Bill Text: MN HF2446 | 2013-2014 | 88th Legislature | Engrossed
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Pharmacy Board cease and desist authority granted to prevent the sale of synthetic drugs, misbranded or adulterated drug laws modified, definition expanded, emergency drug scheduling authority sunset and legislative reporting requirement repealed, mandatory restitution provided, public education plan established, and money appropriated.
Spectrum: Moderate Partisan Bill (Democrat 8-2)
Status: (Passed) 2014-05-21 - Secretary of State Chapter 285 [HF2446 Detail]
Download: Minnesota-2013-HF2446-Engrossed.html
Bill Title: Pharmacy Board cease and desist authority granted to prevent the sale of synthetic drugs, misbranded or adulterated drug laws modified, definition expanded, emergency drug scheduling authority sunset and legislative reporting requirement repealed, mandatory restitution provided, public education plan established, and money appropriated.
Spectrum: Moderate Partisan Bill (Democrat 8-2)
Status: (Passed) 2014-05-21 - Secretary of State Chapter 285 [HF2446 Detail]
Download: Minnesota-2013-HF2446-Engrossed.html
1.2relating to public safety; granting the Board of Pharmacy cease and desist
1.3authority to prevent the sale of synthetic drugs; modifying laws governing
1.4misbranding drugs, adulterated drugs; expanding the definition of drug; repealing
1.5the sunset and legislative reporting requirement for the Board of Pharmacy's
1.6emergency drug scheduling authority; providing training and expert support in
1.7the prosecution of synthetic drug cases; establishing a public education plan;
1.8appropriating money;amending Minnesota Statutes 2012, sections 151.01,
1.9subdivision 5; 151.06, by adding subdivisions; 151.26, subdivision 1; 151.34;
1.10151.35; 151.36; 152.02, subdivision 8b.
1.11BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.12 Section 1. Minnesota Statutes 2012, section 151.01, subdivision 5, is amended to read:
1.13 Subd. 5. Drug.The term "Drug" means all medicinal substances and preparations
1.14recognized by the United States Pharmacopoeia and National Formulary, or any revision
1.15thereof, and all substances and preparations intended for external and internal use in the
1.16diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals,
1.17and all substances and preparations, other than food, intended to affect the structure or any
1.18function of the bodies of humans or other animals. Drug shall also mean any compound,
1.19substance, or derivative which is not regulated or approved for human consumption by
1.20the United States Food and Drug Administration or specifically permitted by Minnesota
1.21law, and when introduced into the body, induces an effect substantially similar to that of a
1.22Schedule I or Schedule II controlled substance listed in section 152.02, subdivisions 2
1.23and 3; and Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of whether the
1.24substance is marketed for the purpose of human consumption.
1.25EFFECTIVE DATE.This section is effective August 1, 2014.
2.1 Sec. 2. Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
2.2to read:
2.3 Subd. 2b. Cease and desist orders. (a) Whenever it appears to the Board of
2.4Pharmacy that a person has engaged or is about to engage in an act or practice constituting
2.5a violation of a law, rule, or order related to the duties and responsibilities entrusted to the
2.6board, the board may issue and cause to be served upon the person an order requiring the
2.7person to cease and desist from violations.
2.8(b) The cease and desist order must be calculated to give reasonable notice of the
2.9rights of the person to request a hearing and must state the reasons for the entry of the
2.10order. A hearing must be held not later than ten days after the request for the hearing is
2.11received by the board. After the completion of the hearing, the administrative law judge
2.12shall issue a report within ten days. Within 15 days after receiving the administrative law
2.13judge's report, the board shall issue a further order vacating or making permanent the
2.14cease and desist order. The time periods provided in this paragraph may be waived by
2.15agreement of the person requesting the hearing, the director, and the person against whom
2.16the cease and desist order is issued. If the person to whom a cease and desist order is
2.17issued fails to appear at the hearing after being duly notified, the person is in default and
2.18the proceeding may be determined against that person upon consideration of the cease
2.19and desist order, the allegations of which may be considered to be true. Unless otherwise
2.20provided, all hearings must be conducted according to chapter 14. The board may adopt
2.21rules of procedure concerning all proceedings conducted under this subdivision.
