Minnesota Legislature
HF 1320
1st Committee Engrossment - 86th Legislature (2009 - 2010) Posted on 03/19/2013 07:28pm
KEY: stricken = removed, old language.
underscored = added, new language.
1.2relating to health; clarifying adoption of rules for the substitution of drugs used
1.3for the treatment of epilepsy or seizures;amending Minnesota Statutes 2008,
1.4section 151.06, subdivision 1.
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.6 Section 1. Minnesota Statutes 2008, section 151.06, subdivision 1, is amended to read:
1.7 Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy
1.8shall have the power and it shall be its duty:
1.9 (1) to regulate the practice of pharmacy;
1.10 (2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
1.11 (3) to regulate the identity, labeling, purity, and quality of all drugs and medicines
1.12dispensed in this state, using the United States Pharmacopeia and the National Formulary,
1.13or any revisions thereof, or standards adopted under the federal act as the standard;
1.14 (4) to enter and inspect by its authorized representative any and all places where
1.15drugs, medicines, medical gases, or veterinary drugs or devices are sold, vended, given
1.16away, compounded, dispensed, manufactured, wholesaled, or held; it may secure samples
1.17or specimens of any drugs, medicines, medical gases, or veterinary drugs or devices
1.18after paying or offering to pay for such sample; it shall be entitled to inspect and make
1.19copies of any and all records of shipment, purchase, manufacture, quality control, and
1.20sale of these items provided, however, that such inspection shall not extend to financial
1.21data, sales data, or pricing data;
1.22 (5) to examine and license as pharmacists all applicants whom it shall deem qualified
1.23to be such;
1.24 (6) to license wholesale drug distributors;
2.1 (7) to deny, suspend, revoke, or refuse to renew any registration or license required
2.2under this chapter, to any applicant or registrant or licensee upon any of the following
2.3grounds:
2.4 (i) fraud or deception in connection with the securing of such license or registration;
2.5 (ii) in the case of a pharmacist, conviction in any court of a felony;
2.6 (iii) in the case of a pharmacist, conviction in any court of an offense involving
2.7moral turpitude;
2.8 (iv) habitual indulgence in the use of narcotics, stimulants, or depressant drugs;
2.9or habitual indulgence in intoxicating liquors in a manner which could cause conduct
2.10endangering public health;
2.11 (v) unprofessional conduct or conduct endangering public health;
2.12 (vi) gross immorality;
2.13 (vii) employing, assisting, or enabling in any manner an unlicensed person to
2.14practice pharmacy;
2.15 (viii) conviction of theft of drugs, or the unauthorized use, possession, or sale thereof;
2.16 (ix) violation of any of the provisions of this chapter or any of the rules of the State
2.17Board of Pharmacy;
2.18 (x) in the case of a pharmacy license, operation of such pharmacy without a
2.19pharmacist present and on duty;
2.20 (xi) in the case of a pharmacist, physical or mental disability which could cause
2.21incompetency in the practice of pharmacy;
2.22 (xii) in the case of a pharmacist, the suspension or revocation of a license to practice
2.23pharmacy in another state; or
2.24 (xiii) in the case of a pharmacist, aiding suicide or aiding attempted suicide in
2.25violation of section609.215 as established by any of the following:
2.26 (A) a copy of the record of criminal conviction or plea of guilty for a felony in
2.27violation of section609.215, subdivision 1 or 2;
2.28 (B) a copy of the record of a judgment of contempt of court for violating an
2.29injunction issued under section609.215, subdivision 4 ;
2.30 (C) a copy of the record of a judgment assessing damages under section609.215,
2.31subdivision 5 ; or
2.32 (D) a finding by the board that the person violated section609.215, subdivision
2.331 or 2. The board shall investigate any complaint of a violation of section
609.215,
2.34subdivision 1 or 2;
2.35 (8) to employ necessary assistants and adopt rules for the conduct of its business;
3.1 (9) to register as pharmacy technicians all applicants who the board determines are
3.2qualified to carry out the duties of a pharmacy technician; and
3.3 (10) to perform such other duties and exercise such other powers as the provisions of
3.4the act may require.
