SF 1081

2nd Engrossment - 88th Legislature (2013 - 2014) Posted on 09/11/2013 03:31pm

A bill for an act
relating to health; changing licensing requirements for businesses regulated
by the Board of Pharmacy; making changes to the prescription monitoring
program; amending Minnesota Statutes 2012, sections 151.01, subdivision 27;
151.19, subdivisions 1, 3; 151.26, subdivision 1; 151.37, subdivision 4; 151.47,
subdivision 1, by adding a subdivision; 151.49; 152.126; proposing coding for
new law in Minnesota Statutes, chapter 151; repealing Minnesota Statutes 2012,
sections 151.19, subdivision 2; 151.25; 151.45; 151.47, subdivision 2; 151.48.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2012, section 151.01, subdivision 27, is amended to read:

Subd. 27.

Practice of pharmacy.

"Practice of pharmacy" means:

(1) interpretation and evaluation of prescription drug orders;

(2) compounding, labeling, and dispensing drugs and devices (except labeling by
a manufacturer or packager of nonprescription drugs or commercially packaged legend
drugs and devices);

(3) participation in clinical interpretations and monitoring of drug therapy for
assurance of safe and effective use of drugs;

(4) participation in drug and therapeutic device selection; drug administration for first
dosage and medical emergencies; drug regimen reviews; and drug or drug-related research;

(5) participation in administration of influenza vaccines to all eligible individuals ten
years of age and older and all other vaccines to patients 18 years of age and older under
standing orders from a physician licensed under chapter 147 or by written protocol with a
physician new text begin licensed under chapter 147 new text end provided that:

new text begin (i) the standing orders or protocol include, at a minimum, the name, dosage, and
route of each vaccine that may be given, the patient population to whom the vaccine may
be given, contraindications and precautions to the vaccine, the procedure for handling an
adverse reaction, the name and signature of the physician, the address of the physician, a
phone number at which the physician can be contacted, and the date and time period for
which the standing orders or protocol are valid;
new text end

deleted text begin (i) deleted text end new text begin (ii) new text end the pharmacist deleted text begin is trained in deleted text end new text begin has successfully completed new text end a program approved
by the deleted text begin American deleted text end new text begin Accreditation new text end Council deleted text begin of Pharmaceutical deleted text end new text begin for Pharmacy new text end Education new text begin ,
specifically new text end for the administration of immunizations new text begin , new text end or deleted text begin graduated from a college of
pharmacy in 2001 or thereafter; and deleted text end new text begin a program approved according to rules adopted by
the board;
new text end

new text begin (iii) the pharmacist completes continuing education concerning the administration of
immunizations, as required by Minnesota Rules;
new text end

new text begin (iv) the pharmacist has a current cardiopulmonary resuscitation certificate;
new text end

deleted text begin (ii) deleted text end new text begin (v) new text end the pharmacist reports the administration of the immunization to the patient's
primary physician or clinic new text begin or to the Minnesota Immunization Information Connection new text end ;

new text begin (vi) the pharmacist complies with guidelines for vaccines and immunizations
established by the federal Advisory Committee on Immunization Practices (ACIP), except
that a pharmacist does not need to comply with those guidelines if administering a vaccine
pursuant to a valid, patient-specific order issued by a physician licensed under chapter 147
when the order is consistent with United States Food and Drug Administration approved
labeling of the vaccine; and
new text end

new text begin (vii) the pharmacist complies with Centers for Disease Control and Prevention
guidelines relating to immunization schedules, vaccine storage and handling, and vaccine
administration and documentation;
new text end

(6) participation in the practice of managing drug therapy and modifying drug
therapy deleted text begin , according to section 151.21, subdivision 1, deleted text end according to a written protocol
between the specific pharmacist and the individual dentist, optometrist, physician,
podiatrist, or veterinarian who is responsible for the patient's care and authorized to
independently prescribe drugs. Any significant changes in drug therapy must be reported
by the pharmacist to the patient's medical record;

(7) participation in the storage of drugs and the maintenance of records;

(8) deleted text begin responsibility for participation in deleted text end patient counseling on therapeutic values,
content, hazards, and uses of drugs and devices; and

(9) offering or performing those acts, services, operations, or transactions necessary
in the conduct, operation, management, and control of a pharmacy.

Sec. 2.

Minnesota Statutes 2012, section 151.19, subdivision 1, is amended to read:

Subdivision 1.

