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Minnesota Legislature

Office of the Revisor of Statutes

HF 2446

1st Engrossment - 88th Legislature (2013 - 2014) Posted on 03/13/2014 03:21pm

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to public safety; granting the Board of Pharmacy cease and desist
authority to prevent the sale of synthetic drugs; modifying laws governing
misbranding drugs, adulterated drugs; expanding the definition of drug; repealing
the sunset and legislative reporting requirement for the Board of Pharmacy's
emergency drug scheduling authority; providing training and expert support in
the prosecution of synthetic drug cases; establishing a public education plan;
appropriating money; amending Minnesota Statutes 2012, sections 151.01,
subdivision 5; 151.06, by adding subdivisions; 151.26, subdivision 1; 151.34;
151.35; 151.36; 152.02, subdivision 8b.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2012, section 151.01, subdivision 5, is amended to read:


Subd. 5.

Drug.

deleted text beginThe termdeleted text end "Drug" means all medicinal substances and preparations
recognized by the United States Pharmacopoeia and National Formulary, or any revision
thereof, and all substances and preparations intended for external and internal use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals,
and all substances and preparations, other than food, intended to affect the structure or any
function of the bodies of humans or other animals.new text begin Drug shall also mean any compound,
substance, or derivative which is not regulated or approved for human consumption by
the United States Food and Drug Administration or specifically permitted by Minnesota
law, and when introduced into the body, induces an effect substantially similar to that of a
Schedule I or Schedule II controlled substance listed in section 152.02, subdivisions 2
and 3; and Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of whether the
substance is marketed for the purpose of human consumption.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014.
new text end

Sec. 2.

Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
to read:


new text begin Subd. 2b. new text end

new text begin Cease and desist orders. new text end

new text begin (a) Whenever it appears to the Board of
Pharmacy that a person has engaged or is about to engage in an act or practice constituting
a violation of a law, rule, or order related to the duties and responsibilities entrusted to the
board, the board may issue and cause to be served upon the person an order requiring the
person to cease and desist from violations.
new text end

new text begin (b) The cease and desist order must be calculated to give reasonable notice of the
rights of the person to request a hearing and must state the reasons for the entry of the
order. A hearing must be held not later than ten days after the request for the hearing is
received by the board. After the completion of the hearing, the administrative law judge
shall issue a report within ten days. Within 15 days after receiving the administrative law
judge's report, the board shall issue a further order vacating or making permanent the
cease and desist order. The time periods provided in this paragraph may be waived by
agreement of the person requesting the hearing, the director, and the person against whom
the cease and desist order is issued. If the person to whom a cease and desist order is
issued fails to appear at the hearing after being duly notified, the person is in default and
the proceeding may be determined against that person upon consideration of the cease
and desist order, the allegations of which may be considered to be true. Unless otherwise
provided, all hearings must be conducted according to chapter 14. The board may adopt
rules of procedure concerning all proceedings conducted under this subdivision.
new text end

new text begin (c) If no hearing is requested within 30 days of service of the order, the cease and
desist order will become permanent.
new text end

new text begin (d) A cease and desist order issued under this subdivision remains in effect until
it is modified or vacated by the board. The administrative proceeding provided by this
subdivision, and subsequent appellate judicial review of that administrative proceeding,
constitutes the exclusive remedy for determining whether the board properly issued the
cease and desist order and whether the cease and desist order should be vacated or made
permanent.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014, and applies to
violations occurring on or after that date.
new text end

Sec. 3.

Minnesota Statutes 2012, section 151.06, is amended by adding a subdivision
to read:


new text begin Subd. 2c. new text end

new text begin Enforcement of violations of cease and desist orders. new text end

new text begin (a) Whenever
the board, under subdivision 2b, seeks to enforce compliance with a cease and desist
order that has been made permanent, the allegations in the cease and desist order are
considered conclusively established for purposes of a proceeding under subdivision 2b
for permanent or temporary relief to enforce the cease and desist order. Whenever the
board, under subdivision 2b, seeks to enforce compliance with a cease and desist order
when a hearing or hearing request on the cease and desist order is pending, or the time
has not yet expired to request a hearing on whether a cease and desist order should be
vacated or made permanent, the allegations in the cease and desist order are considered
conclusively established for purposes of a proceeding under subdivision 2b for temporary
relief to enforce the cease and desist order.
new text end

new text begin (b) Notwithstanding this subdivision or subdivision 2b to the contrary, the person
against whom the cease and desist order is issued and who has requested a hearing under
subdivision 2b may, within 15 days after service of the cease and desist order, bring
an action in Ramsey County District Court for issuance of an injunction to suspend
enforcement of the cease and desist order pending a final decision of the board under
subdivision 2b to vacate or make permanent the cease and desist order. The court shall
determine whether to issue such an injunction based on traditional principles of temporary
relief.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014, and applies to
violations occurring on or after that date.
new text end

Sec. 4.

Minnesota Statutes 2012, section 151.26, subdivision 1, is amended to read:


Subdivision 1.

Generally.