3.5 (b) Temporary suspension. In addition to any other remedy provided by law, the
3.6board may, without a hearing, temporarily suspend a license for not more than 60 days if
3.7the board finds that a pharmacist has violated a statute or rule that the board is empowered
3.8to enforce and continued practice by the pharmacist would create an imminent risk of
3.9harm to others. The suspension shall take effect upon written notice to the pharmacist,
3.10specifying the statute or rule violated. At the time it issues the suspension notice, the
3.11board shall schedule a disciplinary hearing to be held under the Administrative Procedure
3.12Act. The pharmacist shall be provided with at least 20 days' notice of any hearing held
3.13under this subdivision.
3.14 (c) Rules. For the purposes aforesaid, it shall be the duty of the board to make
3.15and publish uniform rules not inconsistent herewith for carrying out and enforcing
3.16the provisions of this chapter. The board shall adopt rules regarding prospective drug
3.17utilization review and patient counseling by pharmacists. A pharmacist in the exercise of
3.18the pharmacist's professional judgment, upon the presentation of a new prescription by a
3.19patient or the patient's caregiver or agent, shall perform the prospective drug utilization
3.20review required by rules issued under this subdivision.
3.21(d) Substitution; rules. If the United States Food and Drug Administration
3.22determines that the substitution of drugs used for the treatment of epilepsy or seizures
3.23poses a health risk to patients, the board shall adopt rules in accordance with accompanying
3.24FDA interchangeability standards regarding the use of substitution for these drugs. If the
3.25board adopts a rule regarding the substitution of drugs used for the treatment of epilepsy
3.26or seizures that conflicts with the substitution requirements of section 151.21, subdivision
3.273, the rule shall supersede the conflicting statute. If the rule proposed by the board would
3.28increase state costs for state public health care programs, the board shall report to the
3.29legislature the proposed rule and the increased cost associated with the proposed rule,
3.30before the board may adopt the rule.
1.3for the treatment of epilepsy or seizures;amending Minnesota Statutes 2008,
1.4section 151.06, subdivision 1.
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.6 Section 1. Minnesota Statutes 2008, section 151.06, subdivision 1, is amended to read:
1.7 Subdivision 1. Generally; rules. (a) Powers and duties. The Board of Pharmacy
1.8shall have the power and it shall be its duty:
1.9 (1) to regulate the practice of pharmacy;
1.10 (2) to regulate the manufacture, wholesale, and retail sale of drugs within this state;
1.11 (3) to regulate the identity, labeling, purity, and quality of all drugs and medicines
1.12dispensed in this state, using the United States Pharmacopeia and the National Formulary,
1.13or any revisions thereof, or standards adopted under the federal act as the standard;
1.14 (4) to enter and inspect by its authorized representative any and all places where
1.15drugs, medicines, medical gases, or veterinary drugs or devices are sold, vended, given
1.16away, compounded, dispensed, manufactured, wholesaled, or held; it may secure samples
1.17or specimens of any drugs, medicines, medical gases, or veterinary drugs or devices
1.18after paying or offering to pay for such sample; it shall be entitled to inspect and make
1.19copies of any and all records of shipment, purchase, manufacture, quality control, and
1.20sale of these items provided, however, that such inspection shall not extend to financial
1.21data, sales data, or pricing data;
1.22 (5) to examine and license as pharmacists all applicants whom it shall deem qualified
1.23to be such;
1.24 (6) to license wholesale drug distributors;
2.1 (7) to deny, suspend, revoke, or refuse to renew any registration or license required
2.2under this chapter, to any applicant or registrant or licensee upon any of the following
2.3grounds:
2.4 (i) fraud or deception in connection with the securing of such license or registration;
2.5 (ii) in the case of a pharmacist, conviction in any court of a felony;
