1.1 	A bill for an act
1.2 	relating to health; establishing an opiate stewardship program; establishing an 
1.3 	opiate manufacturer registration fee to fund the operation of the prescription 
1.4 	monitoring program; requiring a prescriber to access the prescription monitoring 
1.5 	program before prescribing a controlled substance; limiting the quantity of opiates 
1.6 	and narcotics that can be prescribed for acute pain at any one time; appropriating 
1.7 	money; requiring a report;amending Minnesota Statutes 2016, sections 151.01, 
1.8 	subdivision 27; 151.252, subdivision 1; 151.47, by adding a subdivision; 152.11, 
1.9 	subdivisions 1, 2; 152.126, subdivisions 6, 10; Laws 2017, First Special Session 
1.10 	chapter 6, article 12, section 2, subdivision 4; proposing coding for new law in 
1.11 	Minnesota Statutes, chapter 151.
1.12 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.13 	ARTICLE 1
1.14 	OPIATE PRODUCT STEWARDSHIP

1.15 	Section 1. Minnesota Statutes 2016, section 151.252, subdivision 1, is amended to read:
1.16 		Subdivision 1.Requirements. (a) No person shall act as a drug manufacturer without 
1.17 	first obtaining a license from the board and paying any applicable fee specified in section 
1.18 	151.065.
1.19 	(b) In addition to the license required under paragraph (a), a manufacturer of a Schedule 
1.20 	II through IV opiate controlled substance must pay the applicable registration fee specified 
1.21 	in section 151.77, subdivision 3, by June 1 of each year, beginning June 1, 2019. In the 
1.22 	event of a change of ownership of the manufacturer, the new owner must pay the registration 
1.23 	fee specified under section 151.77, subdivision 3, that the original owner would have been 
1.24 	assessed had it retained ownership.
2.1 	(b) (c) Application for a drug manufacturer license under this section shall be made in 
2.2 	a manner specified by the board.
2.3 	(c) (d) No license shall be issued or renewed for a drug manufacturer unless the applicant 
2.4 	agrees to operate in a manner prescribed by federal and state law and according to Minnesota 
2.5 	Rules.
2.6 	(d) (e) No license shall be issued or renewed for a drug manufacturer that is required to 
2.7 	be registered pursuant to United States Code, title 21, section 360, unless the applicant 
2.8 	supplies the board with proof of registration. The board may establish by rule the standards 
2.9 	for licensure of drug manufacturers that are not required to be registered under United States 
2.10 	Code, title 21, section 360.
2.11 	(e) (f) No license shall be issued or renewed for a drug manufacturer that is required to 
2.12 	be licensed or registered by the state in which it is physically located unless the applicant 
2.13 	supplies the board with proof of licensure or registration. The board may establish, by rule, 
2.14 	standards for the licensure of a drug manufacturer that is not required to be licensed or 
2.15 	registered by the state in which it is physically located.
2.16 	(f) (g) The board shall require a separate license for each facility located within the state 
2.17 	at which drug manufacturing occurs and for each facility located outside of the state at 
2.18 	which drugs that are shipped into the state are manufactured.
2.19 	(g) (h) The board shall not issue an initial or renewed license for a drug manufacturing 
2.20 	facility unless the facility passes an inspection conducted by an authorized representative 
2.21 	of the board. In the case of a drug manufacturing facility located outside of the state, the 
2.22 	board may require the applicant to pay the cost of the inspection, in addition to the license 
2.23 	fee in section 151.065, unless the applicant furnishes the board with a report, issued by the 
2.24 	appropriate regulatory agency of the state in which the facility is located or by the United 
2.25 	States Food and Drug Administration, of an inspection that has occurred within the 24 
2.26 	months immediately preceding receipt of the license application by the board. The board 
2.27 	may deny licensure unless the applicant submits documentation satisfactory to the board 
2.28 	that any deficiencies noted in an inspection report have been corrected.

2.29 	Sec. 2. Minnesota Statutes 2016, section 151.47, is amended by adding a subdivision to 
2.30 	read:
2.31 		Subd. 1a.Controlled substance wholesale drug distributor requirements. In addition 
2.32 	to the license required under subdivision 1, a wholesale drug distributor distributing a  
2.33 	Schedule II through IV opiate controlled substance must pay the applicable registration fee 
3.1 	specified in section 151.77, subdivision 4, by June 1 of each year beginning June 1, 2019. 
3.2 	In the event of a change in ownership of the wholesale drug distributor, the new owner must 
3.3 	pay the registration fee specified in section 151.77, subdivision 4, that the original owner 
3.4 	would have been assessed had it retained ownership.

