HF 2446

2nd Unofficial Engrossment - 88th Legislature (2013 - 2014) Posted on 05/08/2014 08:01am

1.1A bill for an act

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 for mandatory restitution when
1.7a person is convicted for selling controlled substance under false pretense of
1.8being legal; establishing a public education plan; appropriating money;amending
1.9Minnesota Statutes 2012, sections 151.01, subdivision 5; 151.06, subdivision
1.101a, by adding a subdivision; 151.26, subdivision 1; 151.34; 151.35; 151.36;
1.11152.02, subdivision 8b.
1.12BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.13    Section 1. Minnesota Statutes 2012, section 151.01, subdivision 5, is amended to read:
1.14    Subd. 5. Drug. The term "drug" means all medicinal substances and preparations
1.15recognized by the United States Pharmacopoeia and National Formulary, or any revision
1.16thereof, and all substances and preparations intended for external and internal use in the
1.17diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals,
1.18and all substances and preparations, other than food, intended to affect the structure or
1.19any function of the bodies of humans or other animals. The term drug shall also mean
1.20any compound, substance, or derivative that is not approved for human consumption by
1.21the United States Food and Drug Administration or specifically permitted for human
1.22consumption under Minnesota law, and when introduced into the body induces an effect
1.23similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
1.24subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
1.25whether the substance is marketed for the purpose of human consumption.
1.26EFFECTIVE DATE.This section is effective August 1, 2014.

2.1    Sec. 2. Minnesota Statutes 2012, section 151.06, subdivision 1a, is amended to read:
2.2    Subd. 1a. Disciplinary action Cease and desist orders. It shall be grounds for
2.3disciplinary action by the Board of Pharmacy against the registration of the pharmacy if
2.4the Board of Pharmacy determines that any person with supervisory responsibilities at the
2.5pharmacy sets policies that prevent a licensed pharmacist from providing drug utilization
2.6review and patient counseling as required by rules adopted under subdivision 1. The
2.7Board of Pharmacy shall follow the requirements of chapter 14 in any disciplinary actions
2.8taken under this section. (a) Whenever it appears to the board that a person has engaged in
2.9an act or practice constituting a violation of a law, rule, or other order related to the duties
2.10and responsibilities entrusted to the board, the board may issue and cause to be served
2.11upon the person an order requiring the person to cease and desist from violations.
2.12(b) The cease and desist order must state the reasons for the issuance of the order
2.13and must give reasonable notice of the rights of the person to request a hearing before
2.14an administrative law judge. A hearing must be held not later than ten days after the
2.15request for the hearing is received by the board. After the completion of the hearing,
2.16the administrative law judge shall issue a report within ten days. Within 15 days after
2.17receiving the report of the administrative law judge, the board shall issue a further order
2.18vacating or making permanent the cease and desist order. The time periods provided in
2.19this provision may be waived by agreement of the executive director of the board and the
2.20person against whom the cease and desist order was issued. If the person to whom a cease
2.21and desist order is issued fails to appear at the hearing after being duly notified, the person
2.22is in default, and the proceeding may be determined against that person upon consideration
2.23of the cease and desist order, the allegations of which may be considered to be true. Unless
2.24otherwise provided, all hearings must be conducted according to chapter 14. The board
2.25may adopt rules of procedure concerning all proceedings conducted under this subdivision.
2.26(c) If no hearing is requested within 30 days of service of the order, the cease and
2.27desist order will become permanent.
2.28(d) A cease and desist order issued under this subdivision remains in effect until
2.29it is modified or vacated by the board. The administrative proceeding provided by this
2.30subdivision, and subsequent appellate judicial review of that administrative proceeding,
2.31constitutes the exclusive remedy for determining whether the board properly issued the
2.32cease and desist order and whether the cease and desist order should be vacated or made
2.33permanent.
2.34EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
2.35violations occurring on or after that date.

