Bill Text: MN HF1136 | 2013-2014 | 88th Legislature | Engrossed
Bill Title: Pharmacy Board business regulation provisions modified.
Spectrum: Slight Partisan Bill (Democrat 2-1)
Status: (Engrossed - Dead) 2013-05-13 - Author added Selcer [HF1136 Detail]
Download: Minnesota-2013-HF1136-Engrossed.html
1.2relating to health; modifying provisions for businesses regulated by the Board of
1.3Pharmacy;amending Minnesota Statutes 2012, sections 151.19, subdivisions 1,
1.43; 151.37, subdivision 4; 151.47, subdivision 1, by adding a subdivision; 151.49;
1.5proposing coding for new law in Minnesota Statutes, chapter 151; repealing
1.6Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47,
1.7subdivision 2; 151.48.
1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.9 Section 1. Minnesota Statutes 2012, section 151.19, subdivision 1, is amended to read:
1.10 Subdivision 1. Pharmacyregistration licensure requirements. The board shall
1.11require and provide for the annual registration of every pharmacy now or hereafter doing
1.12business within this state. Upon the payment of any applicable fee specified in section
1.13151.065, the board shall issue a registration certificate in such form as it may prescribe to
1.14such persons as may be qualified by law to conduct a pharmacy. Such certificate shall
1.15be displayed in a conspicuous place in the pharmacy for which it is issued and expire on
1.16the 30th day of June following the date of issue. It shall be unlawful for any person to
1.17conduct a pharmacy unless such certificate has been issued to the person by the board. (a)
1.18No person shall operate a pharmacy without first obtaining a license from the board and
1.19paying any applicable fee specified in section 151.065. The license shall be displayed in a
1.20conspicuous place in the pharmacy for which it is issued and expires on June 30 following
1.21the date of issue. It is unlawful for any person to operate a pharmacy unless the license
1.22has been issued to the person by the board.
1.23(b) Application for a pharmacy license under this section shall be made in a manner
1.24specified by the board.
2.1(c) No license shall be issued or renewed for a pharmacy located within the state
2.2unless the applicant agrees to operate the pharmacy in a manner prescribed by federal and
2.3state law and according to rules adopted by the board. No license shall be issued for a
2.4pharmacy located outside of the state unless the applicant agrees to operate the pharmacy
2.5in a manner prescribed by federal law and, when dispensing medications for residents of
2.6this state, the laws of this state and Minnesota Rules.
2.7(d) No license shall be issued or renewed for a pharmacy that is required to be
2.8licensed or registered by the state in which it is physically located unless the applicant
2.9supplies the board with proof of such licensure or registration.
2.10(e) The board shall require a separate license for each pharmacy located within
2.11the state and for each pharmacy located outside of the state at which any portion of the
2.12dispensing process occurs for drugs dispensed to residents of this state.
2.13(f) The board shall not issue an initial or renewed license for a pharmacy unless the
2.14pharmacy passes an inspection conducted by an authorized representative of the board. In
2.15the case of a pharmacy located outside of the state, the board may require the applicant to
2.16pay the cost of the inspection, in addition to the license fee in section 151.065, unless the
2.17applicant furnishes the board with a report, issued by the appropriate regulatory agency of
2.18the state in which the facility is located, of an inspection that has occurred within the 24
2.19months immediately preceding receipt of the license application by the board. The board
2.20may deny licensure unless the applicant submits documentation satisfactory to the board
2.21that any deficiencies noted in an inspection report have been corrected.
2.22(g) The board shall not issue an initial or renewed license for a pharmacy located
2.23outside of the state unless the applicant discloses and certifies:
2.24(1) the location, names, and titles of all principal corporate officers and all
2.25pharmacists who are involved in dispensing drugs to residents of this state;
2.26(2) that it maintains its records of drugs dispensed to residents of this state so that the
2.27records are readily retrievable from the records of other drugs dispensed;
2.28(3) that it agrees to cooperate with, and provide information to, the board concerning
2.29matters related to dispensing drugs to residents of this state;
2.30(4) that, during its regular hours of operation, but no less than six days per week, for
2.31a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
2.32communication between patients in this state and a pharmacist at the pharmacy who has
2.33access to the patients' records. The toll-free number must be disclosed on the label affixed
2.34to each container of drugs dispensed to residents of this state; and
2.35(5) that, upon request of a resident of a long-term care facility located in this
2.36state, the resident's authorized representative, or a contract pharmacy or licensed health
3.1care facility acting on behalf of the resident, the pharmacy will dispense medications
3.2prescribed for the resident in unit-dose packaging or, alternatively, comply with section
3.3151.415, subdivision 5.
