HF 1136

2nd Engrossment - 88th Legislature (2013 - 2014) Posted on 05/08/2013 05:41pm

A bill for an act
relating to health; modifying provisions for businesses regulated by the Board of
Pharmacy; amending Minnesota Statutes 2012, sections 151.19, subdivisions 1,
3; 151.37, subdivision 4; 151.47, subdivision 1, by adding a subdivision; 151.49;
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 151.19, 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. 2.

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. 3.

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 drug 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 drug 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 drug 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 drug 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 drug 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 drug 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 drug 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. 4.

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 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.
The protocol for the study shall be considered a prescription drug order and the drug
labeled as required in the protocol. Dispensing of research drugs shall not be considered
compounding or manufacturing or the sale of a drug at wholesale under this chapter.
new text end

Sec. 5.

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, or is accredited by an accreditation program approved by 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, or furnishes the board with proof of current accreditation. 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. 6.

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. 7.

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. 8. 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