HF 1718

1st Engrossment - 91st Legislature (2019 - 2020) Posted on 03/18/2019 03:54pm

A bill for an act
relating to health; making clarifying changes to the Pharmacy Practice Act;
modifying requirements for veterinary compounding; modifying licensure for
wholesale distributors; establishing licensure for third-party logistics providers;
modifying fees; amending Minnesota Statutes 2018, sections 151.01, subdivisions
31, 35, by adding a subdivision; 151.065, subdivisions 1, 3, 6; 151.071, subdivision
2; 151.15, subdivision 1, by adding subdivisions; 151.19, subdivisions 1, 3; 151.252,
subdivisions 1, 1a, 3; 151.253, by adding a subdivision; 151.32; 151.40,
subdivisions 1, 2; 151.43; 151.46; 151.47, subdivision 1, by adding a subdivision;
proposing coding for new law in Minnesota Statutes, chapter 151; repealing
Minnesota Statutes 2018, sections 151.42; 151.44; 151.49; 151.50; 151.51; 151.55.

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

Section 1.

Minnesota Statutes 2018, section 151.01, subdivision 31, is amended to read:

Subd. 31.

Central service pharmacy.

"Central service pharmacy" means a pharmacy
that deleted text begin may provide deleted text end new text begin performs those activities involved in the new text end dispensing deleted text begin functions, deleted text end new text begin of a new text end drug
deleted text begin utilization review, packaging, labeling, or delivery of a prescription product to deleted text end new text begin for new text end another
pharmacy deleted text begin for the purpose of filling a prescription deleted text end new text begin , pursuant to the requirements of this
chapter and the rules of the board new text end .

Sec. 2.

Minnesota Statutes 2018, section 151.01, subdivision 35, is amended to read:

Subd. 35.

Compounding.

"Compounding" means preparing, mixing, assembling,
packaging, and labeling a drug for an identified individual patient as a result of a practitioner's
prescription drug order. Compounding also includes anticipatory compounding, as defined
in this section, and the preparation of drugs in which all bulk drug substances and components
are nonprescription substances. Compounding does not include mixing or reconstituting a
drug according to the product's labeling or to the manufacturer's directions new text begin , provided that
such labeling has been approved by the United States Food and Drug Administration (FDA)
or the manufacturer is licensed under section 151.252 new text end . Compounding does not include the
preparation of a drug for the purpose of, or incident to, research, teaching, or chemical
analysis, provided that the drug is not prepared for dispensing or administration to patients.
All compounding, regardless of the type of product, must be done pursuant to a prescription
drug order unless otherwise permitted in this chapter or by the rules of the board.
Compounding does not include a minor deviation from such directions with regard to
radioactivity, volume, or stability, which is made by or under the supervision of a licensed
nuclear pharmacist or a physician, and which is necessary in order to accommodate
circumstances not contemplated in the manufacturer's instructions, such as the rate of
radioactive decay or geographical distance from the patient.

Sec. 3.

Minnesota Statutes 2018, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 42. new text end

new text begin Syringe services provider. new text end

new text begin "Syringe services provider" means a public health
program, registered with the commissioner of health, that provides cost-free comprehensive
harm reduction services, including: sterile needles, syringes, and other injection equipment;
safe disposal containers for needles and syringes; education about overdose prevention,
safer injection practices, and infectious disease prevention; referral to or provision of blood
borne pathogen testing; referral to substance use disorder treatment, including
medication-assisted treatment; and referral to medical, mental health, and social services.
new text end

Sec. 4.

Minnesota Statutes 2018, section 151.065, subdivision 1, is amended to read:

Subdivision 1.

Application fees.

Application fees for licensure and registration are as
follows:

(1) pharmacist licensed by examination, $145;

(2) pharmacist licensed by reciprocity, $240;

(3) pharmacy intern, $37.50;

(4) pharmacy technician, $37.50;

(5) pharmacy, $225;

(6) drug wholesaler, legend drugs only, $235;

(7) drug wholesaler, legend and nonlegend drugs, $235;

(8) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, $210;

(9) drug wholesaler, medical gases, $175;

(10) deleted text begin drug wholesaler, also licensed as a pharmacy in Minnesota, $150 deleted text end new text begin third-party logistics
provider, $260 new text end ;

(11) drug manufacturer, legend drugs only, $235;

(12) drug manufacturer, legend and nonlegend drugs, $235;

(13) drug manufacturer, nonlegend or veterinary legend drugs, $210;

(14) drug manufacturer, medical gases, $185;

(15) deleted text begin drug manufacturer, also licensed as a pharmacy in Minnesota, $150;
deleted text end

deleted text begin (16) deleted text end medical gas distributor, $110;

deleted text begin (17) deleted text end new text begin (16) new text end controlled substance researcher, $75; and

deleted text begin (18) deleted text end new text begin (17) new text end pharmacy professional corporation, $125.

Sec. 5.

Minnesota Statutes 2018, section 151.065, subdivision 3, is amended to read:

Subd. 3.

Annual renewal fees.

Annual licensure and registration renewal fees are as
follows:

(1) pharmacist, $145;

(2) pharmacy technician, $37.50;

(3) pharmacy, $225;

(4) drug wholesaler, legend drugs only, $235;

(5) drug wholesaler, legend and nonlegend drugs, $235;

(6) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, $210;

(7) drug wholesaler, medical gases, $185;

(8) deleted text begin drug wholesaler, also licensed as a pharmacy in Minnesota, $150 deleted text end new text begin third-party logistics
provider, $260 new text end ;

(9) drug manufacturer, legend drugs only, $235;

(10) drug manufacturer, legend and nonlegend drugs, $235;

(11) drug manufacturer, nonlegend, veterinary legend drugs, or both, $210;

(12) drug manufacturer, medical gases, $185;

(13) deleted text begin drug manufacturer, also licensed as a pharmacy in Minnesota, $150;
deleted text end

deleted text begin (14) deleted text end medical gas distributor, $110;

deleted text begin (15) deleted text end new text begin (14) new text end controlled substance researcher, $75; and

deleted text begin (16) deleted text end new text begin (15) new text end pharmacy professional corporation, $75.

Sec. 6.

Minnesota Statutes 2018, section 151.065, subdivision 6, is amended to read:

Subd. 6.

Reinstatement fees.

(a) A pharmacist who has allowed the pharmacist's license
to lapse may reinstate the license with board approval and upon payment of any fees and
late fees in arrears, up to a maximum of $1,000.

(b) A pharmacy technician who has allowed the technician's registration to lapse may
reinstate the registration with board approval and upon payment of any fees and late fees
in arrears, up to a maximum of $90.

(c) An owner of a pharmacy, deleted text begin a deleted text end drug wholesaler, deleted text begin a deleted text end drug manufacturer, new text begin third-party logistics
provider, new text end or deleted text begin a deleted text end medical gas distributor who has allowed the license of the establishment to
lapse may reinstate the license with board approval and upon payment of any fees and late
fees in arrears.

(d) A controlled substance researcher who has allowed the researcher's registration to
lapse may reinstate the registration with board approval and upon payment of any fees and
late fees in arrears.

(e) A pharmacist owner of a professional corporation who has allowed the corporation's
registration to lapse may reinstate the registration with board approval and upon payment
of any fees and late fees in arrears.

Sec. 7.

Minnesota Statutes 2018, section 151.071, subdivision 2, is amended to read:

Subd. 2.

Grounds for disciplinary action.

The following conduct is prohibited and is
grounds for disciplinary action:

(1) failure to demonstrate the qualifications or satisfy the requirements for a license or
registration contained in this chapter or the rules of the board. The burden of proof is on
the applicant to demonstrate such qualifications or satisfaction of such requirements;

(2) obtaining a license by fraud or by misleading the board in any way during the
application process or obtaining a license by cheating, or attempting to subvert the licensing
examination process. Conduct that subverts or attempts to subvert the licensing examination
process includes, but is not limited to: (i) conduct that violates the security of the examination
materials, such as removing examination materials from the examination room or having
unauthorized possession of any portion of a future, current, or previously administered
licensing examination; (ii) conduct that violates the standard of test administration, such as
communicating with another examinee during administration of the examination, copying
another examinee's answers, permitting another examinee to copy one's answers, or
possessing unauthorized materials; or (iii) impersonating an examinee or permitting an
impersonator to take the examination on one's own behalf;

(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a pharmacist
or pharmacy license, or applicant for a pharmacy technician or pharmacist intern registration,
conviction of a felony reasonably related to the practice of pharmacy. Conviction as used
in this subdivision includes a conviction of an offense that if committed in this state would
be deemed a felony without regard to its designation elsewhere, or a criminal proceeding
where a finding or verdict of guilt is made or returned but the adjudication of guilt is either
withheld or not entered thereon. The board may delay the issuance of a new license or
registration if the applicant has been charged with a felony until the matter has been
adjudicated;

(4) for a facility, other than a pharmacy, licensed or registered by the board, if an owner
or applicant is convicted of a felony reasonably related to the operation of the facility. The
board may delay the issuance of a new license or registration if the owner or applicant has
been charged with a felony until the matter has been adjudicated;

(5) for a controlled substance researcher, conviction of a felony reasonably related to
controlled substances or to the practice of the researcher's profession. The board may delay
the issuance of a registration if the applicant has been charged with a felony until the matter
has been adjudicated;

(6) disciplinary action taken by another state or by one of this state's health licensing
agencies:

(i) revocation, suspension, restriction, limitation, or other disciplinary action against a
license or registration in another state or jurisdiction, failure to report to the board that
charges or allegations regarding the person's license or registration have been brought in
another state or jurisdiction, or having been refused a license or registration by any other
state or jurisdiction. The board may delay the issuance of a new license or registration if an
investigation or disciplinary action is pending in another state or jurisdiction until the
investigation or action has been dismissed or otherwise resolved; and

(ii) revocation, suspension, restriction, limitation, or other disciplinary action against a
license or registration issued by another of this state's health licensing agencies, failure to
report to the board that charges regarding the person's license or registration have been
brought by another of this state's health licensing agencies, or having been refused a license
or registration by another of this state's health licensing agencies. The board may delay the
issuance of a new license or registration if a disciplinary action is pending before another
of this state's health licensing agencies until the action has been dismissed or otherwise
resolved;