3.4 Sec. 2. Minnesota Statutes 2012, section 151.19, subdivision 3, is amended to read:
3.5 Subd. 3. Sale of federally restricted medical gases.The board shall require and
3.6provide for the annual registration of every person or establishment not licensed as a
3.7pharmacy or a practitioner engaged in the retail sale or distribution of federally restricted
3.8medical gases. Upon the payment of any applicable fee specified in section
151.065, the
3.9board shall issue a registration certificate in such form as it may prescribe to those persons
3.10or places that may be qualified to sell or distribute federally restricted medical gases. The
3.11certificate shall be displayed in a conspicuous place in the business for which it is issued
3.12and expire on the date set by the board. It is unlawful for a person to sell or distribute
3.13federally restricted medical gases unless a certificate has been issued to that person by the
3.14board. (a) A person or establishment not licensed as a pharmacy or a practitioner shall not
3.15engage in the retail sale or distribution of federally restricted medical gases without first
3.16obtaining a registration from the board and paying the applicable fee specified in section
3.17151.065. The registration shall be displayed in a conspicuous place in the business for
3.18which it is issued and expires on the date set by the board. It is unlawful for a person to
3.19sell or distribute federally restricted medical gases unless a certificate has been issued to
3.20that person by the board.
3.21(b) Application for a medical gas distributor registration under this section shall be
3.22made in a manner specified by the board.
3.23(c) No registration shall be issued or renewed for a medical gas distributor located
3.24within the state unless the applicant agrees to operate in a manner prescribed by federal
3.25and state law and according to the rules adopted by the board. No license shall be issued
3.26for a medical gas distributor located outside of the state unless the applicant agrees to
3.27operate in a manner prescribed by federal law and, when distributing medical gases for
3.28residents of this state, the laws of this state and Minnesota Rules.
3.29(d) No registration shall be issued or renewed for a medical gas distributor that is
3.30required to be licensed or registered by the state in which it is physically located unless the
3.31applicant supplies the board with proof of the licensure or registration. The board may, by
3.32rule, establish standards for the registration of a medical gas distributor that is not required
3.33to be licensed or registered by the state in which it is physically located.
4.1(e) The board shall require a separate registration for each medical gas distributor
4.2located within the state and for each facility located outside of the state from which
4.3medical gases are distributed to residents of this state.
4.4(f) The board shall not issue an initial or renewed registration for a medical gas
4.5distributor unless the medical gas distributor passes an inspection conducted by an
4.6authorized representative of the board. In the case of a medical gas distributor located
4.7outside of the state, the board may require the applicant to pay the cost of the inspection,
4.8in addition to the license fee in section 151.065, unless the applicant furnishes the board
4.9with a report, issued by the appropriate regulatory agency of the state in which the facility
4.10is located, of an inspection that has occurred within the 24 months immediately preceding
4.11receipt of the license application by the board. The board may deny licensure unless the
4.12applicant submits documentation satisfactory to the board that any deficiencies noted in
4.13an inspection report have been corrected.
4.14 Sec. 3. [151.252] LICENSING OF DRUG MANUFACTURERS; FEES;
4.15PROHIBITIONS.
4.16 Subdivision 1. Requirements. (a) No person shall act as a drug manufacturer
4.17without first obtaining a license from the board and paying any applicable fee specified
4.18in section 151.065.
4.19(b) Application for a drug manufacturer license under this section shall be made in a
4.20manner specified by the board.
4.21(c) No license shall be issued or renewed for a drug manufacturer unless the
4.22applicant agrees to operate in a manner prescribed by federal and state law and according
4.23to Minnesota Rules.
4.24(d) No license shall be issued or renewed for a drug manufacturer that is required
4.25to be registered pursuant to United State Code, title 21, section 360, unless the applicant
4.26supplies the board with proof of registration. The board may establish by rule the
4.27standards for licensure of drug manufacturers that are not required to be registered under
4.28United States Code, title 21, section 360.
