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Minnesota Legislature

Office of the Revisor of Statutes

HF 2446

Conference Committee Report - 88th Legislature (2013 - 2014) Posted on 05/13/2014 11:15am

KEY: stricken = removed, old language.
underscored = added, new language.
1.1CONFERENCE COMMITTEE REPORT ON H. F. No. 2446
1.2A bill for an act
1.3relating to public safety; granting the Board of Pharmacy cease and desist
1.4authority to prevent the sale of synthetic drugs; modifying laws governing
1.5misbranding drugs, adulterated drugs; expanding the definition of drug; repealing
1.6the sunset and legislative reporting requirement for the Board of Pharmacy's
1.7emergency drug scheduling authority; providing for mandatory restitution when
1.8a person is convicted for selling controlled substance under false pretense of
1.9being legal; establishing a public education plan; appropriating money;amending
1.10Minnesota Statutes 2012, sections 151.01, subdivision 5; 151.06, subdivision 1a,
1.11by adding a subdivision; 151.26, subdivision 1; 151.34; 151.35; 151.36; 152.02,
1.12subdivision 8b; proposing coding for new law in Minnesota Statutes, chapter 152.
1.13May 12, 2014
1.14The Honorable Paul Thissen
1.15Speaker of the House of Representatives
1.16The Honorable Sandra L. Pappas
1.17President of the Senate
1.18We, the undersigned conferees for H. F. No. 2446 report that we have agreed upon
1.19the items in dispute and recommend as follows:
1.20That the Senate recede from its amendments and that H. F. No. 2446 be further
1.21amended as follows:
1.22Delete everything after the enacting clause and insert:

1.23    "Section 1. Minnesota Statutes 2012, section 151.01, subdivision 5, is amended to read:
1.24    Subd. 5. Drug. The term "drug" means all medicinal substances and preparations
1.25recognized by the United States Pharmacopoeia and National Formulary, or any revision
1.26thereof, and all substances and preparations intended for external and internal use in the
1.27diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals,
1.28and all substances and preparations, other than food, intended to affect the structure or
1.29any function of the bodies of humans or other animals. The term drug shall also mean
1.30any compound, substance, or derivative that is not approved for human consumption by
1.31the United States Food and Drug Administration or specifically permitted for human
1.32consumption under Minnesota law, and, when introduced into the body, induces an effect
2.1similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
2.2subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
2.3whether the substance is marketed for the purpose of human consumption.
2.4EFFECTIVE DATE.This section is effective August 1, 2014.

2.5    Sec. 2. Minnesota Statutes 2012, section 151.06, subdivision 1a, is amended to read:
2.6    Subd. 1a. Disciplinary action Cease and desist orders. It shall be grounds for
2.7disciplinary action by the Board of Pharmacy against the registration of the pharmacy if
2.8the Board of Pharmacy determines that any person with supervisory responsibilities at the
2.9pharmacy sets policies that prevent a licensed pharmacist from providing drug utilization
2.10review and patient counseling as required by rules adopted under subdivision 1. The
2.11Board of Pharmacy shall follow the requirements of chapter 14 in any disciplinary actions
2.12taken under this section. (a) Whenever it appears to the board that a person has engaged in
2.13an act or practice constituting a violation of a law, rule, or other order related to the duties
2.14and responsibilities entrusted to the board, the board may issue and cause to be served
2.15upon the person an order requiring the person to cease and desist from violations.
2.16(b) The cease and desist order must state the reasons for the issuance of the order
2.17and must give reasonable notice of the rights of the person to request a hearing before
2.18an administrative law judge. A hearing must be held not later than ten days after the
2.19request for the hearing is received by the board. After the completion of the hearing,
2.20the administrative law judge shall issue a report within ten days. Within 15 days after
2.21receiving the report of the administrative law judge, the board shall issue a further order
2.22vacating or making permanent the cease and desist order. The time periods provided in
2.23this provision may be waived by agreement of the executive director of the board and the
2.24person against whom the cease and desist order was issued. If the person to whom a cease
2.25and desist order is issued fails to appear at the hearing after being duly notified, the person
2.26is in default, and the proceeding may be determined against that person upon consideration
2.27of the cease and desist order, the allegations of which may be considered to be true. Unless
2.28otherwise provided, all hearings must be conducted according to chapter 14. The board
2.29may adopt rules of procedure concerning all proceedings conducted under this subdivision.
2.30(c) If no hearing is requested within 30 days of service of the order, the cease and
2.31desist order will become permanent.
2.32(d) A cease and desist order issued under this subdivision remains in effect until
2.33it is modified or vacated by the board. The administrative proceeding provided by this
2.34subdivision, and subsequent appellate judicial review of that administrative proceeding,
2.35constitutes the exclusive remedy for determining whether the board properly issued the
3.1cease and desist order and whether the cease and desist order should be vacated or made
3.2permanent.
3.3EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
3.4violations occurring on or after that date.

