Skip to main content Skip to office menu Skip to footer
Minnesota Legislature

Office of the Revisor of Statutes

HF 1217

2nd Engrossment - 86th Legislature (2009 - 2010) Posted on 02/22/2010 01:36pm

KEY: stricken = removed, old language.
underscored = added, new language.
Line numbers 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10
1.11
1.12 1.13 1.14
1.15
1.16 1.17 1.18 1.19 1.20 1.21 1.22 1.23 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 2.23 2.24 2.25 2.26 2.27 2.28 2.29 2.30 2.31 2.32 2.33 2.34 2.35 2.36 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 3.19 3.20
3.21
3.22 3.23 3.24 3.25 3.26 3.27 3.28 3.29 3.30 3.31 3.32 3.33 3.34 3.35 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 4.21 4.22 4.23 4.24 4.25 4.26
4.27
4.28 4.29 4.30 4.31 4.32 4.33 4.34 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17 5.18 5.19 5.20 5.21 5.22 5.23 5.24 5.25 5.26 5.27 5.28 5.29 5.30 5.31 5.32 5.33 5.34 5.35
5.36
6.1 6.2 6.3 6.4 6.5
6.6
6.7 6.8 6.9 6.10 6.11 6.12 6.13 6.14 6.15 6.16 6.17 6.18 6.19 6.20 6.21 6.22 6.23 6.24 6.25 6.26 6.27 6.28 6.29 6.30 6.31 6.32 6.33 6.34 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8
7.9
7.10 7.11 7.12 7.13 7.14 7.15 7.16
7.17 7.18 7.19 7.20 7.21 7.22 7.23 7.24 7.25 7.26 7.27 7.28 7.29 7.30 7.31 7.32 8.1 8.2 8.3 8.4 8.5
8.6
8.7 8.8 8.9 8.10 8.11 8.12 8.13 8.14 8.15 8.16 8.17
8.18 8.19 8.20 8.21 8.22 8.23 8.24 8.25 8.26 8.27 8.28 8.29 8.30 8.31 8.32 8.33
9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11 9.12 9.13 9.14 9.15 9.16 9.17 9.18 9.19 9.20 9.21 9.22 9.23 9.24 9.25 9.26 9.27 9.28
9.29
9.30
9.31 9.32 9.33 9.34 10.1 10.2 10.3 10.4 10.5 10.6 10.7
10.8 10.9 10.10
10.11 10.12 10.13 10.14 10.15 10.16 10.17 10.18 10.19 10.20 10.21 10.22 10.23 10.24 10.25 10.26 10.27
10.28
10.29 10.30 10.31 10.32 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 11.10
11.11
11.12 11.13 11.14 11.15 11.16 11.17 11.18 11.19 11.20 11.21 11.22 11.23 11.24 11.25 11.26 11.27 11.28 11.29 11.30 11.31 11.32 11.33 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 12.9 12.10 12.11 12.12 12.13 12.14 12.15 12.16 12.17 12.18 12.19 12.20 12.21 12.22 12.23 12.24 12.25 12.26
12.27

A bill for an act
relating to solid waste; requiring drug producers to register and pay a fee;
providing for a drug collection program funded by drug producers; requiring
reports; creating an account; providing penalties; expanding categories of
persons allowed to possess legend and nonprescription drugs to include those
disposing of them; modifying definitions; prohibiting flushing drugs into sewer
system by health care facilities; appropriating money; amending Minnesota
Statutes 2008, sections 151.37, subdivisions 6, 7; 151.44; proposing coding for
new law in Minnesota Statutes, chapters 115A; 144.

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

ARTICLE 1

Section 1.

new text begin [115A.1410] TITLE.
new text end

new text begin Sections 115A.1410 to 115A.1420 may be cited as the "Minnesota Safe Drug
Disposal Act of 2010."
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 2.