3.5 	Sec. 3. [151.75] OPIATE STEWARDSHIP ADVISORY COUNCIL.
3.6 		Subdivision 1.Establishment of the advisory council. (a) The Opiate Stewardship 
3.7 	Advisory Council is established to develop and implement a comprehensive and effective 
3.8 	statewide effort to address the opioid addiction and overdose epidemic in Minnesota. The 
3.9 	council shall focus on:
3.10 	(1) prevention and education, including public education and awareness for adults and 
3.11 	youth, prescriber education, the development and sustainability of opioid overdose prevention 
3.12 	and education programs, and providing financial support to local law enforcement agencies 
3.13 	for opiate antagonist programs;
3.14 	(2) treatment, including statewide access to effective treatment and recovery services 
3.15 	that is aligned with Minnesota's model of care approach to promoting access to treatment 
3.16 	and recovery services. This includes ensuring that individuals throughout the state have 
3.17 	access to treatment and recovery services, including care coordination services; peer recovery 
3.18 	services; medication-assisted treatment and office-based opioid treatment; integrative and 
3.19 	multidisciplinary therapies; and culturally specific services; and
3.20 	(3) innovation and capacity building, including development of evidence-based practices, 
3.21 	using research and evaluation to understand which policies and programs promote efficient 
3.22 	and effective prevention, treatment, and recovery results. This also includes ensuring that 
3.23 	there are qualified providers and a comprehensive set of treatment and recovery services 
3.24 	throughout the state.
3.25 	(b) The council shall:
3.26 	(1) review local, state, and federal initiatives and funding related to prevention and 
3.27 	education, treatment, and services for individuals and families experiencing and affected 
3.28 	by opioid abuse, and promoting innovation and capacity building to address the opioid 
3.29 	addiction and overdose epidemic;
3.30 	(2) establish priorities to address the state's opioid addiction and overdose epidemic for 
3.31 	the purpose of allocating funds and consult with the commissioner of management and 
3.32 	budget to determine whether proposals are for evidence-based practices, promising practices, 
3.33 	or theory-based practices;
4.1 	(3) ensure that available funding under this section is allocated to align with existing 
4.2 	state and federal funding to achieve the greatest impact and ensure a coordinated state effort 
4.3 	to address the opioid addiction and overdose epidemic;
4.4 	(4) develop criteria and procedures to be used in awarding grants and allocating available 
4.5 	funds from the opiate stewardship account and select proposals to receive grant funding. 
4.6 	The council is encouraged to select proposals that are promising practices or theory-based 
4.7 	practices, in addition to evidence-based practices, to help identify new approaches to effective 
4.8 	prevention, treatment, and recovery; and
4.9 	(5) in consultation with the commissioner of management and budget, and within 
4.10 	available appropriations, select from the awarded grants projects that include promising 
4.11 	practices or theory-based activities for which the commissioner of management and budget 
4.12 	shall conduct evaluations using experimental or quasi-experimental design. Grants awarded 
4.13 	to proposals that include promising practices or theory-based activities and that are selected 
4.14 	for an evaluation shall be administered to support the experimental or quasi-experimental 
4.15 	evaluation and require grantees to collect and report information that is needed to complete 
4.16 	the evaluation. The commissioner of management and budget, under section 15.08, may 
4.17 	obtain additional relevant data to support the experimental or quasi-experimental evaluation 
4.18 	studies.
4.19 		Subd. 2.Membership. (a) The council shall consist of 18 members appointed by the 
4.20 	commissioner of human services, except as otherwise specified:
4.21 	(1) two members of the house of representatives, one from the majority party appointed 
4.22 	by the speaker of the house and one from the minority party appointed by the minority 
4.23 	leader;
4.24 	(2) two members of the senate, one from the majority party appointed by the senate 
4.25 	majority leader and one from the minority party appointed by the senate minority leader;
4.26 	(3) one member appointed by the Board of Pharmacy;
4.27 	(4) one member who is a physician appointed by the Minnesota chapter of the American 
4.28 	College of Emergency Physicians;
4.29 	(5) one member representing opioid treatment programs or sober living programs;
4.30 	(6) one member who is a physician appointed by the Minnesota Hospital Association;
4.31 	(7) one member who is a physician appointed by the Minnesota Society of Addiction 
4.32 	Medicine;
5.1 	(8) one member who is a pain psychologist;
5.2 	(9) one member appointed by the Steve Rummler Hope Network;
5.3 	(10) one member appointed by the Minnesota Ambulance Association;
5.4 	(11) one member representing the Minnesota courts who is a judge or law enforcement 
5.5 	officer;
5.6 	(12) one public member who is a Minnesota resident and who has been impacted by the 
5.7 	opioid epidemic;
5.8 	(13) one member representing a manufacturer of opiates;
5.9 	(14) one member representing an Indian tribe;
5.10 	(15) the commissioner of human services or designee; and
5.11 	(16) the commissioner of health or designee.
5.12 	(b) The commissioner of human services shall coordinate appointments to provide 
5.13 	geographic diversity and shall ensure that at least one-half of council members reside outside 
5.14 	of the seven-county metropolitan area.
5.15 	(c) The council is governed by section 15.059, except that members of the council shall 
5.16 	receive no compensation other than reimbursement for expenses. Notwithstanding section 
5.17 	15.059, subdivision 6, the council shall not expire.
5.18 	(d) The chair shall convene the council at least quarterly, and may convene other meetings 
5.19 	as necessary. The chair shall convene meetings at different locations in the state to provide 
5.20 	geographic access, and shall ensure that at least one-half of the meetings are held at locations 
5.21 	outside of the seven-county metropolitan area.
5.22 	(e) The commissioner of human services shall provide staff and administrative services 
5.23 	for the advisory council.
5.24 	(f) The council is subject to chapter 13D.
5.25 		Subd. 3.Conflict of interest. Advisory council members must disclose to the council 
5.26 	and recuse themselves from voting on any matter before the council if the member has a 
5.27 	conflict of interest. A conflict of interest means a financial association that has the potential 
5.28 	to bias or have the appearance of biasing a council member's decision related to the opiate 
5.29 	stewardship grant decision process or other council activities under this section.
5.30 		Subd. 4.Grants. (a) The commissioner of human services shall submit a report of the 
5.31 	grants proposed by the advisory council to be awarded for the upcoming fiscal year to the 
6.1 	chairs and ranking minority members of the legislative committees with jurisdiction over 
6.2 	health and human services policy and finance, by March 1 of each year, beginning March 
6.3 	1, 2019.
6.4 	(b) The commissioner of human services shall award grants from the opiate stewardship 
6.5 	account under section 151.76. The grants shall be awarded to proposals selected by the 
6.6 	advisory council that address the priorities in paragraph (a), clauses (1) to (3), unless 
6.7 	otherwise appropriated by the legislature. No more than three percent of the grant amount 
6.8 	may be used by a grantee for administration.
6.9 		Subd. 5.Reports. (a) The advisory council shall report annually to the chairs and ranking 
6.10 	minority members of the legislative committees with jurisdiction over health and human 
6.11 	services policy and finance by January 1 of each year beginning January 1, 2021, information 
6.12 	about the individual projects that receive grants and the overall role of the project in 
6.13 	addressing the opioid addiction and overdose epidemic in Minnesota. The report must 
6.14 	describe the grantees and the activities implemented, along with measurable outcomes as 
6.15 	determined by the council in consultation with the commissioner of human services and the 
6.16 	commissioner of management and budget. At a minimum, the report must include information 
6.17 	about the number of individuals who received information or treatment, the outcomes the 
6.18 	individuals achieved, and demographic information about the individuals participating in 
6.19 	the project; an assessment of the progress toward achieving statewide access to qualified 
6.20 	providers and comprehensive treatment and recovery services; and an update on the 
6.21 	evaluation implemented by the commissioner of management and budget for the promising 
6.22 	practices and theory-based projects that receive funding.
6.23 	(b) The commissioner of management and budget, in consultation with the Opiate 
6.24 	Stewardship Advisory Council, shall report to the chairs and ranking minority members of 
6.25 	the legislative committees with jurisdiction over health and human services policy and 
6.26 	finance when an evaluation study described in subdivision 1, paragraph (b), clause (5), is 
6.27 	complete on the promising practices or theory-based projects that are selected for evaluation 
6.28 	activities. The report shall include demographic information; outcome information for the 
6.29 	individuals in the program; the results for the program in promoting recovery, employment, 
6.30 	family reunification, and reducing involvement with the criminal justice system; and other 
6.31 	relevant outcomes determined by the commissioner of management and budget that are 
6.32 	specific to the projects that are evaluated. The report shall include information about the 
6.33 	ability of grant programs to be scaled to achieve statewide the results that the grant project 
6.34 	demonstrated.