4.29(e) No license shall be issued or renewed for a drug manufacturer that is required to
4.30be licensed or registered by the state in which it is physically located unless the applicant
4.31supplies the board with proof of licensure or registration. The board may establish, by
4.32rule, standards for the licensure of a drug manufacturer that is not required to be licensed
4.33or registered by the state in which it is physically located.
5.1(f) The board shall require a separate license for each facility located within the state
5.2at which manufacturing occurs and for each facility located outside of the state at which
5.3drugs that are shipped into the state are manufactured.
5.4(g) The board shall not issue an initial or renewed license for a manufacturing
5.5facility unless the facility passes an inspection conducted by an authorized representative
5.6of the board. In the case of a manufacturing facility located outside of the state, the board
5.7may require the applicant to pay the cost of the inspection, in addition to the license fee
5.8in section 151.065, unless the applicant furnishes the board with a report, issued by the
5.9appropriate regulatory agency of the state in which the facility is located or by the United
5.10States Food and Drug Administration, of an inspection that has occurred within the 24
5.11months immediately preceding receipt of the license application by the board. The board
5.12may deny licensure unless the applicant submits documentation satisfactory to the board
5.13that any deficiencies noted in an inspection report have been corrected.
5.14 Subd. 2. Prohibition. It is unlawful for any person engaged in manufacturing to sell
5.15legend drugs to anyone located in this state except as provided in this chapter.
5.16 Sec. 4. Minnesota Statutes 2012, section 151.37, subdivision 4, is amended to read:
5.17 Subd. 4. Research. (a) Any qualified person may use legend drugs in the course
5.18of a bona fide research project, but cannot administer or dispense such drugs to human
5.19beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
5.20authorized to do so.
5.21(b) Drugs may be dispensed by a pharmacy licensed by the board for use by, or
5.22administration to, patients enrolled in a bona fide research study that is being conducted
5.23pursuant to either an investigational new drug application approved by the United States
5.24Food and Drug Administration or that has been approved by an institutional review board.
5.25The protocol for the study shall be considered a prescription drug order and the drug
5.26labeled as required in the protocol. Dispensing of research drugs shall not be considered
5.27compounding or manufacturing or the sale of a drug at wholesale under this chapter.
5.28 Sec. 5. Minnesota Statutes 2012, section 151.47, subdivision 1, is amended to read:
5.29 Subdivision 1. Requirements. (a) All wholesale drug distributors are subject to the
5.30requirementsin paragraphs (a) to (f) of this subdivision.
5.31(a) (b) No person or distribution outlet shall act as a wholesale drug distributor
5.32without first obtaining a license from the board and paying any applicable fee specified
5.33in section151.065 .
6.1(c) Application for a wholesale drug distributor license under this section shall be
6.2made in a manner specified by the board.
6.3(b) (d) No license shall be issued or renewed for a wholesale drug distributor to
6.4operate unless the applicant agrees to operate in a manner prescribed by federal and state
6.5law and according to the rules adopted by the board.
6.6(c) The board may require a separate license for each facility directly or indirectly
6.7owned or operated by the same business entity within the state, or for a parent entity
6.8with divisions, subsidiaries, or affiliate companies within the state, when operations
6.9are conducted at more than one location and joint ownership and control exists among
6.10all the entities.
6.11(e) No license may be issued or renewed for a drug wholesale distributor that is
6.12required to be licensed or registered by the state in which it is physically located unless
6.13the applicant supplies the board with proof of licensure or registration. The board may
6.14establish, by rule, standards for the licensure of a drug wholesale distributor that is not
6.15required to be licensed or registered by the state in which it is physically located.
6.16(f) The board shall require a separate license for each drug wholesale distributor
6.17facility located within the state and for each drug wholesale distributor facility located
6.18outside of the state from which drugs are shipped into the state or to which drugs are
6.19reverse distributed.
6.20(g) The board shall not issue an initial or renewed license for a drug wholesale
6.21distributor facility unless the facility passes an inspection conducted by an authorized
6.22representative of the board, or is accredited by an accreditation program approved by the
6.23board. In the case of a drug wholesale distributor facility located outside of the state, the
6.24board may require the applicant to pay the cost of the inspection, in addition to the license
6.25fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
6.26appropriate regulatory agency of the state in which the facility is located, of an inspection
6.27that has occurred within the 24 months immediately preceding receipt of the license
6.28application by the board, or furnishes the board with proof of current accreditation. The
6.29board may deny licensure unless the applicant submits documentation satisfactory to the
6.30board that any deficiencies noted in an inspection report have been corrected.