new text begin [115A.1411] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Scope. new text end

new text begin For the purposes of sections 115A.1410 to 115A.1420, the
terms in this section have the meanings given.
new text end

new text begin Subd. 2. new text end

new text begin Covered product. new text end

new text begin "Covered product" means all prescription drugs and all
nonprescription drugs, including both brand name and generic drugs.
new text end

new text begin Subd. 3. new text end

new text begin Controlled substance. new text end

new text begin "Controlled substance" means a substance listed
in section 152.02 or a substance designated by the Minnesota State Board of Pharmacy
under section 152.02, subdivision 7, 8, or 12.
new text end

new text begin Subd. 4. new text end

new text begin Drug wholesaler. new text end

new text begin "Drug wholesaler" has the meaning given wholesale
drug distributor in section 151.44, paragraph (b).
new text end

new text begin Subd. 5. new text end

new text begin Drugs. new text end

new text begin "Drugs" means:
new text end

new text begin (1) articles recognized in the official United States pharmacopoeia, the official
national formulary, the official homeopathic pharmacopoeia of the United States, or any
supplement of the formulary or those pharmacopoeias;
new text end

new text begin (2) substances intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans;
new text end

new text begin (3) substances, other than food, intended to affect the structure or any function of
the body of humans; or
new text end

new text begin (4) substances intended for use as a component of any substances specified in this
subdivision, but not including medical devices or their component parts or accessories.
new text end

new text begin Subd. 6. new text end

new text begin Entity. new text end

new text begin "Entity" means a person other than an individual.
new text end

new text begin Subd. 7. new text end

new text begin Generic drug. new text end

new text begin "Generic drug" means a drug that is chemically identical
or bioequivalent to a brand name drug in dosage form, safety, strength, route of
administration, quality, performance characteristics, and intended use, though inactive
ingredients may vary.
new text end

new text begin Subd. 8. new text end

new text begin Mail-back program. new text end

new text begin "Mail-back program" means a system whereby
residential generators of unwanted products obtain prepaid and preaddressed mailing
envelopes in which to place unwanted products for shipment to an entity that will dispose
of them safely and legally.
new text end

new text begin Subd. 9. new text end

new text begin Nonprescription drug. new text end

new text begin "Nonprescription drug" means any drug that
may be lawfully sold without a prescription.
new text end

new text begin Subd. 10. new text end

new text begin Notification. new text end

new text begin "Notification" means a document required under section
115A.1413 that describes the elements of a program and the manner in which it will be
provided.
new text end

new text begin Subd. 11. new text end

new text begin Person. new text end

new text begin "Person" means an individual, firm, sole proprietorship,
corporation, limited liability company, general partnership, limited partnership, limited
liability partnership, association, cooperative, or other legal entity, however organized.
new text end

new text begin Subd. 12. new text end

new text begin Prescription drug. new text end

new text begin "Prescription drug" has the meaning given in section
151.44, paragraph (d).
new text end

new text begin Subd. 13. new text end

new text begin Producer. new text end

new text begin (a) "Producer" means a person who has legal ownership of the
brand, brand name, or co-brand of a covered product or manufactures a generic covered
product sold in Minnesota.
new text end

new text begin (b) Producer does not include a retailer who:
new text end

new text begin (1) puts its store label on a covered product;
new text end

new text begin (2) imports a covered product branded or manufactured by a producer who meets the
requirements of paragraph (a) and who has no physical presence in the United States; or
new text end

new text begin (3) sells at wholesale a covered product, does not have legal ownership of the brand,
and elects to fulfill the responsibilities of the producer for that product.
new text end

new text begin Subd. 14. new text end

new text begin Product stewardship organization. new text end

new text begin "Product stewardship organization"
means an organization designated by a group of producers to act as an agent on behalf of
each producer to operate a program in this state.
new text end

new text begin Subd. 15. new text end

new text begin Program. new text end

new text begin "Program" means a program operated by a county, a producer,
a group of producers, or a product stewardship organization to collect, transport, and
provide for the final disposition of unwanted products.
new text end

new text begin Subd. 16. new text end

new text begin Residential generators. new text end

new text begin "Residential generators" means single- and
multiple-family residences and locations where drugs are unused, unwanted, discarded, or
abandoned, such as hospice services, nursing homes, boarding care homes, schools, foster
care, day care, and other locations where people reside on a temporary or permanent basis.
Residential generators do not include airport security, drug seizures by law enforcement,
pharmacy waste, business waste, or any other source identified by the agency as a
nonresidential source.
new text end

new text begin Subd. 17. new text end

new text begin Unwanted product. new text end

new text begin "Unwanted product" means a covered product no
longer wanted by its owner or that has been abandoned, discarded, or is intended to be
discarded by its owner.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 3.