2.22(c) If no hearing is requested within 30 days of service of the order, the cease and
2.23desist order will become permanent.
2.24(d) A cease and desist order issued under this subdivision remains in effect until
2.25it is modified or vacated by the board. The administrative proceeding provided by this
2.26subdivision, and subsequent appellate judicial review of that administrative proceeding,
2.27constitutes the exclusive remedy for determining whether the board properly issued the
2.28cease and desist order and whether the cease and desist order should be vacated or made
2.29permanent.
2.30EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
2.31violations occurring on or after that date.
2.32 Sec. 3. Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
2.33to read:
2.34 Subd. 2c. Enforcement of violations of cease and desist orders. (a) Whenever
2.35the board, under subdivision 2b, seeks to enforce compliance with a cease and desist
3.1order that has been made permanent, the allegations in the cease and desist order are
3.2considered conclusively established for purposes of a proceeding under subdivision 2b
3.3for permanent or temporary relief to enforce the cease and desist order. Whenever the
3.4board, under subdivision 2b, seeks to enforce compliance with a cease and desist order
3.5when a hearing or hearing request on the cease and desist order is pending, or the time
3.6has not yet expired to request a hearing on whether a cease and desist order should be
3.7vacated or made permanent, the allegations in the cease and desist order are considered
3.8conclusively established for purposes of a proceeding under subdivision 2b for temporary
3.9relief to enforce the cease and desist order.
3.10(b) Notwithstanding this subdivision or subdivision 2b to the contrary, the person
3.11against whom the cease and desist order is issued and who has requested a hearing under
3.12subdivision 2b may, within 15 days after service of the cease and desist order, bring
3.13an action in Ramsey County District Court for issuance of an injunction to suspend
3.14enforcement of the cease and desist order pending a final decision of the board under
3.15subdivision 2b to vacate or make permanent the cease and desist order. The court shall
3.16determine whether to issue such an injunction based on traditional principles of temporary
3.17relief.
3.18EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
3.19violations occurring on or after that date.
3.20 Sec. 4. Minnesota Statutes 2012, section 151.26, subdivision 1, is amended to read:
3.21 Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
3.22licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
3.23by the State Board of Pharmacy, nor prevent the person from administering drugs,
3.24medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
3.25practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
3.26chemicals, or poisons as may be considered appropriate in the treatment of such patient;
3.27unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
3.28provides reasonable notice of an inspection.
3.29Except for the provisions of section151.37 , nothing in this chapter applies to or
3.30interferes with the dispensing, in its original package and at no charge to the patient, of a
3.31legend drug, other than a controlled substance, that was packaged by a manufacturer and
3.32provided to the dispenser for distribution as a professional sample.
3.33Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
3.34poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
3.35practice, nor to hospitals for use therein.
4.1Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
4.2at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
4.3sale of insecticides, as defined in Minnesota Statutes 1974, section24.069 , and nothing in
4.4this chapter shall prevent the sale of common household preparations and other drugs,
4.5chemicals, and poisons sold exclusively for use for nonmedicinal purposes; provided
4.6that this exception does not apply to the sale of any compound, substance, or derivative
4.7which is not regulated or approved for human consumption by the United States Food and
4.8Drug Administration or specifically permitted by Minnesota law, and when introduced
4.9into the body, induces an effect substantially similar to that of a Schedule I or Schedule
4.10II controlled substance listed in section 152.02, subdivisions 2 and 3; and Minnesota
4.11Rules, parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed
4.12for the purpose of human consumption.