7.1 	Sec. 4. [151.76] OPIATE STEWARDSHIP ACCOUNT.
7.2 		Subdivision 1.Establishment. The opiate stewardship account is established in the 
7.3 	special revenue fund in the state treasury. The registration fees collected by the Board of 
7.4 	Pharmacy under section 151.77 shall be deposited into the account.
7.5 		Subd. 2.Use of account funds. (a) Beginning in fiscal year 2019, money in the account 
7.6 	shall be appropriated each fiscal year as specified in this subdivision.
7.7 	(b) $300,000 is appropriated to the commissioner of management and budget for 
7.8 	evaluation activities under section 151.75.
7.9 	(c) $249,000 is appropriated to the commissioner of human services for the provision 
7.10 	of administrative services to the Opiate Stewardship Advisory Council and for the 
7.11 	administration of the grants awarded under paragraph (f).
7.12 	(d) $33,000 is appropriated to the Board of Pharmacy for the collection of the registration 
7.13 	fees under section 151.77.
7.14 	(e) $384,000 is appropriated to the commissioner of public safety for Bureau of Criminal 
7.15 	Apprehension drug scientists and lab supplies.
7.16 	(f) Money remaining in the opiate stewardship account after making the appropriations 
7.17 	required in paragraphs (b) through (e) is appropriated to the commissioner of human services. 
7.18 	The commissioner shall distribute the appropriation as follows:
7.19 	(1) at least 50 percent shall be distributed to county social service agencies to provide 
7.20 	child protection services to children and families who are affected by addiction. The 
7.21 	commissioner shall distribute this money proportionally to counties based on the number 
7.22 	of open child protection case management cases in the county using data from the previous 
7.23 	calendar year; and
7.24 	(2) the remaining money shall be awarded as specified by the Opiate Stewardship 
7.25 	Advisory Council as grants in accordance with section 151.75, unless otherwise appropriated 
7.26 	by the legislature.