Pharmacy deleted text begin registration deleted text end new text begin licensure requirements new text end .

deleted text begin The board shall
require and provide for the annual registration of every pharmacy now or hereafter doing
business within this state. Upon the payment of any applicable fee specified in section
151.065, the board shall issue a registration certificate in such form as it may prescribe to
such persons as may be qualified by law to conduct a pharmacy. Such certificate shall
be displayed in a conspicuous place in the pharmacy for which it is issued and expire on
the 30th day of June following the date of issue. It shall be unlawful for any person to
conduct a pharmacy unless such certificate has been issued to the person by the board. deleted text end new text begin (a)
No person shall operate a pharmacy without first obtaining a license from the board and
paying any applicable fee specified in section 151.065. The license shall be displayed in a
conspicuous place in the pharmacy for which it is issued and expires on June 30 following
the date of issue. It is unlawful for any person to operate a pharmacy unless the license
has been issued to the person by the board.
new text end

new text begin (b) Application for a pharmacy license under this section shall be made in a manner
specified by the board.
new text end

new text begin (c) No license shall be issued or renewed for a pharmacy located within the state
unless the applicant agrees to operate the pharmacy in a manner prescribed by federal and
state law and according to rules adopted by the board. No license shall be issued for a
pharmacy located outside of the state unless the applicant agrees to operate the pharmacy
in a manner prescribed by federal law and, when dispensing medications for residents of
this state, the laws of this state and Minnesota Rules.
new text end

new text begin (d) No license shall be issued or renewed for a pharmacy that is required to be
licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of such licensure or registration.
new text end

new text begin (e) The board shall require a separate license for each pharmacy located within
the state and for each pharmacy located outside of the state at which any portion of the
dispensing process occurs for drugs dispensed to residents of this state.
new text end

new text begin (f) The board shall not issue an initial or renewed license for a pharmacy unless the
pharmacy passes an inspection conducted by an authorized representative of the board. In
the case of a pharmacy located outside of the state, the board may require the applicant to
pay the cost of the inspection, in addition to the license fee in section 151.065, unless the
applicant furnishes the board with a report, issued by the appropriate regulatory agency of
the state in which the facility is located, of an inspection that has occurred within the 24
months immediately preceding receipt of the license application by the board. The board
may deny licensure unless the applicant submits documentation satisfactory to the board
that any deficiencies noted in an inspection report have been corrected.
new text end

new text begin (g) The board shall not issue an initial or renewed license for a pharmacy located
outside of the state unless the applicant discloses and certifies:
new text end

new text begin (1) the location, names, and titles of all principal corporate officers and all
pharmacists who are involved in dispensing drugs to residents of this state;
new text end

new text begin (2) that it maintains its records of drugs dispensed to residents of this state so that the
records are readily retrievable from the records of other drugs dispensed;
new text end

new text begin (3) that it agrees to cooperate with, and provide information to, the board concerning
matters related to dispensing drugs to residents of this state;
new text end

new text begin (4) that, during its regular hours of operation, but no less than six days per week, for
a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
communication between patients in this state and a pharmacist at the pharmacy who has
access to the patients' records; the toll-free number must be disclosed on the label affixed
to each container of drugs dispensed to residents of this state; and
new text end

new text begin (5) that, upon request of a resident of a long-term care facility located in this
state, the resident's authorized representative, or a contract pharmacy or licensed health
care facility acting on behalf of the resident, the pharmacy will dispense medications
prescribed for the resident in unit-dose packaging or, alternatively, comply with section
151.415, subdivision 5.
new text end

Sec. 3.

Minnesota Statutes 2012, section 151.19, subdivision 3, is amended to read:

Subd. 3.

Sale of federally restricted medical gases.

deleted text begin The board shall require and
provide for the annual registration of every person or establishment not licensed as a
pharmacy or a practitioner engaged in the retail sale or distribution of federally restricted
medical gases. Upon the payment of any applicable fee specified in section 151.065, the
board shall issue a registration certificate in such form as it may prescribe to those persons
or places that may be qualified to sell or distribute federally restricted medical gases. The
certificate shall be displayed in a conspicuous place in the business for which it is issued
and expire on the date set by the board. It is unlawful for a person to sell or distribute
federally restricted medical gases unless a certificate has been issued to that person by the
board. deleted text end new text begin (a) A person or establishment not licensed as a pharmacy or a practitioner shall not
engage in the retail sale or distribution of federally restricted medical gases without first
obtaining a registration from the board and paying the applicable fee specified in section
151.065. The registration shall be displayed in a conspicuous place in the business for
which it is issued and expires on the date set by the board. It is unlawful for a person to
sell or distribute federally restricted medical gases unless a certificate has been issued to
that person by the board.
new text end

new text begin (b) Application for a medical gas distributor registration under this section shall be
made in a manner specified by the board.
new text end