4.13Nothing in this chapter shall apply to or interfere with the vending or retailing
4.14of any nonprescription medicine or drug not otherwise prohibited by statute which is
4.15prepackaged, fully prepared by the manufacturer or producer for use by the consumer,
4.16and labeled in accordance with the requirements of the state or federal Food and Drug
4.17Act; nor to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet
4.18articles, cosmetics, perfumes, spices, and other commonly used household articles of a
4.19chemical nature, for use for nonmedicinal purposes; provided that this exception does not
4.20apply to the sale of any compound, substance, or derivative which is not regulated or
4.21approved for human consumption by the United States Food and Drug Administration
4.22or specifically permitted by Minnesota law, and when introduced into the body, induces
4.23an effect substantially similar to that of a Schedule I or Schedule II controlled substance
4.24listed in section 152.02, subdivisions 2 and 3; and Minnesota Rules, parts 6800.4210 and
4.256800.4220, regardless of whether the substance is marketed for the purpose of human
4.26consumption. Nothing in this chapter shall prevent the sale of drugs or medicines by
4.27licensed pharmacists at a discount to persons over 65 years of age.
4.28EFFECTIVE DATE.This section is effective August 1, 2014.
4.29 Sec. 5. Minnesota Statutes 2012, section 151.34, is amended to read:
4.30151.34 PROHIBITED ACTS.
4.31It shall be unlawful to:
4.32(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
4.33or misbranded;
4.34(2) adulterate or misbrand any drug;
5.1(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
5.2proffer delivery thereof for pay or otherwise;
5.3(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
5.4permit access to or copying of any record as authorized by this chapter;
5.5(5) remove or dispose of a detained or embargoed article in violation of this chapter;
5.6(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
5.7of, or to do any other act with respect to a drug, if such act is done while such drug is held
5.8for sale and results in such drug being adulterated or misbranded;
5.9(7) use for a person's own advantage or to reveal other than to the board or its
5.10authorized representative or to the courts when required in any judicial proceeding under
5.11this chapter any information acquired under authority of this chapter concerning any
5.12method or process which is a trade secret and entitled to protection;
5.13(8) use on the labeling of any drug any representation or suggestion that an
5.14application with respect to such drug is effective under the federal act or that such drug
5.15complies with such provisions;
5.16(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
5.17within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
5.18by applicable law to administer such drug who makes written request for information as to
5.19such drug, true and correct copies of all printed matter which is required to be included in
5.20any package in which that drug is distributed or sold, or such other printed matter as is
5.21approved under the federal act. Nothing in this paragraph shall be construed to exempt
5.22any person from any labeling requirement imposed by or under provisions of this chapter;
5.23(10) conduct a pharmacy without a pharmacist in charge;
5.24(11) dispense a legend drug without first obtaining a valid prescription for that drug;
5.25(12) conduct a pharmacy without proper registration with the board;
5.26(13) practice pharmacy without being licensed to do so by the board;or
5.27(14) sell at retail federally restricted medical gases without proper registration with
5.28the board except as provided in this chapter; or
5.29(15) sell any compound, substance, or derivative which is not regulated or approved
5.30for human consumption by the United States Food and Drug Administration or specifically
5.31permitted by Minnesota law, and when introduced into the body, induces an effect
5.32substantially similar to that of a Schedule I or Schedule II controlled substance listed in
5.33section 152.02, subdivisions 2 and 3; and Minnesota Rules, parts 6800.4210 and 6800.4200,
5.34regardless of whether the substance is marketed for the purpose of human consumption.
5.35EFFECTIVE DATE.This section is effective August 1, 2014, and applies to sales
5.36on or after that date.
