Legislature(2017 - 2018)SENATE FINANCE 532
02/05/2018 09:00 AM Senate FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| SB4 | |
| SB37 | |
| SB126 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | SB 37 | TELECONFERENCED | |
| + | SB 126 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
| += | SB 4 | TELECONFERENCED | |
SENATE BILL NO. 37
"An Act relating to the Board of Pharmacy; relating to
the licensing and inspection of certain facilities
located outside the state; relating to drug supply
chain security; and creating a position of executive
administrator for the Board of Pharmacy."
9:11:45 AM
SENATOR CATHY GIESSEL, SPONSOR, discussed the bill. She
noted that the bill would help the Board of Pharmacy but
assuring the safe practices of pharmacists and the safety
of medication entering the state. She offered a Sponsor
Statement:
Passage of Senate Bill 37 will create a more secure
drug supply chain by allowing for licensing and
inspection of wholesale drug distributors outside of
the state. Currently, Alaska is one of the few
remaining states that does not license out-of-state
wholesale drug distributors. With laws and regulations
varying from state to state, licensing an out-of-state
wholesale distributor can prove arduous. With this
legislation, Alaska can take action to eliminate
wholesalers looking for loopholes in the regulatory
system and ensure that out-of-state applicants seeking
licensure comply with the same regulations as Alaska
wholesalers.
This legislation is critical and necessary to bring
Alaska into compliance with the Drug Quality Security
Act (DQSA) and create a new license category for "Out-
of-State Wholesale Drug Distributors." Currently, the
Board of Pharmacy has no authority to regulate out-of-
state wholesale drug distributors or third-party
logistic providers (3PLs).
SB 37 would ensure safe delivery of controlled, non-
counterfeit medications to Alaskans. SB 37 would
require that any out-of-state wholesale drug
distributor or outsourcing facility follow specific
guidelines including obtaining a license, authorizing
inspection of the facility by a designee of the board,
and appointing an agent before shipping, mailing or
delivering prescription drugs to a licensee in the
state or advertising in the state.
Additionally, this legislation allows the Board of
Pharmacy to create a new position titled "Executive
Administrator" to serve as a liaison to the
legislative and executive branches of state
government, the media, and other state pharmacy
boards, as well as implement board statutes and
regulations, and aid in managing current licensees.
Senator Giessel stated that the fiscal note was receipt
services. She added that a recent audit had been completed
on the board, which currently had $275,000 in excess
revenues from licensing fees that would pay for the const
of the range 23 position identified in the bill.
9:16:50 AM
Co-Chair MacKinnon asked whether Alaska was the only state
that lacked the provision for out-of-state drug providers.
Senator Giessel believed that there were 4 states without
the provision.
9:17:22 AM
JANE CONWAY, STAFF, SENATOR CATHY GIESSEL, discussed the
Sectional Analysis (copy on file):
Section 1: Amends AS 08.80.030(b) by adding a new
subsection:
(14): Establishes qualifications and duties of
executive administrator. Executive administrator is
delegated authority in order to conduct board
business.
Section 2: Amends AS 08.80.030(b) by adding a new
subsection:
(15): Amends and allows licensing and inspection for
out-of-state drug distributors, third-party logistics
providers and outsourcing facilities;
Section 3: Amends AS 08.80.030 by adding a new
subsection:
AS 08.80.030(c): Specifications for facilities,
equipment, personnel, and procedures for control of
drugs in compliance with the federal Drug Supply Chain
Security Act.
Section 4: Amends AS 08.80.157 by adding a new
subsection:
(k): Requires wholesale drug distributors, third-party
logistics providers, and outsourcing facilities
outside the state under AS 08.80.159, to be licensed.
Section 5: Amends AS 08.80 by adding a new section:
Sec. 08.80.159: Requires that a wholesale drug
distributor, third party logistics provider, or
outsourcing facility have a license in Alaska before
shipping, mailing, or delivering prescription drugs to
a licensee in the state or before advertising in the
state, an agent must be appointed in the state, and a
designee of the board must authorize inspection of the
facility.
An outsourcing facility, in addition, must comply with
the federal Drug Quality and Security Act of 2013. The
board may require an inspection of facilities located
outside of the state, approve a designee to inspect.
The board shall adopt regulations to implement this
section.
Section 6: Amends AS 08.80 by adding new section to
Article 2:
Sec. 08.80.270: Allows the Board to create an
executive administrator position. Defines the role and
salary range of the executive administrator.
Section 7: Amends AS 08.80.480 by adding a new
paragraph:
AS 08.80.480(37): Defines "outsourcing facility"
AS 08.80.480(38): Defines "third party logistics
provider"
Section 8: Amends AS 39.25.120(c)(7) by adding
(Q) Board of Pharmacy
Sections 9, 10, 11:
Provides transition language and effective date
clause.
9:20:00 AM
Senator Micciche looked at Section 8. He asked about
television commercials that advertised for drugs in the
state.
Ms. Conway replied that the language was directed toward
the licensing for the wholesalers to reach out to
pharmacists to promote their drugs and not for
advertisements for drugs on television.
9:21:23 AM
RICHARD HOLT, VICE CHAIR, ALASKA BOARD OF PHARMACY, EAGLE
RIVER (via teleconference), agreed with Ms. Conway's
response.