3.1    Sec. 3. Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
3.2to read:
3.3    Subd. 1b. Enforcement of violations of cease and desist orders. (a) Whenever
3.4the board under subdivision 1a seeks to enforce compliance with a cease and desist
3.5order that has been made permanent, the allegations of the cease and desist order are
3.6considered conclusively established for purposes of proceeding under subdivision 1a for
3.7permanent or temporary relief to enforce the cease and desist order. Whenever the board
3.8under subdivision 1a seeks to enforce compliance with a cease and desist order when a
3.9hearing or hearing request on the cease and desist order is pending, or the time has not
3.10yet expired to request a hearing on whether a cease and desist order should be vacated or
3.11made permanent, the allegations in the cease and desist order are considered conclusively
3.12established for the purposes of proceeding under subdivision 1a for temporary relief to
3.13enforce the cease and desist order.
3.14(b) Notwithstanding this subdivision or subdivision 1a, the person against whom
3.15the cease and desist order is issued and who has requested a hearing under subdivision 1a
3.16may, within 15 days after service of the cease and desist order, bring an action in Ramsey
3.17County District Court for issuance of an injunction to suspend enforcement of the cease
3.18and desist order pending a final decision of the board under subdivision 1a to vacate or
3.19make permanent the cease and desist order. The court shall determine whether to issue
3.20such an injunction based on traditional principles of temporary relief.
3.21EFFECTIVE DATE.This section is effective August 1, 2014, and applies to
3.22violations occurring on or after that date.

3.23    Sec. 4. Minnesota Statutes 2012, section 151.26, subdivision 1, is amended to read:
3.24    Subdivision 1. Generally. Nothing in this chapter shall subject a person duly
3.25licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
3.26by the State Board of Pharmacy, nor prevent the person from administering drugs,
3.27medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
3.28practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
3.29chemicals, or poisons as may be considered appropriate in the treatment of such patient;
3.30unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
3.31provides reasonable notice of an inspection.
3.32Except for the provisions of section 151.37, nothing in this chapter applies to or
3.33interferes with the dispensing, in its original package and at no charge to the patient, of a
3.34legend drug, other than a controlled substance, that was packaged by a manufacturer and
3.35provided to the dispenser for distribution as a professional sample.
4.1Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
4.2poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
4.3practice, nor to hospitals for use therein.
4.4Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
4.5at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
4.6sale of insecticides, as defined in Minnesota Statutes 1974, section 24.069, and nothing in
4.7this chapter shall prevent the sale of common household preparations and other drugs,
4.8chemicals, and poisons sold exclusively for use for nonmedicinal purposes; provided that
4.9this exception does not apply to any compound, substance, or derivative that is not approved
4.10for human consumption by the United States Food and Drug Administration or specifically
4.11permitted for human consumption under Minnesota law, and when introduced into the body
4.12induces an effect similar to that of a Schedule I or Schedule II controlled substance listed in
4.13section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
4.14regardless of whether the substance is marketed for the purpose of human consumption.
4.15Nothing in this chapter shall apply to or interfere with the vending or retailing
4.16of any nonprescription medicine or drug not otherwise prohibited by statute which is
4.17prepackaged, fully prepared by the manufacturer or producer for use by the consumer, and
4.18labeled in accordance with the requirements of the state or federal Food and Drug Act; nor
4.19to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet articles,
4.20cosmetics, perfumes, spices, and other commonly used household articles of a chemical
4.21nature, for use for nonmedicinal purposes; provided that this exception does not apply
4.22to any compound, substance, or derivative that is not approved for human consumption
4.23by the United States Food and Drug Administration or specifically permitted for human
4.24consumption under Minnesota law, and when introduced into the body induces an effect
4.25similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
4.26subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of
4.27whether the substance is marketed for the purpose of human consumption. Nothing in
4.28this chapter shall prevent the sale of drugs or medicines by licensed pharmacists at a
4.29discount to persons over 65 years of age.
4.30EFFECTIVE DATE.This section is effective August 1, 2014.

