SF 1081

as introduced - 88th Legislature (2013 - 2014) Posted on 04/10/2013 08:34am

A bill for an act
relating to health; changing licensing requirements for businesses regulated by the
Board of Pharmacy; clarifying requirements for compounding; making changes
to the prescription monitoring program; amending Minnesota Statutes 2012,
sections 151.01, subdivisions 14, 16, 17, 27, 28, 29, 30, by adding subdivisions;
151.19, subdivisions 1, 3; 151.211; 151.361, subdivision 2; 151.37, subdivision 2,
by adding subdivisions; 151.44; 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;
151.37, subdivision 11; 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 14, is amended to read:

Subd. 14.

Manufacturing.

deleted text begin The term deleted text end "Manufacturing" deleted text begin except in the case of bulk
compounding, prepackaging or extemporaneous compounding within a pharmacy, deleted text end means
deleted text begin and includes deleted text end the production, deleted text begin quality control and standardization by mechanical, physical,
chemical, or pharmaceutical means, packing, repacking, tableting, encapsulating, labeling,
relabeling, filling or by any other process, of all drugs, medicines, chemicals, or poisons,
without exception, for medicinal purposes deleted text end new text begin preparation, propagation, conversion, or
processing of a drug, either directly or indirectly, by extraction from substances of natural
origin or independently by means of chemical or biological synthesis new text end . new text begin Manufacturing
includes the packaging or repackaging of a drug, or the labeling or relabeling of
the container of a drug, for resale by pharmacies, practitioners, or other persons.
Manufacturing does not include the prepackaging, extemporaneous compounding, or bulk
compounding of a drug within a licensed pharmacy, nor the labeling of a container within
a pharmacy for the purpose of dispensing a drug to a patient with a valid prescription.
new text end

Sec. 2.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 13a. new text end

new text begin Manufacturer. new text end

new text begin "Manufacturer" means anyone engaged in
manufacturing.
new text end

Sec. 3.

Minnesota Statutes 2012, section 151.01, subdivision 16, is amended to read:

Subd. 16.

Prescription new text begin drug order new text end .

The term "prescription new text begin drug order new text end " means a
deleted text begin signed deleted text end new text begin lawful new text end written deleted text begin order deleted text end , deleted text begin or an deleted text end oral new text begin , or electronic new text end order deleted text begin reduced to writing, given by deleted text end new text begin of
new text end a practitioner deleted text begin licensed to prescribe drugs for patients in the course of the practitioner's
practice, issued for an individual patient and containing the following: the date of issue,
name and address of the patient, name and quantity of the drug prescribed, directions for
use, and the name and address of the prescriber deleted text end new text begin for a drug for a specific patient new text end .

Sec. 4.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 16a. new text end

new text begin Prescription. new text end

new text begin The term "prescription" means a prescription drug order
that is written or printed on paper, an oral order reduced to writing by a pharmacist, or
an electronic order. To be valid, a prescription must be issued for an individual patient
by a practitioner within the scope and usual course of the practitioner's practice, and
must contain the date of issue, name and address of the patient, name and quality of the
drug prescribed, directions for use, name and address of the practitioner, and telephone
number at which the practitioner can be reached. A prescription written or printed on
paper that is given to the patient or an agent of the patient or transmitted via facsimile
must contain the practitioner's manual signature. An electronic prescription must contain
the practitioner's electronic signature.
new text end

Sec. 5.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 16b. new text end

new text begin Chart order. new text end

new text begin The term "chart order" means a prescription drug order
for a drug that is to be dispensed by a pharmacist or pharmacist intern under the direct
supervision of a pharmacist and administered by an authorized person only during the
patient's stay in a hospital or long-term care facility. The chart order shall contain the name
of the patient, another patient identifier such as a birth date or medical record number,
the drug ordered, and any directions the practitioner may prescribe concerning strength,
dosage, frequency, and route of administration. The manual or electronic signature of the
practitioner must be affixed to the chart order at the time it is written, or at a later date in
the case of verbal chart orders.
new text end

Sec. 6.

Minnesota Statutes 2012, section 151.01, subdivision 17, is amended to read:

Subd. 17.

Legend drug.