new text begin (c) No registration shall be issued or renewed for a medical gas distributor located
within the state unless the applicant agrees to operate in a manner prescribed by federal
and state law and according to the rules adopted by the board. No license shall be issued
for a medical gas distributor located outside of the state unless the applicant agrees to
operate in a manner prescribed by federal law and, when distributing medical gases for
residents of this state, the laws of this state and Minnesota Rules.
new text end

new text begin (d) No registration shall be issued or renewed for a medical gas distributor that is
required to be licensed or registered by the state in which it is physically located unless the
applicant supplies the board with proof of the licensure or registration. The board may, by
rule, establish standards for the registration of a medical gas distributor that is not required
to be licensed or registered by the state in which it is physically located.
new text end

new text begin (e) The board shall require a separate registration for each medical gas distributor
located within the state and for each facility located outside of the state from which
medical gases are distributed to residents of this state.
new text end

new text begin (f) The board shall not issue an initial or renewed registration for a medical gas
distributor unless the medical gas distributor passes an inspection conducted by an
authorized representative of the board. In the case of a medical gas distributor located
outside of the state, the board may require the applicant to pay the cost of the inspection,
in addition to the license fee in section 151.065, unless the applicant furnishes the board
with a report, issued by the appropriate regulatory agency of the state in which the facility
is located, of an inspection that has occurred within the 24 months immediately preceding
receipt of the license application by the board. The board may deny licensure unless the
applicant submits documentation satisfactory to the board that any deficiencies noted in
an inspection report have been corrected.
new text end

Sec. 4.

new text begin [151.252] LICENSING OF DRUG MANUFACTURERS; FEES;
PROHIBITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Requirements. new text end

new text begin (a) No person shall act as a manufacturer without
first obtaining a license from the board and paying any applicable fee specified in section
151.065.
new text end

new text begin (b) Application for a manufacturer license under this section shall be made in a
manner specified by the board.
new text end

new text begin (c) No license shall be issued or renewed for a manufacturer unless the applicant
agrees to operate in a manner prescribed by federal and state law and according to
Minnesota Rules.
new text end

new text begin (d) No license shall be issued or renewed for a manufacturer that is required to
be registered pursuant to United State Code, title 21, section 360, unless the applicant
supplies the board with proof of registration. The board may establish by rule the
standards for licensure of manufacturers that are not required to be registered under United
States Code, title 21, section 360.
new text end

new text begin (e) No license shall be issued or renewed for a manufacturer that is required to be
licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of licensure or registration. The board may establish, by
rule, standards for the licensure of a manufacturer that is not required to be licensed or
registered by the state in which it is physically located.
new text end

new text begin (f) The board shall require a separate license for each facility located within the state
at which manufacturing occurs and for each facility located outside of the state at which
drugs that are shipped into the state are manufactured.
new text end

new text begin (g) The board shall not issue an initial or renewed license for a manufacturing
facility unless the facility passes an inspection conducted by an authorized representative
of the board. In the case of a manufacturing facility located outside of the state, the board
may require the applicant to pay the cost of the inspection, in addition to the license fee
in section 151.065, unless the applicant furnishes the board with a report, issued by the
appropriate regulatory agency of the state in which the facility is located or by the United
States Food and Drug Administration, of an inspection that has occurred within the 24
months immediately preceding receipt of the license application by the board. The board
may deny licensure unless the applicant submits documentation satisfactory to the board
that any deficiencies noted in an inspection report have been corrected.
new text end

new text begin Subd. 2. new text end

new text begin Prohibition. new text end

new text begin It is unlawful for any person engaged in manufacturing to sell
legend drugs to anyone located in this state except as provided in this chapter.
new text end

Sec. 5.

Minnesota Statutes 2012, section 151.26, subdivision 1, is amended to read:

Subdivision 1.

Generally.

Nothing in this chapter shall subject a person duly
licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
by the State Board of Pharmacy, nor prevent the person from administering drugs,
medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
chemicals, or poisons as may be considered appropriate in the treatment of such patient;
unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
provides reasonable notice of an inspection.

Except for the provisions of section 151.37, nothing in this chapter applies to or
interferes with the dispensing, in its original package and at no charge to the patient, of
a legend drug deleted text begin , other than a controlled substance, deleted text end that was packaged by a manufacturer
and provided to the dispenser for deleted text begin distribution deleted text end new text begin dispensing new text end as a professional sample new text begin , so
long as the sample is prepared and distributed pursuant to Code of Federal Regulations,
title 21, section 203, subpart D new text end .

Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
practice, nor to hospitals for use therein.

Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
sale of insecticides, as defined in Minnesota Statutes 1974, section 24.069, and nothing in
this chapter shall prevent the sale of common household preparations and other drugs,
chemicals, and poisons sold exclusively for use for nonmedicinal purposes.

Nothing in this chapter shall apply to or interfere with the vending or retailing
of any nonprescription medicine or drug not otherwise prohibited by statute which is
prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
cosmetics, perfumes, spices, and other commonly used household articles of a chemical
nature, for use for nonmedicinal purposes. Nothing in this chapter shall prevent the sale of
drugs or medicines by licensed pharmacists at a discount to persons over 65 years of age.

Sec. 6.

Minnesota Statutes 2012, section 151.37, subdivision 4, is amended to read:

Subd. 4.

Research.

new text begin (a) new text end Any qualified person may use legend drugs in the course
of a bona fide research project, but cannot administer or dispense such drugs to human
beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
authorized to do so.

new text begin (b) Drugs may be dispensed or distributed by a pharmacy licensed by the board for
use by, or administration to, patients enrolled in a bona fide research study that is being
conducted pursuant to either an investigational new drug application approved by the
United States Food and Drug Administration or that has been approved by an institutional
review board. For the purposes of this subdivision only:
new text end

new text begin (1) a prescription drug order is not required for a pharmacy to dispense a research
drug, unless the study protocol requires the pharmacy to receive such an order;
new text end

new text begin (2) notwithstanding the prescription labeling requirements found in this chapter or
the rules promulgated by the board, a research drug may be labeled as required by the
study protocol; and
new text end

new text begin (3) dispensing and distribution of research drugs by pharmacies shall not be
considered compounding, manufacturing, or wholesaling under this chapter.
new text end

new text begin (c) An entity that is under contract to a federal agency for the purpose of distributing
drugs for bona fide research studies is exempt from the drug wholesaler licensing
requirements of this chapter. Any other entity is exempt from the drug wholesaler
licensing requirements of this chapter if the board finds that the entity is licensed or
registered according to the laws of the state in which it is physically located and it is
distributing drugs for use by, or administration to, patients enrolled in a bona fide research
study that is being conducted pursuant to either an investigational new drug application
approved by the United States Food and Drug Administration or that has been approved
by an institutional review board.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 7.

Minnesota Statutes 2012, section 151.47, subdivision 1, is amended to read:

Subdivision 1.

Requirements.

new text begin (a) new text end All wholesale drug distributors are subject to the
requirements deleted text begin in paragraphs (a) to (f) deleted text end new text begin of this subdivision new text end .

deleted text begin (a) deleted text end new text begin (b) new text end No person or distribution outlet shall act as a wholesale drug distributor
without first obtaining a license from the board and paying any applicable fee specified
in section 151.065.

new text begin (c) Application for a wholesale drug distributor license under this section shall be
made in a manner specified by the board.
new text end

deleted text begin (b) deleted text end new text begin (d) new text end No license shall be issued or renewed for a wholesale drug distributor to
operate unless the applicant agrees to operate in a manner prescribed by federal and state
law and according to the rules adopted by the board.

deleted text begin (c) The board may require a separate license for each facility directly or indirectly
owned or operated by the same business entity within the state, or for a parent entity
with divisions, subsidiaries, or affiliate companies within the state, when operations
are conducted at more than one location and joint ownership and control exists among
all the entities.
deleted text end

new text begin (e) No license may be issued or renewed for a drug wholesale distributor that is
required to be licensed or registered by the state in which it is physically located unless
the applicant supplies the board with proof of licensure or registration. The board may
establish, by rule, standards for the licensure of a drug wholesale distributor that is not
required to be licensed or registered by the state in which it is physically located.
new text end

new text begin (f) The board shall require a separate license for each drug wholesale distributor
facility located within the state and for each drug wholesale distributor facility located
outside of the state from which drugs are shipped into the state or to which drugs are
reverse distributed.
new text end

new text begin (g) The board shall not issue an initial or renewed license for a drug wholesale
distributor facility unless the facility passes an inspection conducted by an authorized
representative of the board. In the case of a drug wholesale distributor facility located
outside of the state, the board may require the applicant to pay the cost of the inspection,
in addition to the license fee in section 151.065, unless the applicant furnishes the board
with a report, issued by the appropriate regulatory agency of the state in which the facility
is located, of an inspection that has occurred within the 24 months immediately preceding
receipt of the license application by the board. The board may deny licensure unless the
applicant submits documentation satisfactory to the board that any deficiencies noted in
an inspection report have been corrected.
new text end

deleted text begin (d) deleted text end new text begin (h) new text end As a condition for receiving and retaining a wholesale drug distributor license
issued under sections 151.42 to 151.51, an applicant shall satisfy the board that it has
and will continuously maintain:

(1) adequate storage conditions and facilities;

(2) minimum liability and other insurance as may be required under any applicable
federal or state law;

(3) a viable security system that includes an after hours central alarm, or comparable
entry detection capability; restricted access to the premises; comprehensive employment
applicant screening; and safeguards against all forms of employee theft;

(4) a system of records describing all wholesale drug distributor activities set forth
in section 151.44 for at least the most recent two-year period, which shall be reasonably
accessible as defined by board regulations in any inspection authorized by the board;

(5) principals and persons, including officers, directors, primary shareholders,
and key management executives, who must at all times demonstrate and maintain their
capability of conducting business in conformity with sound financial practices as well
as state and federal law;

(6) complete, updated information, to be provided to the board as a condition for
obtaining and retaining a license, about each wholesale drug distributor to be licensed,
including all pertinent corporate licensee information, if applicable, or other ownership,
principal, key personnel, and facilities information found to be necessary by the board;

(7) written policies and procedures that assure reasonable wholesale drug distributor
preparation for, protection against, and handling of any facility security or operation
problems, including, but not limited to, those caused by natural disaster or government
emergency, inventory inaccuracies or product shipping and receiving, outdated product
or other unauthorized product control, appropriate disposition of returned goods, and
product recalls;

(8) sufficient inspection procedures for all incoming and outgoing product
shipments; and

(9) operations in compliance with all federal requirements applicable to wholesale
drug distribution.

deleted text begin (e) deleted text end new text begin (i) new text end An agent or employee of any licensed wholesale drug distributor need not
seek licensure under this section.

deleted text begin (f) A wholesale drug distributor shall file with the board an annual report, in a
form and on the date prescribed by the board, identifying all payments, honoraria,
reimbursement or other compensation authorized under section 151.461, clauses (3) to
(5), paid to practitioners in Minnesota during the preceding calendar year. The report
shall identify the nature and value of any payments totaling $100 or more, to a particular
practitioner during the year, and shall identify the practitioner. Reports filed under this
provision are public data.
deleted text end

Sec. 8.

Minnesota Statutes 2012, section 151.47, is amended by adding a subdivision
to read:

new text begin Subd. 3. new text end

new text begin Prohibition. new text end

new text begin It is unlawful for any person engaged in wholesale drug
distribution to sell drugs to anyone located within the state or to receive drugs in reverse
distribution from anyone located within the state except as provided in this chapter.
new text end

Sec. 9.

Minnesota Statutes 2012, section 151.49, is amended to read:

151.49 LICENSE RENEWAL APPLICATION PROCEDURES.

Application blanks new text begin or notices new text end for renewal of a license required by sections 151.42
to 151.51 shall be mailed new text begin or otherwise provided new text end to each licensee on or before the first
day of the month prior to the month in which the license expires and, if application for
renewal of the license with the required fee new text begin and supporting documents new text end is not made before
the expiration date, the existing license or renewal shall lapse and become null and void
upon the date of expiration.

Sec. 10.

Minnesota Statutes 2012, section 152.126, is amended to read:

152.126 deleted text begin CONTROLLED SUBSTANCES PRESCRIPTION ELECTRONIC
REPORTING SYSTEM deleted text end new text begin PRESCRIPTION MONITORING PROGRAM new text end .

Subdivision 1.

Definitions.

new text begin (a) new text end For purposes of this section, the terms defined in
this subdivision have the meanings given.

deleted text begin (a) deleted text end new text begin (b) new text end "Board" means the Minnesota State Board of Pharmacy established under
chapter 151.

deleted text begin (b) deleted text end new text begin (c) new text end "Controlled substances" means those substances listed in section 152.02,
subdivisions 3 to deleted text begin 5 deleted text end new text begin 6 new text end , and those substances defined by the board pursuant to section
152.02, subdivisions 7, 8, and 12. new text begin For the purpose of this section only, "controlled
substances" includes tramadol and butalbital.
new text end

deleted text begin (c) deleted text end new text begin (d) new text end "Dispense" or "dispensing" has the meaning given in section 151.01,
subdivision 30. Dispensing does not include the direct administering of a controlled
substance to a patient by a licensed health care professional.

deleted text begin (d) deleted text end new text begin (e) new text end "Dispenser" means a person authorized by law to dispense a controlled
substance, pursuant to a valid prescription. For the purposes of this section, a dispenser does
not include a licensed hospital pharmacy that distributes controlled substances for inpatient
hospital care or a veterinarian who is dispensing prescriptions under section 156.18.

deleted text begin (e) deleted text end new text begin (f) new text end "Prescriber" means a licensed health care professional who is authorized to
prescribe a controlled substance under section 152.12, subdivision 1.

deleted text begin (f) deleted text end new text begin (g) new text end "Prescription" has the meaning given in section 151.01, subdivision 16.