new text begin [115A.1412] REGISTRATION; FEE.
new text end

new text begin Subdivision 1. new text end

new text begin Requirement for sale. new text end

new text begin On or after January 1, 2011, a producer may
not sell or offer for sale in this state a covered product unless the producer has filed a
registration with the agency under subdivision 2 and paid a registration fee, unless the
producer is exempt from the fee under subdivision 3, paragraph (c).
new text end

new text begin Subd. 2. new text end

new text begin Producer's registration. new text end

new text begin (a) A producer of covered products must, before
January 1, 2011, submit a registration to the agency that includes:
new text end

new text begin (1) a list of the producer's brands of drugs offered for sale in this state;
new text end

new text begin (2) the name, address, and contact information of a person responsible for ensuring
compliance with sections 115A.1410 to 115A.1420; and
new text end

new text begin (3) an estimate of the revenues from sales of covered products in this state during the
previous calendar year.
new text end

new text begin (b) A producer who begins to sell or offer for sale covered products in this state after
January 1, 2011, and has not filed a registration under this subdivision must submit a
registration to the agency within ten days of beginning to sell or offer for sale covered
products.
new text end

new text begin (c) A registration must be updated within 60 days after a change in the producer's
brands of covered products sold or offered for sale in this state.
new text end

new text begin (d) A registration is effective upon receipt by the agency and is valid until January
1 of each year.
new text end

new text begin (e) The agency must review each registration and notify the producer of any
information required by this section that is omitted from the registration. Within 30 days
of receipt of a notification from the agency, the producer must submit a revised registration
providing the information noted by the agency.
new text end

new text begin Subd. 3. new text end

new text begin Producer's registration fee. new text end

new text begin (a) Each producer that registers under this
section must, by January 1, 2011, and each year thereafter, pay to the commissioner an
annual registration fee of $....... to cover estimated agency costs to administer the program
and the program costs of counties that elect to offer a program during that calendar year,
unless exempted under paragraph (c). The commissioner must deposit the fee in the
account established in section 115A.1416.
new text end

new text begin (b) A producer who begins to sell or offer for sale covered products in this state after
January 1, 2011, must pay the registration fee required by this subdivision when the
producer submits a registration to the agency.
new text end

new text begin (c) A producer that operates its own program under section 115A.1413 individually
or participates in a program in concert with other producers or through a product
stewardship organization is not required to pay a registration fee.
new text end

new text begin Subd. 4. new text end

new text begin Emergency exception. new text end

new text begin The commissioner of health may grant producers a
public health exemption to subdivisions 1 to 3 for prescription drugs if the commissioner
of health determines it is necessary to carry out the duties of sections 144.05, 144.4197,
144.4198, and 151.37, subdivisions 2 and 10.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 4.

new text begin [115A.1413] UNWANTED PRODUCTS COLLECTION PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Program requirements. new text end

new text begin A program established under this section
must:
new text end

new text begin (1) accept all unwanted products presented to the program by a residential generator,
regardless of the producer;
new text end

new text begin (2) offer program services at no cost to a residential generator;
new text end

new text begin (3) offer convenient collection options;
new text end

new text begin (4) comply with applicable state and federal health, safety, controlled substance,
and environmental laws, rules, and regulations regarding handling, transporting, and
arranging for the final disposition of all unwanted products collected, including the
required presence of law enforcement officials;
new text end

new text begin (5) promote the program to residential generators, pharmacists, retailers of covered
products, and health care practitioners as the proper and safe method for the final
disposition of unwanted products;
new text end

new text begin (6) prepare education and outreach materials that publicize the location and
operation of collection locations throughout the county and disseminate them to health
care facilities, pharmacies, and other interested parties. The program may also establish a
Web site publicizing collection locations and program operations and a toll-free telephone
number that residential generators can call to find nearby collection locations and
understand how the program works; and
new text end

new text begin (7) obtain written assurance from the federal Drug Enforcement Agency that the
program complies with the federal Controlled Substances Act and regulations adopted
thereunder.
new text end

new text begin Subd. 2. new text end

new text begin Notification. new text end

new text begin Each county, producer, group of producers, or product
stewardship organization offering a program under this section must submit a notification
before beginning to collect unwanted products. A notification must contain:
new text end

new text begin (1) contact information for the individual directing the program;
new text end

new text begin (2) a description of the methods by which unwanted products from residential
generators will be collected in all areas of the county, including the location of each
collection site, and an explanation of how the collection system will be convenient and
adequate to serve the needs of residents in both urban and rural areas;
new text end