6.1 Sec. 6. Minnesota Statutes 2012, section 151.35, is amended to read:
6.2151.35 DRUGS, ADULTERATION.
6.3A drug shall be deemed to be adulterated:
6.4(1) if it consists in whole or in part of any filthy, putrid or decomposed substance;
6.5or if it has been produced, prepared, packed, or held under unsanitary conditions
6.6whereby it may have been rendered injurious to health, or whereby it may have been
6.7contaminated with filth; or if the methods used in, or the facilities or controls used for, its
6.8manufacture, processing, packing, or holding do not conform to or are not operated or
6.9administered in conformity with current good manufacturing practice as required under
6.10the federal act to assure that such drug is safe and has the identity, strength, quality, and
6.11purity characteristics, which it purports or is represented to possess; or, its container is
6.12composed, in whole or in part, of any poisonous or deleterious substance which may
6.13render the contents injurious to health; or it bears or contains, for purposes of coloring
6.14only, a color additive which is unsafe within the meaning of the federal act, or it is a color
6.15additive, the intended use of which in or on drugs is for the purposes of coloring only, and
6.16is unsafe within the meaning of the federal act; or it has been manufactured at a facility
6.17not licensed pursuant to section 151.252;
6.18(2) if it purports to be or is represented as a drug the name of which is recognized in
6.19the United States Pharmacopoeia or the National Formulary, and its strength differs from,
6.20or its quality or purity falls below, the standard set forth therein. Such determination as
6.21to strength, quality, or purity shall be made in accordance with the tests or methods of
6.22assay set forth in such compendium, or in the absence of or inadequacy of such tests or
6.23methods of assay, those prescribed under authority of the federal act. No drug defined
6.24in the United States Pharmacopoeia or the National Formulary shall be deemed to be
6.25adulterated under this paragraph because it differs from the standard of strength, quality,
6.26or purity therefor set forth in such compendium, if its difference in strength, quality, or
6.27purity from such standard is plainly stated on its label;
6.28(3) if it is not subject to the provisions of paragraph (2) of this section and its
6.29strength differs from, or its purity or quality differs from that which it purports or is
6.30represented to possess;
6.31(4) if any substance has been mixed or packed therewith so as to reduce its quality or
6.32strength, or substituted wholly or in part therefor.
6.33EFFECTIVE DATE.This section is effective August 1, 2014.
7.1 Sec. 7. Minnesota Statutes 2012, section 151.36, is amended to read:
7.2151.36 DRUGS, MISBRANDING.
7.3A drug shall be deemed to be misbranded:
7.4(1) if its labeling is false or misleading in any particular;
7.5(2) if in package form and not dispensed pursuant to a prescription unless it bears
7.6a label containing (a) the name and place of business of the manufacturer, packer, or
7.7distributor, (b) a statement ofidentity ingredients, and (c) an accurate statement of the
7.8net quantity of the contents in terms of weight, measure, or numerical count, provided,
7.9however, that under (c) reasonable variations shall be permitted, and exceptions as to
7.10small packages shall be allowed in accordance with the federal act;
7.11(3) if any word, statement, or other information required by or under authority of
7.12this chapter to appear on the label or labeling is not prominently placed thereon with such
7.13conspicuousness (as compared with other words, statements, designs or devices, in the
7.14labeling) and in such terms as to render it to be read and understood by the ordinary
7.15individual under customary conditions of purchase and use;
7.16(4) if it otherwise fails to meet the labeling requirements of the federal act.
7.17EFFECTIVE DATE.This section is effective August 1, 2014.
7.18 Sec. 8. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
7.19 Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
7.20(a) The state Board of Pharmacy may, by rule, add a substance to Schedule I provided that
7.21it finds that the substance has a high potential for abuse, has no currently accepted medical
7.22use in the United States, has a lack of accepted safety for use under medical supervision,
7.23has known adverse health effects, and is currently available for use within the state. For
7.24the purposes of this subdivision only, the board may use the expedited rulemaking process
7.25under section14.389 . The scheduling of a substance under this subdivision expires the
7.26day after the adjournment of the legislative session immediately following the substance's
7.27scheduling unless the legislature by law ratifies the action.