Subd. 1a.

Treatment of intractable pain.

This section is not intended to limit or
interfere with the legitimate prescribing of controlled substances for pain. No prescriber
shall be subject to disciplinary action by a health-related licensing board for prescribing a
controlled substance according to the provisions of section 152.125.

Subd. 2.

Prescription electronic reporting system.

(a) The board shall establish
by January 1, 2010, an electronic system for reporting the information required under
subdivision 4 for all controlled substances dispensed within the state.

(b) The board may contract with a vendor for the purpose of obtaining technical
assistance in the design, implementation, operation, and maintenance of the electronic
reporting system.

Subd. 3.

Prescription deleted text begin Electronic Reporting deleted text end new text begin Monitoring Program new text end Advisory
Committee.

(a) The board shall convene an advisory committee. The committee must
include at least one representative of:

(1) the Department of Health;

(2) the Department of Human Services;

(3) each health-related licensing board that licenses prescribers;

(4) a professional medical association, which may include an association of pain
management and chemical dependency specialists;

(5) a professional pharmacy association;

(6) a professional nursing association;

(7) a professional dental association;

(8) a consumer privacy or security advocate; deleted text begin and
deleted text end

(9) a consumer or patient rights organization new text begin ; and
new text end

new text begin (10) an association of medical examiners and coroners new text end .

(b) The advisory committee shall advise the board on the development and operation
of the deleted text begin electronic reporting system deleted text end new text begin prescription monitoring program new text end , including, but not
limited to:

(1) technical standards for electronic prescription drug reporting;

(2) proper analysis and interpretation of prescription monitoring data; and

(3) an evaluation process for the program.

Subd. 4.

Reporting requirements; notice.

(a) Each dispenser must submit the
following data to the board or its designated vendor deleted text begin , subject to the notice required under
paragraph (d) deleted text end :

(1) name of the prescriber;

(2) national provider identifier of the prescriber;

(3) name of the dispenser;

(4) national provider identifier of the dispenser;

(5) prescription number;

(6) name of the patient for whom the prescription was written;

(7) address of the patient for whom the prescription was written;

(8) date of birth of the patient for whom the prescription was written;

(9) date the prescription was written;

(10) date the prescription was filled;

(11) name and strength of the controlled substance;

(12) quantity of controlled substance prescribed;

(13) quantity of controlled substance dispensed; and

(14) number of days supply.

(b) The dispenser must submit the required information by a procedure and in a
format established by the board. The board may allow dispensers to omit data listed in this
subdivision or may require the submission of data not listed in this subdivision provided
the omission or submission is necessary for the purpose of complying with the electronic
reporting or data transmission standards of the American Society for Automation in
Pharmacy, the National Council on Prescription Drug Programs, or other relevant national
standard-setting body.

(c) A dispenser is not required to submit this data for those controlled substance
prescriptions dispensed for:

(1) deleted text begin individuals residing in licensed skilled nursing or intermediate care facilities;
deleted text end

deleted text begin (2) individuals receiving assisted living services under chapter 144G or through a
medical assistance home and community-based waiver;
deleted text end

deleted text begin (3) individuals receiving medication intravenously;
deleted text end

deleted text begin (4) individuals receiving hospice and other palliative or end-of-life care; and
deleted text end

deleted text begin (5) individuals receiving services from a home care provider regulated under
chapter 144A. deleted text end new text begin individuals residing in a health care facility as defined in section 151.58,
subdivision 2, paragraph (b), when a drug is distributed through the use of an automated
drug distribution system according to section 151.58; and
new text end

new text begin (2) individuals receiving a drug sample that was packaged by a manufacturer and
provided to the dispenser for dispensing as a professional sample pursuant to Code of
Federal Regulations, title 21, section 203, subpart D.
new text end

(d) A dispenser must deleted text begin not submit data under this subdivision unless deleted text end new text begin provide new text end a
conspicuous notice of the reporting requirements of this section deleted text begin is given deleted text end to the patient for
whom the prescription was written.

Subd. 5.

Use of data by board.

(a) The board shall develop and maintain a database
of the data reported under subdivision 4. The board shall maintain data that could identify
an individual prescriber or dispenser in encrypted form. The database may be used by
permissible users identified under subdivision 6 for the identification of:

(1) individuals receiving prescriptions for controlled substances from prescribers
who subsequently obtain controlled substances from dispensers in quantities or with a
frequency inconsistent with generally recognized standards of use for those controlled
substances, including standards accepted by national and international pain management
associations; and

(2) individuals presenting forged or otherwise false or altered prescriptions for
controlled substances to dispensers.