"Legend drug" means a drug deleted text begin which deleted text end new text begin that new text end is required by
federal law to deleted text begin bear the following statement, "Caution: Federal law prohibits dispensing
without prescription." deleted text end new text begin be dispensed only pursuant to the prescription of a licensed
practitioner.
new text end

Sec. 7.

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 for 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. 8.

Minnesota Statutes 2012, section 151.01, subdivision 28, is amended to read:

Subd. 28.

Veterinary legend drug.

"Veterinary legend drug" means a drug that is
required by federal law to deleted text begin bear the following statement: "Caution: Federal law restricts
this drug to use by or on the order of a licensed veterinarian." deleted text end new text begin be dispensed only pursuant
to the prescription of a licensed veterinarian.
new text end

Sec. 9.

Minnesota Statutes 2012, section 151.01, subdivision 29, is amended to read:

Subd. 29.

Legend medical gas.

"Legend medical gas" means a liquid or gaseous
substance used for medical purposes and that is required by federal law to deleted text begin bear the
following statement: "Caution: Federal law prohibits dispensing without a prescription."
deleted text end new text begin be dispensed only pursuant to the prescription of a licensed practitioner.
new text end

Sec. 10.

Minnesota Statutes 2012, section 151.01, subdivision 30, is amended to read:

Subd. 30.

Dispense or dispensing.

"Dispense or dispensing" means the deleted text begin preparation
or delivery of a drug pursuant to a lawful order of a practitioner in a suitable container
appropriately labeled for subsequent administration to or use by a patient or other
individual entitled to receive the drug deleted text end new text begin interpretation, evaluation, and processing of a
prescription drug order, including the preparation and delivery of a drug to a patient or
patient's agent in a suitable container appropriately labeled for subsequent administration
to, or use by, a patient new text end .

Sec. 11.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 35. new text end

new text begin Compounding. new text end

new text begin The term "compounding" means preparing, mixing,
assembling, packaging, and labeling a drug for an identified individual patient as a
result of a practitioner's prescription drug order, or for the purpose of, or incident to,
research, teaching, or chemical analysis, and not for sale or dispensing. All compounding,
regardless of the type of product, shall be done pursuant to a prescription drug order
unless otherwise permitted in this chapter. Compounding also includes the preparation of
drugs in which all bulk drug substances and components are nonprescription substances.
Compounding does not include mixing or reconstituting a drug according to the product's
labeling or the manufacturer's directions.
new text end

Sec. 12.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 36. new text end

new text begin Anticipatory compounding. new text end

new text begin The term "anticipatory compounding"
means the preparation by a pharmacy of a supply of a compounded drug product that is
sufficient to meet the short-term anticipated need of the pharmacy for filling prescription
drug orders. In the case of practitioners only, bulk compounding means the preparation
of a supply of a compounded drug product that is sufficient to meet the practitioner's
short-term anticipated need for dispensing or administering the drug to patients treated
by the practitioner. Bulk compounding is not the preparation of a compounded drug
product for wholesale distribution.
new text end

Sec. 13.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 37. new text end

new text begin Extemporaneous compounding. new text end

new text begin The term "extemporaneous
compounding" means compounding a drug product upon receipt of a prescription drug
order for a specific patient.
new text end

Sec. 14.

Minnesota Statutes 2012, section 151.01, is amended by adding a subdivision
to read:

new text begin Subd. 38. new text end

new text begin Compounded positron emission tomography drug. new text end

new text begin (a) The term
"compounded positron emission tomography drug" means a drug that:
new text end

new text begin (1) exhibits spontaneous disintegration of unstable nuclei by the emission of
positrons and is used for the purpose of providing dual photon positron emission
tomographic diagnostic images; and
new text end

new text begin (2) has been compounded by or on the order of a practitioner according to Minnesota
Rules, chapters 4731 and 6800, for a patient or for research, teaching, or quality control.
new text end

new text begin (b) Compounded positron emission tomography drug includes any nonradioactive
reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic
synthesizer, or other apparatus or computer program used in the preparation of a drug.
new text end

Sec. 15.

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. 16.

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. 17.

