HF 1503

1st Engrossment - 89th Legislature (2015 - 2016) Posted on 06/08/2016 12:31pm

A bill for an act
relating to health; making changes concerning the collection and disposal of
legend drugs as pharmaceutical waste; amending Minnesota Statutes 2014,
sections 151.01, by adding a subdivision; 151.37, subdivisions 6, 7, by adding a
subdivision; Minnesota Statutes 2015 Supplement, section 151.37, subdivision 2;
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 2014, section 151.01, is amended by adding a
subdivision to read:

Subd. 39.

Ultimate user.

"Ultimate user" means a natural person who possesses
a legend drug that was lawfully obtained for personal use or for the use of a household
member or for the use of an animal owned by the natural person or by a household member.

EFFECTIVE DATE.

This section is effective the day following final enactment.

Sec. 2.

Minnesota Statutes 2015 Supplement, section 151.37, subdivision 2, is
amended to read:

Subd. 2.

Prescribing and filing.

(a) A licensed practitioner in the course of
professional practice only, may prescribe, administer, and dispense a legend drug, and
may cause the same to be administered by a nurse, a physician assistant, or medical
student or resident under the practitioner's direction and supervision, and may cause a
person who is an appropriately certified, registered, or licensed health care professional
to prescribe, dispense, and administer the same within the expressed legal scope of the
person's practice as defined in Minnesota Statutes. A licensed practitioner may prescribe a
legend drug, without reference to a specific patient, by directing a licensed dietitian or
licensed nutritionist, pursuant to section 148.634; a nurse, pursuant to section 148.235,
subdivisions 8 and 9; physician assistant; medical student or resident; or pharmacist
according to section 151.01, subdivision 27, to adhere to a particular practice guideline or
protocol when treating patients whose condition falls within such guideline or protocol,
and when such guideline or protocol specifies the circumstances under which the legend
drug is to be prescribed and administered. An individual who verbally, electronically, or
otherwise transmits a written, oral, or electronic order, as an agent of a prescriber, shall
not be deemed to have prescribed the legend drug. This paragraph applies to a physician
assistant only if the physician assistant meets the requirements of section 147A.18.

(b) The commissioner of health, if a licensed practitioner, or a person designated
by the commissioner who is a licensed practitioner, may prescribe a legend drug to an
individual or by protocol for mass dispensing purposes where the commissioner finds that
the conditions triggering section 144.4197 or 144.4198, subdivision 2, paragraph (b), exist.
The commissioner, if a licensed practitioner, or a designated licensed practitioner, may
prescribe, dispense, or administer a legend drug or other substance listed in subdivision 10
to control tuberculosis and other communicable diseases. The commissioner may modify
state drug labeling requirements, and medical screening criteria and documentation, where
time is critical and limited labeling and screening are most likely to ensure legend drugs
reach the maximum number of persons in a timely fashion so as to reduce morbidity
and mortality.

(c) A licensed practitioner that dispenses for profit a legend drug that is to be
administered orally, is ordinarily dispensed by a pharmacist, and is not a vaccine, must
file with the practitioner's licensing board a statement indicating that the practitioner
dispenses legend drugs for profit, the general circumstances under which the practitioner
dispenses for profit, and the types of legend drugs generally dispensed. It is unlawful to
dispense legend drugs for profit after July 31, 1990, unless the statement has been filed
with the appropriate licensing board. For purposes of this paragraph, "profit" means (1)
any amount received by the practitioner in excess of the acquisition cost of a legend drug
for legend drugs that are purchased in prepackaged form, or (2) any amount received
by the practitioner in excess of the acquisition cost of a legend drug plus the cost of
making the drug available if the legend drug requires compounding, packaging, or other
treatment. The statement filed under this paragraph is public data under section 13.03.
This paragraph does not apply to a licensed doctor of veterinary medicine or a registered
pharmacist. Any person other than a licensed practitioner with the authority to prescribe,
dispense, and administer a legend drug under paragraph (a) shall not dispense for profit.
To dispense for profit does not include dispensing by a community health clinic when the
profit from dispensing is used to meet operating expenses.

(d) A prescription drug order for the following drugs is not valid, unless it can be
established that the prescription drug order was based on a documented patient evaluation,
including an examination, adequate to establish a diagnosis and identify underlying
conditions and contraindications to treatment:

(1) controlled substance drugs listed in section 152.02, subdivisions 3 to 5;

(2) drugs defined by the Board of Pharmacy as controlled substances under section
152.02, subdivisions 7, 8, and 12;

(3) muscle relaxants;

(4) centrally acting analgesics with opioid activity;

(5) drugs containing butalbital; or

(6) phosphodiesterase type 5 inhibitors when used to treat erectile dysfunction.

(e) For the purposes of paragraph (d), the requirement for an examination shall be
met if an in-person examination has been completed in any of the following circumstances:

(1) the prescribing practitioner examines the patient at the time the prescription
or drug order is issued;

(2) the prescribing practitioner has performed a prior examination of the patient;

(3) another prescribing practitioner practicing within the same group or clinic as the
prescribing practitioner has examined the patient;

(4) a consulting practitioner to whom the prescribing practitioner has referred the
patient has examined the patient; or

(5) the referring practitioner has performed an examination in the case of a
consultant practitioner issuing a prescription or drug order when providing services by
means of telemedicine.

(f) Nothing in paragraph (d) or (e) prohibits a licensed practitioner from prescribing
a drug through the use of a guideline or protocol pursuant to paragraph (a).