3.5    Sec. 3. Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
3.6to read:
3.7    Subd. 1b. Enforcement of violations of cease and desist orders. (a) Whenever
3.8the board under subdivision 1a seeks to enforce compliance with a cease and desist
3.9order that has been made permanent, the allegations of the cease and desist order are
3.10considered conclusively established for purposes of proceeding under subdivision 1a for
3.11permanent or temporary relief to enforce the cease and desist order. Whenever the board
3.12under subdivision 1a seeks to enforce compliance with a cease and desist order when a
3.13hearing or hearing request on the cease and desist order is pending, or the time has not
3.14yet expired to request a hearing on whether a cease and desist order should be vacated or
3.15made permanent, the allegations in the cease and desist order are considered conclusively
3.16established for the purposes of proceeding under subdivision 1a for temporary relief to
3.17enforce the cease and desist order.
3.18(b) Notwithstanding this subdivision or subdivision 1a, the person against whom
3.19the cease and desist order is issued and who has requested a hearing under subdivision 1a
3.20may, within 15 days after service of the cease and desist order, bring an action in Ramsey
3.21County District Court for issuance of an injunction to suspend enforcement of the cease
3.22and desist order pending a final decision of the board under subdivision 1a to vacate or
3.23make permanent the cease and desist order. The court shall determine whether to issue
3.24such an injunction based on traditional principles of temporary relief.
3.25EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
3.26violations occurring on or after that date.

3.27    Sec. 4. Minnesota Statutes 2012, section 151.26, subdivision 1, is amended to read:
3.28    Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
3.29licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
3.30by the State Board of Pharmacy, nor prevent the person from administering drugs,
3.31medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
3.32practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
3.33chemicals, or poisons as may be considered appropriate in the treatment of such patient;
4.1unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
4.2provides reasonable notice of an inspection.
4.3Except for the provisions of section 151.37, nothing in this chapter applies to or
4.4interferes with the dispensing, in its original package and at no charge to the patient, of a
4.5legend drug, other than a controlled substance, that was packaged by a manufacturer and
4.6provided to the dispenser for distribution as a professional sample.
4.7Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
4.8poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
4.9practice, nor to hospitals for use therein.
4.10Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
4.11at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
4.12sale of insecticides, as defined in Minnesota Statutes 1974, section 24.069, and nothing in
4.13this chapter shall prevent the sale of common household preparations and other drugs,
4.14chemicals, and poisons sold exclusively for use for nonmedicinal purposes; provided
4.15that this exception does not apply to any compound, substance, or derivative that is not
4.16approved for human consumption by the United States Food and Drug Administration
4.17or specifically permitted for human consumption under Minnesota law, and, when
4.18introduced into the body, induces an effect similar to that of a Schedule I or Schedule II
4.19controlled substance listed in section 152.02, subdivisions 2 and 3, or Minnesota Rules,
4.20parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed for the
4.21purpose of human consumption.
4.22Nothing in this chapter shall apply to or interfere with the vending or retailing
4.23of any nonprescription medicine or drug not otherwise prohibited by statute which is
4.24prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
4.25labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
4.26to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
4.27cosmetics, perfumes, spices, and other commonly used household articles of a chemical
4.28nature, for use for nonmedicinal purposes; provided that this exception does not apply
4.29to any compound, substance, or derivative that is not approved for human consumption
4.30by the United States Food and Drug Administration or specifically permitted for human
4.31consumption under Minnesota law, and, when introduced into the body, induces an effect
4.32similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
4.33subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
4.34whether the substance is marketed for the purpose of human consumption. Nothing in
4.35this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at a
4.36discount to persons over 65 years of age.
5.1EFFECTIVE DATE.This section is effective August 1, 2014.

