An Act To Ensure the Safety of Compounded Drugs
Maine Legislature, Session 126, LD 1315
Committee Amendment CA_A_H299 (House)

COMMITTEE AMENDMENT ,A" to H.P. 934, L.D. 1315, Bill, "An Act To 
Ensure the Safety of Compounded Drugs 
Amend the bill by striking out the title and substituting the following: 
'Resolve, Directing the Commissioner of Professional and Financial Regulation To 
Convene a Stakeholder Group To Review Changes in Federal and State Regulations 
and Rules Governing Compounding Pharmacies' 
Amend the bill by striking out everything after the title and before the summary and 
inserting the following: 
'Sec. 1. Commissioner of Professional and Financial Regulation directed 
to convene stakeholder group. Resolved: That the Commissioner of Professional 
and Financial Regulation shall convene a stakeholder group to review the proposed 
changes in federal and state safety and inspection regulations and rules governing sterile 
and nonsterile compounding pharmacies and identify any remaining gaps in the 
regulatory process that need to be addressed by state regulatory agencies in order to 
protect public health and safety. 
The Commissioner of Professional and Financial 
Regulation shall invite participation from the following stakeholders: the Department of 
Professional and Financial Regulation, Maine Board of Pharmacy; the division of 
licensing and regulatory services and the Maine Center for Disease Control and 
Prevention within the Department of Health and Human Services; and other interested 
parties from the medical and pharmaceutical communities; and be it further 
Sec. 2. Report. Resolved: That the Commissioner of Professional and Financial 
Regulation shall submit a report on the study described in section 1 and any 
recommended legislation to the Joint Standing Committee on Labor, Commerce, 
Research and Economic Development by February 28, 2014. 
The joint standing 
committee is authorized to submit a bill to the Second Regular Session of the 126th 
Legislature related to the subject matter ofthe report.' 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT "A" to H.P. 934, L.D. 1315 
SUMMARY 
This amendment replaces the bill with a resolve that directs the Commissioner of 
Professional and Financial Regulation to convene a stakeholder group to review the 
proposed changes in federal and state safety and inspection regulations and rules 
governing sterile and nonsterile compounding pharmacies and identify any remaining 
gaps in the regulatory process that need to be addressed by state regulatory agencies in 
order to protect public health and safety. It directs the Commissioner of Professional and 
Financial Regulation to invite participation from the following stakeholders: the 
Department of Professional and Financial Regulation, Maine Board of Pharmacy; the 
division of licensing and regulatory services and the Maine Center for Disease Control 
and Prevention within the Department of Health and Human Services; and other 
interested parties from the medical and pharmaceutical communities. It also requires the 
Commissioner of Professional and Financial Regulation to submit a report on the study 
and authorizes the Joint Standing Committee on Labor, Commerce, Research and 
Economic Development t6 submit a bill to the Second Regular Session of the 126th 
Legislature related to the subject matter of the report. 
FISCAL ~OTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 05/30113 
~ac. 
LD 1315 
LR 172(02) 
An Act To Ensure the Safety of Compounded Drugs 
Fiscal Note for Bill as Amended by Committee Amendment 1}' (H -J,qq) 
Committee: Labor, Commerce, Research and Economic Development 
Fiscal Note Required: Yes 
Fiscal Note 
Minor cost increase - General Fund 
Minor cost increase - Other Special Revenue Funds 
Fiscal Detail and Notes 
Additional costs to the Department of Professional and Financial Regulation to convene a stakeholder group to 
conduct the required review and submit the required report can be absorbed within existing budgeted resources. 
Additional costs to the Department of Health and Human Services to participate are expected to be minor and can be 
absorbed within existing budgeted resources. 
LRO 172(02) - Fiscal Note - Page 1 of 1