7.27 	Sec. 5. [151.77] OPIATE PRODUCT REGISTRATION FEE.
7.28 		Subdivision 1.Definition. For purposes of this section, the following terms have the 
7.29 	meanings given to them in this subdivision:
7.30 	(1) "manufacturer" means a manufacturer licensed under section 151.252 that is engaged 
7.31 	in the manufacturing of an opiate;
8.1 	(2) "opiate" means any opiate-containing controlled substance listed in section 152.02, 
8.2 	subdivisions 3 to 5, that is distributed, delivered, sold, or dispensed into or within this state; 
8.3 	and
8.4 	(3) "wholesaler" means a wholesale drug distributor who is licensed under section 151.47, 
8.5 	and is engaged in the wholesale drug distribution of an opiate.
8.6 		Subd. 2.Reporting requirements. (a) By March 1 of each year, beginning March 1, 
8.7 	2019, each manufacturer and each wholesale drug distributor must report to the board every 
8.8 	sale, delivery, or other distribution within or into this state of any opiate that is made to any 
8.9 	practitioner, pharmacy, hospital, veterinary hospital, or other person who is permitted by 
8.10 	section 151.37 to possess controlled substances for administration or dispensing to patients 
8.11 	that occurred during the previous calendar year. Reporting must be in the automation of 
8.12 	reports and consolidated orders system format unless otherwise specified by the board. If 
8.13 	a manufacturer or wholesaler fails to provide information required under this paragraph on 
8.14 	a timely basis, the board may assess an administrative penalty of $100 per day. This penalty 
8.15 	shall not be considered a form of disciplinary action.
8.16 	(b) By March 1 of each year, beginning March 1, 2019, each owner of a pharmacy with 
8.17 	at least one location  within this state must report to the board the intracompany delivery or 
8.18 	distribution into this state, of any opiate, to the extent that those deliveries and distributions 
8.19 	are not reported to the board by a licensed wholesale drug distributor owned by, under 
8.20 	contract to, or otherwise operating on behalf of the owner of the pharmacy. Reporting must 
8.21 	be in the manner and format specified by the board for deliveries and distributions that 
8.22 	occurred during the previous calendar year.
8.23 		Subd. 3.Determination of each manufacturer's registration fee. (a) The board shall 
8.24 	annually assess manufacturer registration fees that in an aggregate amount total $12,000,000. 
8.25 	The board shall determine each manufacturer's annual registration fee that is prorated and 
8.26 	based on the manufacturer's percentage of the total number of units reported to the board 
8.27 	under subdivision 2.
8.28 	(b) By April 1 of each year, beginning April 1, 2019, the board shall notify each 
8.29 	manufacturer of the annual amount of the manufacturer's registration fee to be paid by June 
8.30 	1, in accordance with section 151.252, subdivision 1, paragraph (b).
8.31 	(c) In conjunction with the data reported under this section, and notwithstanding section 
8.32 	152.126, subdivision 6, the board may use the data reported under section 152.126, 
8.33 	subdivision 4, to determine the manufacturer registration fees required under this subdivision.
9.1 	(d) A manufacturer may dispute the registration fee as determined by the board no later 
9.2 	than 30 days after the date of notification. However, the manufacturer must still remit the 
9.3 	fee as required by section 151.252, subdivision 1, paragraph (b). The dispute must be filed 
9.4 	with the board in the manner and using the forms specified by the board. A manufacturer 
9.5 	must submit, with the required forms, data satisfactory to the board that demonstrates that 
9.6 	the registration fee was incorrect. The board must make a decision concerning a dispute no 
9.7 	later than 60 days after receiving the required dispute forms. If the board determines that 
9.8 	the manufacturer has satisfactorily demonstrated that the original fee was incorrect, the 
9.9 	board must adjust the manufacturer's registration fee due the next year by the amount that 
9.10 	is in excess of the correct fee that should have been paid.
9.11 		Subd. 4.Determination of each wholesaler's registration fee. (a) The board shall 
9.12 	annually assess wholesaler registration fees that in an aggregate amount total $8,000,000. 
9.13 	The board shall determine each wholesaler's annual registration fee that is prorated and 
9.14 	based on the wholesaler's percentage of the total number of units reported to the board under 
9.15 	subdivision 2. This paragraph does not apply to a wholesaler if the wholesaler is also licensed 
9.16 	as a drug manufacturer under section 151.252.
9.17 	(b) By April 1 of each year, beginning April 1, 2019, the board shall notify each 
9.18 	wholesaler, the annual amount of the wholesaler's registration fee to be paid by June 1, in 
9.19 	accordance with section 151.47, subdivision 1a.
9.20 	(c) In conjunction with the data reported under this section, and notwithstanding section 
9.21 	152.126, subdivision 6, the board may use the data reported under section 152.126, 
9.22 	subdivision 4, to determine the wholesaler registration fees required under this subdivision.
9.23 	(d) A wholesaler may dispute the registration fee as determined by the board no later 
9.24 	than 30 days after the date of notification. However, the wholesaler must still remit the fee 
9.25 	as required by section 151.47, subdivision 1a. The dispute must be filed with the board in 
9.26 	the manner and using the forms specified by the board. A wholesaler must submit, with the 
9.27 	required forms, data satisfactory to the board that demonstrates that the registration fee was 
9.28 	incorrect. The board must make a decision concerning a dispute no later than 60 days after 
9.29 	receiving the required dispute forms. If the board determines that the wholesaler has 
9.30 	satisfactorily demonstrated that the original fee was incorrect, the board must adjust the 
9.31 	wholesaler's registration fee due the next year by the amount that is in excess of the correct 
9.32 	fee that should have been paid.
9.33 		Subd. 5.Report. (a) The Board of Pharmacy shall evaluate the registration fee on drug 
9.34 	manufacturers and wholesalers established under this section, and whether the fee has 
10.1 	impacted the prescribing practices for opiates by reducing the number of opiate prescriptions 
10.2 	issued during calendar years 2019, 2020, and 2021, to the extent the board has the ability 
10.3 	to effectively identify a correlation. Notwithstanding section 152.126, subdivision 6, the 
10.4 	board may access the data reported under section 152.126, subdivision 4, to conduct this 
10.5 	evaluation.
10.6 	(b) The board shall submit the results of its evaluation to the chairs and ranking minority 
10.7 	members of the legislative committees with jurisdiction over health and human services 
10.8 	policy and finance by March 1, 2022.
10.9 		Subd. 6.Legislative review. The legislature shall review the reports from the Opiate 
10.10 	Stewardship Advisory Council under section 151.75, subdivision 5, paragraph (a), the reports 
10.11 	from the commissioner of management and budget on the Results First evaluation activities 
10.12 	under section 151.75, subdivision 5, paragraph (b), the report from the Board of Pharmacy 
10.13 	under subdivision 5, and any other relevant report or information related to the opioid crisis 
10.14 	in Minnesota, to make a determination about whether the opiate product registration fee 
10.15 	assessed under this section should continue beyond July 1, 2022.

10.16 	Sec. 6. OPIATE STEWARDSHIP ADVISORY COUNCIL FIRST MEETING.
 10.17 	The commissioner of human services shall convene the first meeting of the Opiate 
10.18 	Stewardship Advisory Council established under Minnesota Statutes, section 151.75, no 
10.19 	later than October 1, 2018. The members shall elect a chair at the first meeting.

10.20 	Sec. 7. APPROPRIATIONS.
 10.21 	$19,000 in fiscal year 2019 is appropriated from the special revenue fund to the Board 
10.22 	of Pharmacy for the collection of the registration fee under Minnesota Statutes, section 
10.23 	151.77. This is a onetime appropriation.