Minnesota Statutes 2012, section 151.211, is amended to read:

151.211 RECORDS OF PRESCRIPTIONS.

new text begin Subdivision 1. new text end

new text begin Retention of prescription drug orders. new text end

All deleted text begin prescriptions dispensed
deleted text end new text begin prescription drug orders new text end shall be kept on file at the location deleted text begin in deleted text end new text begin from new text end which deleted text begin such deleted text end dispensing
deleted text begin occurred deleted text end new text begin of the ordered drug occurs new text end for a period of at least two years. new text begin Prescription drug
orders that are electronically prescribed must be kept on file in the format in which
they were originally received. Written or printed prescription drug orders and verbal
prescription drug orders reduced to writing must be kept on file as received or transcribed
unless they are converted to an electronic format that produces an exact and legible copy
of the original document. Electronic systems used to process and store prescription drug
orders must be compliant with the requirements of this chapter and Minnesota Rules.
new text end

new text begin Subd. 2. new text end

new text begin Refill requirements. new text end

deleted text begin No deleted text end new text begin A new text end prescription deleted text begin shall deleted text end new text begin drug order may new text end be refilled
deleted text begin except deleted text end new text begin only new text end with the written new text begin , electronic, new text end or verbal consent of the prescriber new text begin and in
accordance with the requirements of this chapter, section 152.11, and the rules of the board new text end .
The date of deleted text begin such deleted text end new text begin the new text end refill must be recorded and initialed upon the original prescription
new text begin drug order new text end or within the electronically maintained record of the original prescription new text begin drug
order new text end by the pharmacist, pharmacist intern, or practitioner who refills the prescription.

Sec. 18.

new text begin [151.251] PHARMACY COMPOUNDING.
new text end

new text begin Subdivision 1. new text end

new text begin Exemption from manufacturing licensure requirement. new text end

new text begin Section
151.25 shall not apply to a pharmacy or a practitioner that compounds a drug product if
the drug product is compounded for an identified individual patient based on receipt of a
valid prescription drug order, as defined in section 151.01, subdivision 16a, on which the
prescribing practitioner has indicated that compounding of the drug product is medically
necessary for the patient, if the drug product meets the requirements of this section and is
not sold at wholesale and if the compounding:
new text end

new text begin (1) is by a licensed pharmacist or a licensed practitioner, on the prescription order
for the individual patient made by a licensed practitioner authorized to prescribe drugs; or
new text end

new text begin (2) is by a licensed pharmacist or licensed practitioner in limited quantities before
the receipt of a valid prescription order for the individual patient and:
new text end

new text begin (i) is not dispensed or otherwise distributed in any manner prior to receipt of a
valid prescription order; and
new text end

new text begin (ii) is based on a history of the licensed pharmacist or licensed practitioner receiving
valid prescription orders for the compounding of the drug product, and those orders have
been generated solely within an established relationship between the licensed pharmacist
or licensed practitioner and the individual patient for whom the prescription order will be
provided or the licensed practitioner who will write the prescription order.
new text end

new text begin Subd. 2. new text end

new text begin Compounded drug. new text end

new text begin (a) A drug product may be compounded under this
section if the licensed pharmacist or licensed practitioner:
new text end

new text begin (1) compounds the drug product using bulk drug substances, as defined in Code of
Federal Regulations, title 21, section 207.3, subsection (a), paragraph (4), that:
new text end

new text begin (i) complies with the standards of an applicable United States Pharmacopoeia
or National Formulary monograph, if a monograph exists, and the United States
Pharmacopoeia chapter on pharmacy compounding;
new text end

new text begin (ii) if a monograph does not exist, are drug substances that are components of drugs
approved for use in this country by the United States Food and Drug Administration; or
new text end

new text begin (iii) if a monograph does not exist and the drug substance is not a component of a
drug approved for use in this country by the United States Food and Drug Administration,
appears on a list developed by the United States Food and Drug Administration through
regulations issued by the Secretary of the United States Department of Health and Human
Services pursuant to the Food, Drugs, and Cosmetic Act, section 503a, subsection (d) and:
new text end

new text begin (A) are manufactured by an establishment that is registered under the federal Food,
Drug, and Cosmetic Act, section 360, including a foreign establishment registered under
section 360, subsection (i) of the act; and
new text end

new text begin (B) are accompanied by valid certificates of analysis for each bulk drug substance; and
new text end

new text begin (2) compounds the drug product using ingredients, other than bulk drug substances,
that comply with the standards of an applicable United States Pharmacopoeia or National
Formulary monograph, if a monograph exists, and the United States Pharmacopoeia
chapters on pharmacy compounding.
new text end