(b) No permissible user identified under subdivision 6 may access the database
for the sole purpose of identifying prescribers of controlled substances for unusual or
excessive prescribing patterns without a valid search warrant or court order.

(c) No personnel of a state or federal occupational licensing board or agency may
access the database for the purpose of obtaining information to be used to initiate or
substantiate a disciplinary action against a prescriber.

(d) Data reported under subdivision 4 shall be retained by the board in deleted text begin the deleted text end new text begin an active
new text end database for a 12-month period, and shall be removed from the new text begin active new text end database no later
than 12 months from the last day of the month during which the data was received. new text begin The
board may transfer the data into a database that may only be used by the authorized staff
of the board for the purposes of administering, operating, and maintaining the prescription
monitoring program and conducting trend analyses and other studies as necessary to
evaluate the effectiveness of the program. No data that can be used to identify an
individual may be transferred to this database.
new text end

Subd. 6.

Access to reporting system data.

(a) Except as indicated in this
subdivision, the data submitted to the board under subdivision 4 is private data on
individuals as defined in section 13.02, subdivision 12, and not subject to public disclosure.

(b) Except as specified in subdivision 5, the following persons shall be considered
permissible users and may access the data submitted under subdivision 4 in the same or
similar manner, and for the same or similar purposes, as those persons who are authorized
to access similar private data on individuals under federal and state law:

(1) a prescriber or an agent or employee of the prescriber to whom the prescriber has
delegated the task of accessing the data, to the extent the information relates specifically to
a current patient, to whom the prescriber is prescribing or considering prescribing any
controlled substance new text begin or to whom the prescriber is providing other medical treatment for
which access to the data may be necessary new text end and with the provision that the prescriber remains
responsible for the use or misuse of data accessed by a delegated agent or employee;

(2) a dispenser or an agent or employee of the dispenser to whom the dispenser has
delegated the task of accessing the data, to the extent the information relates specifically
to a current patient to whom that dispenser is dispensing or considering dispensing any
controlled substance new text begin or to whom the dispenser is providing other pharmaceutical care for
which access to the data may be necessary new text end and with the provision that the dispenser remains
responsible for the use or misuse of data accessed by a delegated agent or employee;

new text begin (3) a licensed pharmacist who is providing pharmaceutical care for which access to
the data may be necessary or when consulted by a prescriber who is requesting data in
accordance with clause (1);
new text end

deleted text begin (3) deleted text end new text begin (4) new text end an individual who is the recipient of a controlled substance prescription for
which data was submitted under subdivision 4, or a guardian of the individual, parent or
guardian of a minor, or health care agent of the individual acting under a health care
directive under chapter 145C;

deleted text begin (4) deleted text end new text begin (5) new text end personnel of the board specifically assigned to conduct a bona fide
investigation of a specific licensee;

deleted text begin (5) deleted text end new text begin (6) new text end personnel of the board engaged in the collection of controlled substance
prescription information as part of the assigned duties and responsibilities under this
section;

deleted text begin (6) deleted text end new text begin (7) new text end authorized personnel of a vendor under contract with the board who are
engaged in the design, implementation, operation, and maintenance of the deleted text begin electronic
reporting system deleted text end new text begin prescription monitoring program new text end as part of the assigned duties and
responsibilities of their employment, provided that access to data is limited to the
minimum amount necessary to carry out such duties and responsibilities;

deleted text begin (7) deleted text end new text begin (8) new text end federal, state, and local law enforcement authorities acting pursuant to a
valid search warrant; deleted text begin and
deleted text end

deleted text begin (8) deleted text end new text begin (9) new text end personnel of the deleted text begin medical assistance program deleted text end new text begin Minnesota health care programs
new text end assigned to use the data collected under this section to identify new text begin and manage new text end recipients
whose usage of controlled substances may warrant restriction to a single primary care
deleted text begin physician deleted text end new text begin provider new text end , a single outpatient pharmacy, deleted text begin or deleted text end new text begin and new text end a single hospital new text begin ; and
new text end

new text begin (10) a coroner or medical examiner, or an agent or employee of the coroner or
medical examiner to whom the coroner or medical examiner has delegated the task of
accessing the data, conducting an investigation pursuant to section 390.11, and with the
provision that the coroner or medical examiner remains responsible for the use or misuse
of data accessed by a delegated agent or employee new text end .

For purposes of clause deleted text begin (3) deleted text end new text begin (4) new text end , access by an individual includes persons in the
definition of an individual under section 13.02.