new text begin (3) a description of how the unwanted products will be safely and securely tracked
and handled from collection through final disposition and the policies and procedures
to be followed to ensure security and compliance with state and federal health, safety,
controlled substance, and environmental laws and regulations;
new text end

new text begin (4) a description of public education and outreach activities and how their
effectiveness will be evaluated; and
new text end

new text begin (5) a starting date when collection of unwanted products will begin.
new text end

new text begin Subd. 3. new text end

new text begin Election. new text end

new text begin The Western Lake Superior Sanitary District may elect to offer
a program under this section. If the district elects to offer a program, it has identical
authority and responsibilities given to a county under sections 115A.1410 to 115A.1420 to
operate a program within its legal boundaries.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 5.

new text begin [115A.1414] FINAL DISPOSITION OF UNWANTED PRODUCTS.
new text end

new text begin Each county, producer, group of producers, or product stewardship organization
operating a collection program under a notification that has been filed under section
115A.1413 must arrange for final disposition of all unwanted products from residential
generators in accordance with all applicable state and federal laws.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 6.

new text begin [115A.1415] REPORTS.
new text end

new text begin (a) On or before June 30, 2012, and in each subsequent year, each county, producer,
group of producers, or product stewardship organization operating a program under
section 115A.1413 must prepare and submit to the agency an annual report describing
the program's activities during the previous reporting period. The report must include
the following:
new text end

new text begin (1) the amount, by weight, of unwanted products collected from residential
generators at each drop-off site and the total amount by weight collected through a
mail-back program, if applicable;
new text end

new text begin (2) a description of the collection system, including the location of each collection
site and locations where envelopes for a mail-back program are provided, if applicable;
new text end

new text begin (3) the name and location of facilities at which unwanted products were disposed
of and the weight of unwanted products collected from residential generators disposed
of at each facility;
new text end

new text begin (4) the amount and proportion, by weight, of controlled substances collected at each
drop-off site and through a mail-back program, if applicable;
new text end

new text begin (5) whether policies and procedures for collecting, transporting, and final disposition
of unwanted products, as established in the notification, were followed and a description
of any noncompliance;
new text end

new text begin (6) whether any safety or security problems occurred during the collection,
transportation, or final disposition of unwanted products and, if so, what changes have or
will be made to policies, procedures, or tracking mechanisms to alleviate the problem and
to improve safety and security;
new text end

new text begin (7) a description of public education and outreach activities implemented, including
the methodology used to evaluate the outreach and program activities; and
new text end

new text begin (8) any other information that the agency may reasonably require.
new text end

new text begin For the purposes of this section, "reporting period" means the period beginning
January 1 and ending December 31 of the same calendar year.
new text end

new text begin (b) By January 1, 2013, the agency shall submit a report to the chairs and ranking
minority members of the senate and house of representatives committees with jurisdiction
over solid waste policy and solid waste finance that examines options and makes
recommendations regarding methods to estimate the amount of unwanted products
collected and disposed of under all active programs as a proportion of the total amount of
unwanted products extant in this state during that year. The report shall suggest financial
and other incentives that may be offered to producers or counties to increase the proportion
of unwanted products collected.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 7.

new text begin [115A.1416] ACCOUNT; APPROPRIATION.
new text end

new text begin (a) The pharmaceutical waste account is created in the environmental fund. The
commissioner must deposit all revenue from the fee established in section 115A.1412,
subdivision 3, in the account. Any interest earned on the account must be credited to the
account. Money from other sources may be credited to the account.
new text end

new text begin (b) Until June 30, 2012, money in the account is annually appropriated to the
commissioner to implement sections 115A.1410 to 115A.1420.
new text end

Sec. 8.

new text begin [115A.1417] AGENCY DUTIES.
new text end

new text begin (a) The agency shall administer sections 115.1410 to 115A.1420.
new text end

new text begin (b) The agency shall review notifications submitted under section 115A.1413.
new text end

new text begin (c) The agency shall manage the account established in section 115A.1416 and
shall reimburse counties for reasonable program costs incurred by the counties. If the
revenues in the account exceed the amount that the agency determines is necessary for
efficient and effective operation and administration of the program, including any amount
for contingencies, the agency must recommend to the legislature that the producer fee be
lowered in order to reduce revenues collected in the subsequent program year by the
estimated amount of the excess.
new text end