(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation of
any order of the board, of any of the provisions of this chapter or any rules of the board or
violation of any federal, state, or local law or rule reasonably pertaining to the practice of
pharmacy;

(8) for a facility, other than a pharmacy, licensed by the board, violations of any order
of the board, of any of the provisions of this chapter or the rules of the board or violation
of any federal, state, or local law relating to the operation of the facility;

(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm the
public, or demonstrating a willful or careless disregard for the health, welfare, or safety of
a patient; or pharmacy practice that is professionally incompetent, in that it may create
unnecessary danger to any patient's life, health, or safety, in any of which cases, proof of
actual injury need not be established;

(10) aiding or abetting an unlicensed person in the practice of pharmacy, except that it
is not a violation of this clause for a pharmacist to supervise a properly registered pharmacy
technician or pharmacist intern if that person is performing duties allowed by this chapter
or the rules of the board;

(11) for an individual licensed or registered by the board, adjudication as mentally ill
or developmentally disabled, or as a chemically dependent person, a person dangerous to
the public, a sexually dangerous person, or a person who has a sexual psychopathic
personality, by a court of competent jurisdiction, within or without this state. Such
adjudication shall automatically suspend a license for the duration thereof unless the board
orders otherwise;

(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as specified
in the board's rules. In the case of a pharmacy technician, engaging in conduct specified in
board rules that would be unprofessional if it were engaged in by a pharmacist or pharmacist
intern or performing duties specifically reserved for pharmacists under this chapter or the
rules of the board;

(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
duty except as allowed by a variance approved by the board;

(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and safety
to patients by reason of illness, deleted text begin drunkenness, deleted text end use of new text begin alcohol, new text end drugs, narcotics, chemicals, or
any other type of material or as a result of any mental or physical condition, including
deterioration through the aging process or loss of motor skills. In the case of registered
pharmacy technicians, pharmacist interns, or controlled substance researchers, the inability
to carry out duties allowed under this chapter or the rules of the board with reasonable skill
and safety to patients by reason of illness, deleted text begin drunkenness, deleted text end use of new text begin alcohol, new text end drugs, narcotics,
chemicals, or any other type of material or as a result of any mental or physical condition,
including deterioration through the aging process or loss of motor skills;

(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical gas
distributor, or controlled substance researcher, revealing a privileged communication from
or relating to a patient except when otherwise required or permitted by law;

(16) for a pharmacist or pharmacy, improper management of patient records, including
failure to maintain adequate patient records, to comply with a patient's request made pursuant
to sections 144.291 to 144.298, or to furnish a patient record or report required by law;

(17) fee splitting, including without limitation:

(i) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
kickback, or other form of remuneration, directly or indirectly, for the referral of patients;
deleted text begin and
deleted text end

(ii) referring a patient to any health care provider as defined in sections 144.291 to
144.298 in which the licensee or registrant has a financial or economic interest as defined
in section 144.6521, subdivision 3, unless the licensee or registrant has disclosed the
licensee's or registrant's financial or economic interest in accordance with section 144.6521; new text begin
and
new text end

new text begin (iii) any arrangement through which a pharmacy, in which the prescribing practitioner
does not have a significant ownership interest, fills a prescription drug order and the
prescribing practitioner is involved in any manner, directly or indirectly, in setting the price
for the filled prescription that is charged to the patient, the patient's insurer or pharmacy
benefit manager, or other person paying for the prescription or, in the case of veterinary
patients, the price for the filled prescription that is charged to the client or other person
paying for the prescription, except that a veterinarian and a pharmacy may enter into such
an arrangement provided that the client or other person paying for the prescription is notified,
in writing and with each prescription dispensed, about the arrangement, unless such
arrangement involves pharmacy services provided for livestock, poultry, and agricultural
production systems, in which case client notification would not be required;
new text end

(18) engaging in abusive or fraudulent billing practices, including violations of the
federal Medicare and Medicaid laws or state medical assistance laws or rules;

(19) engaging in conduct with a patient that is sexual or may reasonably be interpreted
by the patient as sexual, or in any verbal behavior that is seductive or sexually demeaning
to a patient;

(20) failure to make reports as required by section 151.072 or to cooperate with an
investigation of the board as required by section 151.074;

(21) knowingly providing false or misleading information that is directly related to the
care of a patient unless done for an accepted therapeutic purpose such as the dispensing and
administration of a placebo;

(22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
established by any of the following:

(i) a copy of the record of criminal conviction or plea of guilty for a felony in violation
of section 609.215, subdivision 1 or 2;

(ii) a copy of the record of a judgment of contempt of court for violating an injunction
issued under section 609.215, subdivision 4;

(iii) a copy of the record of a judgment assessing damages under section 609.215,
subdivision 5; or

(iv) a finding by the board that the person violated section 609.215, subdivision 1 or 2.
The board shall investigate any complaint of a violation of section 609.215, subdivision 1
or 2;

(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license. For
a pharmacist intern, pharmacy technician, or controlled substance researcher, performing
duties permitted to such individuals by this chapter or the rules of the board under a lapsed
or nonrenewed registration. For a facility required to be licensed under this chapter, operation
of the facility under a lapsed or nonrenewed license or registration; and

(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination or discharge
from the health professionals services program for reasons other than the satisfactory
completion of the program.

Sec. 8.

Minnesota Statutes 2018, section 151.15, subdivision 1, is amended to read:

Subdivision 1.

Location.

It shall be unlawful for any person to compound deleted text begin , deleted text end new text begin or new text end dispense deleted text begin ,
vend, or sell deleted text end drugs deleted text begin , medicines, chemicals, or poisons deleted text end in any place other than a pharmacy,
except as provided in this chapter new text begin ; except that a licensed pharmacist or pharmacist intern
working within a licensed hospital may receive a prescription drug order and access the
hospital's pharmacy prescription processing system through secure and encrypted electronic
means in order to process the prescription drug order new text end .

Sec. 9.

Minnesota Statutes 2018, section 151.15, is amended by adding a subdivision to
read:

new text begin Subd. 5. new text end

new text begin Receipt of emergency prescription orders. new text end

new text begin A pharmacist, when that pharmacist
is not present within a licensed pharmacy, may accept a written, verbal, or electronic
prescription drug order from a practitioner only if:
new text end

new text begin (1) the prescription drug order is for an emergency situation where waiting for the
pharmacist to travel to a licensed pharmacy to accept the prescription drug order would
likely cause the patient to experience significant physical harm or discomfort;
new text end

new text begin (2) the pharmacy from which the prescription drug order will be dispensed is closed for
business;
new text end

new text begin (3) the pharmacist has been designated to be on call for the licensed pharmacy that will
fill the prescription drug order;
new text end

new text begin (4) electronic prescription drug orders are received through secure and encrypted
electronic means;
new text end

new text begin (5) the pharmacist takes reasonable precautions to ensure that the prescription drug order
will be handled in a manner consistent with federal and state statutes regarding the handling
of protected health information; and
new text end

new text begin (6) the pharmacy from which the prescription drug order will be dispensed has relevant
and appropriate policies and procedures in place and makes them available to the board
upon request.
new text end

Sec. 10.

Minnesota Statutes 2018, section 151.15, is amended by adding a subdivision to
read:

new text begin Subd. 6. new text end

new text begin Processing of emergency prescription orders. new text end

new text begin A pharmacist, when that
pharmacist is not present within a licensed pharmacy, may access a pharmacy prescription
processing system through secure and encrypted electronic means in order to process an
emergency prescription accepted pursuant to subdivision 5 only if:
new text end

new text begin (1) the pharmacy from which the prescription drug order will be dispensed is closed for
business;
new text end

new text begin (2) the pharmacist has been designated to be on call for the licensed pharmacy that will
fill the prescription drug order;
new text end

new text begin (3) the prescription drug order is for a patient of a long-term care facility or a county
correctional facility;
new text end

new text begin (4) the prescription drug order is not being processed pursuant to section 151.58;
new text end

new text begin (5) the prescription drug order is processed pursuant to this chapter and the rules
promulgated thereunder; and
new text end

new text begin (6) the pharmacy from which the prescription drug order will be dispensed has relevant
and appropriate policies and procedures in place and makes them available to the board
upon request.
new text end

Sec. 11.

Minnesota Statutes 2018, section 151.19, subdivision 1, is amended to read:

Subdivision 1.

Pharmacy licensure requirements.

(a) No person shall operate a
pharmacy without first obtaining a license from the board and paying any applicable fee
specified in section 151.065. The license shall be displayed in a conspicuous place in the
pharmacy for which it is issued and expires on June 30 following the date of issue. It is
unlawful for any person to operate a pharmacy unless the license has been issued to the
person by the board.

(b) Application for a pharmacy license under this section shall be made in a manner
specified by the board.

(c) No license shall be issued or renewed for a pharmacy located within the state unless
the applicant agrees to operate the pharmacy in a manner prescribed by federal and state
law and according to rules adopted by the board. No license shall be issued for a pharmacy
located outside of the state unless the applicant agrees to operate the pharmacy in a manner
prescribed by federal law and, when dispensing medications for residents of this state, the
laws of this state, and Minnesota Rules.

(d) No license shall be issued or renewed for a pharmacy that is required to be licensed
or registered by the state in which it is physically located unless the applicant supplies the
board with proof of such licensure or registration.

(e) The board shall require a separate license for each pharmacy located within the state
and for each pharmacy located outside of the state at which any portion of the dispensing
process occurs for drugs dispensed to residents of this state.

(f) deleted text begin The board shall not issue deleted text end new text begin Prior to the issuance of new text end an initial or renewed license for a
pharmacy deleted text begin unless deleted text end new text begin , the board may require new text end the pharmacy deleted text begin passes deleted text end new text begin to pass new text end an inspection conducted
by an authorized representative of the board. In the case of a pharmacy located outside of
the state, the board may require the applicant to pay the cost of the inspection, in addition
to the license fee in section 151.065, unless the applicant furnishes the board with a report,
issued by the appropriate regulatory agency of the state in which the facility is located, of
an inspection that has occurred within the 24 months immediately preceding receipt of the
license application by the board. The board may deny licensure unless the applicant submits
documentation satisfactory to the board that any deficiencies noted in an inspection report
have been corrected.