10.24 	ARTICLE 2
10.25 	OTHER OPIATE PROVISIONS

10.26 	Section 1. Minnesota Statutes 2016, section 151.01, subdivision 27, is amended to read:
10.27 		Subd. 27.Practice of pharmacy. "Practice of pharmacy" means:
10.28 	(1) interpretation and evaluation of prescription drug orders;
10.29 	(2) compounding, labeling, and dispensing drugs and devices (except labeling by a 
10.30 	manufacturer or packager of nonprescription drugs or commercially packaged legend drugs 
10.31 	and devices);
11.1 	(3) participation in clinical interpretations and monitoring of drug therapy for assurance 
11.2 	of safe and effective use of drugs, including the performance of laboratory tests that are 
11.3 	waived under the federal Clinical Laboratory Improvement Act of 1988, United States Code, 
11.4 	title 42, section 263a et seq., provided that a pharmacist may interpret the results of laboratory 
11.5 	tests but may modify drug therapy only pursuant to a protocol or collaborative practice 
11.6 	agreement;
11.7 	(4) participation in drug and therapeutic device selection; drug administration for first 
11.8 	dosage and medical emergencies; intramuscular and subcutaneous administration of drugs 
11.9 	used for the treatment of alcohol or opioid dependence and treatment of mental health 
11.10 	conditions; drug regimen reviews; and drug or drug-related research;
11.11 	(5) participation in administration of influenza vaccines to all eligible individuals six 
11.12 	years of age and older and all other vaccines to patients 13 years of age and older by written 
11.13 	protocol with a physician licensed under chapter 147, a physician assistant authorized to 
11.14 	prescribe drugs under chapter 147A, or an advanced practice registered nurse authorized to 
11.15 	prescribe drugs under section 148.235, provided that:
11.16 	(i) the protocol includes, at a minimum:
11.17 	(A) the name, dose, and route of each vaccine that may be given;
11.18 	(B) the patient population for whom the vaccine may be given;
11.19 	(C) contraindications and precautions to the vaccine;
11.20 	(D) the procedure for handling an adverse reaction;
11.21 	(E) the name, signature, and address of the physician, physician assistant, or advanced 
11.22 	practice registered nurse;
11.23 	(F) a telephone number at which the physician, physician assistant, or advanced practice 
11.24 	registered nurse can be contacted; and
11.25 	(G) the date and time period for which the protocol is valid;
11.26 	(ii) the pharmacist has successfully completed a program approved by the Accreditation 
11.27 	Council for Pharmacy Education specifically for the administration of immunizations or a 
11.28 	program approved by the board;
11.29 	(iii) the pharmacist utilizes the Minnesota Immunization Information Connection to 
11.30 	assess the immunization status of individuals prior to the administration of vaccines, except 
11.31 	when administering influenza vaccines to individuals age nine and older;
12.1 	(iv) the pharmacist reports the administration of the immunization to the Minnesota 
12.2 	Immunization Information Connection; and
12.3 	(v) the pharmacist complies with guidelines for vaccines and immunizations established 
12.4 	by the federal Advisory Committee on Immunization Practices, except that a pharmacist 
12.5 	does not need to comply with those portions of the guidelines that establish immunization 
12.6 	schedules when administering a vaccine pursuant to a valid, patient-specific order issued 
12.7 	by a physician licensed under chapter 147, a physician assistant authorized to prescribe 
12.8 	drugs under chapter 147A, or an advanced practice nurse authorized to prescribe drugs 
12.9 	under section 148.235, provided that the order is consistent with the United States Food 
12.10 	and Drug Administration approved labeling of the vaccine;
12.11 	(6) participation in the initiation, management, modification, and discontinuation of 
12.12 	drug therapy according to a written protocol or collaborative practice agreement between: 
12.13 	(i) one or more pharmacists and one or more dentists, optometrists, physicians, podiatrists, 
12.14 	or veterinarians; or (ii) one or more pharmacists and one or more physician assistants 
12.15 	authorized to prescribe, dispense, and administer under chapter 147A, or advanced practice 
12.16 	nurses authorized to prescribe, dispense, and administer under section 148.235. Any changes 
12.17 	in drug therapy made pursuant to a protocol or collaborative practice agreement must be 
12.18 	documented by the pharmacist in the patient's medical record or reported by the pharmacist 
12.19 	to a practitioner responsible for the patient's care;
12.20 	(7) participation in the storage of drugs and the maintenance of records;
12.21 	(8) patient counseling on therapeutic values, content, hazards, and uses of drugs and 
12.22 	devices;
12.23 	(9) offering or performing those acts, services, operations, or transactions necessary in 
12.24 	the conduct, operation, management, and control of a pharmacy; and
12.25 	(10) participation in the initiation, management, modification, and discontinuation of 
12.26 	therapy with opiate antagonists, as defined in section 604A.04, subdivision 1, pursuant to:
12.27 	(i) a written protocol as allowed under clause (6); or
12.28 	(ii) a written protocol with a community health board medical consultant or a practitioner 
12.29 	designated by the commissioner of health, as allowed under section 151.37, subdivision 13.

12.30 	Sec. 2. Minnesota Statutes 2016, section 152.11, subdivision 1, is amended to read:
12.31 		Subdivision 1.General prescription requirements for controlled substances. (a) A 
12.32 	written prescription or an oral prescription reduced to writing, when issued for a controlled 
13.1 	substance in Schedule II, III, IV, or V, is void unless (1) it is written in ink and contains the 
13.2 	name and address of the person for whose use it is intended; (2) it states the amount of the 
13.3 	controlled substance to be compounded or dispensed, with directions for its use; (3) if a 
13.4 	written prescription, it contains the handwritten signature, address, and federal registry 
13.5 	number of the prescriber and a designation of the branch of the healing art pursued by the 
13.6 	prescriber; and if an oral prescription, the name and address of the prescriber and a 
13.7 	designation of the prescriber's branch of the healing art; and (4) it shows the date when 
13.8 	signed by the prescriber, or the date of acceptance in the pharmacy if an oral prescription.
13.9 	(b) An electronic prescription for a controlled substance in Schedule II, III, IV, or V is 
13.10 	void unless it complies with the standards established pursuant to section 62J.497 and with 
13.11 	those portions of Code of Federal Regulations, title 21, parts 1300, 1304, 1306, and 1311, 
13.12 	that pertain to electronic prescriptions.
13.13 	(c) A prescription for a controlled substance in Schedule II, III, IV, or V that is transmitted 
13.14 	by facsimile, either computer to facsimile machine or facsimile machine to facsimile machine, 
13.15 	is void unless it complies with the applicable requirements of Code of Federal Regulations, 
13.16 	title 21, part 1306.
13.17 	(d) Every licensed pharmacy that dispenses a controlled substance prescription shall 
13.18 	retain the original prescription in a file for a period of not less than two years, open to 
13.19 	inspection by any officer of the state, county, or municipal government whose duty it is to 
13.20 	aid and assist with the enforcement of this chapter. An original electronic or facsimile 
13.21 	prescription may be stored in an electronic database, provided that the database provides a 
13.22 	means by which original prescriptions can be retrieved, as transmitted to the pharmacy, for 
13.23 	a period of not less than two years.
13.24 	(e) Every licensed pharmacy shall distinctly label the container in which a controlled 
13.25 	substance is dispensed with the directions contained in the prescription for the use of that 
13.26 	controlled substance.
13.27 	(f) No prescription for an opiate or narcotic pain reliever listed in Schedules II through 
13.28 	IV of section 152.02 shall be dispensed more than 30 days after the date on which the 
13.29 	prescription was issued. After 30 days from the date of issuance of the prescription, no 
13.30 	additional authorizations may be accepted for that prescription. If continued therapy is 
13.31 	necessary, a new prescription must be issued by the prescriber.