(c) Any permissible user identified in paragraph (b), who directly accesses
the data electronically, shall implement and maintain a comprehensive information
security program that contains administrative, technical, and physical safeguards that
are appropriate to the user's size and complexity, and the sensitivity of the personal
information obtained. The permissible user shall identify reasonably foreseeable internal
and external risks to the security, confidentiality, and integrity of personal information
that could result in the unauthorized disclosure, misuse, or other compromise of the
information and assess the sufficiency of any safeguards in place to control the risks.

(d) The board shall not release data submitted under this section unless it is provided
with evidence, satisfactory to the board, that the person requesting the information is
entitled to receive the data.

(e) deleted text begin The board shall not release the name of a prescriber without the written consent
of the prescriber or a valid search warrant or court order. The board shall provide a
mechanism for a prescriber to submit to the board a signed consent authorizing the release
of the prescriber's name when data containing the prescriber's name is requested.
deleted text end

deleted text begin (f) deleted text end The board shall maintain a log of all persons who access the data new text begin for a period of
at least five years new text end and shall ensure that any permissible user complies with paragraph (c)
prior to attaining direct access to the data.

deleted text begin (g) deleted text end new text begin (f) new text end Section 13.05, subdivision 6, shall apply to any contract the board enters into
pursuant to subdivision 2. A vendor shall not use data collected under this section for
any purpose not specified in this section.

new text begin (g) The board may participate in an interstate prescription monitoring program data
exchange system provided that permissible users in other states may have access to the data
only as allowed under this section and that section 13.05, subdivision 6, shall apply to any
contract or memorandum of understanding that the board enters into under this paragraph.
new text end

Subd. 7.

Disciplinary action.

(a) A dispenser who knowingly fails to submit data to
the board as required under this section is subject to disciplinary action by the appropriate
health-related licensing board.

(b) A prescriber or dispenser authorized to access the data who knowingly discloses
the data in violation of state or federal laws relating to the privacy of health care data
shall be subject to disciplinary action by the appropriate health-related licensing board,
and appropriate civil penalties.

deleted text begin Subd. 8. deleted text end

deleted text begin Evaluation and reporting. deleted text end

deleted text begin (a) The board shall evaluate the prescription
electronic reporting system to determine if the system is negatively impacting appropriate
prescribing practices of controlled substances. The board may contract with a vendor to
design and conduct the evaluation.
deleted text end

deleted text begin (b) The board shall submit the evaluation of the system to the legislature by July
15, 2011.
deleted text end

Subd. 9.

Immunity from liability; no requirement to obtain information.

(a) A
pharmacist, prescriber, or other dispenser making a report to the program in good faith
under this section is immune from any civil, criminal, or administrative liability, which
might otherwise be incurred or imposed as a result of the report, or on the basis that the
pharmacist or prescriber did or did not seek or obtain or use information from the program.

(b) Nothing in this section shall require a pharmacist, prescriber, or other dispenser
to obtain information about a patient from the program, and the pharmacist, prescriber,
or other dispenser, if acting in good faith, is immune from any civil, criminal, or
administrative liability that might otherwise be incurred or imposed for requesting,
receiving, or using information from the program.

Subd. 10.

Funding.

(a) The board may seek grants and private funds from nonprofit
charitable foundations, the federal government, and other sources to fund the enhancement
and ongoing operations of the prescription deleted text begin electronic reporting system deleted text end new text begin monitoring
program new text end established under this section. Any funds received shall be appropriated to the
board for this purpose. The board may not expend funds to enhance the program in a way
that conflicts with this section without seeking approval from the legislature.

(b) new text begin Notwithstanding any other section, new text end the administrative services unit for the
health-related licensing boards shall apportion between the Board of Medical Practice, the
Board of Nursing, the Board of Dentistry, the Board of Podiatric Medicine, the Board of
Optometry, new text begin the Board of Veterinary Medicine, new text end and the Board of Pharmacy an amount to
be paid through fees by each respective board. The amount apportioned to each board
shall equal each board's share of the annual appropriation to the Board of Pharmacy
from the state government special revenue fund for operating the prescription deleted text begin electronic
reporting system deleted text end new text begin monitoring program new text end under this section. Each board's apportioned share
shall be based on the number of prescribers or dispensers that each board identified in
this paragraph licenses as a percentage of the total number of prescribers and dispensers
licensed collectively by these boards. Each respective board may adjust the fees that the
boards are required to collect to compensate for the amount apportioned to each board by
the administrative services unit.

Sec. 11. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47,
subdivision 2; and 151.48, new text end new text begin are repealed.
new text end