaning other pharmacy program funds supplement this activity. The proposed fees cover the average costs of conducting the inspections for this registration.
In addition to the costs to issue and renew the controlled substance researcher credential, the inspection process requires additional costs. Most CSA researchers conduct unique research, leading to great variation in the expertise needed and a lengthier inspection process than the standard inspections for facilities such as pharmacies. The CSA researcher registration requires an inspection upon application and regular inspections thereafter. Those inspections consist of:
Initial applications: Require up to six hours of a pharmacy investigator's time, at a rate of $110 per hour, which consists of technical assistance to help the researcher develop:
. | Compliant record systems; |
. | Security and handling; and |
. | Storage and disposal of drugs used in the research project. |
Ongoing inspections: Require up to four hours of an investigator's time, at $110 per hour, which consists of:
. | Auditing of records regarding procurement, storage, use and disposal of drugs; |
. | Inspection of security and environmental measures implemented for storage of drugs; |
. | A review of written policies and procedures implemented by the researcher regarding procurement, compliant record systems, security and handling, storage and disposal of drugs used in the research project. This includes review of which personnel are authorized to access drugs; and |
. | Technical assistance to give guidance on how to correct any deficiencies found during the inspection. |
It can also involve a review of updated written policy and procedures that have been implemented post-inspection as a result of deficiencies noted during the inspection.
Given their current annual growth rate of 12.2 percent, regulation of CSA researchers will place an ever greater burden on the pharmacy program. The number of CSA researchers is growing, as an increasing number of privately owned biotech and pharmaceutical firms are opening in Washington.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of health, governmental.
Name of Agency Personnel Responsible for Drafting and Implementation: Sherry Thomas, 111 Israel Road, Tumwater, WA 98501, (360) 236-4612; and Enforcement: Doreen Beebe, 111 Israel Road, Tumwater, WA 98501, (360) 236-4834.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW
19.85.025 and
34.05.310 (4)(f), a small business economic impact statement is not required for proposed rules that set or adjust fees or rates pursuant to legislative standards.
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.
May 25, 2016
John Wiesman, DrPH, MPH
Secretary
AMENDATORY SECTION (Amending WSR 11-20-092, filed 10/4/11, effective 12/1/11)
WAC 246-907-030 Pharmaceutical licensing periods and fees-Fees and renewal cycle.
(1) Pharmacist, pharmacy technician, and pharmacy intern licenses 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), Controlled Substances Act researcher registration, pharmacy technician utilization, and shopkeepers differential hours licenses will expire on June 1 of each year.
(3) All other licenses, including health care entity licenses, registrations, permits, or certifications will expire on October 1 of each year.
(4) The following nonrefundable fees will be charged for pharmacy location:
| |
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 |
135.00 |