14.1 	Sec. 3. Minnesota Statutes 2016, section 152.11, subdivision 2, is amended to read:
14.2 		Subd. 2. Prescription requirements for Schedule III or IV controlled substances.
 14.3 	No person may dispense a controlled substance included in Schedule III or IV of section 
14.4 	152.02 without a prescription issued, as permitted under subdivision 1, by a doctor of 
14.5 	medicine, a doctor of osteopathic medicine licensed to practice medicine, a doctor of dental 
14.6 	surgery, a doctor of dental medicine, a doctor of podiatry, a doctor of optometry limited to 
14.7 	Schedule IV, or a doctor of veterinary medicine, lawfully licensed to prescribe in this state 
14.8 	or from a practitioner licensed to prescribe controlled substances by the state in which the 
14.9 	prescription is issued, and having a current federal drug enforcement administration 
14.10 	registration number. Such prescription may not be dispensed or refilled except with the 
14.11 	documented consent of the prescriber, and in no event more than six months after the date 
14.12 	on which such prescription was issued and no such prescription may be refilled more than 
14.13 	five times.

14.14 	Sec. 4. Minnesota Statutes 2016, section 152.126, subdivision 6, is amended to read:
14.15 		Subd. 6.Access to reporting system data. (a) Except as indicated in this subdivision, 
14.16 	the data submitted to the board under subdivision 4 is private data on individuals as defined 
14.17 	in section 13.02, subdivision 12, and not subject to public disclosure.
14.18 	(b) Except as specified in subdivision 5, the following persons shall be considered 
14.19 	permissible users and may access the data submitted under subdivision 4 in the same or 
14.20 	similar manner, and for the same or similar purposes, as those persons who are authorized 
14.21 	to access similar private data on individuals under federal and state law:
14.22 	(1) a prescriber or an agent or employee of the prescriber to whom the prescriber has 
14.23 	delegated the task of accessing the data, to the extent the information relates specifically to 
14.24 	a current patient, to whom the prescriber is:
14.25 	(i) prescribing or considering prescribing any controlled substance;
14.26 	(ii) providing emergency medical treatment for which access to the data may be necessary;
14.27 	(iii) providing care, and the prescriber has reason to believe, based on clinically valid 
14.28 	indications, that the patient is potentially abusing a controlled substance; or
14.29 	(iv) providing other medical treatment for which access to the data may be necessary 
14.30 	for a clinically valid purpose and the patient has consented to access to the submitted data, 
14.31 	and with the provision that the prescriber remains responsible for the use or misuse of data 
14.32 	accessed by a delegated agent or employee;
15.1 	(2) a dispenser or an agent or employee of the dispenser to whom the dispenser has 
15.2 	delegated the task of accessing the data, to the extent the information relates specifically to 
15.3 	a current patient to whom that dispenser is dispensing or considering dispensing any 
15.4 	controlled substance and with the provision that the dispenser remains responsible for the 
15.5 	use or misuse of data accessed by a delegated agent or employee;
15.6 	(3) a licensed pharmacist who is providing pharmaceutical care for which access to the 
15.7 	data may be necessary to the extent that the information relates specifically to a current 
15.8 	patient for whom the pharmacist is providing pharmaceutical care: (i) if the patient has 
15.9 	consented to access to the submitted data; or (ii) if the pharmacist is consulted by a prescriber 
15.10 	who is requesting data in accordance with clause (1);
15.11 	(4) an individual who is the recipient of a controlled substance prescription for which 
15.12 	data was submitted under subdivision 4, or a guardian of the individual, parent or guardian 
15.13 	of a minor, or health care agent of the individual acting under a health care directive under 
15.14 	chapter 145C. For purposes of this clause, access by individuals includes persons in the 
15.15 	definition of an individual under section 13.02;
15.16 	(5) personnel or designees of a health-related licensing board listed in section 214.01, 
15.17 	subdivision 2, or of the Emergency Medical Services Regulatory Board, assigned to conduct 
15.18 	a bona fide investigation of a complaint received by that board that alleges that a specific 
15.19 	licensee is impaired by use of a drug for which data is collected under subdivision 4, has 
15.20 	engaged in activity that would constitute a crime as defined in section 152.025, or has 
15.21 	engaged in the behavior specified in subdivision 5, paragraph (a);
15.22 	(6) personnel of the board engaged in the collection, review, and analysis of controlled 
15.23 	substance prescription information as part of the assigned duties and responsibilities under 
15.24 	this section;
15.25 	(7) authorized personnel of a vendor under contract with the state of Minnesota who are 
15.26 	engaged in the design, implementation, operation, and maintenance of the prescription 
15.27 	monitoring program as part of the assigned duties and responsibilities of their employment, 
15.28 	provided that access to data is limited to the minimum amount necessary to carry out such 
15.29 	duties and responsibilities, and subject to the requirement of de-identification and time limit 
15.30 	on retention of data specified in subdivision 5, paragraphs (d) and (e);
15.31 	(8) federal, state, and local law enforcement authorities acting pursuant to a valid search 
15.32 	warrant;
15.33 	(9) personnel of the Minnesota health care programs assigned to use the data collected 
15.34 	under this section to identify and manage recipients whose usage of controlled substances 
16.1 	may warrant restriction to a single primary care provider, a single outpatient pharmacy, and 
16.2 	a single hospital;
16.3 	(10) personnel of the Department of Human Services assigned to access the data pursuant 
16.4 	to paragraph (i);
16.5 	(11) personnel of the health professionals services program established under section 
16.6 	214.31, to the extent that the information relates specifically to an individual who is currently 
16.7 	enrolled in and being monitored by the program, and the individual consents to access to 
16.8 	that information. The health professionals services program personnel shall not provide this 
16.9 	data to a health-related licensing board or the Emergency Medical Services Regulatory 
16.10 	Board, except as permitted under section 214.33, subdivision 3.; and
16.11 	For purposes of clause (4), access by an individual includes persons in the definition of 
16.12 	an individual under section 13.02; and