(g) The board shall not issue an initial or renewed license for a pharmacy located outside
of the state unless the applicant discloses and certifies:

(1) the location, names, and titles of all principal corporate officers and all pharmacists
who are involved in dispensing drugs to residents of this state;

(2) that it maintains its records of drugs dispensed to residents of this state so that the
records are readily retrievable from the records of other drugs dispensed;

(3) that it agrees to cooperate with, and provide information to, the board concerning
matters related to dispensing drugs to residents of this state;

(4) that, during its regular hours of operation, but no less than six days per week, for a
minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
communication between patients in this state and a pharmacist at the pharmacy who has
access to the patients' records; the toll-free number must be disclosed on the label affixed
to each container of drugs dispensed to residents of this state; and

(5) that, upon request of a resident of a long-term care facility located in this state, the
resident's authorized representative, or a contract pharmacy or licensed health care facility
acting on behalf of the resident, the pharmacy will dispense medications prescribed for the
resident in unit-dose packaging or, alternatively, comply with section 151.415, subdivision
5.

new text begin (h) This subdivision does not apply to a manufacturer licensed under section 151.252,
subdivision 1, a wholesale drug distributor licensed under section 151.47, or a third-party
logistics provider, to the extent the manufacturer, wholesale drug distributor, or third-party
logistics provider is engaged in the distribution of dialysate or devices necessary to perform
home peritoneal dialysis on patients with end-stage renal disease, if:
new text end

new text begin (1) the manufacturer or its agent leases or owns the licensed manufacturing or wholesaling
facility from which the dialysate or devices will be delivered;
new text end

new text begin (2) the dialysate is comprised of dextrose or icodextrin and has been approved by the
United States Food and Drug Administration;
new text end

new text begin (3) the dialysate is stored and delivered in its original, sealed, and unopened
manufacturer's packaging;
new text end

new text begin (4) the dialysate or devices are delivered only upon:
new text end

new text begin (i) receipt of a physician's order by a Minnesota licensed pharmacy; and
new text end

new text begin (ii) the review and processing of the prescription by a pharmacist licensed by the state
in which the pharmacy is located, who is employed by or under contract to the pharmacy;
new text end

new text begin (5) prescriptions, policies, procedures, and records of delivery are maintained by the
manufacturer for a minimum of three years and are made available to the board upon request;
and
new text end

new text begin (6) the manufacturer or the manufacturer's agent delivers the dialysate or devices directly
to:
new text end

new text begin (i) a patient with end-stage renal disease for whom the prescription was written or the
patient's designee, for the patient's self-administration of the dialysis therapy; or
new text end

new text begin (ii) a health care provider or institution, for administration or delivery of the dialysis
therapy to a patient with end-stage renal disease for whom the prescription was written.
new text end

Sec. 12.

Minnesota Statutes 2018, section 151.19, subdivision 3, is amended to read:

Subd. 3.

Sale of federally restricted medical gases.

(a) A person or establishment not
licensed as a pharmacy or a practitioner shall not engage in the retail sale or distribution of
federally restricted medical gases without first obtaining a registration from the board and
paying the applicable fee specified in section 151.065. The registration shall be displayed
in a conspicuous place in the business for which it is issued and expires on the date set by
the board. It is unlawful for a person to sell or distribute federally restricted medical gases
unless a certificate has been issued to that person by the board.

(b) Application for a medical gas distributor registration under this section shall be made
in a manner specified by the board.

(c) No registration shall be issued or renewed for a medical gas distributor located within
the state unless the applicant agrees to operate in a manner prescribed by federal and state
law and according to the rules adopted by the board. No license shall be issued for a medical
gas distributor located outside of the state unless the applicant agrees to operate in a manner
prescribed by federal law and, when distributing medical gases for residents of this state,
the laws of this state and Minnesota Rules.

(d) No registration shall be issued or renewed for a medical gas distributor that is required
to be licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of the licensure or registration. The board may, by rule,
establish standards for the registration of a medical gas distributor that is not required to be
licensed or registered by the state in which it is physically located.

(e) The board shall require a separate registration for each medical gas distributor located
within the state and for each facility located outside of the state from which medical gases
are distributed to residents of this state.

(f) deleted text begin The board shall not issue deleted text end new text begin Prior to the issuance of new text end an initial or renewed registration
for a medical gas distributor deleted text begin unless deleted text end new text begin , the board may require new text end the medical gas distributor deleted text begin passes deleted text end
new text begin to pass new text end an inspection conducted by an authorized representative of the board. In the case of
a medical gas distributor located outside of the state, the board may require the applicant
to pay the cost of the inspection, in addition to the license fee in section 151.065, unless the
applicant furnishes the board with a report, issued by the appropriate regulatory agency of
the state in which the facility is located, of an inspection that has occurred within the 24
months immediately preceding receipt of the license application by the board. The board
may deny licensure unless the applicant submits documentation satisfactory to the board
that any deficiencies noted in an inspection report have been corrected.

Sec. 13.

Minnesota Statutes 2018, section 151.252, subdivision 1, is amended to read:

Subdivision 1.

Requirements.

(a) No person shall act as a drug manufacturer without
first obtaining a license from the board and paying any applicable fee specified in section
151.065.

(b) Application for a drug manufacturer license under this section shall be made in a
manner specified by the board.

(c) No license shall be issued or renewed for a drug manufacturer unless the applicant
agrees to operate in a manner prescribed by federal and state law and according to Minnesota
Rules.

(d) No license shall be issued or renewed for a drug manufacturer that is required to be
registered pursuant to United States Code, title 21, section 360, unless the applicant supplies
the board with proof of registration. The board may establish by rule the standards for
licensure of drug manufacturers that are not required to be registered under United States
Code, title 21, section 360.

(e) No license shall be issued or renewed for a drug manufacturer that is required to be
licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of licensure or registration. The board may establish, by rule,
standards for the licensure of a drug manufacturer that is not required to be licensed or
registered by the state in which it is physically located.

(f) The board shall require a separate license for each facility located within the state at
which drug manufacturing occurs and for each facility located outside of the state at which
drugs that are shipped into the state are manufactured.

(g) deleted text begin The board shall not issue deleted text end new text begin Prior to the issuance of new text end an initial or renewed license for a
drug manufacturing facility deleted text begin unless deleted text end new text begin , the board may require new text end the facility deleted text begin passes an deleted text end new text begin to pass a
current good manufacturing practices new text end inspection conducted by an authorized representative
of the board. In the case of a drug manufacturing facility located outside of the state, the
board may require the applicant to pay the cost of the inspection, in addition to the license
fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
appropriate regulatory agency of the state in which the facility is located or by the United
States Food and Drug Administration, of an inspection that has occurred within the 24
months immediately preceding receipt of the license application by the board. The board
may deny licensure unless the applicant submits documentation satisfactory to the board
that any deficiencies noted in an inspection report have been corrected.

Sec. 14.

Minnesota Statutes 2018, section 151.252, subdivision 1a, is amended to read:

Subd. 1a.

Outsourcing facility.

(a) No person shall act as an outsourcing facility without
first obtaining a license from the board and paying any applicable manufacturer licensing
fee specified in section 151.065.

(b) Application for an outsourcing facility license under this section shall be made in a
manner specified by the board and may differ from the application required of other drug
manufacturers.

(c) No license shall be issued or renewed for an outsourcing facility unless the applicant
agrees to operate in a manner prescribed for outsourcing facilities by federal and state law
and according to Minnesota Rules.

(d) No license shall be issued or renewed for an outsourcing facility unless the applicant
supplies the board with proof of such registration by the United States Food and Drug
Administration as required by United States Code, title 21, section 353b.

(e) No license shall be issued or renewed for an outsourcing facility that is required to
be licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of such licensure or registration. The board may establish, by
rule, standards for the licensure of an outsourcing facility that is not required to be licensed
or registered by the state in which it is physically located.

(f) The board shall require a separate license for each outsourcing facility located within
the state and for each outsourcing facility located outside of the state at which drugs that
are shipped into the state are prepared.

(g) The board shall not issue an initial or renewed license for an outsourcing facility
unless the facility passes deleted text begin an deleted text end new text begin a current good manufacturing practices new text end inspection conducted
by an authorized representative of the board. In the case of an outsourcing facility located
outside of the state, the board may require the applicant to pay the cost of the inspection,
in addition to the license fee in section 151.065, unless the applicant furnishes the board
with a report, issued by the appropriate regulatory agency of the state in which the facility
is located or by the United States Food and Drug Administration, of deleted text begin an deleted text end new text begin a current good
manufacturing practices new text end inspection that has occurred within the 24 months immediately
preceding receipt of the license application by the board. The board may deny licensure
unless the applicant submits documentation satisfactory to the board that any deficiencies
noted in an inspection report have been corrected.

Sec. 15.

Minnesota Statutes 2018, section 151.252, subdivision 3, is amended to read:

Subd. 3.

Payment to practitioner; reporting.

Unless prohibited by United States Code,
title 42, section 1320a-7h, a drug manufacturer new text begin or outsourcing facility new text end shall file with the
board an annual report, in a form and on the date prescribed by the board, identifying all
payments, honoraria, reimbursement, or other compensation authorized under section
151.461, clauses (4) and (5), paid to practitioners in Minnesota during the preceding calendar
year. The report shall identify the nature and value of any payments totaling $100 or more
to a particular practitioner during the year, and shall identify the practitioner. Reports filed
under this subdivision are public data.

Sec. 16.