7.28(b) If the board schedules a substance under this subdivision, the board shall notify
7.29in a timely manner the chairs and ranking minority members of the senate and house of
7.30representatives committees having jurisdiction over criminal justice and health policy
7.31and finance of the action and the reasons for it. The notice must include a copy of the
7.32administrative law judge's decision on the matter.
7.33(c) This subdivision expires August 1, 2014.
7.34EFFECTIVE DATE.This section is effective the day following final enactment.
8.1 Sec. 9. MINNESOTA DEPARTMENT OF EDUCATION.
8.2$....... in fiscal year 2014 and $....... in fiscal year 2015 are appropriated from the
8.3general fund to the Department of Education for increasing public awareness of the
8.4dangers of synthetic drugs. The educational awareness campaign should be designed to
8.5reach a broad audience but contain targeted messages for students and young adults. The
8.6commissioners of education, health, and human services shall cooperate in the formulation
8.7and implementation of the educational awareness campaign. If the appropriation for either
8.8year is insufficient, the appropriation for the other year is available for it.
8.9EFFECTIVE DATE.This section is effective the day following final enactment.
1.3authority to prevent the sale of synthetic drugs; modifying laws governing
1.4misbranding drugs, adulterated drugs; expanding the definition of drug; repealing
1.5the sunset and legislative reporting requirement for the Board of Pharmacy's
1.6emergency drug scheduling authority; providing training and expert support in
1.7the prosecution of synthetic drug cases; establishing a public education plan;
1.8appropriating money;amending Minnesota Statutes 2012, sections 151.01,
1.9subdivision 5; 151.06, by adding subdivisions; 151.26, subdivision 1; 151.34;
1.10151.35; 151.36; 152.02, subdivision 8b.
1.11BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.12 Section 1. Minnesota Statutes 2012, section 151.01, subdivision 5, is amended to read:
1.13 Subd. 5. Drug.
1.14recognized by the United States Pharmacopoeia and National Formulary, or any revision
1.15thereof, and all substances and preparations intended for external and internal use in the
1.16diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals,
1.17and all substances and preparations, other than food, intended to affect the structure or any
1.18function of the bodies of humans or other animals. Drug shall also mean any compound,
1.19substance, or derivative which is not regulated or approved for human consumption by
1.20the United States Food and Drug Administration or specifically permitted by Minnesota
1.21law, and when introduced into the body, induces an effect substantially similar to that of a
1.22Schedule I or Schedule II controlled substance listed in section 152.02, subdivisions 2
1.23and 3; and Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of whether the
1.24substance is marketed for the purpose of human consumption.
1.25EFFECTIVE DATE.This section is effective August 1, 2014.
2.1 Sec. 2. Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
2.2to read:
2.3 Subd. 2b. Cease and desist orders. (a) Whenever it appears to the Board of
2.4Pharmacy that a person has engaged or is about to engage in an act or practice constituting
2.5a violation of a law, rule, or order related to the duties and responsibilities entrusted to the
2.6board, the board may issue and cause to be served upon the person an order requiring the
2.7person to cease and desist from violations.
2.8(b) The cease and desist order must be calculated to give reasonable notice of the
2.9rights of the person to request a hearing and must state the reasons for the entry of the
2.10order. A hearing must be held not later than ten days after the request for the hearing is
2.11received by the board. After the completion of the hearing, the administrative law judge
2.12shall issue a report within ten days. Within 15 days after receiving the administrative law
2.13judge's report, the board shall issue a further order vacating or making permanent the
2.14cease and desist order. The time periods provided in this paragraph may be waived by
2.15agreement of the person requesting the hearing, the director, and the person against whom
2.16the cease and desist order is issued. If the person to whom a cease and desist order is
2.17issued fails to appear at the hearing after being duly notified, the person is in default and
2.18the proceeding may be determined against that person upon consideration of the cease
2.19and desist order, the allegations of which may be considered to be true. Unless otherwise
2.20provided, all hearings must be conducted according to chapter 14. The board may adopt
2.21rules of procedure concerning all proceedings conducted under this subdivision.