Nothing in this chapter shall subject a person duly
licensed in this state to practice medicine, dentistry, or veterinary medicine, to inspection
by the State Board of Pharmacy, nor prevent the person from administering drugs,
medicines, chemicals, or poisons in the person's practice, nor prevent a duly licensed
practitioner from furnishing to a patient properly packaged and labeled drugs, medicines,
chemicals, or poisons as may be considered appropriate in the treatment of such patient;
unless the person is engaged in the dispensing, sale, or distribution of drugs and the board
provides reasonable notice of an inspection.

Except for the provisions of section 151.37, nothing in this chapter applies to or
interferes with the dispensing, in its original package and at no charge to the patient, of a
legend drug, other than a controlled substance, that was packaged by a manufacturer and
provided to the dispenser for distribution as a professional sample.

Nothing in this chapter shall prevent the sale of drugs, medicines, chemicals, or
poisons at wholesale to licensed physicians, dentists and veterinarians for use in their
practice, nor to hospitals for use therein.

Nothing in this chapter shall prevent the sale of drugs, chemicals, or poisons either
at wholesale or retail for use for commercial purposes, or in the arts, nor interfere with the
sale of insecticides, as defined in Minnesota Statutes 1974, section 24.069, and nothing in
this chapter shall prevent the sale of common household preparations and other drugs,
chemicals, and poisons sold exclusively for use for nonmedicinal purposesnew text begin; provided
that this exception does not apply to the sale of any compound, substance, or derivative
which is not regulated or approved for human consumption by the United States Food and
Drug Administration or specifically permitted by Minnesota law, and when introduced
into the body, induces an effect substantially similar to that of a Schedule I or Schedule
II controlled substance listed in section 152.02, subdivisions 2 and 3; and Minnesota
Rules, parts 6800.4210 and 6800.4220, regardless of whether the substance is marketed
for the purpose of human consumption
new text end.

Nothing in this chapter shall apply to or interfere with the vending or retailing
of any nonprescription medicine or drug not otherwise prohibited by statute which is
prepackaged, fully prepared by the manufacturer or producer for use by the consumer,
and labeled in accordance with the requirements of the state or federal Food and Drug
Act; nor to the manufacture, wholesaling, vending, or retailing of flavoring extracts, toilet
articles, cosmetics, perfumes, spices, and other commonly used household articles of a
chemical nature, for use for nonmedicinal purposesnew text begin; provided that this exception does not
apply to the sale of any compound, substance, or derivative which is not regulated or
approved for human consumption by the United States Food and Drug Administration
or specifically permitted by Minnesota law, and when introduced into the body, induces
an effect substantially similar to that of a Schedule I or Schedule II controlled substance
listed in section 152.02, subdivisions 2 and 3; and Minnesota Rules, parts 6800.4210 and
6800.4220, regardless of whether the substance is marketed for the purpose of human
consumption
new text end. Nothing in this chapter shall prevent the sale of drugs or medicines by
licensed pharmacists at a discount to persons over 65 years of age.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014.
new text end

Sec. 5.

Minnesota Statutes 2012, section 151.34, is amended to read:


151.34 PROHIBITED ACTS.

It shall be unlawful to:

(1) manufacture, sell or deliver, hold or offer for sale any drug that is adulterated
or misbranded;

(2) adulterate or misbrand any drug;

(3) receive in commerce any drug that is adulterated or misbranded, and to deliver or
proffer delivery thereof for pay or otherwise;

(4) refuse to permit entry or inspection, or to permit the taking of a sample, or to
permit access to or copying of any record as authorized by this chapter;

(5) remove or dispose of a detained or embargoed article in violation of this chapter;

(6) alter, mutilate, destroy, obliterate, or remove the whole or any part of the labeling
of, or to do any other act with respect to a drug, if such act is done while such drug is held
for sale and results in such drug being adulterated or misbranded;

(7) use for a person's own advantage or to reveal other than to the board or its
authorized representative or to the courts when required in any judicial proceeding under
this chapter any information acquired under authority of this chapter concerning any
method or process which is a trade secret and entitled to protection;

(8) use on the labeling of any drug any representation or suggestion that an
application with respect to such drug is effective under the federal act or that such drug
complies with such provisions;

(9) in the case of a manufacturer, packer, or distributor offering legend drugs for sale
within this state, fail to maintain for transmittal or to transmit, to any practitioner licensed
by applicable law to administer such drug who makes written request for information as to
such drug, true and correct copies of all printed matter which is required to be included in
any package in which that drug is distributed or sold, or such other printed matter as is
approved under the federal act. Nothing in this paragraph shall be construed to exempt
any person from any labeling requirement imposed by or under provisions of this chapter;

(10) conduct a pharmacy without a pharmacist in charge;

(11) dispense a legend drug without first obtaining a valid prescription for that drug;

(12) conduct a pharmacy without proper registration with the board;

(13) practice pharmacy without being licensed to do so by the board; deleted text beginor
deleted text end

(14) sell at retail federally restricted medical gases without proper registration with
the board except as provided in this chapternew text begin; or
new text end

new text begin (15) sell any compound, substance, or derivative which is not regulated or approved
for human consumption by the United States Food and Drug Administration or specifically
permitted by Minnesota law, and when introduced into the body, induces an effect
substantially similar to that of a Schedule I or Schedule II controlled substance listed in
section 152.02, subdivisions 2 and 3; and Minnesota Rules, parts 6800.4210 and 6800.4200,
regardless of whether the substance is marketed for the purpose of human consumption
new text end.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014, and applies to sales
on or after that date.
new text end

Sec. 6.