5.2    Sec. 5. Minnesota Statutes 2012, section 151.34, is amended to read:
5.3151.34 PROHIBITED ACTS.
5.4It shall be unlawful to:
5.5(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
5.6or misbranded;
5.7(2) adulterate or misbrand any drug;
5.8(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
5.9proffer delivery thereof for pay or otherwise;
5.10(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
5.11permit access to or copying of any record as authorized by this chapter;
5.12(5) remove or dispose of a detained or embargoed article in violation of this chapter;
5.13(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
5.14of, or to do any other act with respect to a drug, if such act is done while such drug is held
5.15for sale and results in such drug being adulterated or misbranded;
5.16(7) use for a person's own advantage or to reveal other than to the board or its
5.17authorized representative or to the courts when required in any judicial proceeding under
5.18this chapter any information acquired under authority of this chapter concerning any
5.19method or process which that is a trade secret and entitled to protection;
5.20(8) use on the labeling of any drug any representation or suggestion that an
5.21application with respect to such drug is effective under the federal act or that such drug
5.22complies with such provisions;
5.23(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
5.24within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
5.25by applicable law to administer such drug who makes written request for information as to
5.26such drug, true and correct copies of all printed matter which that is required to be included
5.27in any package in which that drug is distributed or sold, or such other printed matter as is
5.28approved under the federal act. Nothing in this paragraph shall be construed to exempt
5.29any person from any labeling requirement imposed by or under provisions of this chapter;
5.30(10) conduct a pharmacy without a pharmacist in charge;
5.31(11) dispense a legend drug without first obtaining a valid prescription for that drug;
5.32(12) conduct a pharmacy without proper registration with the board;
5.33(13) practice pharmacy without being licensed to do so by the board; or
5.34(14) sell at retail federally restricted medical gases without proper registration with
5.35the board except as provided in this chapter.; or
6.1(15) sell any compound, substance, or derivative that is not approved for human
6.2consumption by the United States Food and Drug Administration or specifically permitted
6.3for human consumption under Minnesota law, and, when introduced into the body, induces
6.4an effect similar to that of a Schedule I or Schedule II controlled substance listed in
6.5section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
6.6regardless of whether the substance is marketed for the purpose of human consumption.
6.7EFFECTIVE DATE.This section is effective August 1, 2014, and applies to sales
6.8on or after that date.

6.9    Sec. 6. Minnesota Statutes 2012, section 151.35, is amended to read:
6.10151.35 DRUGS, ADULTERATION.
6.11A drug shall be deemed to be adulterated:
6.12(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
6.13if it has been produced, prepared, packed, or held under unsanitary conditions whereby it
6.14may have been rendered injurious to health, or whereby it may have been contaminated
6.15with filth; or if the methods used in, or the facilities or controls used for, its manufacture,
6.16processing, packing, or holding do not conform to or are not operated or administered
6.17in conformity with current good manufacturing practice as required under the federal
6.18act to assure that such drug is safe and has the identity, strength, quality, and purity
6.19characteristics, which it purports or is represented to possess; or the facility in which it
6.20was produced was not registered by the United States Food and Drug Administration or
6.21licensed by the board; or, its container is composed, in whole or in part, of any poisonous
6.22or deleterious substance which may render the contents injurious to health; or it bears
6.23or contains, for purposes of coloring only, a color additive which is unsafe within the
6.24meaning of the federal act, or it is a color additive, the intended use of which in or on drugs
6.25is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
6.26(2) if it purports to be or is represented as a drug the name of which is recognized in
6.27the United States Pharmacopoeia or the National Formulary, and its strength differs from,
6.28or its quality or purity falls below, the standard set forth therein. Such determination as
6.29to strength, quality, or purity shall be made in accordance with the tests or methods of
6.30assay set forth in such compendium, or in the absence of or inadequacy of such tests or
6.31methods of assay, those prescribed under authority of the federal act. No drug defined
6.32in the United States Pharmacopoeia or the National Formulary shall be deemed to be
6.33adulterated under this paragraph because it differs from the standard of strength, quality,
7.1or purity therefor set forth in such compendium, if its difference in strength, quality, or
7.2purity from such standard is plainly stated on its label;
7.3(3) if it is not subject to the provisions of paragraph (2) of this section and its
7.4strength differs from, or its purity or quality differs from that which it purports or is
7.5represented to possess;
7.6(4) if any substance has been mixed or packed therewith so as to reduce its quality or
7.7strength, or substituted wholly or in part therefor.
7.8EFFECTIVE DATE.This section is effective August 1, 2014.