new text begin (b) A licensed pharmacist or licensed practitioner, when compounding a drug product,
is prohibited from using any product that appears on a list published by the secretary of the
United States Department of Health and Human Services in the Federal Register of drug
products that have been withdrawn or removed from the market because the drug products
or components of the drug products have been found to be unsafe or not effective.
new text end

new text begin (c) A licensed pharmacist or licensed practitioner shall not compound any drug
product that is essentially a copy of a commercially available drug product. For purposes
of this paragraph, "essentially a copy of a commercially available drug product" does
not include a drug product in which there is a change, made for an identified individual
patient, that produces for that patient a sufficient difference between the compounded
drug and the comparable commercially available drug product, as determined by the
prescribing practitioner.
new text end

new text begin Subd. 3. new text end

new text begin Exceptions. new text end

new text begin (a) This section does not apply to:
new text end

new text begin (1) drugs compounded 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;
new text end

new text begin (2) compounded positron emission tomography drugs as defined in section 151.01,
subdivision 38; or
new text end

new text begin (3) radiopharmaceuticals.
new text end

new text begin (b) As used in this section, "compounding" does not include mixing, reconstituting,
or other acts performed according to directions contained in approved labeling provided by
the product's manufacturer and other manufacturer directions consistent with that labeling.
new text end

Sec. 19.

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. 20.

Minnesota Statutes 2012, section 151.361, subdivision 2, is amended to read:

Subd. 2.

After January 1, 1983.

(a) No legend drug in solid oral dosage form may
be manufactured, packaged or distributed for sale in this state after January 1, 1983 unless
it is clearly marked or imprinted with a symbol, number, company name, words, letters,
national drug code or other mark uniquely identifiable to that drug product. An identifying
mark or imprint made as required by federal law or by the deleted text begin federal deleted text end new text begin United States new text end Food and
Drug Administration shall be deemed to be in compliance with this section.

(b) The Board of Pharmacy may grant exemptions from the requirements of this
section on its own initiative or upon application of a manufacturer, packager, or distributor
indicating size or other characteristics which render the product impractical for the
imprinting required by this section.

(c) deleted text begin The provisions of clauses deleted text end new text begin Paragraphs new text end (a) and (b) shall not apply to any of the
following:

(1) drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to
January 1, 1983, and held in stock for resale deleted text begin . deleted text end new text begin ; and
new text end

(2) drugs deleted text begin which deleted text end new text begin that new text end are deleted text begin manufactured deleted text end new text begin compounded new text end by or upon the order of a
practitioner licensed by law to prescribe or administer drugs and which are to be used
solely by the patient for whom prescribed.

Sec. 21.

Minnesota Statutes 2012, section 151.37, subdivision 2, is amended to read:

Subd. 2.

Prescribing and filing.

(a) A licensed practitioner in the course of
professional practice only, may prescribe, administer, and dispense a legend drug, and may
cause the same to be administered by a nurse, a physician assistant, or medical student or
resident under the practitioner's direction and supervision, and may cause a person who
is an appropriately certified, registered, or licensed health care professional to prescribe,
dispense, and administer the same within the expressed legal scope of the person's practice
as defined in Minnesota Statutes. A licensed practitioner may prescribe a legend drug,
without reference to a specific patient, by directing a nurse, pursuant to section 148.235,
subdivisions 8 and 9, physician assistant, medical student or resident, or pharmacist
according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
protocol when treating patients whose condition falls within such guideline or protocol,
and when such guideline or protocol specifies the circumstances under which the legend
drug is to be prescribed and administered. An individual who verbally, electronically, or
otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
not be deemed to have prescribed the legend drug. This paragraph applies to a physician
assistant only if the physician assistant meets the requirements of section 147A.18.

(b) The commissioner of health, if a licensed practitioner, or a person designated
by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
individual or by protocol for mass dispensing purposes where the commissioner finds that
the conditions triggering section 144.4197 or 144.4198, subdivision 2, paragraph (b), exist.
The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
to control tuberculosis and other communicable diseases. The commissioner may modify
state drug labeling requirements, and medical screening criteria and documentation, where
time is critical and limited labeling and screening are most likely to ensure legend drugs
reach the maximum number of persons in a timely fashion so as to reduce morbidity
and mortality.