2.22(c) If no hearing is requested within 30 days of service of the order, the cease and
2.23desist order will become permanent.
2.24(d) A cease and desist order issued under this subdivision remains in effect until
2.25it is modified or vacated by the board. The administrative proceeding provided by this
2.26subdivision, and subsequent appellate judicial review of that administrative proceeding,
2.27constitutes the exclusive remedy for determining whether the board properly issued the
2.28cease and desist order and whether the cease and desist order should be vacated or made
2.29permanent.
2.30EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
2.31violations occurring on or after that date.
2.32 Sec. 3. Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
2.33to read:
2.34 Subd. 2c. Enforcement of violations of cease and desist orders. (a) Whenever
2.35the board, under subdivision 2b, seeks to enforce compliance with a cease and desist
3.1order that has been made permanent, the allegations in the cease and desist order are
3.2considered conclusively established for purposes of a proceeding under subdivision 2b
3.3for permanent or temporary relief to enforce the cease and desist order. Whenever the
3.4board, under subdivision 2b, seeks to enforce compliance with a cease and desist order
3.5when a hearing or hearing request on the cease and desist order is pending, or the time
3.6has not yet expired to request a hearing on whether a cease and desist order should be
3.7vacated or made permanent, the allegations in the cease and desist order are considered
3.8conclusively established for purposes of a proceeding under subdivision 2b for temporary
3.9relief to enforce the cease and desist order.
3.10(b) Notwithstanding this subdivision or subdivision 2b to the contrary, the person
3.11against whom the cease and desist order is issued and who has requested a hearing under
3.12subdivision 2b may, within 15 days after service of the cease and desist order, bring
3.13an action in Ramsey County District Court for issuance of an injunction to suspend
3.14enforcement of the cease and desist order pending a final decision of the board under
3.15subdivision 2b to vacate or make permanent the cease and desist order. The court shall
3.16determine whether to issue such an injunction based on traditional principles of temporary
3.17relief.
3.18EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
3.19violations occurring on or after that date.
3.20 Sec. 4. Minnesota Statutes 2012, section 151.26, subdivision 1, is amended to read:
3.21 Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
3.22licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
3.23by the State Board of Pharmacy, nor prevent the person from administering drugs,
3.24medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
3.25practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
3.26chemicals, or poisons as may be considered appropriate in the treatment of such patient;
3.27unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
3.28provides reasonable notice of an inspection.
3.29Except for the provisions of section
3.30interferes with the dispensing, in its original package and at no charge to the patient, of a
3.31legend drug, other than a controlled substance, that was packaged by a manufacturer and
3.32provided to the dispenser for distribution as a professional sample.
3.33Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
3.34poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
3.35practice, nor to hospitals for use therein.
4.1Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
4.2at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
4.3sale of insecticides, as defined in Minnesota Statutes 1974, section
4.4this chapter shall prevent the sale of common household preparations and other drugs,
4.5chemicals, and poisons sold exclusively for use for nonmedicinal purposes; provided
4.6that this exception does not apply to the sale of any compound, substance, or derivative
4.7which is not regulated or approved for human consumption by the United States Food and
4.8Drug Administration or specifically permitted by Minnesota law, and when introduced
4.9into the body, induces an effect substantially similar to that of a Schedule I or Schedule
4.10II controlled substance listed in section 152.02, subdivisions 2 and 3; and Minnesota
4.11Rules, parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed
4.12for the purpose of human consumption.
