Legislature(2017 - 2018)BELTZ 105 (TSBldg)
03/14/2017 01:30 PM Senate LABOR & COMMERCE
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| Audio | Topic |
|---|---|
| Start | |
| SB4 | |
| SB16 | |
| SB32 | |
| SB64 | |
| SB79 | |
| SB37 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| + | SB 64 | TELECONFERENCED | |
| *+ | SB 79 | TELECONFERENCED | |
| *+ | SB 37 | TELECONFERENCED | |
| += | SB 4 | TELECONFERENCED | |
| += | SB 16 | TELECONFERENCED | |
| += | SB 32 | TELECONFERENCED | |
SB 37-PHARMA BD & EMPLOYEES; DRUG DIST/MANUFAC
3:01:47 PM
CHAIR COSTELLO announced the consideration of SB 37. She noted
this is the first hearing. The intent is to hear from the
sponsor, take members' questions, take public testimony, and
hold the bill for further consideration.
3:02:40 PM
SENATOR CATHY GIESSEL, Alaska State Legislature, sponsor of SB
37, said she appreciates teaming SB 79 with SB 37. She noted the
bill is at the request of the Board of Pharmacy. It is not a new
issue; a similar bill was heard last session.
She stated that SB 37 ensures a more secure drug supply chain to
ensure that Alaskans receive safe, non-counterfeit,
unadulterated medications. In Alaska, when a pharmacy, doctor,
or hospital orders a supply of prescription medications, they
may order from one of the wholesale distributors in Alaska or
one in the Lower 48. Alaska is one of two states that does not
license out-of-state wholesale distributors. In 2012
contaminated medicines were distributed that resulted in the
death of many people in the Lower 48. To protect Alaska, SB 37
would ensure that out-of-state applicants seek licensure and
comply with the same regulations Alaska wholesale distributors
comply with.
She said that SB 37 also brings Alaska into compliance with a
federal law - the Drug Quality Security Act of 2013 - and will
create a new license category under the Board of Pharmacy for
out-of-state wholesale distributors. The Division of
Corporations, Business, and Professional Licensing estimates
that this will equal about 400 new licensees. Currently, the
Alaska Board of Pharmacy has no authority to regulate out-of-
state wholesale distributors and SB 37 would provide that. It
would require certain guidelines for the distributor: obtain a
license in Alaska, authorize inspection by a designee of the
Board, and give the Board the authority to appoint an agent to
examine the distributor's facility.
She highlighted the definition section of the bill, noting that
one definition - "outsourcing facility" - is a facility that
compounds sterile drugs. It is an example of an entity that
would fall under SB 37.
3:05:55 PM
SENATOR GIESSEL advised that the Board of Pharmacy is being
asked to take on more responsibilities. Last year under the
Medicaid reform bill the Prescription Drug Monitoring [Program]
(PDMP) was established, which puts more responsibilities on the
Board. SB 37 will allow the Board to create an executive
administrator position to implement statutes and regulations and
manage the Board's new responsibilities.
She noted a fiscal note for SB 37 and that the services provided
are all receipt services. Monies will be recovered through
wholesale license fees and the executive administrative position
will be funded by licensees of the Board of Pharmacy.
CHAIR COSTELLO noted that Sara Chambers from the Division of
Corporations, Business, and Professional Licensing, Department
of Commerce, Community and Economic Development was available to
answer questions.
3:07:45 PM
JANE CONWAY, Staff, Senator Cathy Giessel, Alaska State
Legislature, presented the sectional analysis of SB 37 on behalf
of the sponsor. She read the following:
Section 1: Amends AS 08.80.030(b)
(14): Amends and allows licensing and inspection for
out-of-state drug distributors and outsourcing
facilities
(15): 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 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 3: Amends AS 08.80.157 by adding a new
subsection:
(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, that 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.
3:09:53 PM
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: Amends AS 08.80.480 by adding a new
paragraph:
AS 08.80.480(37): Defines "outsourcing facility"
3:10:26 PM
SENATOR STEVENS asked if Alaska wholesalers receive federal
inspections and inspections by other states.
SENATOR GIESSEL said she did not know. She suggested asking
pharmacists.
3:11:00 PM
SENATOR GARDNER asked about reciprocity and why Alaska can't
rely on inspection standards of other states for wholesale drug
companies.
3:11:33 PM
SENATOR GIESSEL said she did not know. She suggested asking the
pharmacists. She said one provision in the bill is that the
Board could designate someone in another state to examine that
state's wholesaler.
SENATOR GARDNER asked how much medication is brought into Alaska
by wholesalers and how many wholesalers are in Alaska.
SENATOR GIESSEL said she believes there is one wholesale
distributor in Alaska.
3:13:23 PM
CHAIR COSTELLO opened public testimony on SB 37. She requested
that Mr. Christensen address members' questions.
BARRY CHRISTENSEN, Co-Chair, Alaska Pharmacists Association,
testified in support SB 37. He deferred to Mr. Holm to answer
members' questions. He said the bill is necessary to ensure that
Alaskans are receiving good medications. He agreed that the
Board of Pharmacy has been taxed with doing more with minimal
staffing. He supported having an executive administrator on the
Board.
3:15:00 PM
LEIF HOLM, Chair, Board of Pharmacy, testified in support of SB
37. He reiterated the purpose of the bill. He voiced support for
the executive assistant position due to the increased workload
of the Board. He repeated the funding mechanisms outlined in the
fiscal note.
SENATOR STEVENS asked, if the federal government inspects
wholesalers in Alaska, why there is a need for an extra
inspection. He also wondered whether other states inspect Alaska
wholesalers.
MR. HOLM clarified that the bill is written so that Alaska "may"
do an inspection. He did not have information on what other
states do. He added that there are 21 states that recognize the
National Association of the Boards of Pharmacy's Verified
Accredited Wholesale Distributor Program (VAWD), which is a
built-in inspection. The Alaska Board of Pharmacy accepts that
as part of the licensure process.
3:18:37 PM
CHAIR COSTELLO asked if the Board can direct an individual to
conduct the inspection. She asked whether the VAWD fulfills that
requirement.
MR. HOLM said he believes that would work.
3:19:14 PM
SENATOR GARDNER asked if it is customary in some places for
pharmaceutical wholesalers to be licensed to hold VAWD
accreditation.
MR. HOLM responded that four states require that accreditation
to do business in their state.
SENATOR GARDNER asked if it would make sense for Alaska to
require VAWD certification.
MR. HOLM said not at this point. Other states also have other
extensive pharmacy inspections that Alaska accepts. He did not
want to limit the drug supply, just insure its quality.
3:20:50 PM
SENATOR GARDNER asked if passing SB 37 means that if an Alaskan
pharmacist were to purchase drugs they would have to buy them
from an Alaskan wholesaler or an outside distributer with an
Alaskan license and certificate of inspection.
MR. HOLM said he believes they would have to have an Alaskan
wholesale license.
3:22:07 PM
SENATOR HUGHES asked Mr. Holms to explain the current makeup of
the Board. She wondered if the new executive position would be
covered by outside license fees and if pharmacist license fees
will increase. She also inquired whether pharmacists support SB
37.
3:23:08 PM
MR. HOLM related that the Board's licensing examiner is
backlogged with work. The wholesale license fee is anticipated
to be $1,000 to $5,000, which should be more than sufficient to
cover the cost of an executive administrator. He did not
anticipate that pharmacist license fees will increase.
CHAIR COSTELLO closed public testimony on SB 37 and held the
bill in committee for further consideration.