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HOUSE BILL 505
57
TH LEGISLATURE
-
STATE
OF
NEW
MEXICO
-
FIRST SESSION
,
2025
INTRODUCED BY
Cristina Parajón and Antoinette Sedillo Lopez
AN ACT
RELATING TO OPIOIDS; REQUIRING RETAIL PHARMACIES TO KEEP STOCKS
OF CERTAIN TYPES OF DRUGS THAT TREAT OPIOID USE DISORDER;
REQUIRING WHOLESALE DRUG DISTRIBUTORS TO REPORT INSTANCES IN
WHICH THE DISTRIBUTORS DO NOT FILL ORDERS FOR BUPRENORPHINE
MADE BY RETAIL PHARMACIES; REQUIRING REPORTS; PROVIDING
PENALTIES.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF NEW MEXICO:
SECTION 1. A new section of the New Mexico Drug, Device
and Cosmetic Act is enacted to read:
"[NEW MATERIAL] BUPRENORPHINE STOCKING REQUIREMENTS.--
A. At least once every thirty days, each retail
pharmacy that stocks controlled substances shall compute the
retail pharmacy's minimum daily buprenorphine stocking
requirement by determining the average amount of buprenorphine
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dispensed per day in the previous thirty days, rounding to the
nearest milligram. Each retail pharmacy shall maintain a stock
of buprenorphine sufficient to satisfy the minimum daily
buprenorphine stocking requirement, plus at least three
additional prescriptions for buprenorphine, including at least
one prescription for buprenorphine that is a buprenorphine
monoproduct and one prescription for buprenorphine that is a
buprenorphine-naloxone combination product. A retail pharmacy
that fails to satisfy the stocking requirements of this section
is not in violation of this section if the retail pharmacy
takes any of the following actions within three days of failing
to satisfy the stocking requirements:
(1) ordering a replacement stock of
buprenorphine sufficient to satisfy the stocking requirements
of this section; or
(2) requesting a wholesale drug distributor to
increase the retail pharmacy's allotment of buprenorphine, and:
(a) once the wholesale drug distributor
approves the request, ordering a replacement stock of
buprenorphine within three days of receiving the approval; or
(b) the wholesale drug distributor
denies the request.
B. A retail pharmacy shall maintain records of the
retail pharmacy's minimum daily buprenorphine stocking
requirements. Records shall be maintained for a period of at
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least three years from the date of the record and may be
inspected as required by authorized agents of the board.
C. A wholesale drug distributor shall report to the
board on a monthly basis, in a form and manner prescribed by
the board, each instance in which the wholesale drug
distributor:
(1) denied, in whole or in part, an order for
buprenorphine submitted by a retail pharmacy;
(2) delayed an order for buprenorphine
submitted by a retail pharmacy due to the retail pharmacy's
threshold of buprenorphine; or
(3) denied a request by a retail pharmacy to
increase the retail pharmacy's threshold of buprenorphine.
D. A report submitted by a wholesale drug
distributor pursuant to this subsection shall include:
(1) the name of the retail pharmacy affected;
(2) the date on which the retail pharmacy
submitted the order for buprenorphine or requested an increase
to the retail pharmacy's threshold of buprenorphine;
(3) the date on which the wholesale drug
distributor denied or delayed the retail pharmacy's order for
buprenorphine or denied the requested increase in the retail
pharmacy's threshold of buprenorphine;
(4) the reason the wholesale drug distributor
denied or delayed the retail pharmacy's order for buprenorphine
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or denied the requested increase in the retail pharmacy's
threshold of buprenorphine; and
(5) any other information required by the
board.
E. The board shall submit data gathered pursuant to
this section to the department of health. The department of
health shall analyze the data and publish a biannual report on
access to buprenorphine in retail pharmacies. The report shall
include:
(1) information on the frequency with which
each wholesale drug distributor:
(a) denied a retail pharmacy's order for
buprenorphine;
(b) delayed a retail pharmacy's order
for buprenorphine due to the retail pharmacy's threshold of
buprenorphine; or
(c) denied a retail pharmacy's requested
increase in the retail pharmacy's threshold of buprenorphine;
(2) aggregated data on the reasons reported by
wholesale drug distributors for denying a retail pharmacy's
order for buprenorphine or a request by a retail pharmacy to
increase the retail pharmacy's threshold of buprenorphine;
(3) a description of how denials or delays of
retail pharmacy orders for buprenorphine affected access to
buprenorphine;
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(4) a description of how denials of retail
pharmacy requests to increase their threshold of buprenorphine
affected access to buprenorphine;
(5) geographic and demographic disparities in
access to buprenorphine in retail pharmacies, to the extent the
data is available;
(6) the impact of insufficient access to
buprenorphine in retail pharmacies on initiation of and
retention in treatment for opioid use disorder, overdose
morbidity and mortality and other health outcomes associated
with substance use disorder; and
(7) any other relevant information.
F. Reports published pursuant to Subsection E of
this section shall comply with state and federal privacy and
confidentiality laws, rules and regulations.
G. The board may impose the following penalties on
retail pharmacies that violate this section:
(1) for a first or second violation, notice of
the violation that includes information on the requirements to
comply with this section; and
(2) for a third violation or any subsequent
violation within a thirty-six-month period following the
previous violation, a fine not to exceed two thousand five
hundred dollars ($2,500).
H. The board may impose the following penalties on
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wholesale drug distributors that violate this section:
(1) for a first violation, notice of the
violation that includes information on the requirements to
comply with this section; and
(2) for a second violation or any subsequent
violation within a thirty-six-month period following the
previous violation, a fine not to exceed ten thousand dollars
($10,000).
I. As used in this section:
(1) "buprenorphine" means the drug
buprenorphine, including any official, generic or chemical name
used to describe buprenorphine prescribed for the treatment of
opioid use disorder;
(2) "minimum daily buprenorphine stocking
requirement" means the average number of milligrams of
buprenorphine dispensed by a retail pharmacy per day over a
thirty-day period, in formulations, dosages and brand names
consistent with the prescriptions for buprenorphine dispensed
by the retail pharmacy during the thirty-day period;
(3) "prescription for buprenorphine" means
sufficient buprenorphine in tablet or film form to provide a
patient with twenty-four milligrams per day for two weeks;
(4) "retail pharmacy" means a pharmacy
physically located, and licensed to dispense drugs, in the
state; and
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(5) "wholesale drug distributor" means a
person licensed to engage in the wholesale distribution of
prescription drugs in the state."
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