(c) A licensed practitioner that dispenses for profit a legend drug that is to be
administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
file with the practitioner's licensing board a statement indicating that the practitioner
dispenses legend drugs for profit, the general circumstances under which the practitioner
dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
any amount received by the practitioner in excess of the acquisition cost of a legend drug
for legend drugs that are purchased in prepackaged form, or (2) any amount received
by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
making the drug available if the legend drug requires compounding, packaging, or other
treatment. The statement filed under this paragraph is public data under section 13.03.
This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
To dispense for profit does not include dispensing by a community health clinic when the
profit from dispensing is used to meet operating expenses.

(d) A prescription deleted text begin or deleted text end drug order for the following drugs is not valid, unless it can
be established that the prescription deleted text begin or deleted text end new text begin drug new text end order was based on a documented patient
evaluation, including an examination, adequate to establish a diagnosis and identify
underlying conditions and contraindications to treatment:

(1) controlled substance drugs listed in section 152.02, subdivisions 3 to 5;

(2) drugs defined by the Board of Pharmacy as controlled substances under section
152.02, subdivisions 7, 8, and 12;

(3) muscle relaxants;

(4) centrally acting analgesics with opioid activity;

(5) drugs containing butalbital; or

(6) phoshodiesterase type 5 inhibitors when used to treat erectile dysfunction.

(e) For the purposes of paragraph (d), the requirement for an examination shall be
met if an in-person examination has been completed in any of the following circumstances:

(1) the prescribing practitioner examines the patient at the time the prescription
deleted text begin or deleted text end drug order is issued;

(2) the prescribing practitioner has performed a prior examination of the patient;

(3) another prescribing practitioner practicing within the same group or clinic as the
prescribing practitioner has examined the patient;

(4) a consulting practitioner to whom the prescribing practitioner has referred the
patient has examined the patient; or

(5) the referring practitioner has performed an examination in the case of a
consultant practitioner issuing a prescription or drug order when providing services by
means of telemedicine.

(f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
a drug through the use of a guideline or protocol pursuant to paragraph (a).

(g) Nothing in this chapter prohibits a licensed practitioner from issuing a
prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
in the Management of Sexually Transmitted Diseases guidance document issued by the
United States Centers for Disease Control.

(h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
of legend drugs through a public health clinic or other distribution mechanism approved
by the commissioner of health or a board of health in order to prevent, mitigate, or treat
a pandemic illness, infectious disease outbreak, or intentional or accidental release of a
biological, chemical, or radiological agent.

(i) No pharmacist employed by, under contract to, or working for a pharmacy
licensed under section 151.19, subdivision 1, may dispense a legend drug based on a
prescription that the pharmacist knows, or would reasonably be expected to know, is not
valid under paragraph (d).

(j) No pharmacist employed by, under contract to, or working for a pharmacy
licensed under section 151.19, subdivision 2, may dispense a legend drug to a resident
of this state based on a prescription that the pharmacist knows, or would reasonably be
expected to know, is not valid under paragraph (d).

Sec. 22.

Minnesota Statutes 2012, section 151.37, is amended by adding a subdivision
to read:

new text begin Subd. 10a. new text end

new text begin Emergency use authorizations. new text end

new text begin Nothing in this chapter prohibits the
purchase, possession, or use of a legend drug by an entity authorized by an emergency
use authorization issued by the United States Food and Drug Administration pursuant to
United States Code, title 21, section 360.bbb-3. The entity must be specifically tasked
in a public health response plan to perform critical functions necessary to support the
response to a public health incident or event.
new text end

Sec. 23.

Minnesota Statutes 2012, section 151.37, is amended by adding a subdivision
to read:

new text begin Subd. 10b. new text end

new text begin Exclusion for health care educational programs. new text end

new text begin (a) Nothing in this
chapter prohibits an accredited public or private postsecondary school from possessing a
legend drug that is not a controlled substance listed in section 152.02, provided that:
new text end

new text begin (1) the school is approved by the United States Secretary of Education according
to the Higher Education Act of 1965, as amended, published in United States Code, title
20, chapter 28;
new text end

new text begin (2) the school provides a course of instruction that prepares individuals for
employment in a health care occupation or profession;
new text end

new text begin (3) the school only possesses those drugs necessary for instruction of individuals; and
new text end

new text begin (4) the drugs may only be used in the course of providing such instruction and are
labeled by the purchaser to indicate that they are not to be administered to patients.
new text end

new text begin (b) Those areas of the school in which legend drugs are stored are subject to section
151.06, subdivision 1, paragraph (a), clause (4).
new text end

Sec. 24.