9:21:43 AM
Mr. Holt added that the legislation had many positive
aspects. He believed that the bill would ultimately protect
the health and safety of Alaskans. He reiterated that the
bill would have no financial impact to Tribal Health
facility purchasing.
9:24:01 AM
LEIF HOLM, CHAIR, ALASKA BOARD OF PHARMACY, NORTH POLE (via
teleconference), testified in support of the legislation.
He echoed previous testimony. He stated that licensing
wholesalers in Alaska was important for the safety of
Alaskans. He said that it could be difficult for
pharmacists to know who they were doing business with and
the kinds of medications those businesses were offering. He
felt that the addition of the administrative position was
long overdue. He reiterated the non-fiscal impact of the
fiscal note.
9:28:36 AM
BARRY CHRISTENSEN, LEGISLATIVE CO-CHAIR, ALASKA PHARMACY
ASSOCIATION, KETCHIKAN (via teleconference), spoke in
strong support of the bill.
9:29:22 AM
Senator Micciche said that he had further questions for
DCCED.
9:29:33 AM
DERIK WHITE, PHARMACIST, SITKA (via teleconference),
testified in support of the legislation. He spoke of the
importance of regualtion of pharmaceutical ingredients and
storage.
9:31:26 AM
Senator Stevens asked whether the bill would affect the
many Alaskans who received their prescriptions through
Tribal Health and Veteran Associations.
Senator Geissel replied in the negative.
9:32:33 AM
Co-Chair MacKinnon CLOSED public testimony.
9:32:56 AM
Vice-Chair Bishop MOVED to ADOPT Amendment 1, 30-
LS0191\R.1, Radford, 2/2/18 (copy on file):
Page 6, line 25:
Delete "2018
Insert "2019"
Co-Chair MacKinnon OBJECTED for discussion.
9:33:06 AM
Co-Chair MacKinnon explained the amendment.
WITHDREW the OBJECTION. There being NO OBJECTION, it was so
ordered.
9:33:25 AM
Vice-Chair Bishop adopt Amendment 2, 30-LS0191\R.2,
Radford, 2/2/18 (copy on file):
Page 5, line 16, following "shall":
Insert "(1)"
Page 5, line 17, following "board":
Insert"; and
(2) serve as a liaison to the legislative
and executive branches of state government,
the media, and other state pharmacy boards"
Co-Chair MacKinnon OBJECTED for discussion.
Co-Chair MacKinnon explained the amendment.
Co-Chair MacKinnon WITHDREW the OBJECTION. There being NO
OBJECTION, it was so ordered.
9:34:30 AM
Senator Giessel supported the amendments.
9:35:04 AM
JANEY MCCULLOUGH, DIRECTOR, CORPORATIONS, BUSINESS, AND
PROFESSIONAL LICENSING, DEPARTMENT OF COMMERCE, COMMUNITY
AND ECONOMIC DEVELOPMENT, related that she was available
for questions.
9:35:12 AM
Senator Micciche asked Ms. McCullough to explain that the
bill would be of no cost to the state.
Ms. McCullough explained that statute required any costs
associated with regulating an occupation would be covered
by licensing fees for said occupation.
9:36:40 AM
Ms. McCullough explained that an increase in revenue would
be offset any costs.
9:37:56 AM
Co-Chair MacKinnon asked Ms. McCullough to discuss the
fiscal note in further detail.
Ms. McCullough read from the analysis:
If the bill passes the following expenses will be
incurred: Personal Services: $136.5 (one permanent
full-time executive administrator, range 23)
Travel: $6.0 (one executive administrator to attend
four board meetings per year)
Services: $16.7 (legal costs to amend regulations,
printing, and postage in the first year) $15.0
(statewide core services RSAs: Human Resources,
financial support, mail, software licenses, and
department support costs)
Commodities: $10.0 (computer, office furniture, and
other one-time needs in the first year)
9:38:18 AM
Vice-Chair Bishop expressed support for the legislation.
9:38:46 AM
Vice-Chair Bishop MOVED to REPORT CS SB 37(FIN) out of
committee with individual recommendations and attached
fiscal notes. There being NO OBJECTION, it was so ordered.
CSSB 37(FIN) was REPORTED out of committee with a "do pass"
recommendation and with one new fiscal note from Department
of Commerce, Community and Economic Development.
9:39:13 AM
AT EASE
9:40:45 AM
RECONVENED
| Document Name | Date/Time | Subjects |
|---|---|---|
| SB 4 CSSSSB 4 work draft version U.pdf |
SFIN 2/5/2018 9:00:00 AM |
SB 4 |
| SB 37 Amendment 1 MacKinnon R.1 (002).pdf |
SFIN 2/5/2018 9:00:00 AM |
SB 37 |
| SB 37 Amendment 2 Mackinnon R.2 (002).pdf |
SFIN 2/5/2018 9:00:00 AM |
SB 37 |
| SB 126 Sectional Analysis.pdf |
SFIN 2/5/2018 9:00:00 AM |
SB 126 |
| SB 126 Testimony.pdf |
SFIN 2/5/2018 9:00:00 AM |
SB 126 |
| SB 126 Sponsor Statement.pdf |
SFIN 2/5/2018 9:00:00 AM |
SB 126 |