Minnesota Statutes 2018, section 151.253, is amended by adding a subdivision
to read:

new text begin Subd. 4. new text end

new text begin Emergency veterinary compounding. new text end

new text begin A pharmacist working within a pharmacy
licensed by the board in the veterinary pharmacy license category may compound and
provide a drug product to a veterinarian without first receiving a patient-specific prescription
only when:
new text end

new text begin (1) the compounded drug product is needed to treat animals in urgent or emergency
situations, meaning where the health of an animal is threatened, or where suffering or death
of an animal is likely to result from failure to immediately treat;
new text end

new text begin (2) timely access to a compounding pharmacy is not available, as determined by the
prescribing veterinarian;
new text end

new text begin (3) there is no commercially manufactured drug, approved by the United States Food
and Drug Administration, that is suitable for treating the animal, or there is a documented
shortage of such drug;
new text end

new text begin (4) the compounded drug is to be administered by a veterinarian or a bona fide employee
of the veterinarian, or dispensed to a client of a veterinarian in an amount not to exceed
what is necessary to treat an animal for a period of ten days;
new text end

new text begin (5) the pharmacy has selected the sterile or nonsterile compounding license category,
in addition to the veterinary pharmacy licensing category; and
new text end

new text begin (6) the pharmacy is appropriately registered by the United States Drug Enforcement
Administration when providing compounded products that contain controlled substances.
new text end

Sec. 17.

Minnesota Statutes 2018, section 151.32, is amended to read:

151.32 CITATION.

The title of sections 151.01 to deleted text begin 151.40 deleted text end new text begin 151.58 new text end shall be the Pharmacy Practice new text begin and
Wholesale Distribution new text end Act.

Sec. 18.

Minnesota Statutes 2018, section 151.40, subdivision 1, is amended to read:

Subdivision 1.

Generally.

deleted text begin Except as otherwise provided in subdivision 2, deleted text end It is unlawful
for any person to possess, control, manufacture, sell, furnish, dispense, or otherwise dispose
of hypodermic syringes or needles or any instrument or implement which can be adapted
for subcutaneous injections, except deleted text begin by deleted text end new text begin for:
new text end

new text begin (1) new text end The following persons when acting in the course of their practice or employment:

new text begin (i) new text end licensed practitioners deleted text begin , registered deleted text end new text begin and their employees, agents, or delegates;
new text end

new text begin (ii) licensed new text end pharmacies and their employees or agents deleted text begin , deleted text end new text begin ;
new text end

new text begin (iii) new text end licensed pharmacists deleted text begin , licensed doctors of veterinary medicine or their assistants, deleted text end new text begin ;
new text end

new text begin (iv) new text end registered nurses deleted text begin , deleted text end new text begin and licensed practical nurses;
new text end

new text begin (v) new text end registered medical technologists deleted text begin , deleted text end new text begin ;
new text end

new text begin (vi) new text end medical interns deleted text begin , deleted text end new text begin and residents;
new text end

new text begin (vii) new text end licensed drug wholesalers deleted text begin , deleted text end new text begin and new text end their employees or agents deleted text begin , deleted text end new text begin ;
new text end

new text begin (viii) new text end licensed hospitals deleted text begin , deleted text end new text begin ;
new text end

new text begin (ix) bona fide hospitals in which animals are treated;
new text end

new text begin (x) new text end licensed nursing homes deleted text begin , bona fide hospitals where animals are treated, deleted text end new text begin ;
new text end

new text begin (xi) new text end licensed morticians deleted text begin , deleted text end new text begin ;
new text end

new text begin (xii) new text end syringe and needle manufacturers deleted text begin , deleted text end new text begin and new text end their dealers and agents deleted text begin , deleted text end new text begin ;
new text end

new text begin (xiii) new text end persons engaged in animal husbandry deleted text begin , deleted text end new text begin ;
new text end

new text begin (xiv) new text end clinical laboratories new text begin and their employees new text end deleted text begin , deleted text end new text begin ;
new text end

new text begin (xv) new text end persons engaged in bona fide research or education or industrial use of hypodermic
syringes and needles provided such persons cannot use hypodermic syringes and needles
for the administration of drugs to human beings unless such drugs are prescribed, dispensed,
and administered by a person lawfully authorized to do so deleted text begin , deleted text end new text begin ;
new text end

new text begin (xvi) new text end persons who administer drugs pursuant to an order or direction of a licensed deleted text begin doctor
of medicine or of a licensed doctor of osteopathic medicine duly licensed to practice
medicine. deleted text end new text begin practitioner; and
new text end

new text begin (xvii) syringe service providers and their employees or agents and individuals who obtain
and dispose of hypodermic syringes and needles through such providers;
new text end

new text begin (2) a person who self-administers drugs pursuant to either the prescription or the direction
of a practitioner, or a family member, caregiver, or other individual who is designated by
such person to assist the person in obtaining and using needles and syringes for the
administration of such drugs;
new text end

new text begin (3) a person who is disposing of hypodermic syringes and needles through an activity
or program developed under section 325F.785; or
new text end

new text begin (4) a person who sells, possesses, or handles hypodermic syringes and needles pursuant
to subdivision 2.
new text end

Sec. 19.

Minnesota Statutes 2018, section 151.40, subdivision 2, is amended to read:

Subd. 2.

Sales of limited quantities of clean needles and syringes.

(a) A registered
pharmacy deleted text begin or its agent deleted text end or a licensed pharmacist may sell, without deleted text begin a deleted text end new text begin the new text end prescription new text begin or
direction of a practitioner new text end , unused hypodermic needles and syringes in quantities of ten or
fewer, provided the pharmacy or pharmacist complies with all of the requirements of this
subdivision.

(b) At any location where hypodermic needles and syringes are kept for retail sale under
this subdivision, the needles and syringes shall be stored in a manner that makes them
available only to authorized personnel and not openly available to customers.

deleted text begin (c) No registered pharmacy or licensed pharmacist may advertise to the public the
availability for retail sale, without a prescription, of hypodermic needles or syringes in
quantities of ten or fewer.
deleted text end

deleted text begin (d) deleted text end new text begin (c) new text end A registered pharmacy or licensed pharmacist that sells hypodermic needles or
syringes under this subdivision may give the purchaser the materials developed by the
commissioner of health under section 325F.785.

deleted text begin (e) deleted text end new text begin (d) new text end A registered pharmacy or licensed pharmacist that sells hypodermic needles or
syringes new text begin under this subdivision new text end must certify to the commissioner of health participation in
an activity, including but not limited to those developed under section 325F.785, that supports
proper disposal of used hypodermic needles or syringes.

Sec. 20.

Minnesota Statutes 2018, section 151.43, is amended to read:

151.43 SCOPE.

Sections deleted text begin 151.42 deleted text end new text begin 151.43 new text end to 151.51 apply to any person deleted text begin , partnership, corporation, or
business firm deleted text end engaging in the wholesale distribution of deleted text begin prescription deleted text end drugs within the state new text begin ,
and to persons operating as third-party logistics providers new text end .

Sec. 21.

new text begin [151.441] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin As used in sections 151.43 to 151.51, the following terms have
the meanings given in this section.
new text end

new text begin Subd. 2. new text end

new text begin Dispenser. new text end

new text begin "Dispenser" means a retail pharmacy, hospital pharmacy, a group
of chain pharmacies under common ownership and control that do not act as a wholesale
distributor, or any other person authorized by law to dispense or administer prescription
drugs, and the affiliated warehouses or distribution centers of such entities under common
ownership and control that do not act as a wholesale distributor, but does not include a
person who dispenses only products to be used in animals in accordance with United States
Code, title 21, section 360b(a)(5).
new text end

new text begin Subd. 3. new text end

new text begin Disposition. new text end

new text begin "Disposition," with respect to a product within the possession or
control of an entity, means the removal of such product from the pharmaceutical distribution
supply chain, which may include disposal or return of the product for disposal or other
appropriate handling and other actions, such as retaining a sample of the product for further
additional physical examination or laboratory analysis of the product by a manufacturer or
regulatory or law enforcement agency.
new text end

new text begin Subd. 4. new text end

new text begin Distribute or distribution. new text end

new text begin "Distribute" or "distribution" means the sale,
purchase, trade, delivery, handling, storage, or receipt of a product, and does not include
the dispensing of a product pursuant to a prescription executed in accordance with United
States Code, title 21, section 353(b)(1), or the dispensing of a product approved under United
States Code, title 21, section 360b(b).
new text end

new text begin Subd. 5. new text end

new text begin Manufacturer. new text end

new text begin "Manufacturer" means, with respect to a product:
new text end

new text begin (1) a person who holds an application approved under United States Code, title 21,
section 355, or a license issued under United States Code, title 42, section 262, for such
product, or if such product is not the subject of an approved application or license, the person
who manufactured the product;
new text end

new text begin (2) a co-licensed partner of the person described in clause (1) that obtains the product
directly from a person described in this subdivision; or
new text end

new text begin (3) an affiliate of a person described in clause (1) or (2) that receives the product directly
from a person described in this subdivision.
new text end

new text begin Subd. 6. new text end

new text begin Medical convenience kit. new text end

new text begin "Medical convenience kit" means a collection of
finished medical devices, which may include a product or biological product, assembled in
kit form strictly for the convenience of the purchaser or user.
new text end

new text begin Subd. 7. new text end

new text begin Package. new text end

new text begin "Package" means the smallest individual salable unit of product for
distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate
sale to the dispenser of such product. For purposes of this subdivision, an "individual salable
unit" is the smallest container of product introduced into commerce by the manufacturer or
repackager that is intended by the manufacturer or repackager for individual sale to a
dispenser.
new text end

new text begin Subd. 8. new text end

new text begin Prescription drug. new text end

new text begin "Prescription drug" means a drug for human use subject
to United States Code, title 21, section 353(b)(1).
new text end

new text begin Subd. 9. new text end

new text begin Product. new text end

new text begin "Product" means a prescription drug in a finished dosage form for
administration to a patient without substantial further manufacturing, but does not include
blood or blood components intended for transfusion; radioactive drugs or radioactive
biological products as defined in Code of Federal Regulations, title 21, section 600.3(ee),
that are regulated by the Nuclear Regulatory Commission or by a state pursuant to an
agreement with such commission under United States Code, title 42, section 2021; imaging
drugs; an intravenous product described in subdivision 12, paragraph (b), clauses (14) to
(16); any medical gas defined in United States Code, title 21, section 360ddd; homeopathic
drugs marketed in accordance with applicable federal law; or a drug compounded in
compliance with United States Code, title 21, section 353a or 353b.
new text end

