HF 3604

as introduced - 90th Legislature (2017 - 2018) Posted on 03/12/2018 02:12pm

A bill for an act
relating to health; creating an exemption to pharmacy practice for certain
investigation activities; amending Minnesota Statutes 2016, section 151.26;
proposing coding for new law in Minnesota Statutes, chapter 151.

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

Section 1.

Minnesota Statutes 2016, section 151.26, is amended to read:

151.26 EXCEPTIONS.

Subdivision 1.

Generally.

new text begin (a) new text end 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.

new text begin (b) new text end 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 that was packaged by a manufacturer and provided to the dispenser for dispensing
as a professional sample. Samples of a controlled substance shall only be dispensed when
one of the approved indications for the controlled substance is a seizure disorder and when
the sample is prepared and distributed pursuant to Code of Federal Regulations, title 21,
part 203, subpart D.

new text begin (c) new text end 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.

new text begin (d) new text end 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; 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 begin (e) 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 that 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; 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. 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 (f) A person who is engaged in an investigation of the counterfeit drug trade may engage
in pharmacy-related activities pursuant to section 151.311.
new text end

Sec. 2.

new text begin [151.311] INVESTIGATION OF COUNTERFEIT DRUGS.
new text end

new text begin (a) For the purposes of this section, "investigator" means a person who is engaged in an
investigation of the counterfeit drug trade.
new text end

new text begin (b) A person who is employed or retained as an investigator by a pharmaceutical
manufacturer or practitioner may dispense a prescription drug order for the purpose of
determining whether a legend drug has been counterfeited, adulterated, or misbranded.
new text end

new text begin (c) A drug sample collected by an investigator during an investigation of counterfeit
drugs may only be used for testing or as evidence in a civil or criminal action, and may not
be resold or used for human consumption.
new text end

new text begin (d) A pharmaceutical manufacturer that collects drug samples during an investigation
of counterfeit drugs must: (1) maintain records of the drug samples, and (2) make the records
available to law enforcement agencies or other entities engaged in enforcement of this
chapter.
new text end