4.13Nothing in this chapter shall apply to or interfere with the vending or retailing
4.14of any nonprescription medicine or drug not otherwise prohibited by statute which is
4.15prepackaged, fully prepared by the manufacturer or producer for use by the consumer,
4.16and labeled in accordance with the requirements of the state or federal Food and Drug
4.17Act; nor to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet
4.18articles, cosmetics, perfumes, spices, and other commonly used household articles of a
4.19chemical nature, for use for nonmedicinal purposes; provided that this exception does not
4.20apply to the sale of any compound, substance, or derivative which is not regulated or
4.21approved for human consumption by the United States Food and Drug Administration
4.22or specifically permitted by Minnesota law, and when introduced into the body, induces
4.23an effect substantially similar to that of a Schedule I or Schedule II controlled substance
4.24listed in section 152.02, subdivisions 2 and 3; and Minnesota Rules, parts 6800.4210 and
4.256800.4220, regardless of whether the substance is marketed for the purpose of human
4.26consumption. Nothing in this chapter shall prevent the sale of drugs or medicines by
4.27licensed pharmacists at a discount to persons over 65 years of age.
4.28EFFECTIVE DATE.This section is effective August 1, 2014.
4.29 Sec. 5. Minnesota Statutes 2012, section 151.34, is amended to read:
4.30151.34 PROHIBITED ACTS.
4.31It shall be unlawful to:
4.32(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
4.33or misbranded;
4.34(2) adulterate or misbrand any drug;
5.1(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
5.2proffer delivery thereof for pay or otherwise;
5.3(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
5.4permit access to or copying of any record as authorized by this chapter;
5.5(5) remove or dispose of a detained or embargoed article in violation of this chapter;
5.6(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
5.7of, or to do any other act with respect to a drug, if such act is done while such drug is held
5.8for sale and results in such drug being adulterated or misbranded;
5.9(7) use for a person's own advantage or to reveal other than to the board or its
5.10authorized representative or to the courts when required in any judicial proceeding under
5.11this chapter any information acquired under authority of this chapter concerning any
5.12method or process which is a trade secret and entitled to protection;
5.13(8) use on the labeling of any drug any representation or suggestion that an
5.14application with respect to such drug is effective under the federal act or that such drug
5.15complies with such provisions;
5.16(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
5.17within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
5.18by applicable law to administer such drug who makes written request for information as to
5.19such drug, true and correct copies of all printed matter which is required to be included in
5.20any package in which that drug is distributed or sold, or such other printed matter as is
5.21approved under the federal act. Nothing in this paragraph shall be construed to exempt
5.22any person from any labeling requirement imposed by or under provisions of this chapter;
5.23(10) conduct a pharmacy without a pharmacist in charge;
5.24(11) dispense a legend drug without first obtaining a valid prescription for that drug;
5.25(12) conduct a pharmacy without proper registration with the board;
5.26(13) practice pharmacy without being licensed to do so by the board;
5.27(14) sell at retail federally restricted medical gases without proper registration with
5.28the board except as provided in this chapter; or
5.29(15) sell any compound, substance, or derivative which is not regulated or approved
5.30for human consumption by the United States Food and Drug Administration or specifically
5.31permitted by Minnesota law, and when introduced into the body, induces an effect
5.32substantially similar to that of a Schedule I or Schedule II controlled substance listed in
5.33section 152.02, subdivisions 2 and 3; and Minnesota Rules, parts 6800.4210 and 6800.4200,
5.34regardless of whether the substance is marketed for the purpose of human consumption.
5.35EFFECTIVE DATE.This section is effective August 1, 2014, and applies to sales
5.36on or after that date.