6.31(d) (h) As a condition for receiving and retaining a wholesale drug distributor license
6.32issued under sections151.42 to
151.51 , an applicant shall satisfy the board that it has
6.33and will continuously maintain:
6.34(1) adequate storage conditions and facilities;
6.35(2) minimum liability and other insurance as may be required under any applicable
6.36federal or state law;
7.1(3) a viable security system that includes an after hours central alarm, or comparable
7.2entry detection capability; restricted access to the premises; comprehensive employment
7.3applicant screening; and safeguards against all forms of employee theft;
7.4(4) a system of records describing all wholesale drug distributor activities set forth
7.5in section151.44 for at least the most recent two-year period, which shall be reasonably
7.6accessible as defined by board regulations in any inspection authorized by the board;
7.7(5) principals and persons, including officers, directors, primary shareholders,
7.8and key management executives, who must at all times demonstrate and maintain their
7.9capability of conducting business in conformity with sound financial practices as well
7.10as state and federal law;
7.11(6) complete, updated information, to be provided to the board as a condition for
7.12obtaining and retaining a license, about each wholesale drug distributor to be licensed,
7.13including all pertinent corporate licensee information, if applicable, or other ownership,
7.14principal, key personnel, and facilities information found to be necessary by the board;
7.15(7) written policies and procedures that assure reasonable wholesale drug distributor
7.16preparation for, protection against, and handling of any facility security or operation
7.17problems, including, but not limited to, those caused by natural disaster or government
7.18emergency, inventory inaccuracies or product shipping and receiving, outdated product
7.19or other unauthorized product control, appropriate disposition of returned goods, and
7.20product recalls;
7.21(8) sufficient inspection procedures for all incoming and outgoing product
7.22shipments; and
7.23(9) operations in compliance with all federal requirements applicable to wholesale
7.24drug distribution.
7.25(e) (i) An agent or employee of any licensed wholesale drug distributor need not
7.26seek licensure under this section.
7.27(f) A wholesale drug distributor shall file with the board an annual report, in a
7.28form and on the date prescribed by the board, identifying all payments, honoraria,
7.29reimbursement or other compensation authorized under section
151.461, clauses (3) to
7.30(5), paid to practitioners in Minnesota during the preceding calendar year. The report
7.31shall identify the nature and value of any payments totaling $100 or more, to a particular
7.32practitioner during the year, and shall identify the practitioner. Reports filed under this
7.33provision are public data.
7.34 Sec. 6. Minnesota Statutes 2012, section 151.47, is amended by adding a subdivision
7.35to read:
8.1 Subd. 3. Prohibition. It is unlawful for any person engaged in wholesale drug
8.2distribution to sell drugs to anyone located within the state or to receive drugs in reverse
8.3distribution from anyone located within the state except as provided in this chapter.
8.4 Sec. 7. Minnesota Statutes 2012, section 151.49, is amended to read:
8.5151.49 LICENSE RENEWAL APPLICATION PROCEDURES.
8.6Application blanks or notices for renewal of a license required by sections151.42
8.7to151.51 shall be mailed or otherwise provided to each licensee on or before the first
8.8day of the month prior to the month in which the license expires and, if application for
8.9renewal of the license with the required fee and supporting documents is not made before
8.10the expiration date, the existing license or renewal shall lapse and become null and void
8.11upon the date of expiration.
8.12 Sec. 8. REPEALER.
8.13Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47,
8.14subdivision 2; and 151.48, are repealed.
1.3Pharmacy;amending Minnesota Statutes 2012, sections 151.19, subdivisions 1,
1.43; 151.37, subdivision 4; 151.47, subdivision 1, by adding a subdivision; 151.49;
1.5proposing coding for new law in Minnesota Statutes, chapter 151; repealing
1.6Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47,
1.7subdivision 2; 151.48.
1.8BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.9 Section 1. Minnesota Statutes 2012, section 151.19, subdivision 1, is amended to read:
1.10 Subdivision 1. Pharmacy
1.11
1.12
1.13
1.14
1.15
1.16
1.17
1.18No person shall operate a pharmacy without first obtaining a license from the board and
1.19paying any applicable fee specified in section 151.065. The license shall be displayed in a
1.20conspicuous place in the pharmacy for which it is issued and expires on June 30 following
1.21the date of issue. It is unlawful for any person to operate a pharmacy unless the license
1.22has been issued to the person by the board.
