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SF 2128

as introduced - 87th Legislature (2011 - 2012) Posted on 04/20/2012 08:39am

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; allowing the electronic prescribing of controlled substances;
amending Minnesota Statutes 2010, section 152.11.

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

Section 1.

Minnesota Statutes 2010, section 152.11, is amended to read:


152.11 deleted text begin WRITTEN OR ORALdeleted text end PRESCRIPTIONSdeleted text begin , REQUISITESdeleted text end .

Subdivision 1.

deleted text begin Writtendeleted text end new text begin Generalnew text end prescription deleted text begin requirementdeleted text end new text begin requirementsnew text end for
deleted text begin Schedule IIdeleted text end controlled substances.

new text begin (a) A written prescription or an oral prescription
reduced to writing, when issued for a controlled substance in Schedule II, III, IV, or V,
is void unless (1) it is written in ink and contains the name and address of the person
for whose use it is intended; (2) it states the amount of the controlled substance to be
compounded or dispensed, with directions for its use; (3) if a written prescription, it
contains the handwritten signature, address, and federal registry number of the prescriber
and a designation of the branch of the healing art pursued by the prescriber; and if an oral
prescription, the name and address of the prescriber and a designation of the prescriber's
branch of the healing art; and (4) it shows the date when signed by the prescriber, or the
date of acceptance in the pharmacy if an oral prescription.
new text end

new text begin (b) An electronic prescription for a controlled substance in Schedule II, III, IV, or V
is void unless it complies with the standards established pursuant to section 62J.497 and
with those portions of Code of Federal Regulations, title 21, parts 1300, 1304, 1306 and
1311 that pertain to electronic prescriptions.
new text end

new text begin (c) A prescription for a controlled substance in Schedule II, III, IV, or V that is
transmitted by facsimile, either computer to facsimile machine or facsimile machine to
facsimile machine, is void unless it complies with the applicable requirements of Code of
Federal Regulations, title 21, part 1306.
new text end

new text begin (d) Every licensed pharmacy that dispenses a controlled substance prescription shall
retain the original prescription in a file for a period of not less than two years, open to
inspection by any officer of the state, county, or municipal government whose duty it is to
aid and assist with the enforcement of this chapter. An original electronic or facsimile
prescription may be stored in an electronic database, provided that the database provides a
means by which original prescriptions can be retrieved, as transmitted to the pharmacy, for
a period of not less than two years.
new text end

new text begin (e) Every licensed pharmacy shall distinctly label the container in which a controlled
substance is dispensed with the directions contained in the prescription for the use of
that controlled substance.
new text end

new text begin Subd. 1a. new text end

new text begin Prescription requirements for Schedule II controlled substances. new text end

No
person may dispense a controlled substance included in Schedule II of section 152.02
without a prescription deleted text begin writtendeleted text end new text begin issuednew text end by a doctor of medicine, a doctor of osteopathy
licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a
doctor of podiatry, or a doctor of veterinary medicine, lawfully licensed to prescribe in this
state or by a practitioner licensed to prescribe controlled substances by the state in which
the prescription is issued, and having a current federal Drug Enforcement Administration
registration number.new text begin The prescription must either be printed or written in ink and contain
the handwritten signature of the prescriber or be transmitted electronically or by facsimile
as permitted under subdivision 1.
new text end Provided that in emergency situations, as authorized
by federal law, such drug may be dispensed upon oral prescription reduced promptly to
writing and filed by the pharmacist. Such prescriptions shall be retained in conformity
with section 152.101. No prescription for a Schedule II substance may be refilled.