6.1 Sec. 6. Minnesota Statutes 2012, section 151.35, is amended to read:
6.2151.35 DRUGS, ADULTERATION.
6.3A drug shall be deemed to be adulterated:
6.4(1) if it consists in whole or in part of any filthy, putrid or decomposed substance;
6.5or if it has been produced, prepared, packed, or held under unsanitary conditions
6.6whereby it may have been rendered injurious to health, or whereby it may have been
6.7contaminated with filth; or if the methods used in, or the facilities or controls used for, its
6.8manufacture, processing, packing, or holding do not conform to or are not operated or
6.9administered in conformity with current good manufacturing practice as required under
6.10the federal act to assure that such drug is safe and has the identity, strength, quality, and
6.11purity characteristics, which it purports or is represented to possess; or, its container is
6.12composed, in whole or in part, of any poisonous or deleterious substance which may
6.13render the contents injurious to health; or it bears or contains, for purposes of coloring
6.14only, a color additive which is unsafe within the meaning of the federal act, or it is a color
6.15additive, the intended use of which in or on drugs is for the purposes of coloring only, and
6.16is unsafe within the meaning of the federal act; or it has been manufactured at a facility
6.17not licensed pursuant to section 151.252;
6.18(2) if it purports to be or is represented as a drug the name of which is recognized in
6.19the United States Pharmacopoeia or the National Formulary, and its strength differs from,
6.20or its quality or purity falls below, the standard set forth therein. Such determination as
6.21to strength, quality, or purity shall be made in accordance with the tests or methods of
6.22assay set forth in such compendium, or in the absence of or inadequacy of such tests or
6.23methods of assay, those prescribed under authority of the federal act. No drug defined
6.24in the United States Pharmacopoeia or the National Formulary shall be deemed to be
6.25adulterated under this paragraph because it differs from the standard of strength, quality,
6.26or purity therefor set forth in such compendium, if its difference in strength, quality, or
6.27purity from such standard is plainly stated on its label;
6.28(3) if it is not subject to the provisions of paragraph (2) of this section and its
6.29strength differs from, or its purity or quality differs from that which it purports or is
6.30represented to possess;
6.31(4) if any substance has been mixed or packed therewith so as to reduce its quality or
6.32strength, or substituted wholly or in part therefor.
6.33EFFECTIVE DATE.This section is effective August 1, 2014.
7.1 Sec. 7. Minnesota Statutes 2012, section 151.36, is amended to read:
7.2151.36 DRUGS, MISBRANDING.
7.3A drug shall be deemed to be misbranded:
7.4(1) if its labeling is false or misleading in any particular;
7.5(2) if in package form and not dispensed pursuant to a prescription unless it bears
7.6a label containing (a) the name and place of business of the manufacturer, packer, or
7.7distributor, (b) a statement of
7.8net quantity of the contents in terms of weight, measure, or numerical count, provided,
7.9however, that under (c) reasonable variations shall be permitted, and exceptions as to
7.10small packages shall be allowed in accordance with the federal act;
7.11(3) if any word, statement, or other information required by or under authority of
7.12this chapter to appear on the label or labeling is not prominently placed thereon with such
7.13conspicuousness (as compared with other words, statements, designs or devices, in the
7.14labeling) and in such terms as to render it to be read and understood by the ordinary
7.15individual under customary conditions of purchase and use;
7.16(4) if it otherwise fails to meet the labeling requirements of the federal act.
7.17EFFECTIVE DATE.This section is effective August 1, 2014.
7.18 Sec. 8. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
7.19 Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
7.20
7.21it finds that the substance has a high potential for abuse, has no currently accepted medical
7.22use in the United States, has a lack of accepted safety for use under medical supervision,
7.23has known adverse health effects, and is currently available for use within the state. For
7.24the purposes of this subdivision only, the board may use the expedited rulemaking process
7.25under section
7.26
7.27
7.28
7.29
7.30
7.31
7.32
7.33
7.34EFFECTIVE DATE.This section is effective the day following final enactment.
8.1 Sec. 9. MINNESOTA DEPARTMENT OF EDUCATION.
8.2$....... in fiscal year 2014 and $....... in fiscal year 2015 are appropriated from the
8.3general fund to the Department of Education for increasing public awareness of the
8.4dangers of synthetic drugs. The educational awareness campaign should be designed to
8.5reach a broad audience but contain targeted messages for students and young adults. The
8.6commissioners of education, health, and human services shall cooperate in the formulation
8.7and implementation of the educational awareness campaign. If the appropriation for either
8.8year is insufficient, the appropriation for the other year is available for it.
8.9EFFECTIVE DATE.This section is effective the day following final enactment.