1.23(b) Application for a pharmacy license under this section shall be made in a manner
1.24specified by the board.
2.1(c) No license shall be issued or renewed for a pharmacy located within the state
2.2unless the applicant agrees to operate the pharmacy in a manner prescribed by federal and
2.3state law and according to rules adopted by the board. No license shall be issued for a
2.4pharmacy located outside of the state unless the applicant agrees to operate the pharmacy
2.5in a manner prescribed by federal law and, when dispensing medications for residents of
2.6this state, the laws of this state and Minnesota Rules.
2.7(d) No license shall be issued or renewed for a pharmacy that is required to be
2.8licensed or registered by the state in which it is physically located unless the applicant
2.9supplies the board with proof of such licensure or registration.
2.10(e) The board shall require a separate license for each pharmacy located within
2.11the state and for each pharmacy located outside of the state at which any portion of the
2.12dispensing process occurs for drugs dispensed to residents of this state.
2.13(f) The board shall not issue an initial or renewed license for a pharmacy unless the
2.14pharmacy passes an inspection conducted by an authorized representative of the board. In
2.15the case of a pharmacy located outside of the state, the board may require the applicant to
2.16pay the cost of the inspection, in addition to the license fee in section 151.065, unless the
2.17applicant furnishes the board with a report, issued by the appropriate regulatory agency of
2.18the state in which the facility is located, of an inspection that has occurred within the 24
2.19months immediately preceding receipt of the license application by the board. The board
2.20may deny licensure unless the applicant submits documentation satisfactory to the board
2.21that any deficiencies noted in an inspection report have been corrected.
2.22(g) The board shall not issue an initial or renewed license for a pharmacy located
2.23outside of the state unless the applicant discloses and certifies:
2.24(1) the location, names, and titles of all principal corporate officers and all
2.25pharmacists who are involved in dispensing drugs to residents of this state;
2.26(2) that it maintains its records of drugs dispensed to residents of this state so that the
2.27records are readily retrievable from the records of other drugs dispensed;
2.28(3) that it agrees to cooperate with, and provide information to, the board concerning
2.29matters related to dispensing drugs to residents of this state;
2.30(4) that, during its regular hours of operation, but no less than six days per week, for
2.31a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
2.32communication between patients in this state and a pharmacist at the pharmacy who has
2.33access to the patients' records. The toll-free number must be disclosed on the label affixed
2.34to each container of drugs dispensed to residents of this state; and
2.35(5) that, upon request of a resident of a long-term care facility located in this
2.36state, the resident's authorized representative, or a contract pharmacy or licensed health
3.1care facility acting on behalf of the resident, the pharmacy will dispense medications
3.2prescribed for the resident in unit-dose packaging or, alternatively, comply with section
3.3151.415, subdivision 5.
3.4 Sec. 2. Minnesota Statutes 2012, section 151.19, subdivision 3, is amended to read:
3.5 Subd. 3. Sale of federally restricted medical gases.
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15engage in the retail sale or distribution of federally restricted medical gases without first
3.16obtaining a registration from the board and paying the applicable fee specified in section
3.17151.065. The registration shall be displayed in a conspicuous place in the business for
3.18which it is issued and expires on the date set by the board. It is unlawful for a person to
3.19sell or distribute federally restricted medical gases unless a certificate has been issued to
3.20that person by the board.
3.21(b) Application for a medical gas distributor registration under this section shall be
3.22made in a manner specified by the board.
3.23(c) No registration shall be issued or renewed for a medical gas distributor located
3.24within the state unless the applicant agrees to operate in a manner prescribed by federal
3.25and state law and according to the rules adopted by the board. No license shall be issued
3.26for a medical gas distributor located outside of the state unless the applicant agrees to
3.27operate in a manner prescribed by federal law and, when distributing medical gases for
3.28residents of this state, the laws of this state and Minnesota Rules.
3.29(d) No registration shall be issued or renewed for a medical gas distributor that is
3.30required to be licensed or registered by the state in which it is physically located unless the
3.31applicant supplies the board with proof of the licensure or registration. The board may, by
3.32rule, establish standards for the registration of a medical gas distributor that is not required
3.33to be licensed or registered by the state in which it is physically located.