2.6 (iii) in the case of a pharmacist, conviction in any court of an offense involving
2.7moral turpitude;
2.8 (iv) habitual indulgence in the use of narcotics, stimulants, or depressant drugs;
2.9or habitual indulgence in intoxicating liquors in a manner which could cause conduct
2.10endangering public health;
2.11 (v) unprofessional conduct or conduct endangering public health;
2.12 (vi) gross immorality;
2.13 (vii) employing, assisting, or enabling in any manner an unlicensed person to
2.14practice pharmacy;
2.15 (viii) conviction of theft of drugs, or the unauthorized use, possession, or sale thereof;
2.16 (ix) violation of any of the provisions of this chapter or any of the rules of the State
2.17Board of Pharmacy;
2.18 (x) in the case of a pharmacy license, operation of such pharmacy without a
2.19pharmacist present and on duty;
2.20 (xi) in the case of a pharmacist, physical or mental disability which could cause
2.21incompetency in the practice of pharmacy;
2.22 (xii) in the case of a pharmacist, the suspension or revocation of a license to practice
2.23pharmacy in another state; or
2.24 (xiii) in the case of a pharmacist, aiding suicide or aiding attempted suicide in
2.25violation of section
2.26 (A) a copy of the record of criminal conviction or plea of guilty for a felony in
2.27violation of section
2.28 (B) a copy of the record of a judgment of contempt of court for violating an
2.29injunction issued under section
2.30 (C) a copy of the record of a judgment assessing damages under section
2.31subdivision 5
2.32 (D) a finding by the board that the person violated section
2.331
2.34subdivision 1
2.35 (8) to employ necessary assistants and adopt rules for the conduct of its business;
3.1 (9) to register as pharmacy technicians all applicants who the board determines are
3.2qualified to carry out the duties of a pharmacy technician; and
3.3 (10) to perform such other duties and exercise such other powers as the provisions of
3.4the act may require.
3.5 (b) Temporary suspension. In addition to any other remedy provided by law, the
3.6board may, without a hearing, temporarily suspend a license for not more than 60 days if
3.7the board finds that a pharmacist has violated a statute or rule that the board is empowered
3.8to enforce and continued practice by the pharmacist would create an imminent risk of
3.9harm to others. The suspension shall take effect upon written notice to the pharmacist,
3.10specifying the statute or rule violated. At the time it issues the suspension notice, the
3.11board shall schedule a disciplinary hearing to be held under the Administrative Procedure
3.12Act. The pharmacist shall be provided with at least 20 days' notice of any hearing held
3.13under this subdivision.
3.14 (c) Rules. For the purposes aforesaid, it shall be the duty of the board to make
3.15and publish uniform rules not inconsistent herewith for carrying out and enforcing
3.16the provisions of this chapter. The board shall adopt rules regarding prospective drug
3.17utilization review and patient counseling by pharmacists. A pharmacist in the exercise of
3.18the pharmacist's professional judgment, upon the presentation of a new prescription by a
3.19patient or the patient's caregiver or agent, shall perform the prospective drug utilization
3.20review required by rules issued under this subdivision.
3.21(d) Substitution; rules. If the United States Food and Drug Administration
3.22determines that the substitution of drugs used for the treatment of epilepsy or seizures
3.23poses a health risk to patients, the board shall adopt rules in accordance with accompanying
3.24FDA interchangeability standards regarding the use of substitution for these drugs. If the
3.25board adopts a rule regarding the substitution of drugs used for the treatment of epilepsy
3.26or seizures that conflicts with the substitution requirements of section 151.21, subdivision
3.273, the rule shall supersede the conflicting statute. If the rule proposed by the board would
3.28increase state costs for state public health care programs, the board shall report to the
3.29legislature the proposed rule and the increased cost associated with the proposed rule,
3.30before the board may adopt the rule.