An Act To Improve Accountability of Opioid Manufacturers
Maine Legislature, Session 129, LD 0793
Committee Amendment CA_A_S320 (Senate)
Amends: 5 MRSA §20010, 22 MRSA §7249-B, 32 MRSA §13724, 32 MRSA §13800-C

COMMITTEE AMENDMENT "f1 " to S.P. 237, L.D. 793, Bill, "An Act To 
Improve Accountability of Opioid Manufacturers" 
Amend the bill by striking out everything after the enacting clause and inserting the 
following: 
'Sec. 1. 5 MRSA §20010 is enacted to read: 
§20010. Opioid Use Disorder Prevention and Treatment Fund 
1. Fund established. The Opioid Use Disorder Prevention and Treatment Fund, 
referred to in this section as "the fund," is established for the purpose of supporting opioid 
use disorder analysis. prevention and treatment and is administered by the department. 
The fund consists of: 
A. Money received from proceeds from the registration fee under Title 32. section 
13800-C; 
B. Money received from proceeds from the fee under Title 32, section 13724, less 
$325, which may be retained by the Department of Professional and Financial 
Regulation; and 
C. Appropriations. allocations and contributions from private and public sources. 
The fund must be held separate and apart from all other money. funds and accounts. 
Eligible investment earnings credited to the assets of the fund become part of the assets of 
the fund. Any unexpended balances remaining in the fund at the end of any fiscal year do 
not lapse and must be carried forward to the next fiscal year. 
2. Uses of fund proceeds. The proceeds of the fund must be used for the following 
purposes: 
A. Opioid use disorder prevention services; 
B. Opioid use disorder treatment services. including: 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" A "to S.P. 237, L.D. 793 l 5 -5 80) 
(1) Inpatient and outpatient treatment programs and facilities, including short-
term and long-term residential treatment programs and sober living facilities; 
(2) Treating substance use disorder for the underinsured and uninsured; and 
(3) Research regarding opioid use disorder prevention and treatment; 
C. The department's reasonable expenses in administering the fund; and 
D. The Maine Board of Pharmacy's reasonable expenses in administering Title 32, 
section 13800-C and in providing the report required under Title 32, section 13800-C. 
The department shall award grants and contracts from proceeds of the fund to persons and 
organizations to carry out the purposes of the fund. 
Sec. 2. 22 MRSA §7249-B is enacted to read: 
§7249-B. Opioid medication distribution monitoring information 
A manufacturer of an opioid medication that is available in this State and a 
wholesaler that sells or distributes an opioid medication in this State shall submit to the 
department, by electronic means or other format specified in a waiver granted by the 
department, information for this State submitted to the United States Drug Enforcement 
Administration's Automation of Reports and Consolidated Orders System pursuant to 21 
United States Code, Subchapter I and 21 Code of Federal Regulations, Section 1304.33 at 
the time that information is submitted to the United States Drug Enforcement 
Administration. As used in this section, the terms "manufacturer" and "opioid 
medication" have the same meanings as in Title 32, section 13702-A. 
Sec. 3. 32 MRSA §13724, as amended by PL 2007, c. 402, Pt. DD, §11 and PL 
2011, c. 286, Pt. B, §5, is repealed and the following enacted in its place: 
§13724. Fees 
The Director of the Office of Professional and Occupational Regulation may establish 
by rule fees for purposes authorized under this chapter in amounts that are reasonable and 
necessary for their respective purposes in accordance with this section. Rules adopted 
pursuant to this section are routine technical rules as defined in Title 5, chapter 375, 
subchapter 2-A. 
1. General fees. Except as provided in subsection 2, the fee for any one purpose 
may not exceed $325. 
2. Manufacturer of an opioid medication fee. The fee for a manufacturer of an 
opioid medication is $55,000. 
Sec. 4. 32 MRSA §13800-C is enacted to read: 
§13800-C. Opioid medication product registration fee 
This section governs opioid medication product registration fees. As used in this 
section, "unit of an opioid medication" means the lowest identifiable quantity of the 
opioid medication that is dispensed. 
COMMITTEE AMENDMENT 
COMMITTEEAMEND:MENT" f\ "to S.P. 237, L.D. 793 ( S-· 396) 
1. Registration fee. Except as provided in subsection 2, a manufacturer that sells, 
delivers or distributes an opioid medication in this State shall pay an annual registration 
fee of $250.000 to the board on December 31st of each year. 
2. Exception. A manufacturer that does not sell, deliver or distribute 2.000.000 or 
more units of an opioid medication within this State in the year in which a registration fee 
is due is not required to pay the registration fee. To qualify for the exception under this 
subsection. a manufacturer must demonstrate to the board. by January 31st of the year 
following the year in which the registration fee is due, in a manner determined by the 
board. that the manufacturer did not sell. deliver or distribute 2,000,000 or more units of 
an opioid medication within this State in the year in which the manufacturer seeks to 
claim the exception. The board may adopt rules to implement this section. Rules adopted 
pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, 
subchapter 2-A. 
3. Calculation of units of an opioid medication sold, delivered or distributed. 
When calculating the number of units of an opioid medication sold. delivered or 
distributed by a manufacturer under subsection 2, units of an opioid medication may be 
excluded when prescribed for the purpose of medication-assisted treatment of substance 
use disorder. The board periodically shall provide to the Department of Health and 
Human Services a list of medications exempted under this subsection. 