4.1(e) The board shall require a separate registration for each medical gas distributor
4.2located within the state and for each facility located outside of the state from which
4.3medical gases are distributed to residents of this state.
4.4(f) The board shall not issue an initial or renewed registration for a medical gas
4.5distributor unless the medical gas distributor passes an inspection conducted by an
4.6authorized representative of the board. In the case of a medical gas distributor located
4.7outside of the state, the board may require the applicant to pay the cost of the inspection,
4.8in addition to the license fee in section 151.065, unless the applicant furnishes the board
4.9with a report, issued by the appropriate regulatory agency of the state in which the facility
4.10is located, of an inspection that has occurred within the 24 months immediately preceding
4.11receipt of the license application by the board. The board may deny licensure unless the
4.12applicant submits documentation satisfactory to the board that any deficiencies noted in
4.13an inspection report have been corrected.
4.14 Sec. 3. [151.252] LICENSING OF DRUG MANUFACTURERS; FEES;
4.15PROHIBITIONS.
4.16 Subdivision 1. Requirements. (a) No person shall act as a drug manufacturer
4.17without first obtaining a license from the board and paying any applicable fee specified
4.18in section 151.065.
4.19(b) Application for a drug manufacturer license under this section shall be made in a
4.20manner specified by the board.
4.21(c) No license shall be issued or renewed for a drug manufacturer unless the
4.22applicant agrees to operate in a manner prescribed by federal and state law and according
4.23to Minnesota Rules.
4.24(d) No license shall be issued or renewed for a drug manufacturer that is required
4.25to be registered pursuant to United State Code, title 21, section 360, unless the applicant
4.26supplies the board with proof of registration. The board may establish by rule the
4.27standards for licensure of drug manufacturers that are not required to be registered under
4.28United States Code, title 21, section 360.
4.29(e) No license shall be issued or renewed for a drug manufacturer that is required to
4.30be licensed or registered by the state in which it is physically located unless the applicant
4.31supplies the board with proof of licensure or registration. The board may establish, by
4.32rule, standards for the licensure of a drug manufacturer that is not required to be licensed
4.33or registered by the state in which it is physically located.
5.1(f) The board shall require a separate license for each facility located within the state
5.2at which manufacturing occurs and for each facility located outside of the state at which
5.3drugs that are shipped into the state are manufactured.
5.4(g) The board shall not issue an initial or renewed license for a manufacturing
5.5facility unless the facility passes an inspection conducted by an authorized representative
5.6of the board. In the case of a manufacturing facility located outside of the state, the board
5.7may require the applicant to pay the cost of the inspection, in addition to the license fee
5.8in section 151.065, unless the applicant furnishes the board with a report, issued by the
5.9appropriate regulatory agency of the state in which the facility is located or by the United
5.10States Food and Drug Administration, of an inspection that has occurred within the 24
5.11months immediately preceding receipt of the license application by the board. The board
5.12may deny licensure unless the applicant submits documentation satisfactory to the board
5.13that any deficiencies noted in an inspection report have been corrected.
5.14 Subd. 2. Prohibition. It is unlawful for any person engaged in manufacturing to sell
5.15legend drugs to anyone located in this state except as provided in this chapter.
5.16 Sec. 4. Minnesota Statutes 2012, section 151.37, subdivision 4, is amended to read:
5.17 Subd. 4. Research. (a) Any qualified person may use legend drugs in the course
5.18of a bona fide research project, but cannot administer or dispense such drugs to human
5.19beings unless such drugs are prescribed, dispensed, and administered by a person lawfully
5.20authorized to do so.
5.21(b) Drugs may be dispensed by a pharmacy licensed by the board for use by, or
5.22administration to, patients enrolled in a bona fide research study that is being conducted
5.23pursuant to either an investigational new drug application approved by the United States
5.24Food and Drug Administration or that has been approved by an institutional review board.
5.25The protocol for the study shall be considered a prescription drug order and the drug
5.26labeled as required in the protocol. Dispensing of research drugs shall not be considered
5.27compounding or manufacturing or the sale of a drug at wholesale under this chapter.
5.28 Sec. 5. Minnesota Statutes 2012, section 151.47, subdivision 1, is amended to read:
5.29 Subdivision 1. Requirements. (a) All wholesale drug distributors are subject to the
5.30requirements
5.31
5.32without first obtaining a license from the board and paying any applicable fee specified
5.33in section
6.1(c) Application for a wholesale drug distributor license under this section shall be
6.2made in a manner specified by the board.