(g) Nothing in this chapter prohibits a licensed practitioner from issuing a
prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy
in the Management of Sexually Transmitted Diseases guidance document issued by the
United States Centers for Disease Control.

(h) Nothing in paragraph (d) or (e) limits prescription, administration, or dispensing
of legend drugs through a public health clinic or other distribution mechanism approved
by the commissioner of health or a community health board in order to prevent, mitigate,
or treat a pandemic illness, infectious disease outbreak, or intentional or accidental release
of a biological, chemical, or radiological agent.

(i) No pharmacist employed by, under contract to, or working for a pharmacy located
within the state and licensed under section 151.19, subdivision 1, may dispense a legend
drug based on a prescription that the pharmacist knows, or would reasonably be expected
to know, is not valid under paragraph (d).

(j) No pharmacist employed by, under contract to, or working for a pharmacy located
outside the state and licensed under section 151.19, subdivision 2 1, may dispense a legend
drug to a resident of this state based on a prescription that the pharmacist knows, or would
reasonably be expected to know, is not valid under paragraph (d).

(k) Nothing in this chapter prohibits the commissioner of health, if a licensed
practitioner, or, if not a licensed practitioner, a designee of the commissioner who is
a licensed practitioner, from prescribing legend drugs for field-delivered therapy in the
treatment of a communicable disease according to the Centers For Disease Control and
Prevention Partner Services Guidelines.

EFFECTIVE DATE.

This section is effective the day following final enactment.

Sec. 3.

Minnesota Statutes 2014, section 151.37, subdivision 6, is amended to read:

Subd. 6.

Exclusion for course of employment.

(a) Nothing in this chapter shall
prohibit the possession of a legend drug by an employee, agent, or sales representative of
a registered drug manufacturer, or an employee or agent of a registered drug wholesaler,
or registered pharmacy, while acting in the course of employment.

(b) Nothing in this chapter shall prohibit an employee of the following entities, while
acting in the course of employment, from possessing a legend drug for the purpose of
disposing of the legend drug as pharmaceutical waste, provided that controlled substances
listed in section 152.02, subdivisions 3 to 6, may only be collected and disposed of as
allowed under section 152.105:

(1) a law enforcement officer agency;

(2) a hazardous waste transporter licensed by the Department of Transportation that
has notified the Pollution Control Agency of its activity;

(3) a facility permitted by the Pollution Control Agency to treat, store, or dispose of
hazardous waste, including household hazardous waste;

(4) a facility licensed by the Pollution Control Agency or a metropolitan county,
as defined in section 473.121, as a very small quantity generator collection program or a
minimal generator or household hazardous waste collection program; or

(5) a county that collects, stores, transports, or disposes of a legend drug pursuant to
a program in compliance with applicable federal law or a person authorized by the county
to conduct one or more of these activities; or

(6) a sanitary district organized under chapter 115, or a special law.

EFFECTIVE DATE.

This section is effective the day following final enactment.

Sec. 4.

Minnesota Statutes 2014, section 151.37, is amended by adding a subdivision
to read:

Subd. 6a.

Collection of legend drugs by pharmacies.

A pharmacy licensed under
section 151.19 may collect a legend drug from an ultimate user, or from a long-term care
facility on behalf of an ultimate user who resides or resided at the long-term care facility,
for the purpose of disposing of the legend drug as pharmaceutical waste, provided that:

(1) a pharmacy may collect and dispose of controlled substances listed in section
152.02, subdivisions 3 to 6, only as allowed under section 152.105; and

(2) only a pharmacy that has established a controlled substance disposal program
pursuant to section 152.105 may also collect and dispose of noncontrolled substance
legend and nonlegend drugs, but only in the same manner in which it collects and disposes
of controlled substances.

EFFECTIVE DATE.

This section is effective the day following final enactment.

Sec. 5.

Minnesota Statutes 2014, section 151.37, subdivision 7, is amended to read:

Subd. 7.

Exclusion for prescriptions.

(a) Nothing in this chapter shall prohibit the
possession of a legend drug by a person for that person's use when it has been dispensed to
the person in accordance with a valid prescription issued by a practitioner.

(b) Nothing in this chapter shall prohibit a person, for whom a legend drug has
been dispensed in accordance with a written or oral prescription by a practitioner, from
designating a family member, caregiver, or other individual to handle the legend drug for
the purpose of assisting the person in obtaining or administering the drug or sending
the drug for destruction.

(c) Nothing in this chapter shall prohibit a person for whom a prescription legend
drug has been dispensed in accordance with a valid prescription issued by a practitioner
from transferring the legend drug to a county that collects, stores, transports, or disposes
of a legend drug pursuant to a program in compliance with applicable federal law or to
a person authorized by the county to conduct one or more of these activities. an entity
identified in subdivision 6 or 6a, provided that controlled substances listed in section
152.02, subdivisions 3 to 6, may only be collected, stored, transported, and disposed of as
allowed under section 152.105, by those entities identified in subdivisions 6 and 6a that
are allowed to collect controlled substances from end users.

EFFECTIVE DATE.

This section is effective the day following final enactment.

Sec. 6.

[152.105] DISPOSAL.

Controlled substances listed in section 152.02, subdivisions 3 to 6, may be collected
and disposed of only pursuant to the provisions of Code of Federal Regulations, Title
21, parts 1300, 1301, 1304, 1305, 1307, and 1317, that are applicable to the disposal of
controlled substances. Disposal of controlled substances and legend and nonlegend drugs
must also comply with the requirements of section 116.07 governing the disposal of
hazardous waste, and the rules promulgated thereunder.

EFFECTIVE DATE.

This section is effective the day following final enactment.