4. Registration fee review and report. By March 1st of each year following 
calendar years 2020. 2021 and 2022. the board shall evaluate and report whether the 
registration fee due under this section and the fee due under section 13 724 have affected 
the prescribing practices of opioid medications by reducing the number of opioid 
medication prescriptions issued during calendar years 2020. 2021 and 2022 or whether 
the fees have created any unintended consequences in the availability of opioid 
medications for the treatment of chronic or intractable pain, to the extent the board has 
the ability to identify a correlation. The board shall provide the report to the joint standing 
committee of the Legislature having jurisdiction over health and human services matters. 
which may report out legislation based upon the report. 
This subsection is repealed September 1, 2023. 
Sec. 5. Appropriations and allocations. The following appropriations and 
allocations are made. 
HEALTH AND HUMAN SERVICES, DEPARTMENT OF 
Opioid Use Disorder Prevention and Treatment Fund N307 
Initiative: Provides base allocation for the Opioid Use Disorder Prevention and Treatment 
Fund. 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
2019-20 
$500 
$500 
COMMITTEE AMENDMENT 
2020-21 
$500 
$500 
COMMITTEE AMENDMENT" 11" to S.P. 237, L.D. 793 (S- 3d0 
HEALTH AND HUMAN SERVICES, 
DEPARTMENT OF 
DEPARTMENT TOTALS 
2019-20 
OTHER SPECIAL REVENUE FUNDS 
$500 
DEPARTMENT TOTAL-ALL FUNDS 
$500 
PROFESSIONAL AND FINANCIAL REGULATION, DEPARTMENT OF 
Licensing and Enforcement 0352 
2020-21 
$500 · 
$500 
Initiative: Allocates funds for the contracting and general operating costs associated with 
the development of the registration fee review report, determination and report of 
exempted medications, rulemaking and additional board meetings. 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
PROFESSIONAL AND FINANCIAL 
REGULATION, DEPARTMENT OF 
DEPARTMENT TOTALS 
OTHER SPECIAL REVENUE FUNDS 
DEPARTMENT TOTAL-ALL FUNDS 
SECTION TOTALS 
OTHER SPECIAL REVENUE FUNDS 
SECTION TOTAL - ALL FUNDS 
SUMMARY 
This amendment replaces the bill. 
2019-20 
$53,000 
$53,000 
2019-20 
$53,000 
--$53,000 
2019-20 
$53,500 
$53,500 
2020-21 
$53,000 
$53,000 
2020-21 
$53,000 
$53,000 
2020-21 
$53,500 
$53,500 
The amendment raises the annual fee for a manufacturer of opioid medication to 
$55,000. The amendment establishes a registration fee due from manufacturers of opioid 
medications of $250,000 if the manufacturer sells, delivers or distributes 2,000,000 or 
more units of an opioid medication within this State, not including units that are 
prescribed for the purpose of medication-assisted treatment of substance use disorder. 
The fees are deposited into the Opioid Use Disorder Prevention and Treatment Fund, 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT"(-\ "to S.P. 237,L.D. 793 ( 6-39Cl 
which is established to provide opioid use disorder prevention and treatment services and 
administered by the Department of Health and Human Services. 
The amendment also requires manufacturers and wholesale distributors of opioid 
medications to provide to the State the same information as provided to the United States 
Drug Enforcement Administration under its Automation of Reports and Consolidated 
Orders System regarding controlled substances transactions in this State on the same 
schedule that information is provided to the Federal Government. 
The amendment requires the Maine Board of Pharmacy to evaluate and report 
whether the fees have affected the prescribing practices for opioid medications by 
reducing the number of opioid medication prescriptions issued during calendar years 
2020, 2021 and 2022 or whether the fees have created any unintended consequences in 
the availability of opioid medications for the treatment of chronic or intractable pain, to 
the extent the board has the ability to identify a correlation. The board shall provide the 
report to the joint standing committee of the Legislature having jurisdiction over health 
and human services matters, which may report out legislation based upon the report. The 
reports must be submitted annually by March 1st. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 06/14/19 :tPae 
LD793 
LR 1130(02) 
An Act To Improve Accountability of Opioid Manufacturers 
Fiscal Note for Bill as Amended by Committee Amendment "A" { S-GS)0,\ 
Committee: Judiciary 
.) ) 
Fiscal Note Required: Yes 
Fiscal Note 
Current biennium revenue increase - Other Special Revenue Funds 
FY2019-20 
FY2020-21 
Projections 
FY 2021-22 
Projections 
FY2022-23 
Appropriations/ Allocations 
Other Special Revenue Funds 
$53,500 
$53,500 
$53,500 
$3,50( 
Fiscal Detail and Notes 
This bill includes Other Special Revenue Funds allocations of $53,000 in fiscal year 2019-20 and $53,000 in fiscal 
year 2020-21 to the Licensing and Enforcement program within the Depaiiment of Professional and Financial 
Regulation for the contracting and general operating costs associated with the development of the registration fee 
review report, determination and report of exempted medications, rulemaking and additional board meetings. 
This bill raises the annual license fee for a manufacturer of opiod medication to $55,000 and establishes an annual 
registration fee of $250,000 for a manufacturer of an opioid product that sells, delivers or distributes an opioid 
medication in the State and requires that the revenue from these fees, excluding $325 per license that may be retained 
by the Department of Professional and Financial Regulation, be credited to the Opiod Use Disorder Prevention and 
Treatment Fund. The estimated revenue to be received from the license and registration fees can not be estimated at 
this time. 
The bill also includes Other Special Revenue Funds allocations to the Department of Health and Human Services of 
$500 beginning in fiscal year 2019-20 for the base allocation for the Opioid Use Disorder Prevention and Treatment 
Fund. 
LRl 130(02) - Fiscal Note - Page 1 of 1