HF 2446

4th Engrossment - 88th Legislature (2013 - 2014) Posted on 05/15/2014 04:29pm

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 for mandatory restitution when
a person is convicted for selling controlled substance under false pretense of
being legal; establishing a public education plan; appropriating money; amending
Minnesota Statutes 2012, sections 151.01, subdivision 5; 151.06, subdivision 1a,
by adding a subdivision; 151.26, subdivision 1; 151.34; 151.35; 151.36; 152.02,
subdivision 8b; proposing coding for new law in Minnesota Statutes, chapter 152.

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.

The term "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 The term drug shall also mean
any compound, substance, or derivative that is not approved for human consumption by
the United States Food and Drug Administration or specifically permitted for human
consumption under Minnesota law, and, when introduced into the body, induces an effect
similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
subdivisions 2 and 3, or 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, subdivision 1a, is amended to read:

Subd. 1a.

deleted text begin Disciplinary action deleted text end new text begin Cease and desist orders new text end .

deleted text begin It shall be grounds for
disciplinary action by the Board of Pharmacy against the registration of the pharmacy if
the Board of Pharmacy determines that any person with supervisory responsibilities at the
pharmacy sets policies that prevent a licensed pharmacist from providing drug utilization
review and patient counseling as required by rules adopted under subdivision 1. The
Board of Pharmacy shall follow the requirements of chapter 14 in any disciplinary actions
taken under this section. deleted text end new text begin (a) Whenever it appears to the board that a person has engaged in
an act or practice constituting a violation of a law, rule, or other 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 state the reasons for the issuance of the order
and must give reasonable notice of the rights of the person to request a hearing before
an administrative law judge. 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 report of the administrative law judge, the board shall issue a further order
vacating or making permanent the cease and desist order. The time periods provided in
this provision may be waived by agreement of the executive director of the board and the
person against whom the cease and desist order was 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. 1b. 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 1a seeks to enforce compliance with a cease and desist
order that has been made permanent, the allegations of the cease and desist order are
considered conclusively established for purposes of proceeding under subdivision 1a for
permanent or temporary relief to enforce the cease and desist order. Whenever the board
under subdivision 1a 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 the purposes of proceeding under subdivision 1a for temporary relief to
enforce the cease and desist order.
new text end

new text begin (b) Notwithstanding this subdivision or subdivision 1a, the person against whom
the cease and desist order is issued and who has requested a hearing under subdivision 1a
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 1a 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 purposes new text begin ; provided
that this exception does not apply to any compound, substance, or derivative that is not
approved for human consumption by the United States Food and Drug Administration
or specifically permitted for human consumption under Minnesota law, and, when
introduced into the body, induces an effect similar to that of a Schedule I or Schedule II
controlled substance listed in section 152.02, subdivisions 2 and 3, or 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 purposes new text begin ; provided that this exception does not apply
to any compound, substance, or derivative that is not approved for human consumption
by the United States Food and Drug Administration or specifically permitted for human
consumption under Minnesota law, and, when introduced into the body, induces an effect
similar to that of a Schedule I or Schedule II controlled substance listed in section 152.02,
subdivisions 2 and 3, or 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 deleted text begin which deleted text end new text begin that new text end 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 deleted text begin which deleted text end new text begin that new text end 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 begin or
deleted text end

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

new text begin (15) sell any compound, substance, or derivative that is not approved for human
consumption by the United States Food and Drug Administration or specifically permitted
for human consumption under Minnesota law, and, when introduced into the body, induces
an effect similar to that of a Schedule I or Schedule II controlled substance listed in
section 152.02, subdivisions 2 and 3, or 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, 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; new text begin or the facility in which it
was produced was not registered by the United States Food and Drug Administration or
licensed by the board; new text end 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;

(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 begin identity deleted text end new text begin ingredients new 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 begin The 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 begin [152.0273] SYNTHETIC DRUG SALES; MANDATORY RESTITUTION.
new text end

new text begin The court shall order a person convicted of selling a controlled substance or analog
of a controlled substance under the false pretense that the substance is legal to pay
restitution for the costs and expenses resulting from the crime. Costs and expenses include,
but are not limited to, the medical costs of persons who consumed the substances sold by
the offender and the reasonable costs incurred by public and private entities that provided
an emergency response to a person who consumed the substances sold by the offender.
new text end

Sec. 10. new text begin EDUCATIONAL AWARENESS CAMPAIGN; APPROPRIATION.
new text end

new text begin $163,000 in fiscal year 2014 is appropriated from the general fund to the Department
of Human Services for increasing public awareness of the dangers of synthetic drugs. The
appropriation is onetime and available until June 30, 2015. 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, human services, and
public safety shall cooperate in the formulation and implementation of the educational
awareness campaign.
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

Sec. 11. new text begin PHARMACY BOARD; APPROPRIATION.
new text end

new text begin $5,000 in fiscal year 2015 is appropriated from the state government special revenue
fund to the Board of Pharmacy for the costs attributable to the board's cease and desist
authority.
new text end