deleted text begin For the purposes of this chapter, a written prescription or oral prescription, which
shall be reduced to writing, for a controlled substance in Schedule II, III, IV or V is void
unless (1) it is written in ink and contains the name and address of the person for whose
use it is intended; (2) it states the amount of the controlled substance to be compounded or
dispensed, with directions for its use; (3) if a written prescription, it contains the signature,
address and federal registry number of the prescriber and a designation of the branch of
the healing art pursued by the prescriber; and if an oral prescription, the name and address
of the prescriber and a designation of the prescriber's branch of the healing art; and (4) it
shows the date when signed by the prescriber, or the date of acceptance in the pharmacy if
an oral prescription. Every licensed pharmacist who compounds any such prescription
shall retain such prescription in a file for a period of not less than two years, open to
inspection by any officer of the state, county, or municipal government, whose duty it is to
aid and assist with the enforcement of this chapter. Every such pharmacist shall distinctly
label the container with the directions contained in the prescription for the use thereof.
deleted text end

Subd. 2.

deleted text begin Written or oraldeleted text end Prescription deleted text begin requirementdeleted text end new text begin requirementsnew text end for Schedule
III or IV controlled substances.

No person may dispense a controlled substance included
in Schedule III or IV of section 152.02 without a deleted text begin written or oraldeleted text end prescription deleted text begin fromdeleted text end new text begin issued,
as permitted under subdivision 1, by
new text end a doctor of medicine, a doctor of osteopathy licensed
to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a doctor of
podiatry, a doctor of optometry limited to Schedule IV, or a doctor of veterinary medicine,
lawfully licensed to prescribe in this state or from a practitioner licensed to prescribe
controlled substances by the state in which the prescription is issued, and having a current
federal drug enforcement administration registration number. Such prescription may not
be dispensed or refilled except with the deleted text begin written or verbaldeleted text end new text begin documentednew text end consent of the
prescriber, and in no event more than six months after the date on which such prescription
was issued and no such prescription may be refilled more than five times.

Subd. 2a.

Federal registration number exemption.

A prescription need not
bear a federal drug enforcement administration registration number that authorizes the
prescriber to prescribe controlled substances if the drug prescribed is not a controlled
substance in Schedule II, III, IV, or V. No person shall impose a requirement inconsistent
with this subdivision.

Subd. 2b.

Restriction on release of federal registration number.

No person or
entity may offer for sale, sell, lease, or otherwise release a federal drug enforcement
administration registration number for any reason, except for drug enforcement purposes
authorized by this chapter and the federal controlled substances registration system. For
purposes of this section, an entity includes a state governmental agency or regulatory
board, a health plan company as defined under section 62Q.01, subdivision 4, a managed
care organization as defined under section 62Q.01, subdivision 5, or any other entity
that maintains prescription data.

Subd. 2c.

Restriction on use of federal registration number.

No entity may use a
federal drug enforcement administration registration number to identify or monitor the
prescribing practices of a prescriber to whom that number has been assigned, except for
drug enforcement purposes authorized by this chapter and the federal controlled substances
registration system. For purposes of this section, an entity includes a health plan company
as defined under section 62Q.01, subdivision 4, a managed care organization as defined
under section 62Q.01, subdivision 5, or any other entity that maintains prescription data.

Subd. 2d.

Identification requirement for Schedule II or III controlled substancenew text begin
prescriptions
new text end .

(a) No person may dispense a controlled substance included in Schedule
II or III without requiring the person purchasing the controlled substance, who need
not be the person for whom the controlled substance prescription is written, to present
valid photographic identification, unless the person purchasing the controlled substance,
or if applicable the person for whom the controlled substance prescription is written, is
known to the dispenser.

(b) This subdivision applies only to purchases of controlled substances that are
not covered, in whole or in part, by a health plan company or other third-party payor.
deleted text begin The Board of Pharmacy shall report to the legislature by July 1, 2009, on the effect of
this subdivision. The board shall include in the report the incidence of complaints, if any,
generated by the requirements of this subdivision and whether this subdivision is creating
barriers to pharmaceutical access.
deleted text end

Subd. 3.

Dispensing orphan drugs.

For the purpose of deleted text begin subdivisions 1 and 2deleted text end new text begin this
section
new text end , nothing shall prohibit the dispensing of orphan drugs prescribed by a person
practicing in and licensed by another state as a physician, dentist, veterinarian, or
podiatrist; who has a current federal drug enforcement administration registration number;
and who may legally prescribe Schedule II, III, IV, or V controlled substances in that state.