Minnesota Statutes 2012, section 151.44, is amended to read:

151.44 DEFINITIONS.

As used in sections 151.43 to 151.51, the following terms have the meanings given
in paragraphs (a) to (h):

(a) "Wholesale drug distribution" means distribution of prescription or
nonprescription drugs to persons other than a consumer or patient or reverse distribution
of such drugs, but does not include:

(1) a sale between a division, subsidiary, parent, affiliated, or related company under
the common ownership and control of a corporate entity;

(2) the purchase or other acquisition, by a hospital or other health care entity that is a
member of a group purchasing organization, of a drug for its own use from the organization
or from other hospitals or health care entities that are members of such organizations;

(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a
drug by a charitable organization described in section 501(c)(3) of the Internal Revenue
Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the
organization to the extent otherwise permitted by law;

(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
among hospitals or other health care entities that are under common control;

(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug
for emergency medical reasons;

(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or
the dispensing of a drug pursuant to a prescription;

(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to
another retail pharmacy to alleviate a temporary shortage;

(8) the distribution of prescription or nonprescription drug samples by manufacturers
representatives; or

(9) the sale, purchase, or trade of blood and blood components.

(b) "Wholesale drug distributor" means anyone engaged in wholesale drug
distribution including, but not limited to, manufacturers; deleted text begin repackers deleted text end new text begin repackagers new text end ; own-label
distributors; jobbers; brokers; warehouses, including manufacturers' and distributors'
warehouses, chain drug warehouses, and wholesale drug warehouses; independent
wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A
wholesale drug distributor does not include a common carrier or individual hired primarily
to transport prescription or nonprescription drugs.

(c) "Manufacturer" deleted text begin means anyone who is engaged in the manufacturing, preparing,
propagating, compounding, processing, packaging, repackaging, or labeling of a
prescription drug deleted text end new text begin has the meaning provided in section 151.01, subdivision 13a new text end .

(d) "Prescription drug" means a drug required by federal or state law or regulation
to be dispensed only by a prescription, including finished dosage forms and active
ingredients subject to United States Code, title 21, sections 811 and 812.

(e) "Blood" means whole blood collected from a single donor and processed either
for transfusion or further manufacturing.

(f) "Blood components" means that part of blood separated by physical or
mechanical means.

(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs
received from or shipped to Minnesota locations for the purpose of returning the drugs
to their producers or distributors.

(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.

Sec. 25.

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. 26.

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. 27.

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. 28.

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 deleted text begin :
deleted text end

deleted text begin (1) 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.
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 is given 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 new text begin when the disciplinary action relates
to allegations involving unusual or excessive prescribing of the drugs for which data
is collected under subdivision 4 new text end .

(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 data into an inactive database provided that the data thus transferred
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. Data
in the inactive database shall not be accessible to any other persons for any reason.
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;

(3) 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;

(4) personnel of deleted text begin the deleted text end new text begin a health-related licensing new text end board deleted text begin specifically deleted text end new text begin listed in section
214.01, subdivision 2, or of the Emergency Medical Services Regulatory Board new text end assigned
to conduct a bona fide investigation of a new text begin complaint received by that board alleging that
a new text end specific licensee new text begin is chemically dependent, has diverted controlled substances, or has
engaged in the behavior specified in subdivision 5, paragraph (a) new text end ;

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

(6) 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;

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

(8) 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 ;
new text end

new text begin (9) 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; and
new text end

new text begin (10) personnel of the health professionals services program established pursuant to
section 214.31, to the extent that the information relates specifically to an individual
who is currently enrolled in and being monitored by the program and provided that
the information cannot be given to a health-related licensing board except as provided
by section 214.33, subdivision 3 new text end .

For purposes of clause (3), 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. 29. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.37,
subdivision 11; 151.45; 151.47, subdivision 2; and 151.48, new text end new text begin are repealed.
new text end