new text begin (d) The agency shall provide on its Web site a list of all producers that have filed a
complete registration and paid a registration fee to the agency and a list of all producers
the agency has identified as noncompliant with section 115A.1412 or 115A.1415.
new text end

new text begin (e) The agency shall consult with counties and producers to estimate the costs of
collection, transportation, and final disposition of drugs and may set maximum rates, on a
per-pound or other basis, at which counties may be reimbursed for program activities.
new text end

new text begin (f) The agency shall provide technical assistance to counties seeking to develop a
program or to improve an existing program's operations, including producing a program
template.
new text end

new text begin (g) The agency shall research alternative options for the final disposition of
unwanted products.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 9.

new text begin [115A.1418] OTHER COLLECTION PROGRAMS.
new text end

new text begin (a) Nothing in sections 115A.1410 to 115A.1420 prohibits or restricts the operation
of any program collecting, transporting, and providing for final disposition of covered
products in addition to those approved by the agency under section 115A.1413 or prohibits
or restricts any persons from receiving, collecting, transporting, or providing for final
disposition of covered products, provided that those persons are registered with the agency
under section 115A.1412 and comply with the reporting requirements under section
115A.1415, paragraph (a), and all other applicable state and federal laws.
new text end

new text begin (b) A county or other public agency may not require households to use public
facilities to collect, transport, and arrange for final disposition of covered products to the
exclusion of other lawful programs available.
new text end

Sec. 10.

new text begin [115A.1419] ANTICOMPETITIVE CONDUCT.
new text end

new text begin (a) A producer, group of producers, or product stewardship organization that
organizes a system to collect, transport, and arrange for the final disposition of unwanted
products under sections 115A.1410 to 115A.1420 may engage in anticompetitive conduct
to the extent necessary to plan and implement its chosen organized collection system and
is immune from liability under state laws relating to antitrust, restraint of trade, unfair
trade practices, and other regulation of trade or commerce.
new text end

new text begin (b) An organization of producers, an individual producer, and its officers, members,
employees, and agents who cooperate with a political subdivision that organizes a system
to collect, transport, and arrange for the final disposition of unwanted products under
sections 115A.1410 to 115A.1420 may engage in anticompetitive conduct to the extent
necessary to plan and implement the organized collection system, provided that the
political subdivision actively supervises the participation of each entity. An organization,
entity, or person covered by this paragraph is immune from liability under state law
relating to antitrust, restraint of trade, unfair trade practices, and other regulation of trade
or commerce.
new text end

Sec. 11.

new text begin [115A.1420] ENFORCEMENT.
new text end

new text begin Subdivision 1. new text end

new text begin Generally. new text end

new text begin Sections 115A.1410 to 115A.1420 shall be enforced in
the manner provided by section 115.071, subdivisions 1 to 6.
new text end

new text begin Subd. 2. new text end

new text begin Producer penalties. new text end

new text begin (a) Upon first determining that a producer is offering
a covered product for sale in this state but has not filed a complete registration with the
agency, or has not paid a registration fee, the agency shall send the producer a written
warning that the producer is in violation of section 115A.1412.
new text end

new text begin (b) A producer that has not filed a complete registration or paid a registration fee
to the agency and whose covered product continues to be sold in this state 60 days after
receiving a written warning from the agency must be assessed a penalty of $10,000 for
each calendar day that the violation continues.
new text end

new text begin (c) All penalties levied under this section must be deposited into the pharmaceutical
waste account established under section 115A.1416.
new text end

new text begin Subd. 3. new text end

new text begin Wholesaler penalties. new text end

new text begin (a) It is the responsibility of a drug wholesaler
offering covered products for sale in this state to view the agency's Web site to determine
if a producer of products the wholesaler is offering for sale in this state is in compliance
with sections 115A.1412 and 115A.1415. If a drug wholesaler is unsure of the status of a
producer or believes a producer is not in compliance, the drug wholesaler shall contact the
agency to determine the producer's status.
new text end

new text begin (b) The agency shall send a written notice to a drug wholesaler known to be selling a
product in this state from a producer who is not in compliance with section 115A.1412
or 115A.1415.
new text end

new text begin (c) A drug wholesaler that continues to sell a covered product from a producer
that is not in compliance with section 115A.1412 or 115A.1415 60 days after receiving
a written notice from the agency must be assessed a penalty of $1,000 for each day of
noncompliance.
new text end

new text begin (d) All penalties levied under this section must be deposited into the pharmaceutical
waste account established under section 115A.1416.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