Minnesota Statutes 2012, section 151.35, is amended to read:


151.35 DRUGS, ADULTERATION.

A drug shall be deemed to be adulterated:

(1) if it consists in whole or in part of any filthy, putrid or decomposed substance;
or if it has been produced, prepared, packed, or held under unsanitary conditions
whereby it may have been rendered injurious to health, or whereby it may have been
contaminated with filth; or if the methods used in, or the facilities or controls used for, its
manufacture, processing, packing, or holding do not conform to or are not operated or
administered in conformity with current good manufacturing practice as required under
the federal act to assure that such drug is safe and has the identity, strength, quality, and
purity characteristics, which it purports or is represented to possess; or, its container is
composed, in whole or in part, of any poisonous or deleterious substance which may
render the contents injurious to health; or it bears or contains, for purposes of coloring
only, a color additive which is unsafe within the meaning of the federal act, or it is a color
additive, the intended use of which in or on drugs is for the purposes of coloring only, and
is unsafe within the meaning of the federal act;new text begin or it has been manufactured at a facility
not licensed pursuant to section 151.252;
new text end

(2) if it purports to be or is represented as a drug the name of which is recognized in
the United States Pharmacopoeia or the National Formulary, and its strength differs from,
or its quality or purity falls below, the standard set forth therein. Such determination as
to strength, quality, or purity shall be made in accordance with the tests or methods of
assay set forth in such compendium, or in the absence of or inadequacy of such tests or
methods of assay, those prescribed under authority of the federal act. No drug defined
in the United States Pharmacopoeia or the National Formulary shall be deemed to be
adulterated under this paragraph because it differs from the standard of strength, quality,
or purity therefor set forth in such compendium, if its difference in strength, quality, or
purity from such standard is plainly stated on its label;

(3) if it is not subject to the provisions of paragraph (2) of this section and its
strength differs from, or its purity or quality differs from that which it purports or is
represented to possess;

(4) if any substance has been mixed or packed therewith so as to reduce its quality or
strength, or substituted wholly or in part therefor.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014.
new text end

Sec. 7.

Minnesota Statutes 2012, section 151.36, is amended to read:


151.36 DRUGS, MISBRANDING.

A drug shall be deemed to be misbranded:

(1) if its labeling is false or misleading in any particular;

(2) if in package form and not dispensed pursuant to a prescription unless it bears
a label containing (a) the name and place of business of the manufacturer, packer, or
distributor, (b) a statement of deleted text beginidentitydeleted text endnew text begin ingredientsnew text end, and (c) an accurate statement of the
net quantity of the contents in terms of weight, measure, or numerical count, provided,
however, that under (c) reasonable variations shall be permitted, and exceptions as to
small packages shall be allowed in accordance with the federal act;

(3) if any word, statement, or other information required by or under authority of
this chapter to appear on the label or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements, designs or devices, in the
labeling) and in such terms as to render it to be read and understood by the ordinary
individual under customary conditions of purchase and use;

(4) if it otherwise fails to meet the labeling requirements of the federal act.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2014.
new text end

Sec. 8.

Minnesota Statutes 2012, section 152.02, subdivision 8b, is amended to read:


Subd. 8b.

Board of Pharmacy; expedited scheduling of additional substances.

deleted text begin (a)deleted text end The state Board of Pharmacy may, by rule, add a substance to Schedule I provided that
it finds that the substance has a high potential for abuse, has no currently accepted medical
use in the United States, has a lack of accepted safety for use under medical supervision,
has known adverse health effects, and is currently available for use within the state. For
the purposes of this subdivision only, the board may use the expedited rulemaking process
under section 14.389. deleted text beginThe scheduling of a substance under this subdivision expires the
day after the adjournment of the legislative session immediately following the substance's
scheduling unless the legislature by law ratifies the action.
deleted text end

deleted text begin (b) If the board schedules a substance under this subdivision, the board shall notify
in a timely manner the chairs and ranking minority members of the senate and house of
representatives committees having jurisdiction over criminal justice and health policy
and finance of the action and the reasons for it. The notice must include a copy of the
administrative law judge's decision on the matter.
deleted text end

deleted text begin (c) This subdivision expires August 1, 2014.
deleted text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 9. new text beginMINNESOTA DEPARTMENT OF EDUCATION.
new text end

new text begin $....... in fiscal year 2014 and $....... in fiscal year 2015 are appropriated from the
general fund to the Department of Education for increasing public awareness of the
dangers of synthetic drugs. The educational awareness campaign should be designed to
reach a broad audience but contain targeted messages for students and young adults. The
commissioners of education, health, and human services shall cooperate in the formulation
and implementation of the educational awareness campaign. If the appropriation for either
year is insufficient, the appropriation for the other year is available for it.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end