SF 4083

as introduced - 92nd Legislature (2021 - 2022) Posted on 03/17/2022 10:45am

A bill for an act
relating to health; establishing protections for practitioners and pharmacists when
prescribing or dispensing a prescription drug for off-label use; proposing coding
for new law in Minnesota Statutes, chapter 151.

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

Section 1.

new text begin [151.376] PRESCRIBING AND DISPENSING DRUGS FOR OFF-LABEL
USE.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following terms have
the meanings given.
new text end

new text begin (b) "Disciplinary action" means any action taken by a health-related licensing board
against a licensee, including but not limited to revocation, limitation, suspension, or denial
of a license or any other disciplinary action taken by a health-related licensing board against
the licensee for unprofessional conduct.
new text end

new text begin (c) "Health-related licensing board" has the meaning given in section 214.01, subdivision
2.
new text end

new text begin (d) "Off-label use" means prescribing a prescription drug for treatments other than those
stated in the labeling approved by the United States Food and Drug Administration (FDA).
new text end

new text begin (e) "Pharmacist" means any person licensed by the Board of Pharmacy under chapter
151 to practice pharmacy as defined in section 151.01, subdivision 27.
new text end

new text begin (f) "Prescriber" means a physician licensed under chapter 147, a physician assistant
licensed under chapter 147A, a dentist licensed under chapter 150A, or an advanced practice
registered nurse licensed under sections 148.171 to 148.285.
new text end

new text begin Subd. 2. new text end

new text begin General provision. new text end

new text begin (a) Notwithstanding any other law to the contrary, a
prescriber may prescribe and a pharmacist must dispense in accordance with a valid
prescription order a prescription drug approved by the FDA for off-label use.
new text end

new text begin (b) This subdivision does not apply to a controlled substance.
new text end

new text begin Subd. 3. new text end

new text begin Immunity from civil liability. new text end

new text begin Notwithstanding any law to the contrary, a
prescriber or pharmacist is immune from civil liability for damages, administrative fines,
or penalties for acts, omissions, health care decisions, or the rendering of or the failure to
render health care services if the prescriber or pharmacist is acting pursuant to this section.
new text end

new text begin Subd. 4. new text end

new text begin Professional conduct. new text end

new text begin (a) A prescriber or pharmacist must not face retribution
or disciplinary action from a health-related licensing board or employer, including loss of
employment, hospital privileges, or credentials, solely on the basis that a prescriber prescribed
an FDA-approved prescription drug for an off-label use or a pharmacist dispensed the
prescription drug prescribed for off-label use pursuant to a valid prescription order.
new text end

new text begin (b) Any action taken by a prescriber or pharmacist authorized under this section must
not be considered unprofessional conduct.
new text end

new text begin (c) This subdivision applies retroactively to any disciplinary action occurring on or after
March 12, 2020.
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. 2. new text begin REVIEW OF DISCIPLINARY ACTION AGAINST PRESCRIBERS AND
PHARMACISTS.
new text end

new text begin (a) Any health-related licensing board that regulates prescribers or pharmacists must
independently review all complaints and disciplinary action for acts occurring on or after
March 12, 2020, through the effective date of Minnesota Statutes, section 151.376. If any
health-related licensing board took disciplinary action based on conduct described in
Minnesota Statutes, section 151.376, in whole or in part, the board must reconsider such
action and rescind any disciplinary action taken against the licensee if prohibited under
Minnesota Statutes, section 151.376.
new text end

new text begin (b) For purposes of this section, "prescriber" and "disciplinary action" have the meanings
given in Minnesota Statutes, section 151.376.
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