16.13 	(12) personnel or designees of a health-related licensing board listed in section 214.01, 
16.14 	subdivision 2, assigned to conduct a bona fide investigation of a complaint received by that 
16.15 	board that alleges that a specific licensee is inappropriately prescribing controlled substances 
16.16 	as defined in this section.
16.17 	(c) By July 1, 2017, every prescriber licensed by a health-related licensing board listed 
16.18 	in section 214.01, subdivision 2, practicing within this state who is authorized to prescribe 
16.19 	controlled substances for humans and who holds a current registration issued by the federal 
16.20 	Drug Enforcement Administration, and every pharmacist licensed by the board and practicing 
16.21 	within the state, shall register and maintain a user account with the prescription monitoring 
16.22 	program. Data submitted by a prescriber, pharmacist, or their delegate during the registration 
16.23 	application process, other than their name, license number, and license type, is classified 
16.24 	as private pursuant to section 13.02, subdivision 12.
16.25 	(d) Notwithstanding paragraph (b), beginning January 1, 2020, a prescriber or an agent 
16.26 	or employee of the prescriber to whom the prescriber has delegated the task of accessing 
16.27 	the data, must access the data submitted under subdivision 4 to the extent the information 
16.28 	relates specifically to the patient before the prescriber issues an initial prescription order 
16.29 	for a controlled substance to the patient. For patients receiving an opiate for treatment of 
16.30 	chronic pain or participating in medication-assisted treatment for an opioid addiction, the 
16.31 	data must be accessed at least once every three months.
16.32 	(e) Paragraph (d) does not apply if:
16.33 	(1) the patient is receiving hospice care;
17.1 	(2) the patient is being treated for pain due to cancer or the treatment of cancer;
17.2 	(3) the prescription order is issued within 14 days following surgery or three days 
17.3 	following oral surgery;
17.4 	(4) the controlled substance is prescribed or administered to a patient who is admitted 
17.5 	to an inpatient hospital;
17.6 	(5) the prescription order is for a number of doses that is intended to last the patient five 
17.7 	days or less and is not subject to a refill;
17.8 	(6) the controlled substance is lawfully administered by injection, ingestion, or any other 
17.9 	means to the patient by the prescriber, a pharmacist, or by the patient at the direction of a 
17.10 	prescriber and in the presence of the prescriber or pharmacist;
17.11 	(7) the prescriber is a veterinarian and the patient is an animal under the care of the 
17.12 	veterinarian;
17.13 	(8) due to an emergency, it is not possible for the prescriber to review the data before 
17.14 	the prescriber issues the prescription order for the patient; or
17.15 	(9) the prescriber is unable to access the data due to operational or other technological 
17.16 	failure of the program so long as the prescriber reports the failure to the board.
17.17 	(f) Only permissible users identified in paragraph (b), clauses (1), (2), (3), (6), (7), (9), 
17.18 	and (10), may directly access the data electronically. No other permissible users may directly 
17.19 	access the data electronically. If the data is directly accessed electronically, the permissible 
17.20 	user shall implement and maintain a comprehensive information security program that 
17.21 	contains administrative, technical, and physical safeguards that are appropriate to the user's 
17.22 	size and complexity, and the sensitivity of the personal information obtained. The permissible 
17.23 	user shall identify reasonably foreseeable internal and external risks to the security, 
17.24 	confidentiality, and integrity of personal information that could result in the unauthorized 
17.25 	disclosure, misuse, or other compromise of the information and assess the sufficiency of 
17.26 	any safeguards in place to control the risks.
17.27 	(e) (g) The board shall not release data submitted under subdivision 4 unless it is provided 
17.28 	with evidence, satisfactory to the board, that the person requesting the information is entitled 
17.29 	to receive the data.
17.30 	(f) (h) The board shall maintain a log of all persons who access the data for a period of 
17.31 	at least three years and shall ensure that any permissible user complies with paragraph (c) 
17.32 	prior to attaining direct access to the data.
18.1 	(g) (i) Section 13.05, subdivision 6, shall apply to any contract the board enters into 
18.2 	pursuant to subdivision 2. A vendor shall not use data collected under this section for any 
18.3 	purpose not specified in this section.
18.4 	(h) (j) The board may participate in an interstate prescription monitoring program data 
18.5 	exchange system provided that permissible users in other states have access to the data only 
18.6 	as allowed under this section, and that section 13.05, subdivision 6, applies to any contract 
18.7 	or memorandum of understanding that the board enters into under this paragraph.
18.8 	(i) (k) With available appropriations, the commissioner of human services shall establish 
18.9 	and implement a system through which the Department of Human Services shall routinely 
18.10 	access the data for the purpose of determining whether any client enrolled in an opioid 
18.11 	treatment program licensed according to chapter 245A has been prescribed or dispensed a 
18.12 	controlled substance in addition to that administered or dispensed by the opioid treatment 
18.13 	program. When the commissioner determines there have been multiple prescribers or multiple 
18.14 	prescriptions of controlled substances, the commissioner shall:
18.15 	(1) inform the medical director of the opioid treatment program only that the 
18.16 	commissioner determined the existence of multiple prescribers or multiple prescriptions of 
18.17 	controlled substances; and
18.18 	(2) direct the medical director of the opioid treatment program to access the data directly, 
18.19 	review the effect of the multiple prescribers or multiple prescriptions, and document the 
18.20 	review.
18.21 	If determined necessary, the commissioner of human services shall seek a federal waiver 
18.22 	of, or exception to, any applicable provision of Code of Federal Regulations, title 42, section 
18.23 	2.34, paragraph (c), prior to implementing this paragraph.
18.24 	(j) (l) The board shall review the data submitted under subdivision 4 on at least a quarterly 
18.25 	basis and shall establish criteria, in consultation with the advisory task force, for referring 
18.26 	information about a patient to prescribers and dispensers who prescribed or dispensed the 
18.27 	prescriptions in question if the criteria are met.