4.31    Sec. 5. Minnesota Statutes 2012, section 151.34, is amended to read:
4.32151.34 PROHIBITED ACTS.
4.33It shall be unlawful to:
5.1(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
5.2or misbranded;
5.3(2) adulterate or misbrand any drug;
5.4(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
5.5proffer delivery thereof for pay or otherwise;
5.6(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
5.7permit access to or copying of any record as authorized by this chapter;
5.8(5) remove or dispose of a detained or embargoed article in violation of this chapter;
5.9(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
5.10of, or to do any other act with respect to a drug, if such act is done while such drug is held
5.11for sale and results in such drug being adulterated or misbranded;
5.12(7) use for a person's own advantage or to reveal other than to the board or its
5.13authorized representative or to the courts when required in any judicial proceeding under
5.14this chapter any information acquired under authority of this chapter concerning any
5.15method or process which that is a trade secret and entitled to protection;
5.16(8) use on the labeling of any drug any representation or suggestion that an
5.17application with respect to such drug is effective under the federal act or that such drug
5.18complies with such provisions;
5.19(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
5.20within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
5.21by applicable law to administer such drug who makes written request for information as to
5.22such drug, true and correct copies of all printed matter which that is required to be included
5.23in any package in which that drug is distributed or sold, or such other printed matter as is
5.24approved under the federal act. Nothing in this paragraph shall be construed to exempt
5.25any person from any labeling requirement imposed by or under provisions of this chapter;
5.26(10) conduct a pharmacy without a pharmacist in charge;
5.27(11) dispense a legend drug without first obtaining a valid prescription for that drug;
5.28(12) conduct a pharmacy without proper registration with the board;
5.29(13) practice pharmacy without being licensed to do so by the board; or
5.30(14) sell at retail federally restricted medical gases without proper registration with
5.31the board except as provided in this chapter.; or
5.32(15) sell any compound, substance, or derivative that is not approved for human
5.33consumption by the United States Food and Drug Administration or specifically permitted
5.34for human consumption under Minnesota law, and when introduced into the body induces
5.35an effect similar to that of a Schedule I or Schedule II controlled substance listed in
6.1section 152.02, subdivisions 2 and 3, or Minnesota Rules, parts 6800.4210 and 6800.4220,
6.2regardless of whether the substance is marketed for the purpose of human consumption.
6.3EFFECTIVE DATE.This section is effective August 1, 2014, and applies to sales
6.4on or after that date.

6.5    Sec. 6. Minnesota Statutes 2012, section 151.35, is amended to read:
6.6151.35 DRUGS, ADULTERATION.
6.7A drug shall be deemed to be adulterated:
6.8(1) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
6.9if it has been produced, prepared, packed, or held under unsanitary conditions whereby it
6.10may have been rendered injurious to health, or whereby it may have been contaminated
6.11with filth; or if the methods used in, or the facilities or controls used for, its manufacture,
6.12processing, packing, or holding do not conform to or are not operated or administered
6.13in conformity with current good manufacturing practice as required under the federal
6.14act to assure that such drug is safe and has the identity, strength, quality, and purity
6.15characteristics, which it purports or is represented to possess; or the facility in which it
6.16was produced was not registered by the United States Food and Drug Administration or
6.17licensed by the board; or, its container is composed, in whole or in part, of any poisonous
6.18or deleterious substance which may render the contents injurious to health; or it bears
6.19or contains, for purposes of coloring only, a color additive which is unsafe within the
6.20meaning of the federal act, or it is a color additive, the intended use of which in or on drugs
6.21is for the purposes of coloring only, and is unsafe within the meaning of the federal act;
6.22(2) if it purports to be or is represented as a drug the name of which is recognized in
6.23the United States Pharmacopoeia or the National Formulary, and its strength differs from,
6.24or its quality or purity falls below, the standard set forth therein. Such determination as
6.25to strength, quality, or purity shall be made in accordance with the tests or methods of
6.26assay set forth in such compendium, or in the absence of or inadequacy of such tests or
6.27methods of assay, those prescribed under authority of the federal act. No drug defined
6.28in the United States Pharmacopoeia or the National Formulary shall be deemed to be
6.29adulterated under this paragraph because it differs from the standard of strength, quality,
6.30or purity therefor set forth in such compendium, if its difference in strength, quality, or
6.31purity from such standard is plainly stated on its label;
6.32(3) if it is not subject to the provisions of paragraph (2) of this section and its
6.33strength differs from, or its purity or quality differs from that which it purports or is
6.34represented to possess;
7.1(4) if any substance has been mixed or packed therewith so as to reduce its quality or
7.2strength, or substituted wholly or in part therefor.
7.3EFFECTIVE DATE.This section is effective August 1, 2014.