new text begin Subd. 10. new text end

new text begin Repackager. new text end

new text begin "Repackager" means a person who owns or operates an
establishment that repacks and relabels a product or package for further sale or for distribution
without a further transaction.
new text end

new text begin Subd. 11. new text end

new text begin Third-party logistics provider. new text end

new text begin "Third-party logistics provider" means an
entity that provides or coordinates warehousing or other logistics services of a product in
interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a
product, but does not take ownership of the product nor have responsibility to direct the
sale or disposition of the product.
new text end

new text begin Subd. 12. new text end

new text begin Transaction. new text end

new text begin (a) "Transaction" means the transfer of product between persons
in which a change of ownership occurs.
new text end

new text begin (b) The term "transaction" does not include:
new text end

new text begin (1) intracompany distribution of any product between members of an affiliate or within
a manufacturer;
new text end

new text begin (2) the distribution of a product among hospitals or other health care entities that are
under common control;
new text end

new text begin (3) the distribution of a drug or an offer to distribute a drug for emergency medical
reasons, including:
new text end

new text begin (i) a public health emergency declaration pursuant to United States Code, title 42, section
247d;
new text end

new text begin (ii) a national security or peacetime emergency declared by the governor pursuant to
section 12.31; or
new text end

new text begin (iii) a situation involving an action taken by the commissioner of health pursuant to
section 144.4197, 144.4198 or 151.37, subdivisions 2, paragraph (b), and 10, except that,
for purposes of this paragraph, a drug shortage not caused by a public health emergency
shall not constitute an emergency medical reason;
new text end

new text begin (4) the dispensing of a drug pursuant to a valid prescription issued by a licensed
practitioner;
new text end

new text begin (5) the distribution of product samples by a manufacturer or a licensed wholesale
distributor in accordance with United States Code, title 21, section 353(d);
new text end

new text begin (6) the distribution of blood or blood components intended for transfusion;
new text end

new text begin (7) the distribution of minimal quantities of product by a licensed retail pharmacy to a
licensed practitioner for office use;
new text end

new text begin (8) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by
a charitable organization described in United States Code, title 26, section 501(c)(3), to a
nonprofit affiliate of the organization to the extent otherwise permitted by law;
new text end

new text begin (9) the distribution of a product pursuant to the sale or merger of a pharmacy or
pharmacies or a wholesale distributor or wholesale distributors, except that any records
required to be maintained for the product shall be transferred to the new owner of the
pharmacy or pharmacies or wholesale distributor or wholesale distributors;
new text end

new text begin (10) the dispensing of a product approved under United States Code, title 21, section
360b(c);
new text end

new text begin (11) transfer of products to or from any facility that is licensed by the Nuclear Regulatory
Commission or by a state pursuant to an agreement with such commission under United
States Code, title 42, section 2021;
new text end

new text begin (12) transfer of a combination product that is not subject to approval under United States
Code, title 21, section 355, or licensure under United States Code, title 42, section 262, and
that is:
new text end

new text begin (i) a product comprised of a device and one or more other regulated components (such
as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically,
or otherwise combined or mixed and produced as a single entity;
new text end

new text begin (ii) two or more separate products packaged together in a single package or as a unit
and comprised of a drug and device or device and biological product; or
new text end

new text begin (iii) two or more finished medical devices plus one or more drug or biological products
that are packaged together in a medical convenience kit;
new text end

new text begin (13) the distribution of a medical convenience kit if:
new text end

new text begin (i) the medical convenience kit is assembled in an establishment that is registered with
the Food and Drug Administration as a device manufacturer in accordance with United
States Code, title 21, section 360(b)(2);
new text end

new text begin (ii) the medical convenience kit does not contain a controlled substance that appears in
a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of
1970, United States Code, title 21, section 801, et seq.;
new text end

new text begin (iii) in the case of a medical convenience kit that includes a product, the person who
manufactures the kit:
new text end

new text begin (A) purchased the product directly from the pharmaceutical manufacturer or from a
wholesale distributor that purchased the product directly from the pharmaceutical
manufacturer; and
new text end

new text begin (B) does not alter the primary container or label of the product as purchased from the
manufacturer or wholesale distributor; and
new text end

new text begin (iv) in the case of a medical convenience kit that includes a product, the product is:
new text end

new text begin (A) an intravenous solution intended for the replenishment of fluids and electrolytes;
new text end

new text begin (B) a product intended to maintain the equilibrium of water and minerals in the body;
new text end

new text begin (C) a product intended for irrigation or reconstitution;
new text end

new text begin (D) an anesthetic;
new text end

new text begin (E) an anticoagulant;
new text end

new text begin (F) a vasopressor; or
new text end

new text begin (G) a sympathomimetic;
new text end

new text begin (14) the distribution of an intravenous product that, by its formulation, is intended for
the replenishment of fluids and electrolytes, such as sodium, chloride, and potassium; or
calories, such as dextrose and amino acids;
new text end

new text begin (15) the distribution of an intravenous product used to maintain the equilibrium of water
and minerals in the body, such as dialysis solutions;
new text end

new text begin (16) the distribution of a product that is intended for irrigation, or sterile water, whether
intended for such purposes or for injection;
new text end

new text begin (17) the distribution of a medical gas as defined in United States Code, title 21, section
360ddd; or
new text end

new text begin (18) the distribution or sale of any licensed product under United States Code, title 42,
section 262, that meets the definition of a device under United States Code, title 21, section
321(h).
new text end

new text begin Subd. 13. new text end

new text begin Wholesale distribution. new text end

new text begin "Wholesale distribution" means the distribution of
a drug to a person other than a consumer or patient, or receipt of a drug by a person other
than the consumer or patient, but does not include:
new text end

new text begin (1) intracompany distribution of any drug between members of an affiliate or within a
manufacturer;
new text end

new text begin (2) the distribution of a drug or an offer to distribute a drug among hospitals or other
health care entities that are under common control;
new text end

new text begin (3) the distribution of a drug or an offer to distribute a drug for emergency medical
reasons, including:
new text end

new text begin (i) a public health emergency declaration pursuant to United States Code, title 42, section
247d;
new text end

new text begin (ii) a national security or peacetime emergency declared by the governor pursuant to
section 12.31; or
new text end

new text begin (iii) a situation involving an action taken by the commissioner of health pursuant to
sections 144.4197, 144.4198 or 151.37, subdivisions 2, paragraph (b), and 10, except that,
for purposes of this paragraph, a drug shortage not caused by a public health emergency
shall not constitute an emergency medical reason;
new text end

new text begin (4) the dispensing of a drug pursuant to a valid prescription issued by a licensed
practitioner;
new text end

new text begin (5) the distribution of minimal quantities of a drug by a licensed retail pharmacy to a
licensed practitioner for office use;
new text end

new text begin (6) the distribution of a drug or an offer to distribute a drug by a charitable organization
to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
new text end

new text begin (7) the purchase or other acquisition by a dispenser, hospital, or other health care entity
of a drug for use by such dispenser, hospital, or other health care entity;
new text end

new text begin (8) the distribution of a drug by the manufacturer of such drug;
new text end

new text begin (9) the receipt or transfer of a drug by an authorized third-party logistics provider provided
that such third-party logistics provider does not take ownership of the drug;
new text end

new text begin (10) a common carrier that transports a drug, provided that the common carrier does not
take ownership of the drug;
new text end

new text begin (11) the distribution of a drug or an offer to distribute a drug by an authorized repackager
that has taken ownership or possession of the drug and repacks it in accordance with United
States Code, title 21, section 360eee-1(e);
new text end

new text begin (12) salable drug returns when conducted by a dispenser;
new text end

new text begin (13) the distribution of a collection of finished medical devices, which may include a
product or biological product, assembled in kit form strictly for the convenience of the
purchaser or user, referred to in this section as a medical convenience kit, if:
new text end

new text begin (i) the medical convenience kit is assembled in an establishment that is registered with
the Food and Drug Administration as a device manufacturer in accordance with United
States Code, title 21, section 360(b)(2);
new text end

new text begin (ii) the medical convenience kit does not contain a controlled substance that appears in
a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of
1970, United States Code, title 21, section 801, et seq.;
new text end

new text begin (iii) in the case of a medical convenience kit that includes a product, the person that
manufactures the kit:
new text end

new text begin (A) purchased such product directly from the pharmaceutical manufacturer or from a
wholesale distributor that purchased the product directly from the pharmaceutical
manufacturer; and
new text end

new text begin (B) does not alter the primary container or label of the product as purchased from the
manufacturer or wholesale distributor; and
new text end

new text begin (iv) in the case of a medical convenience kit that includes a product, the product is:
new text end

new text begin (A) an intravenous solution intended for the replenishment of fluids and electrolytes;
new text end

new text begin (B) a product intended to maintain the equilibrium of water and minerals in the body;
new text end

new text begin (C) a product intended for irrigation or reconstitution;
new text end

new text begin (D) an anesthetic;
new text end

new text begin (E) an anticoagulant;
new text end

new text begin (F) a vasopressor; or
new text end

new text begin (G) a sympathomimetic;
new text end

new text begin (14) the distribution of an intravenous drug that, by its formulation, is intended for the
replenishment of fluids and electrolytes, such as sodium, chloride, and potassium; or calories,
such as dextrose and amino acids;
new text end

new text begin (15) the distribution of an intravenous drug used to maintain the equilibrium of water
and minerals in the body, such as dialysis solutions;
new text end

new text begin (16) the distribution of a drug that is intended for irrigation, or sterile water, whether
intended for such purposes or for injection;
new text end

new text begin (17) the distribution of medical gas, as defined in United States Code, title 21, section
360ddd;
new text end

new text begin (18) facilitating the distribution of a product by providing solely administrative services,
including processing of orders and payments; or
new text end

new text begin (19) the transfer of a product by a hospital or other health care entity, or by a wholesale
distributor or manufacturer operating at the direction of the hospital or other health care
entity, to a repackager described in United States Code, title 21, section 360eee(16)(B), and
registered under United States Code, title 21, section 360, for the purpose of repackaging
the drug for use by that hospital, or other health care entity and other health care entities
that are under common control, if ownership of the drug remains with the hospital or other
health care entity at all times.
new text end

new text begin Subd. 14. new text end

new text begin Wholesale distributor. new text end

new text begin "Wholesale distributor" means a person engaged in
wholesale distribution but does not include a manufacturer, a manufacturer's co-licensed
partner, a third-party logistics provider, or a repackager.
new text end

Sec. 22.