7.9    Sec. 7. Minnesota Statutes 2012, section 151.36, is amended to read:
7.10151.36 DRUGS, MISBRANDING.
7.11A drug shall be deemed to be misbranded:
7.12(1) if its labeling is false or misleading in any particular;
7.13(2) if in package form and not dispensed pursuant to a prescription unless it bears
7.14a label containing (a) the name and place of business of the manufacturer, packer, or
7.15distributor, (b) a statement of identity ingredients, and (c) an accurate statement of the
7.16net quantity of the contents in terms of weight, measure, or numerical count, provided,
7.17however, that under (c) reasonable variations shall be permitted, and exceptions as to
7.18small packages shall be allowed in accordance with the federal act;
7.19(3) if any word, statement, or other information required by or under authority of
7.20this chapter to appear on the label or labeling is not prominently placed thereon with such
7.21conspicuousness (as compared with other words, statements, designs or devices, in the
7.22labeling) and in such terms as to render it to be read and understood by the ordinary
7.23individual under customary conditions of purchase and use;
7.24(4) if it otherwise fails to meet the labeling requirements of the federal act.
7.25EFFECTIVE DATE.This section is effective August 1, 2014.

7.26    Sec. 8. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
7.27    Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
7.28(a) The state Board of Pharmacy may, by rule, add a substance to Schedule I provided that
7.29it finds that the substance has a high potential for abuse, has no currently accepted medical
7.30use in the United States, has a lack of accepted safety for use under medical supervision,
7.31has known adverse health effects, and is currently available for use within the state. For
7.32the purposes of this subdivision only, the board may use the expedited rulemaking process
7.33under section 14.389. The scheduling of a substance under this subdivision expires the
8.1day after the adjournment of the legislative session immediately following the substance's
8.2scheduling unless the legislature by law ratifies the action.
8.3(b) If the board schedules a substance under this subdivision, the board shall notify
8.4in a timely manner the chairs and ranking minority members of the senate and house of
8.5representatives committees having jurisdiction over criminal justice and health policy
8.6and finance of the action and the reasons for it. The notice must include a copy of the
8.7administrative law judge's decision on the matter.
8.8(c) This subdivision expires August 1, 2014.
8.9EFFECTIVE DATE.This section is effective the day following final enactment.

8.10    Sec. 9. [152.0273] SYNTHETIC DRUG SALES; MANDATORY RESTITUTION.
8.11The court shall order a person convicted of selling a controlled substance or analog
8.12of a controlled substance under the false pretense that the substance is legal to pay
8.13restitution for the costs and expenses resulting from the crime. Costs and expenses include,
8.14but are not limited to, the medical costs of persons who consumed the substances sold by
8.15the offender and the reasonable costs incurred by public and private entities that provided
8.16an emergency response to a person who consumed the substances sold by the offender.

8.17    Sec. 10. EDUCATIONAL AWARENESS CAMPAIGN; APPROPRIATION.
8.18    $163,000 in fiscal year 2014 is appropriated from the general fund to the Department
8.19of Human Services for increasing public awareness of the dangers of synthetic drugs. The
8.20appropriation is onetime and available until June 30, 2015. The educational awareness
8.21campaign should be designed to reach a broad audience but contain targeted messages for
8.22students and young adults. The commissioners of education, health, human services, and
8.23public safety shall cooperate in the formulation and implementation of the educational
8.24awareness campaign.
8.25EFFECTIVE DATE.This section is effective the day following final enactment.

8.26    Sec. 11. PHARMACY BOARD; APPROPRIATION.
8.27$5,000 in fiscal year 2015 is appropriated from the state government special revenue
8.28fund to the Board of Pharmacy for the costs attributable to the board's cease and desist
8.29authority."
8.30Delete the title and insert:
8.31"A bill for an act
8.32relating to public safety; granting the Board of Pharmacy cease and desist
8.33authority to prevent the sale of synthetic drugs; modifying laws governing
9.1misbranding drugs, adulterated drugs; expanding the definition of drug; repealing
9.2the sunset and legislative reporting requirement for the Board of Pharmacy's
9.3emergency drug scheduling authority; providing for mandatory restitution when
9.4a person is convicted for selling controlled substance under false pretense of
9.5being legal; establishing a public education plan; appropriating money;amending
9.6Minnesota Statutes 2012, sections 151.01, subdivision 5; 151.06, subdivision 1a,
9.7by adding a subdivision; 151.26, subdivision 1; 151.34; 151.35; 151.36; 152.02,
9.8subdivision 8b; proposing coding for new law in Minnesota Statutes, chapter 152."
10.1
We request the adoption of this report and repassage of the bill.
10.2
House Conferees:
10.3
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10.4
Erik Simonson
John Ward
10.5
.....
10.6
Kathy Lohmer
10.7
Senate Conferees:
10.8
.....
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10.9
Roger J. Reinert
Chris A. Eaton
10.10
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10.11
Jeremy R. Miller