Legislature(2015 - 2016)SENATE FINANCE 532
04/09/2016 10:00 AM Senate FINANCE
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| Audio | Topic |
|---|---|
| Start | |
| SB201 | |
| SB200 | |
| SJR12 | |
| SB8 | |
| SB163 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 201 | TELECONFERENCED | |
| + | SB 200 | TELECONFERENCED | |
| + | SJR 12 | TELECONFERENCED | |
| + | SB 163 | TELECONFERENCED | |
| + | SB 8 | TELECONFERENCED | |
| + | TELECONFERENCED |
SENATE BILL NO. 201
"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."
10:08:34 AM
EMMIE VAN WYHE, STAFF, SENATOR CATHY GIESSEL,
offered a sponsor statement (copy on file):
Passage of SB 201 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 all 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, there
is no authority by the Board of Pharmacy to regulate
Out-of-State Wholesale Drug Distributors or third
party logistic providers (3PLs). SB 201 would ensure
safe delivery of controlled, non-counterfeit
medications to Alaskans.
SB 201 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.
10:11:14 AM
Co-Chair MacKinnon requested a sectional analysis.
JANE CONWAY, STAFF, SENATOR CATHY GIESSEL, addressed the
sectional analysis (copy on file):
Section 1:
AS 08.80.130(13): Allows licensing and inspecting
for out-of-state drug distributors and
outsourcing facilities.
AS 08.80.130(14): Establishes qualifications and
duties of executive administrator. Executive
administrator is delegated authority in order to
conduct board business.
Section 2:
AS 08.80.03(c): Specifications for facilities,
equipment, personnel, and procedures for control
of drugs
Section 3:
AS 08.80.157(k): Applies to wholesale drug
distributors and outsourcing facilities outside
the state under
AS 08.80.159, regarding licensing.
Section 4: Amends AS 08.80 by adding a new section:
Sec. 08.80.159: Requires that a wholesale drug
distributor 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 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 5: 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 of the executive administrator.
Section 6:
AS 08.80.480(37): Defines "outsourcing facility"
10:13:50 AM
Co-Chair MacKinnon solicited questions on the intent of the
legislation.
10:14:01 AM
Senator Bishop understood that the legislation was driven
by the Drug Supply Chain Act of 2013.
Ms. Conway replied in the affirmative. She added that
Alaska would be the final state to comply with the
regulations.
Senator Bishop referred to section 2 of the bill, and
wondered how much complying with the legislation would cost
pharmacies in the state.
Ms. Conway replied that the legislation should not cost
pharmacies in the state any funds. She explained that the
bill solely pertained to the regulation of out-of-state
wholesalers in order to protect pharmacies in Alaska from
receiving counterfeit, or contaminated, drugs.
10:16:04 AM
Co-Chair MacKinnon OPENED public testimony.
10:16:44 AM
JOHN COTTER, CHAIR, BOARD OF PHARMACY, FAIRBANKS (via
teleconference), testified in support of the bill. He noted
that the major component of the bill was the licensure of
wholesalers, which would insure the integrity of the drugs
being sold within the state. He added that the Drug Quality
Security Act (2013) had secured the pedigree of drugs, and
the bill would ensure that out-of-state wholesalers were
compliant to that end. He said that the hope was that any
revenue from the bill would offset the cost of adding an
executive administrator to manage the Board of Pharmacy and
the growing complexity of board business.
10:19:09 AM
DIRK WHITE, SELF, SITKA (via teleconference), testified in
support of the legislation. He echoed the testimony of the
previous speaker. He believed the bill would bring the
state in to compliance with the Drug Quality Security Act.
He restated that the bill was financially neutral to
pharmacies in the state. He reiterated that the bill would
protect the integrity of the pedigree of the drugs that are
sold to the state.
10:21:25 AM
TARA RUFFNER, ALASKA PHARMACISTS ASSOCIATION, KENAI (via
teleconference), testified in support of the bill. She
believed that the legislation would make sure
pharmaceuticals were tracked through the supply change in a
transparent way.
10:22:49 AM
Co-Chair MacKinnon asked whether the outsourcing facility
had to be in the United States, or would the tracking reach
international borders.
Ms. Ruffner replied that she was not sure of the answer.
She offered to get back to the committee with the
information.
10:23:18 AM
Vice-Chair Micciche asked whether an Alaska resident could
order pharmaceuticals from outside the state, and if so,
would the bill cover internet suppliers.
Ms. Ruffner stated that anyone could go on the internet and
order drugs, and doubted that they were regulated.
Vice-Chair Micciche hoped the sponsor would address the
issue.
10:24:02 AM
Co-Chair MacKinnon CLOSED public testimony.
Co-Chair MacKinnon asked Ms. Conway to respond to the two
previous questions regarding international and internet
activity.
Ms. Conway stated that she would provide a response to
those issues to the committee at a later date.
10:25:09 AM
Vice-Chair Micciche discussed the fiscal notes attached to
the legislation (copy on file).
10:26:04 AM
Co-Chair MacKinnon queried the perspective of the
Department of Commerce, Community and Economic Development
on the estimation of receipts coming in to monitor the
program.
10:26:27 AM
JANEY HOVENDEN, DIRECTOR, DIVISION OF CORPORATIONS,
BUSINESS AND PROFESSIONAL LICENSING, DEPARTMENT OF
COMMERCE, COMMUNITY AND ECONOMIC DEVELOPMENT, stated that
the cost of the fiscal note was expected to be covered by
new licensees.
SB 201 was HEARD and HELD in committee for further
consideration.
10:27:06 AM
Co-Chair MacKinnon welcomed Co-Chair Kelly to the table.
| Document Name | Date/Time | Subjects |
|---|---|---|
| SB 8 Public Testimony Packet 1.pdf |
SFIN 4/9/2016 10:00:00 AM |
SB 8 |