Minnesota Statutes 2018, section 151.46, is amended to read:

151.46 PROHIBITED DRUG PURCHASES OR RECEIPT.

It is unlawful for any person to knowingly purchase or receive a prescription drug from
a source other than a person or entity licensed under the laws of the state, except where
otherwise provided. Licensed wholesale drug distributors deleted text begin other than pharmacies deleted text end new text begin and licensed
third-party logistics providers new text end shall not dispense or distribute deleted text begin prescription deleted text end drugs directly to
patients. A person violating the provisions of this section is guilty of a misdemeanor.

Sec. 23.

Minnesota Statutes 2018, section 151.47, subdivision 1, is amended to read:

Subdivision 1.

deleted text begin Requirements deleted text end new text begin Generally new text end .

deleted text begin (a) All wholesale drug distributors are subject
to the requirements of this subdivision. deleted text end new text begin Each manufacturer, repackager, wholesale distributor,
and dispenser shall comply with the requirements set forth in United States Code, title 21,
section 360eee-1, with respect to the role of such manufacturer, repackager, wholesale
distributor, or dispenser in a transaction involving a product. If an entity meets the definition
of more than one of the entities listed in the preceding sentence, such entity shall comply
with all applicable requirements in United States Code, title 21, section 360eee-1, but shall
not be required to duplicate requirements.
new text end

deleted text begin (b) No person or distribution outlet shall act as a wholesale drug distributor without first
obtaining a license from the board and paying any applicable fee specified in section 151.065.
deleted text end

deleted text begin (c) Application for a wholesale drug distributor license under this section shall be made
in a manner specified by the board.
deleted text end

deleted text begin (d) No license shall be issued or renewed for a wholesale drug distributor to operate
unless the applicant agrees to operate in a manner prescribed by federal and state law and
according to the rules adopted by the board.
deleted text end

deleted text begin (e) No license may be issued or renewed for a drug wholesale distributor that is required
to be licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of licensure or registration. The board may establish, by rule,
standards for the licensure of a drug wholesale distributor that is not required to be licensed
or registered by the state in which it is physically located.
deleted text end

deleted text begin (f) The board shall require a separate license for each drug wholesale distributor facility
located within the state and for each drug wholesale distributor facility located outside of
the state from which drugs are shipped into the state or to which drugs are reverse distributed.
deleted text end

deleted text begin (g) The board shall not issue an initial or renewed license for a drug wholesale distributor
facility unless the facility passes an inspection conducted by an authorized representative
of the board, or is accredited by an accreditation program approved by the board. In the
case of a drug wholesale distributor facility located outside of the state, the board may
require the applicant to pay the cost of the inspection, in addition to the license fee in section
151.065, unless the applicant furnishes the board with a report, issued by the appropriate
regulatory agency of the state in which the facility is located, of an inspection that has
occurred within the 24 months immediately preceding receipt of the license application by
the board, or furnishes the board with proof of current accreditation. The board may deny
licensure unless the applicant submits documentation satisfactory to the board that any
deficiencies noted in an inspection report have been corrected.
deleted text end

deleted text begin (h) As a condition for receiving and retaining a wholesale drug distributor license issued
under sections 151.42 to 151.51, an applicant shall satisfy the board that it has and will
continuously maintain:
deleted text end

deleted text begin (1) adequate storage conditions and facilities;
deleted text end

deleted text begin (2) minimum liability and other insurance as may be required under any applicable
federal or state law;
deleted text end

deleted text begin (3) a viable security system that includes an after hours central alarm, or comparable
entry detection capability; restricted access to the premises; comprehensive employment
applicant screening; and safeguards against all forms of employee theft;
deleted text end

deleted text begin (4) a system of records describing all wholesale drug distributor activities set forth in
section 151.44 for at least the most recent two-year period, which shall be reasonably
accessible as defined by board regulations in any inspection authorized by the board;
deleted text end

deleted text begin (5) principals and persons, including officers, directors, primary shareholders, and key
management executives, who must at all times demonstrate and maintain their capability
of conducting business in conformity with sound financial practices as well as state and
federal law;
deleted text end

deleted text begin (6) complete, updated information, to be provided to the board as a condition for obtaining
and retaining a license, about each wholesale drug distributor to be licensed, including all
pertinent corporate licensee information, if applicable, or other ownership, principal, key
personnel, and facilities information found to be necessary by the board;
deleted text end

deleted text begin (7) written policies and procedures that assure reasonable wholesale drug distributor
preparation for, protection against, and handling of any facility security or operation
problems, including, but not limited to, those caused by natural disaster or government
emergency, inventory inaccuracies or product shipping and receiving, outdated product or
other unauthorized product control, appropriate disposition of returned goods, and product
recalls;
deleted text end

deleted text begin (8) sufficient inspection procedures for all incoming and outgoing product shipments;
and
deleted text end

deleted text begin (9) operations in compliance with all federal requirements applicable to wholesale drug
distribution.
deleted text end

deleted text begin (i) An agent or employee of any licensed wholesale drug distributor need not seek
licensure under this section.
deleted text end

Sec. 24.

Minnesota Statutes 2018, section 151.47, is amended by adding a subdivision to
read:

new text begin Subd. 1a. new text end

new text begin Licensing. new text end

new text begin (a) The board shall license wholesale distributors in a manner that
is consistent with United States Code, title 21, section 360eee-2, and the regulations
promulgated thereunder. In the event that the provisions of this section, or of the rules of
the board, conflict with the provisions of United States Code, title 21, section 360eee-2, or
the rules promulgated thereunder, the federal provisions shall prevail. The board shall not
license a person as a wholesale distributor unless the person is engaged in wholesale
distribution.
new text end

new text begin (b) No person shall act as a wholesale distributor without first obtaining a license from
the board and paying any applicable fee specified in section 151.065.
new text end

new text begin (c) Application for a wholesale distributor license under this section shall be made in a
manner specified by the board.
new text end

new text begin (d) No license shall be issued or renewed for a wholesale distributor unless the applicant
agrees to operate in a manner prescribed by federal and state law and according to the rules
adopted by the board.
new text end

new text begin (e) No license may be issued or renewed for a wholesale distributor facility that is located
in another state unless the applicant supplies the board with proof of licensure or registration
by the state in which the wholesale distributor is physically located or by the United States
Food and Drug Administration.
new text end

new text begin (f) The board shall require a separate license for each drug wholesale distributor facility
located within the state and for each drug wholesale distributor facility located outside of
the state from which drugs are shipped into the state or to which drugs are reverse distributed.
new text end

new text begin (g) The board shall not issue an initial or renewed license for a drug wholesale distributor
facility unless the facility passes an inspection conducted by an authorized representative
of the board or is inspected and accredited by an accreditation program approved by the
board. In the case of a drug wholesale distributor facility located outside of the state, the
board may require the applicant to pay the cost of the inspection, in addition to the license
fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
appropriate regulatory agency of the state in which the facility is located, of an inspection
that has occurred within the 24 months immediately preceding receipt of the license
application by the board, or furnishes the board with proof of current accreditation. The
board may deny licensure unless the applicant submits documentation satisfactory to the
board that any deficiencies noted in an inspection report have been corrected.
new text end

new text begin (h) As a condition for receiving and retaining a wholesale drug distributor license issued
under this section, an applicant shall satisfy the board that it:
new text end

new text begin (1) has adequate storage conditions and facilities to allow for the safe receipt, storage,
handling, and sale of drugs;
new text end

new text begin (2) has minimum liability and other insurance as may be required under any applicable
federal or state law;
new text end

new text begin (3) has a functioning security system that includes an after-hours central alarm or
comparable entry detection capability, and security policies and procedures that include
provisions for restricted access to the premises, comprehensive employee applicant screening,
and safeguards against all forms of employee theft;
new text end

new text begin (4) will maintain appropriate records of the distribution of drugs, which shall be kept
for a minimum of two years and be made available to the board upon request;
new text end

new text begin (5) employs principals and other persons, including officers, directors, primary
shareholders, and key management executives, who will at all times demonstrate and maintain
their capability of conducting business in conformity with state and federal law, at least one
of whom will serve as the primary designated representative for each licensed facility and
who will be responsible for ensuring that the facility operates in a manner consistent with
state and federal law;
new text end

new text begin (6) will ensure that all personnel have sufficient education, training, and experience, in
any combination, so that they may perform assigned duties in a manner that maintains the
quality, safety, and security of drugs;
new text end

new text begin (7) will provide the board with updated information about each wholesale distributor
facility to be licensed, as requested by the board;
new text end

new text begin (8) will develop and, as necessary, update written policies and procedures that assure
reasonable wholesale drug distributor preparation for, protection against, and handling of
any facility security or operation problems, including but not limited to those caused by
natural disaster or government emergency, inventory inaccuracies or drug shipping and
receiving, outdated drugs, appropriate handling of returned goods, and drug recalls;
new text end

new text begin (9) will have sufficient policies and procedures in place for the inspection of all incoming
and outgoing drug shipments;
new text end

new text begin (10) will operate in compliance with all state and federal requirements applicable to
wholesale drug distribution; and
new text end

new text begin (11) will meet the requirements for inspections found in this subdivision.
new text end

new text begin (i) An agent or employee of any licensed wholesale drug distributor need not seek
licensure under this section. Paragraphs (i) to (p) apply to wholesaler personnel.
new text end

new text begin (j) The board is authorized to and shall require fingerprint-based criminal background
checks of facility managers or designated representatives, as required under United States
Code, title 21, section 360eee-2. The criminal background checks shall be conducted as
provided in section 214.075. The board shall use the criminal background check data received
to evaluate the qualifications of persons for ownership of or employment by a licensed
wholesaler and shall not disseminate this data except as allowed by law.
new text end

new text begin (k) A licensed wholesaler shall not be owned by, or employ, a person who has:
new text end

new text begin (1) been convicted of any felony for conduct relating to wholesale distribution, any
felony violation of United States Code, title 21, section 331, subsections (i) or (k), or any
felony violation of United States Code, title 18, section 1365, relating to product tampering;
or
new text end

new text begin (2) engaged in a pattern of violating the requirements of United States Code, title 21,
section 360eee-2, or the regulations promulgated thereunder, or state requirements for
licensure, that presents a threat of serious adverse health consequences or death to humans.
new text end

new text begin (l) An applicant for the issuance or renewal of a wholesale distributor license shall
execute and file with the board a surety bond.
new text end

new text begin (m) Prior to issuing or renewing a wholesale distributor license, the board shall require
an applicant that is not a government owned and operated wholesale distributor to submit
a surety bond of $100,000, except that if the annual gross receipts of the applicant for the
previous tax year is $10,000,000 or less, a surety bond of $25,000 shall be required.
new text end

new text begin (n) If a wholesale distributor can provide evidence satisfactory to the board that it
possesses the required bond in another state, the requirement for a bond shall be waived.
new text end

new text begin (o) The purpose of the surety bond required under this subdivision is to secure payment
of any civil penalty imposed by the board pursuant to section 151.071, subdivision 1. The
board may make a claim against the bond if the licensee fails to pay a civil penalty within
30 days after the order imposing the fine or costs become final.
new text end

new text begin (p) A single surety bond shall satisfy the requirement for the submission of a bond for
all licensed wholesale distributor facilities under common ownership.
new text end

