2013 WISCONSIN ACT 198
An Act to renumber and amend 961.335 (1); to amend subchapter III (title) of chapter 961 [precedes 961.31]; and to create 66.0437, 165.65, 450.01 (23) (n), 450.01 (23) (o), 450.115, 961.32 (2) (e), 961.335 (1) (c) 1. and 2. and 961.337 of the statutes; relating to: programs for the disposal of drugs, including controlled substances, and certain medical or drug-related items, and the regulation of prescription drugs.
The people of the state of Wisconsin, represented in senate and assembly, do enact as follows:
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Section
1. 66.0437 of the statutes is created to read:
66.0437 Drug disposal programs. (1) In this section, "political subdivision" has the meaning given in s. 165.65 (1) (e).
(2) A political subdivision may operate or authorize a person to operate a drug disposal program as provided under s. 165.65 (3).
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2. 165.65 of the statutes is created to read:
165.65 Drug disposal program. (1) Definitions. In this section:
(a) "Authorized under federal law" means permitted under
21 USC 801 to
971 or
21 CFR 1300 to
1321.
(am) "Controlled substance" has the meaning given in s. 961.01 (4).
(b) "Controlled substance analog" has the meaning given in s. 961.01 (4m).
(c) "Drug disposal program" means a program to receive household pharmaceutical items and to recycle, destroy, or otherwise dispose of those items. "Drug disposal program" does not include a sharps collection station operated in compliance with rules promulgated by the department of natural resources.
(d) 1. Except as provided under subd. 2., "household pharmaceutical item" means any of the following if lawfully possessed by an individual for the individual's own use, for the use of a member of the individual's household, or for the use of an animal owned by the individual or a member of the individual's household:
a. A drug, as defined in s. 450.01 (10); a prescription drug, as defined in s. 450.01 (20); or a controlled substance or controlled substance analog, if the drug, prescription drug, or controlled substance or controlled substance analog is located in or comes from a place where the individual, a member of the individual's household, an in-home hospice service, or an adult family home serving fewer than 5 adult members manages the use of the drug, prescription drug, or controlled substance or controlled substance analog.
b. A device, as defined in s. 450.01 (6), or an object used for administering a drug, if the device or object is located in or comes from a place where the individual, a member of the individual's household, an in-home hospice service, or an adult family home serving fewer than 5 adult members manages the use of the device or object.
2. "Household pharmaceutical item" does not include any of the following:
a. Any item that may be contaminated with antineoplastic chemotherapy drugs, including objects used to administer drugs, gloves, and other items that have come into contact with chemotherapy drugs.
b. Any item containing elemental mercury.
(e) "Political subdivision" means a city, village, town, or county.
(2) Department of justice authorization to operate a drug disposal program. (a) Except as provided under sub. (3), no person may receive household pharmaceutical items pursuant to a drug disposal program unless the department of justice grants written authorization for that program under par. (b) or the program is authorized under federal law.
(b) The department of justice may, without a hearing, grant written authorization to a person to operate a drug disposal program if all of the following conditions are satisfied:
1. The person adopts written policies and procedures that comply with sub. (5). The department of justice shall review and either approve or disapprove in writing those policies and procedures. The department of justice shall approve the policies and procedures if the department of justice determines that the policies and procedures do not violate the requirements of this section or any other applicable federal or state law, and shall disapprove them otherwise. If the department of justice disapproves the policies and procedures, the department of justice shall state the reasons for that disapproval in writing to the person. At any time, the person may resubmit revised policies and procedures to the department of justice for its review and approval under this subdivision.
2. If the drug disposal program will receive household pharmaceutical items in any manner other than the transfer of a household pharmaceutical item in person to the program by a person that lawfully possesses the household pharmaceutical item, the person demonstrates to the satisfaction of the department of justice that those transfers will comply with any federal or state law applicable to the transportation and delivery of household pharmaceutical items.
(c) A person may not revise policies and procedures approved by the department of justice under par. (b) 1. unless the department of justice approves the revisions under par. (b) 1.
(d) Any determination or action by the department of justice under par. (b) or (c) is not subject to judicial review.
(3) Authorization by a political subdivision to operate a drug disposal program. A political subdivision may operate or the governing body of a political subdivision may grant written authorization for a person to operate a drug disposal program only if all of the following apply:
(a) The political subdivision or the authorized person operates the drug disposal program only within the boundaries of the political subdivision, except as provided under sub. (4).
(b) The applicable requirements under sub. (5) are satisfied.
(c) The drug disposal program receives household pharmaceutical items only by means of delivery in person by a person that lawfully possesses the household pharmaceutical item, unless the drug disposal program is authorized under federal law to receive household pharmaceutical items by other means.
(4) Multijurisdictional drug disposal program. A drug disposal program may operate within more than one political subdivision if the department of justice authorizes that program under sub. (2), all political subdivisions within which the drug disposal program operates authorize that program under sub. (3), or the program is authorized under federal law.
