Legislature(2023 - 2024)BELTZ 105 (TSBldg)
04/24/2023 01:30 PM Senate LABOR & COMMERCE
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| Audio | Topic |
|---|---|
| Start | |
| HB51 | |
| SB73 | |
| SB94 | |
| SB108 | |
| Adjourn |
* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
| += | HB 51 | TELECONFERENCED | |
| += | SB 73 | TELECONFERENCED | |
| += | SB 94 | TELECONFERENCED | |
| *+ | SB 108 | TELECONFERENCED | |
| + | TELECONFERENCED | ||
SB 94-PROFESSION OF PHARMACY
1:54:01 PM
CHAIR BJORKMAN reconvened the meeting and announced the
consideration of SENATE BILL NO. 94 "An Act relating to the
Board of Pharmacy; relating to the practice of pharmacy;
relating to pharmacies; relating to prescription drug
manufacturers; relating to prescriptions for epinephrine;
relating to the administration of epinephrine; and providing for
an effective date."
He stated that this is the third hearing of the bill and there
is one friendly amendment for the committee to consider. He
invited Ms. Conway to provide a recap of SB 94.
1:54:59 PM
JANE CONWAY, Staff, Senator Cathy Giessel, Alaska State
Legislature, Juneau, Alaska, gave a recap of SB 94. She
explained that SB 94 updates pharmacy statutes by bringing them
into the modern era. She said that the Board of Pharmacy and the
Alaska Pharmacist Association collaborated for months on the
bill which covers out-of-state pharmacies, wholesalers, and
distribution centers among other areas. SB 94 clarifies powers
for the Board of Pharmacy and adds a national criminal
background check for pharmacists.
1:56:21 PM
CHAIR BJORKMAN found no questions and requested a motion to
adopt the proposed amendment.
1:56:35 PM
SENATOR GRAY-JACKSON moved to adopt Amendment 1, work order 33-
LS0293\U.1, for SB 94.
33-LS0293\U.1
Bergerud
4/21/23
AMENDMENT 1
OFFERED IN THE SENATE
TO: SB 94
Page 1, line 2, following "manufacturers;":
Insert "relating to licensing and registration
requirements for certain wholesale drug distributors;"
Page 4, following line 11:
Insert a new bill section to read:
"*Sec. 4. AS 08.80.157(h) is amended to read:
(h) The board may suspend, revoke, deny, or
refuse to renew the license of a facility or
pharmacy on the following grounds:
(1) the finding by the board of
violations of a federal, state, or local law
relating to the practice of pharmacy, drug
samples, wholesale or retail drug or device
distribution, or distribution of controlled
substances;
(2) a felony conviction under federal,
state, or local law of an owner of the facility
or pharmacy or of an employee of the facility or
pharmacy;
(3) the furnishing of false or
fraudulent material in an application made in
connection with drug or device manufacturing or
distribution;
(4) suspension or revocation by
federal, state, or local government of a license
currently or previously held by the applicant for
the manufacture or distribution of drugs or
devices, including controlled substances;
(5) obtaining remuneration by fraud,
misrepresentation, or deception;
(6) dealing with drugs or devices that
are known or should have been known to be stolen
drugs or devices;
(7) dispensing or distributing drugs or
devices directly to patients by a wholesale drug
distributor other than a pharmacy unless
(A) the drug or device is a
dialysate, drug composed solely of fluids,
electrolytes, and sugars, or device that is
(i) necessary to perform
home dialysis;
(ii) approved by the United
States Food and Drug Administration, as
required by federal law; and
(iii) delivered in its
original, sealed, and labeled packaging
only upon the receipt of a physician's
order; and
(B) the wholesale drug distributor
(i) delivers the dialysate
drug or device directly to a patient
with end-stage renal disease, or to the
patient's designee, for the patient's
self-administration of dialysis
therapy;
(ii) uses a bar code
scanning and verification system
confirming that the dialysate drug or
device selected to fill the patient-
specific order matches the information
on the patient-specific label; and
(iii) has additional
secondary accuracy and delivery checks
in place; and
(C) a licensed pharmacist serves
as a consultant to the wholesale drug
distributor to
(i) conduct a retrospective
audit of 10 percent of the dialysate
drug and device orders provided
directly to patients processed by the
wholesale drug distributor every month;
and
(ii) perform assessments at
least twice monthly to ensure quality
of product storage, handling, and
distribution by the wholesale drug
distributor, and to ensure product
expiration dates are later than three
months after the date of assessment;
(8) violation of this chapter or a
regulation adopted under this chapter."
Renumber the following bill sections accordingly.
Page 9, line 20:
Delete "sec. 18"
Insert "sec. 19"
Page 9, line 21:
Delete "sec. 18"
Insert "sec. 19"
Page 9, line 31:
Delete "Section 20"
Insert "Sections 4 and 21"
Page 10, line 1:
Delete "sec. 21"
Insert "sec. 22"
CHAIR BJORKMAN asked Ms. Conway to explain Amendment 1 to SB 94.
1:56:51 PM
MS. CONWAY explained the following changes Amendment 1 would
make to SB 94:
[Original punctuation provided.]
Senate Bill 94 Profession of Pharmacy
Explanation of Changes if Amendment LS0293\U.1 is
adopted:
Amendment U.1 adds language to the bill regarding the
direct shipping of dialysate and other dialysis
treatment devices and supplies to the patient. This
language comes from CSHB 96 (Rep. Prax) and is being
added to mirror changes made in the companion bill to
SB 94.
The amendment requires that the dialysate and dialysis
devices and supplies
• Must be approved by the FDA
• Must arrive in a sealed and labeled package and
ordered via a physician
• Must be directly sent to the patient (with end-stage
renal disease or acute kidney injury) or patient
designee. Currently there are 154 home-dialysis
patients (as of 2020 statistics)
• Must be marked with a scannable bar code matched to
the patient-specific label
• A licensed pharmacist must serve as a consultant to
ensure wholesale drug distributors test each month
the dialysate and devices sent to patients AND they
must perform quality assessments 2X a month to
ensure proper storage, handling and distribution.
The dialysate must have an expiration date that is
good for 3 months following the assessment date.
And because of the provisions set out in this SB 94,
the facility would be licensed and under the
jurisdiction of the AK Board of Pharmacy.
Currently 24 states use this model, 8 other states
have something similar. There have been no known cases
of harm reported. 2 states have legislation pending to
allow this program.
A short deck of slides is attached for additional
information for your review.
2:01:19 PM
At ease.
2:02:43 PM
CHAIR BJORKMAN reconvened the meeting and held SB 94 in
committee with Amendment 1 pending.