6.3
6.4operate unless the applicant agrees to operate in a manner prescribed by federal and state
6.5law and according to the rules adopted by the board.
6.6
6.7
6.8
6.9
6.10
6.11(e) No license may be issued or renewed for a drug wholesale distributor that is
6.12required to be licensed or registered by the state in which it is physically located unless
6.13the applicant supplies the board with proof of licensure or registration. The board may
6.14establish, by rule, standards for the licensure of a drug wholesale distributor that is not
6.15required to be licensed or registered by the state in which it is physically located.
6.16(f) The board shall require a separate license for each drug wholesale distributor
6.17facility located within the state and for each drug wholesale distributor facility located
6.18outside of the state from which drugs are shipped into the state or to which drugs are
6.19reverse distributed.
6.20(g) The board shall not issue an initial or renewed license for a drug wholesale
6.21distributor facility unless the facility passes an inspection conducted by an authorized
6.22representative of the board, or is accredited by an accreditation program approved by the
6.23board. In the case of a drug wholesale distributor facility located outside of the state, the
6.24board may require the applicant to pay the cost of the inspection, in addition to the license
6.25fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
6.26appropriate regulatory agency of the state in which the facility is located, of an inspection
6.27that has occurred within the 24 months immediately preceding receipt of the license
6.28application by the board, or furnishes the board with proof of current accreditation. The
6.29board may deny licensure unless the applicant submits documentation satisfactory to the
6.30board that any deficiencies noted in an inspection report have been corrected.
6.31
6.32issued under sections
6.33and will continuously maintain:
6.34(1) adequate storage conditions and facilities;
6.35(2) minimum liability and other insurance as may be required under any applicable
6.36federal or state law;
7.1(3) a viable security system that includes an after hours central alarm, or comparable
7.2entry detection capability; restricted access to the premises; comprehensive employment
7.3applicant screening; and safeguards against all forms of employee theft;
7.4(4) a system of records describing all wholesale drug distributor activities set forth
7.5in section
7.6accessible as defined by board regulations in any inspection authorized by the board;
7.7(5) principals and persons, including officers, directors, primary shareholders,
7.8and key management executives, who must at all times demonstrate and maintain their
7.9capability of conducting business in conformity with sound financial practices as well
7.10as state and federal law;
7.11(6) complete, updated information, to be provided to the board as a condition for
7.12obtaining and retaining a license, about each wholesale drug distributor to be licensed,
7.13including all pertinent corporate licensee information, if applicable, or other ownership,
7.14principal, key personnel, and facilities information found to be necessary by the board;
7.15(7) written policies and procedures that assure reasonable wholesale drug distributor
7.16preparation for, protection against, and handling of any facility security or operation
7.17problems, including, but not limited to, those caused by natural disaster or government
7.18emergency, inventory inaccuracies or product shipping and receiving, outdated product
7.19or other unauthorized product control, appropriate disposition of returned goods, and
7.20product recalls;
7.21(8) sufficient inspection procedures for all incoming and outgoing product
7.22shipments; and
7.23(9) operations in compliance with all federal requirements applicable to wholesale
7.24drug distribution.
7.25
7.26seek licensure under this section.
7.27
7.28
7.29
7.30
7.31
7.32
7.33
7.34 Sec. 6. Minnesota Statutes 2012, section 151.47, is amended by adding a subdivision
7.35to read:
8.1 Subd. 3. Prohibition. It is unlawful for any person engaged in wholesale drug
8.2distribution to sell drugs to anyone located within the state or to receive drugs in reverse
8.3distribution from anyone located within the state except as provided in this chapter.
8.4 Sec. 7. Minnesota Statutes 2012, section 151.49, is amended to read:
8.5151.49 LICENSE RENEWAL APPLICATION PROCEDURES.
8.6Application blanks or notices for renewal of a license required by sections
8.7to
8.8day of the month prior to the month in which the license expires and, if application for
8.9renewal of the license with the required fee and supporting documents is not made before
8.10the expiration date, the existing license or renewal shall lapse and become null and void
8.11upon the date of expiration.
8.12 Sec. 8. REPEALER.
8.13Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47,
8.14subdivision 2; and 151.48, are repealed.