Sec. 25.

new text begin [151.471] THIRD-PARTY LOGISTICS PROVIDER REQUIREMENTS.
new text end

new text begin Subdivision 1. new text end

new text begin Generally. new text end

new text begin Each third-party logistics provider shall comply with the
requirements set forth in United States Code, title 21, section 360eee to 360eee-4, that are
applicable to third-party logistics providers.
new text end

new text begin Subd. 2. new text end

new text begin Licensing. new text end

new text begin (a) The board shall license third-party logistics providers in a manner
that is consistent with United States Code, title 21, section 360eee-3, and the regulations
promulgated thereunder. In the event that the provisions of this section or of the rules of
the board conflict with the provisions of United States Code, title 21, section 360eee-3, or
the rules promulgated thereunder, the federal provisions shall prevail. The board shall not
license a person as a third-party logistics provider unless the person is operating as such.
new text end

new text begin (b) No person shall act as a third-party logistics provider without first obtaining a license
from the board and paying any applicable fee specified in section 151.065.
new text end

new text begin (c) Application for a third-party logistics provider license under this section shall be
made in a manner specified by the board.
new text end

new text begin (d) No license shall be issued or renewed for a third-party logistics provider unless the
applicant agrees to operate in a manner prescribed by federal and state law and according
to the rules adopted by the board.
new text end

new text begin (e) No license may be issued or renewed for a third-party logistics provider facility that
is located in another state unless the applicant supplies the board with proof of licensure or
registration by the state in which the third-party logistics provider facility is physically
located or by the United States Food and Drug Administration.
new text end

new text begin (f) The board shall require a separate license for each third-party logistics provider
facility located within the state and for each third-party logistics provider facility located
outside of the state from which drugs are shipped into the state or to which drugs are reverse
distributed.
new text end

new text begin (g) The board shall not issue an initial or renewed license for a third-party logistics
provider facility unless the facility passes an inspection conducted by an authorized
representative of the board or is inspected and accredited by an accreditation program
approved by the board. In the case of a third-party logistics provider facility located outside
of the state, the board may require the applicant to pay the cost of the inspection, in addition
to the license fee in section 151.065, unless the applicant furnishes the board with a report,
issued by the appropriate regulatory agency of the state in which the facility is located, of
an inspection that has occurred within the 24 months immediately preceding receipt of the
license application by the board, or furnishes the board with proof of current accreditation.
The board may deny licensure unless the applicant submits documentation satisfactory to
the board that any deficiencies noted in an inspection report have been corrected.
new text end

new text begin (h) As a condition for receiving and retaining a third-party logistics provider facility
license issued under this section, an applicant shall satisfy the board that it:
new text end

new text begin (1) has adequate storage conditions and facilities to allow for the safe receipt, storage,
handling, and transfer of drugs;
new text end

new text begin (2) has minimum liability and other insurance as may be required under any applicable
federal or state law;
new text end

new text begin (3) has a functioning security system that includes an after-hours central alarm or
comparable entry detection capability, and security policies and procedures that include
provisions for restricted access to the premises, comprehensive employee applicant screening,
and safeguards against all forms of employee theft;
new text end

new text begin (4) will maintain appropriate records of the handling of drugs, which shall be kept for
a minimum of two years and be made available to the board upon request;
new text end

new text begin (5) employs principals and other persons, including officers, directors, primary
shareholders, and key management executives, who will at all times demonstrate and maintain
their capability of conducting business in conformity with state and federal law, at least one
of whom will serve as the primary designated representative for each licensed facility and
who will be responsible for ensuring that the facility operates in a manner consistent with
state and federal law;
new text end

new text begin (6) will ensure that all personnel have sufficient education, training, and experience, in
any combination, so that they may perform assigned duties in a manner that maintains the
quality, safety, and security of drugs;
new text end

new text begin (7) will provide the board with updated information about each third-party logistics
provider facility to be licensed by the board;
new text end

new text begin (8) will develop and, as necessary, update written policies and procedures that ensure
reasonable preparation for, protection against, and handling of any facility security or
operation problems, including, but not limited to, those caused by natural disaster or
government emergency, inventory inaccuracies or drug shipping and receiving, outdated
drug, appropriate handling of returned goods, and drug recalls;
new text end

new text begin (9) will have sufficient policies and procedures in place for the inspection of all incoming
and outgoing drug shipments;
new text end

new text begin (10) will operate in compliance with all state and federal requirements applicable to
third-party logistics providers; and
new text end

new text begin (11) will meet the requirements for inspections found in this subdivision.
new text end

new text begin (i) An agent or employee of any licensed third-party logistics provider need not seek
licensure under this section. Paragraphs (j) and (k) apply to third-party logistics provider
personnel.
new text end

new text begin (j) The board is authorized to and shall require fingerprint-based criminal background
checks of facility managers or designated representatives. The criminal background checks
shall be conducted as provided in section 214.075. The board shall use the criminal
background check data received to evaluate the qualifications of persons for ownership of
or employment by a licensed third-party logistics provider and shall not disseminate this
data except as allowed by law.
new text end

new text begin (k) A licensed third-party logistics provider shall not have as a facility manager or
designated representative any person who has been convicted of any felony for conduct
relating to wholesale distribution, any felony violation of United States Code, title 21, section
331, subsection (i) or (k), or any felony violation of United States Code, title 18, section
1365, relating to product tampering.
new text end

Sec. 26. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2018, sections 151.42; 151.44; 151.49; 151.50; 151.51; and 151.55, new text end new text begin
are repealed.
new text end

APPENDIX

Repealed Minnesota Statutes: H1718-1

151.42 CITATION.

Sections 151.42 to 151.51 may be cited as the "Wholesale Drug Distribution Licensing Act of 1990."

151.44 DEFINITIONS.

As used in sections 151.43 to 151.51, the following terms have the meanings given in paragraphs (a) to (h):

(a) "Wholesale drug distribution" means distribution of prescription or nonprescription drugs to persons other than a consumer or patient or reverse distribution of such drugs, but does not include:

(1) a sale between a division, subsidiary, parent, affiliated, or related company under the common ownership and control of a corporate entity;

(2) the purchase or other acquisition, by a hospital or other health care entity that is a member of a group purchasing organization, of a drug for its own use from the organization or from other hospitals or health care entities that are members of such organizations;

(3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1986, as amended through December 31, 1988, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(4) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control;

(5) the sale, purchase, or trade of a drug or offer to sell, purchase, or trade a drug for emergency medical reasons;

(6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;

(7) the transfer of prescription or nonprescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;

(8) the distribution of prescription or nonprescription drug samples by manufacturers representatives; or

(9) the sale, purchase, or trade of blood and blood components.

(b) "Wholesale drug distributor" means anyone engaged in wholesale drug distribution including, but not limited to, manufacturers; repackagers; own-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and pharmacies that conduct wholesale drug distribution. A wholesale drug distributor does not include a common carrier or individual hired primarily to transport prescription or nonprescription drugs.

(c) "Manufacturer" has the meaning provided in section 151.01, subdivision 14a.

(d) "Prescription drug" means a drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to United States Code, title 21, sections 811 and 812.

(e) "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(f) "Blood components" means that part of blood separated by physical or mechanical means.

(g) "Reverse distribution" means the receipt of prescription or nonprescription drugs received from or shipped to Minnesota locations for the purpose of returning the drugs to their producers or distributors.

(h) "Reverse distributor" means a person engaged in the reverse distribution of drugs.

151.49 LICENSE RENEWAL APPLICATION PROCEDURES.

Application blanks or notices for renewal of a license required by sections 151.42 to 151.51 shall be mailed or otherwise provided to each licensee on or before the first day of the month prior to the month in which the license expires and, if application for renewal of the license with the required fee and supporting documents is not made before the expiration date, the existing license or renewal shall lapse and become null and void upon the date of expiration.

151.50 RULES.

The board shall adopt rules to carry out the purposes and enforce the provisions of sections 151.42 to 151.51. All rules adopted under this section shall conform to wholesale drug distributor licensing guidelines formally adopted by the United States Food and Drug Administration; and in case of conflict between a rule adopted by the board and a Food and Drug Administration wholesale drug distributor guideline, the latter shall control.

151.51 BOARD ACCESS TO WHOLESALE DRUG DISTRIBUTOR RECORDS.

Wholesale drug distributors may keep records at a central location apart from the principal office of the wholesale drug distributor or the location at which the drugs were stored and from which they were shipped, provided that the records shall be made available for inspection within two working days of a request by the board. The records may be kept in any form permissible under federal law applicable to prescription drugs record keeping.

151.55 CANCER DRUG REPOSITORY PROGRAM.

Subdivision 1.

Definitions.