7.4    Sec. 7. Minnesota Statutes 2012, section 151.36, is amended to read:
7.5151.36 DRUGS, MISBRANDING.
7.6A drug shall be deemed to be misbranded:
7.7(1) if its labeling is false or misleading in any particular;
7.8(2) if in package form and not dispensed pursuant to a prescription unless it bears
7.9a label containing (a) the name and place of business of the manufacturer, packer, or
7.10distributor, (b) a statement of identity ingredients, and (c) an accurate statement of the
7.11net quantity of the contents in terms of weight, measure, or numerical count, provided,
7.12however, that under (c) reasonable variations shall be permitted, and exceptions as to
7.13small packages shall be allowed in accordance with the federal act;
7.14(3) if any word, statement, or other information required by or under authority of
7.15this chapter to appear on the label or labeling is not prominently placed thereon with such
7.16conspicuousness (as compared with other words, statements, designs or devices, in the
7.17labeling) and in such terms as to render it to be read and understood by the ordinary
7.18individual under customary conditions of purchase and use;
7.19(4) if it otherwise fails to meet the labeling requirements of the federal act.
7.20EFFECTIVE DATE.This section is effective August 1, 2014.

7.21    Sec. 8. Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:
7.22    Subd. 8b. Board of Pharmacy; expedited scheduling of additional substances.
7.23(a) The state Board of Pharmacy may, by rule, add a substance to Schedule I provided that
7.24it finds that the substance has a high potential for abuse, has no currently accepted medical
7.25use in the United States, has a lack of accepted safety for use under medical supervision,
7.26has known adverse health effects, and is currently available for use within the state. For
7.27the purposes of this subdivision only, the board may use the expedited rulemaking process
7.28under section 14.389. The scheduling of a substance under this subdivision expires the
7.29day after the adjournment of the legislative session immediately following the substance's
7.30scheduling unless the legislature by law ratifies the action.
7.31(b) If the board schedules a substance under this subdivision, the board shall notify
7.32in a timely manner the chairs and ranking minority members of the senate and house of
7.33representatives committees having jurisdiction over criminal justice and health policy
8.1and finance of the action and the reasons for it. The notice must include a copy of the
8.2administrative law judge's decision on the matter.
8.3(c) This subdivision expires August 1, 2014.
8.4EFFECTIVE DATE.This section is effective the day following final enactment.

8.5    Sec. 9. PUBLIC AWARENESS CAMPAIGN.
8.6The commissioner of human services shall increase public awareness of the dangers
8.7of synthetic drugs. Within the limits of available appropriation, the public awareness
8.8campaign must be designed to reach a broad audience, but contain targeted messages for
8.9students and young adults. The commissioners of education, health, human services,
8.10and public safety shall cooperate in the formulation and implementation of the public
8.11awareness campaign.

8.12    Sec. 10. APPROPRIATION.
8.13$5,000 in fiscal year 2015 is appropriated from the state government special revenue
8.14fund to the Board of Pharmacy for the costs attributable to the board's cease and desist
8.15authority.
8.16EFFECTIVE DATE.This section is effective the day following final enactment.