18.28 	Sec. 5. Minnesota Statutes 2016, section 152.126, subdivision 10, is amended to read:
18.29 		Subd. 10.Funding. (a) The board may seek grants and private funds from nonprofit 
18.30 	charitable foundations, the federal government, and other sources to fund the enhancement 
18.31 	and ongoing operations of the prescription monitoring program established under this section. 
18.32 	Any funds received shall be appropriated to the board for this purpose. The board may not 
19.1 	expend funds to enhance the program in a way that conflicts with this section without seeking 
19.2 	approval from the legislature.
19.3 	(b) Notwithstanding any other section, the administrative services unit for the 
19.4 	health-related licensing boards shall apportion between the Board of Medical Practice, the 
19.5 	Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of 
19.6 	Optometry, the Board of Veterinary Medicine, and the Board of Pharmacy an amount to be 
19.7 	paid through fees by each respective board. The amount apportioned to each board shall 
19.8 	equal each board's share of the annual appropriation to the Board of Pharmacy from the 
19.9 	state government special revenue fund for operating the prescription monitoring program 
19.10 	under this section. Each board's apportioned share shall be based on the number of prescribers 
19.11 	or dispensers that each board identified in this paragraph licenses as a percentage of the 
19.12 	total number of prescribers and dispensers licensed collectively by these boards. Each 
19.13 	respective board may adjust the fees that the boards are required to collect to compensate 
19.14 	for the amount apportioned to each board by the administrative services unit.
19.15 	(c) The board shall have the authority to modify its contract with its vendor as provided 
19.16 	in subdivision 2, to authorize that vendor to provide a service to prescribers and pharmacies 
19.17 	that allows them to access prescription monitoring program data from within the electronic 
19.18 	health record system or pharmacy software used by those prescribers and pharmacists. 
19.19 	Beginning July 1, 2018, the board has the authority to collect an annual fee from each 
19.20 	prescriber or pharmacist who accesses prescription monitoring program data through the 
19.21 	service offered by the vendor. The annual fee collected must not exceed $50 per user. The 
19.22 	fees collected by the board under this paragraph shall be deposited in the state government 
19.23 	special revenue fund and is appropriated to the board for the purposes of this paragraph.

19.24 	Sec. 6. Laws 2017, First Special Session chapter 6, article 12, section 2, subdivision 4, is 
19.25 	amended to read:
19.26 		Subd. 4.Limit on quantity of opiates prescribed for acute dental and ophthalmic 
19.27 	pain. (a) When used for the treatment of acute pain, prescriptions for opiates or narcotic 
19.28 	pain relievers listed in Schedules II through IV in section 152.02 shall not exceed a seven-day 
19.29 	supply for an adult and shall not exceed a five-day supply for a minor under 18 years of 
19.30 	age.
19.31 	(a) (b) Notwithstanding paragraph (a), when used for the treatment of acute dental pain 
19.32 	or acute pain associated with refractive surgery, prescriptions for opiate or narcotic pain 
19.33 	relievers listed in Schedules II through IV of section 152.02 shall not exceed a four-day 
19.34 	supply. The quantity prescribed shall be consistent with the dosage listed in the professional 
20.1 	labeling for the drug that has been approved by the United States Food and Drug 
20.2 	Administration.
20.3 	(b) (c) For the purposes of this subdivision, "acute pain" means pain resulting from 
20.4 	disease, accidental or intentional trauma, surgery, or another cause, that the practitioner 
20.5 	reasonably expects to last only a short period of time. Acute pain does not include chronic 
20.6 	pain or pain being treated as part of cancer care, palliative care, or hospice or other end-of-life 
20.7 	care.
20.8 	(c) Notwithstanding paragraph (a), if in the professional clinical judgment of a practitioner 
20.9 	more than a four-day supply of a prescription listed in Schedules II through IV of section 
20.10 	152.02 is required to treat a patient's acute pain, the practitioner may issue a prescription 
20.11 	for the quantity needed to treat such acute pain.
20.12 	(d) Notwithstanding paragraph (a) or (b), if, in the professional clinical judgment of a 
20.13 	practitioner, more than the limit specified in paragraph (a) or (b) is required to treat a patient's 
20.14 	acute pain, the practitioner may issue a prescription for the quantity needed to treat the 
20.15 	patient's acute pain.

20.16 	ARTICLE 3
20.17 	PRESCRIPTION MONITORING PROGRAM FUNDING

20.18 	Section 1. APPROPRIATION.
 20.19 	$326,000 is appropriated in fiscal year 2019 from the state government special revenue 
20.20 	fund to the Board of Pharmacy for the prescription monitoring program. Of this amount, 
20.21 	$284,000 is for information technology migration to a new platform for the prescription 
20.22 	monitoring program and $42,000 is for administration of the prescription monitoring program. 
20.23 	This is an ongoing appropriation. In fiscal year 2019, the Board of Pharmacy shall not pay 
20.24 	MN.IT for requirement gathering and quality assurance related to the prescription monitoring 
20.25 	program.