(a) For the purposes of this section, the terms defined in this subdivision have the meanings given.

(b) "Board" means the Board of Pharmacy.

(c) "Cancer drug" means a prescription drug that is used to treat:

(1) cancer or the side effects of cancer; or

(2) the side effects of any prescription drug that is used to treat cancer or the side effects of cancer.

(d) "Cancer drug repository" means a medical facility or pharmacy that has notified the board of its election to participate in the cancer drug repository program.

(e) "Cancer supply" or "supplies" means prescription and nonprescription cancer supplies needed to administer a cancer drug.

(f) "Dispense" has the meaning given in section 151.01, subdivision 30.

(g) "Distribute" means to deliver, other than by administering or dispensing.

(h) "Donor" means an individual and not a drug manufacturer or wholesale drug distributor who donates a cancer drug or supply according to the requirements of the cancer drug repository program.

(i) "Medical facility" means an institution defined in section 144.50, subdivision 2.

(j) "Medical supplies" means any prescription and nonprescription medical supply needed to administer a cancer drug.

(k) "Pharmacist" has the meaning given in section 151.01, subdivision 3.

(l) "Pharmacy" means any pharmacy registered with the Board of Pharmacy according to section 151.19, subdivision 1.

(m) "Practitioner" has the meaning given in section 151.01, subdivision 23.

(n) "Prescription drug" means a legend drug as defined in section 151.01, subdivision 17.

(o) "Side effects of cancer" means symptoms of cancer.

(p) "Single-unit-dose packaging" means a single-unit container for articles intended for administration as a single dose, direct from the container.

(q) "Tamper-evident unit dose packaging" means a container within which a drug is sealed so that the contents cannot be opened without obvious destruction of the seal.

Subd. 2.

Establishment.

The Board of Pharmacy shall establish and maintain a cancer drug repository program, under which any person may donate a cancer drug or supply for use by an individual who meets the eligibility criteria specified under subdivision 4. Under the program, donations may be made on the premises of a medical facility or pharmacy that elects to participate in the program and meets the requirements specified under subdivision 3.

Subd. 3.

Requirements for participation by pharmacies and medical facilities.

(a) To be eligible for participation in the cancer drug repository program, a pharmacy or medical facility must be licensed and in compliance with all applicable federal and state laws and administrative rules.

(b) Participation in the cancer drug repository program is voluntary. A pharmacy or medical facility may elect to participate in the cancer drug repository program by submitting the following information to the board, in a form provided by the board:

(1) the name, street address, and telephone number of the pharmacy or medical facility;

(2) the name and telephone number of a pharmacist who is employed by or under contract with the pharmacy or medical facility, or other contact person who is familiar with the pharmacy's or medical facility's participation in the cancer drug repository program; and

(3) a statement indicating that the pharmacy or medical facility meets the eligibility requirements under paragraph (a) and the chosen level of participation under paragraph (c).

(c) A pharmacy or medical facility may fully participate in the cancer drug repository program by accepting, storing, and dispensing or administering donated drugs and supplies, or may limit its participation to only accepting and storing donated drugs and supplies. If a pharmacy or facility chooses to limit its participation, the pharmacy or facility shall distribute any donated drugs to a fully participating cancer drug repository according to subdivision 8.

(d) A pharmacy or medical facility may withdraw from participation in the cancer drug repository program at any time upon notification to the board. A notice to withdraw from participation may be given by telephone or regular mail.

Subd. 4.

Individual eligibility requirements.

Any Minnesota resident who is diagnosed with cancer is eligible to receive drugs or supplies under the cancer drug repository program. Drugs and supplies shall be dispensed or administered according to the priority given under subdivision 6, paragraph (d).

Subd. 5.

Donations of cancer drugs and supplies.

(a) Any one of the following persons may donate legally obtained cancer drugs or supplies to a cancer drug repository, if the drugs or supplies meet the requirements under paragraph (b) or (c) as determined by a pharmacist who is employed by or under contract with a cancer drug repository:

(1) an individual who is 18 years old or older; or

(2) a pharmacy, medical facility, drug manufacturer, or wholesale drug distributor, if the donated drugs have not been previously dispensed.

(b) A cancer drug is eligible for donation under the cancer drug repository program only if the following requirements are met:

(1) the donation is accompanied by a cancer drug repository donor form described under paragraph (d) that is signed by the person making the donation or that person's authorized representative;

(2) the drug's expiration date is at least six months later than the date that the drug was donated;

(3) the drug is in its original, unopened, tamper-evident unit dose packaging that includes the drug's lot number and expiration date. Single-unit dose drugs may be accepted if the single-unit-dose packaging is unopened; and

(4) the drug is not adulterated or misbranded.

(c) Cancer supplies are eligible for donation under the cancer drug repository program only if the following requirements are met:

(1) the supplies are not adulterated or misbranded;

(2) the supplies are in their original, unopened, sealed packaging; and

(3) the donation is accompanied by a cancer drug repository donor form described under paragraph (d) that is signed by the person making the donation or that person's authorized representative.

(d) The cancer drug repository donor form must be provided by the board and shall state that to the best of the donor's knowledge the donated drug or supply has been properly stored and that the drug or supply has never been opened, used, tampered with, adulterated, or misbranded. The board shall make the cancer drug repository donor form available on the Board of Pharmacy's website.

(e) Controlled substances and drugs and supplies that do not meet the criteria under this subdivision are not eligible for donation or acceptance under the cancer drug repository program.

(f) Drugs and supplies may be donated on the premises of a cancer drug repository to a pharmacist designated by the repository. A drop box may not be used to deliver or accept donations.

(g) Cancer drugs and supplies donated under the cancer drug repository program must be stored in a secure storage area under environmental conditions appropriate for the drugs or supplies being stored. Donated drugs and supplies may not be stored with nondonated inventory.

Subd. 6.

Dispensing requirements.

(a) Drugs and supplies must be dispensed by a licensed pharmacist pursuant to a prescription by a practitioner or may be dispensed or administered by a practitioner according to the requirements of this chapter and within the practitioner's scope of practice.

(b) Cancer drugs and supplies shall be visually inspected by the pharmacist or practitioner before being dispensed or administered for adulteration, misbranding, and date of expiration. Drugs or supplies that have expired or appear upon visual inspection to be adulterated, misbranded, or tampered with in any way may not be dispensed or administered.

(c) Before a cancer drug or supply may be dispensed or administered to an individual, the individual must sign a cancer drug repository recipient form provided by the board acknowledging that the individual understands the information stated on the form. The form shall include the following information:

(1) that the drug or supply being dispensed or administered has been donated and may have been previously dispensed;

(2) that a visual inspection has been conducted by the pharmacist or practitioner to ensure that the drug has not expired, has not been adulterated or misbranded, and is in its original, unopened packaging; and

(3) that the dispensing pharmacist, the dispensing or administering practitioner, the cancer drug repository, the Board of Pharmacy, and any other participant of the cancer drug repository program cannot guarantee the safety of the drug or supply being dispensed or administered and that the pharmacist or practitioner has determined that the drug or supply is safe to dispense or administer based on the accuracy of the donor's form submitted with the donated drug or supply and the visual inspection required to be performed by the pharmacist or practitioner before dispensing or administering.

The board shall make the cancer drug repository form available on the Board of Pharmacy's website.

(d) Drugs and supplies shall only be dispensed or administered to individuals who meet the eligibility requirements in subdivision 4 and in the following order of priority:

(1) individuals who are uninsured;

(2) individuals who are enrolled in medical assistance, MinnesotaCare, Medicare, or other public assistance health care; and

(3) all other individuals who are otherwise eligible under subdivision 4 to receive drugs or supplies from a cancer drug repository.

Subd. 7.

Handling fees.

A cancer drug repository may charge the individual receiving a drug or supply a handling fee of no more than 250 percent of the medical assistance program dispensing fee for each cancer drug or supply dispensed or administered.

Subd. 8.

Distribution of donated cancer drugs and supplies.

(a) Cancer drug repositories may distribute drugs and supplies donated under the cancer drug repository program to other repositories if requested by a participating repository.

(b) A cancer drug repository that has elected not to dispense donated drugs or supplies shall distribute any donated drugs and supplies to a participating repository upon request of the repository.

(c) If a cancer drug repository distributes drugs or supplies under paragraph (a) or (b), the repository shall complete a cancer drug repository donor form provided by the board. The completed form and a copy of the donor form that was completed by the original donor under subdivision 5 shall be provided to the fully participating cancer drug repository at the time of distribution.

Subd. 9.

Resale of donated drugs or supplies.

Donated drugs and supplies may not be resold.

Subd. 10.

Record-keeping requirements.

(a) Cancer drug repository donor and recipient forms shall be maintained for at least five years.

(b) A record of destruction of donated drugs and supplies that are not dispensed under subdivision 6 shall be maintained by the dispensing repository for at least five years. For each drug or supply destroyed, the record shall include the following information:

(1) the date of destruction;

(2) the name, strength, and quantity of the cancer drug destroyed;

(3) the name of the person or firm that destroyed the drug; and

(4) the source of the drugs or supplies destroyed.

Subd. 11.

Liability.

(a) The manufacturer of a drug or supply is not subject to criminal or civil liability for injury, death, or loss to a person or to property for causes of action described in clauses (1) and (2). A manufacturer is not liable for:

(1) the intentional or unintentional alteration of the drug or supply by a party not under the control of the manufacturer; or

(2) the failure of a party not under the control of the manufacturer to transfer or communicate product or consumer information or the expiration date of the donated drug or supply.

(b) A medical facility or pharmacy participating in the program, a pharmacist dispensing a drug or supply pursuant to the program, a practitioner dispensing or administering a drug or supply pursuant to the program, or a donor of a cancer drug or supply as defined in subdivision 1 is immune from civil liability for an act or omission that causes injury to or the death of an individual to whom the cancer drug or supply is dispensed and no disciplinary action shall be taken against a pharmacist or practitioner so long as the drug or supply is donated, accepted, distributed, and dispensed according to the requirements of this section. This immunity does not apply if the act or omission involves reckless, wanton, or intentional misconduct, or malpractice unrelated to the quality of the cancer drug or supply.