(5) Operation of a drug disposal program. (a) A person that operates a drug disposal program, except a drug disposal program that is authorized under federal law, shall establish and promptly update as appropriate written policies and procedures that do all of the following:
1. Describe in detail the manner in which the program operates, including an identification of the kinds of household pharmaceutical items that may be received under the program, whether the program may receive controlled substances and controlled substance analogs, whether household pharmaceutical items will be transferred by mail under the program, and the locations at which household pharmaceutical items may be transferred in person under the program.
2. List the name, address, telephone number, and 24-hour contact information for one or more persons in this state who are responsible for the operation of the program.
3. Ensure compliance with chs. 450 and 961; with any applicable provision under chs. 287, 289, and 291 and s. 299.51 relating to medical waste, solid waste, or hazardous waste; and with any other applicable federal or state law.
(b) 1. The policies and procedures for a drug disposal program authorized under sub. (2) and any changes to those policies and procedures are subject to review and approval under sub. (2) (b) 1.
2. Legal counsel for the political subdivision, or, at the discretion of the political subdivision, the department of justice if the political subdivision's legal counsel is not an employee of the political subdivision, shall review and either approve or disapprove the policies and procedures for a drug disposal program implemented or authorized under sub. (3) and any changes to those policies and procedures. Legal counsel, or the department of justice if appropriate, shall approve the policies and procedures or changes if it determines that the policies and procedures or changes do not violate the requirements of this section or any other applicable federal or state law, and shall disapprove them otherwise. Any approval under this subdivision shall be in writing. The political subdivision shall provide a copy of the approval and a copy of the policies and procedures or changes to the policies and procedures to the department of justice.
(c) The operation of a drug disposal program, including a drug disposal program that is authorized under federal law, shall immediately cease if a law enforcement officer, as defined in s. 165.85 (2) (c), a federal law enforcement officer, as defined in s. 175.40 (7) (a) 1., the department of justice, or another federal or state agency notifies a designated contact person for the program that the program is in violation of any federal or state law enforceable by the officer, department of justice, or other agency. That notification is not subject to judicial review. The program may resume operation only upon the program's receipt of written notice from the officer, department of justice, or other agency that the program is no longer in violation of the federal or state law.
(d) Each person that operates a drug disposal program in this state shall, within 30 days after the drug disposal program begins operation, notify and provide all of the following information to the department of natural resources:
1. The location and hours of operation of the drug disposal program.
2. The name, address, telephone number, and 24-hour contact information for one or more persons in this state who are responsible for the operation of the program.
3. A description of the household pharmaceutical items the drug disposal program may receive.
(6) Transfer and receipt of household pharmaceutical items. (a) Notwithstanding ss. 450.03 (1) and 450.11 (7) (g) and (h) and (9) (b), a person that lawfully possesses a household pharmaceutical item may transfer, and it is not a crime for such a person to transfer, the household pharmaceutical item to a drug disposal program if the program is authorized under sub. (2) or (3) or is authorized under federal law.
(b) Notwithstanding s. 450.11 (7) (g) and (h) and (9) (b), a person may receive, and it is not a crime for a person to possess, a household pharmaceutical item pursuant to a drug disposal program if the receipt or possession is within the scope of the program and the program is authorized under sub. (2) or (3) or is authorized under federal law or, if the receipt or possession is not within the scope of the program, the receipt or possession is inadvertent and the program promptly notifies an appropriate law enforcement officer of the receipt or possession and complies with any instructions the law enforcement officer provides.
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3. 450.01 (23) (n) of the statutes is created to read:
450.01 (23) (n) The operation or implementation of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a), or the possession or delivery of a household pharmaceutical item, as defined in s. 165.65 (1) (d), within the scope of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law.
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4. 450.01 (23) (o) of the statutes is created to read:
450.01 (23) (o) The possession or delivery of a prescription drug within the scope of a written authorization under s. 450.115 (3).
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5. 450.115 of the statutes is created to read:
450.115 Drug disposal programs and authorizations. (1) In this section:
(a) "Guardian" means the person named by the court under ch. 880, 2003 stats., or ch. 48 or 54 that has the duty and authority of guardianship.
(b) "Personal representative" means an executor, administrator, or special administrator of a decedent's estate, a person legally authorized to perform substantially the same functions, or a successor to any of those persons.
(c) "Trustee" means a person that holds in trust title to or power over property. "Trustee" includes an original, added, or successor trustee.
(d) "Ward" means a person for whom a guardian has been appointed.
(2) Nothing in this chapter, or rules promulgated under this chapter, prohibits any of the following:
(a) The direct operation or implementation of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a).
(b) The transfer of a prescription drug by a person that lawfully possesses the prescription drug to a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a), and that accepts the prescription drug.
(c) Subject to sub. (4), the possession of a prescription drug under a written authorization described in sub. (3).