ARTICLE 2

Section 1.

new text begin [144.569] HANDLING OF PHARMACEUTICAL WASTE IN
HEALTH CARE FACILITIES.
new text end

new text begin Subdivision 1. new text end

new text begin Pharmaceutical waste disposal. new text end

new text begin Health care facilities licensed or
regulated by the commissioner of health, including but not limited to nursing homes,
home care and hospice entities, boarding care homes, and supervised living facilities, must
not destroy or dispose of any drug by flushing the drug into the sewer or septic system.
Health care facilities licensed or regulated under chapters 144, 144A, 144D, and 144G
must comply with the requirements of sections 115A.1410 to 115A.1420 for the final
disposition of unused or contaminated drugs.
new text end

new text begin Subd. 2. new text end

new text begin Penalty. new text end

new text begin For a violation of subdivision 1, the commissioner of health may
impose a civil penalty not exceeding $10,000 for each separate violation.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective six months after the United States
Drug Enforcement Administration approves an alternative system of disposal for
unwanted drugs that complies with the federal Controlled Substances Act.
new text end

Sec. 2.

Minnesota Statutes 2008, section 151.37, subdivision 6, is amended to read:


Subd. 6.

Exclusion for course of employment.

new text begin(a) new text endNothing in this chapter shall
prohibit the possession of a legend drug by an employee, agent, or sales representative of
a registered drug manufacturer, or an employee or agent of a registered drug wholesaler,
or registered pharmacy, while acting in the course of employment.

new text begin (b) Nothing in this chapter shall prohibit the following entities from possessing a
legend drug for the purpose of disposing of the legend drug as pharmaceutical waste:
new text end

new text begin (1) a law enforcement officer;
new text end

new text begin (2) a hazardous waste transporter licensed by the Department of Transportation;
new text end

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

new text begin (4) a facility licensed by the Pollution Control Agency or a metropolitan county as a
very small quantity generator collection program or a minimal generator; or
new text end

new text begin (5) a county or other entity that collects, stores, transports, or disposes of a legend
drug pursuant to a notification filed with the Pollution Control Agency under section
115A.1413 or a person authorized by one of these entities to conduct one or more of
these activities.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 3.

Minnesota Statutes 2008, section 151.37, subdivision 7, is amended to read:


Subd. 7.

Exclusion for prescriptions.

new text begin(a) new text endNothing in this chapter shall prohibit the
possession of a legend drug by a person for that person's use when it has been dispensed to
the person in accordance with a deleted text beginwritten or oraldeleted text endnew text begin validnew text end prescription new text beginissued new text endby a practitioner.

new text begin (b) new text endNothing in this chapter shall prohibit a person, for whom a legend drug has
been dispensed in accordance with a written or oral prescription by a practitioner, from
designating a family member, caregiver, or other individual to handle the legend drug for
the purpose of assisting the person in obtaining or administering the drugnew text begin or sending
the drug for destruction
new text end.

new text begin (c) Nothing in this chapter shall prohibit a person for whom a prescription drug has
been dispensed in accordance with a valid prescription issued by a practitioner from
transferring the legend drug to a county or other entity that collects, stores, transports, or
disposes of a legend drug pursuant to a notification filed under section 115A.1413 or to a
person authorized by one of these entities to conduct one or more of these activities.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 4.

Minnesota Statutes 2008, section 151.44, is amended to read:


151.44 DEFINITIONS.

As used in sections 151.43 to 151.51, the following terms have the meanings given
in paragraphs (a) to deleted text begin(f)deleted text endnew text begin (h)new text end:

(a) "Wholesale drug distribution" means distribution of prescription new text beginor
nonprescription
new text enddrugs to persons other than a consumer or patientnew text begin or reverse distribution
of such drugs
new text end, 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 new text beginor nonprescription new text enddrugs by a retail pharmacy to
another retail pharmacy to alleviate a temporary shortage;

(8) the distribution of prescription new text beginor nonprescription new text enddrug 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; repackers; 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 new text beginor nonprescription new text enddrugs.

(c) "Manufacturer" means anyone who is engaged in the manufacturing, preparing,
propagating, compounding, processing, packaging, repackaging, or labeling of a
prescription drug.

(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.

new text begin (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.
new text end

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

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end