October 31, 2013, Introduced by Senators KAHN and RICHARDVILLE and referred to the Committee on Government Operations.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 7212, 7214, 7301a, 7303, 16169, 16170a,
16174, 16192, 16216, 16221, 16222, 16226, 16231, 16231a, 16232,
16233, 16237, 16241, 16245, 16315, 17754, 17768, 17775, and
20176a (MCL 333.7212, 333.7214, 333.7301a, 333.7303, 333.16169,
333.16170a, 333.16174, 333.16192, 333.16216, 333.16221,
333.16222, 333.16226, 333.16231, 333.16231a, 333.16232,
333.16233, 333.16237, 333.16241, 333.16245, 333.16315, 333.17754,
333.17768, 333.17775, and 333.20176a), section 7212 as amended by
2012 PA 183, section 7214 as amended by 1982 PA 352, section
7301a as amended by 2006 PA 392, section 7303 as amended by 1988
PA 60, sections 16169 and 16170a as added and section 16192 as
amended by 1993 PA 80, section 16174 as amended by 2012 PA 49,
sections 16216 and 16237 as added and section 16241 as amended by
1993 PA 87, section 16221 as amended by 2012 PA 501, sections
16222 and 16231a as added and sections 16232 and 17768 as amended
by 1993 PA 79, section 16226 as amended by 2012 PA 499, sections
16231 and 16233 as amended by 2010 PA 382, section 16245 as
amended by 2011 PA 223, section 16315 as amended by 2009 PA 216,
section 17754 as amended by 2012 PA 209, section 17775 as added
by 2012 PA 383, and section 20176a as amended by 1994 PA 52, and
by adding article 8; and to repeal acts and parts of acts.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
1 Sec. 7212. (1) The following controlled substances are
2 included in schedule 1:
3 (a) Any of the following opiates, including their isomers,
4 esters, the ethers, salts, and salts of isomers, esters, and
5 ethers, unless specifically excepted, when the existence of these
6 isomers, esters, ethers, and salts is possible within the
7 specific chemical designation:
|
8 |
Acetylmethadol |
Difenoxin |
Noracymethadol |
|
9 |
Allylprodine |
Dimenoxadol |
Norlevorphanol |
|
10 |
Alpha-acetylmethadol |
Dimepheptanol |
Normethadone |
|
11 |
Alphameprodine |
Dimethylthiambutene |
Norpipanone |
|
12 |
Alphamethadol |
Dioxaphetyl butyrate |
Phenadoxone |
|
13 |
Benzethidine |
Dipipanone |
Phenampromide |
|
14 |
Betacetylmethadol |
Ethylmethylthiambutene |
Phenomorphan |
|
15 |
Betameprodine |
Etonitazene |
Phenoperidine |
|
16 |
Betamethadol |
Etoxeridine |
Piritramide |
|
17 |
Betaprodine |
Furethidine |
Proheptazine |
|
18 |
Clonitazene |
Hydroxypethidine |
Properidine |
|
1 |
Dextromoramide |
Ketobemidone |
Propiram |
|
2 |
Diampromide |
Levomoramide |
Racemoramide |
|
3 |
Diethylthiambutene |
Levophenacylmorphan |
Trimeperidine |
|
4 |
|
Morpheridine |
|
5 (b) Any of the following opium derivatives, their salts,
6 isomers, and salts of isomers, unless specifically excepted, when
7 the existence of these salts, isomers, and salts of isomers is
8 possible within the specific chemical designation:
|
9 |
Acetorphine |
Drotebanol |
Morphine-N-Oxide |
|
10 |
Acetyldihydrocodeine |
Etorphine |
Myrophine |
|
11 |
Benzylmorphine |
Heroin |
Nicocodeine |
|
12 |
Codeine methylbromide |
Hydromorphinol |
Nicomorphine |
|
13 |
Codeine-N-Oxide |
Methyldesorphine |
Normorphine |
|
14 |
Cyprenorphine |
Methyldihydromorphine |
Pholcodine |
|
15 |
Desomorphine |
Morphine methylbromide |
Thebacon |
|
16 |
Dihydromorphine |
Morphine methylsulfonate |
|
17 (c) Any material, compound, mixture, or preparation which
18 contains any quantity of the following hallucinogenic substances,
19 their salts, isomers, and salts of isomers, unless specifically
20 excepted, when the existence of these salts, isomers, and salts
21 of isomers is possible within the specific chemical designation:
|
22 |
2-Methylamino-1-phenylpropan-1-one |
|
23 |
Some trade and other names: |
|
24 |
Methcathinone |
|
25 |
Cat |
|
26 |
Ephedrone |
|
1 |
3, 4-methylenedioxy amphetamine |
|
2 |
5-methoxy-3, 4-methylenedioxy |
|
3 |
amphetamine |
|
4 |
3, 4, 5-trimethoxy amphetamine |
|
5 |
Bufotenine |
|
6 |
Some trade and other names: |
|
7 |
3-(B-dimethylaminoethyl)-5 hydrozyindole |
|
8 |
3-(2-dimethylaminoethyl)-5 indolol |
|
9 |
N,N-dimethylserotonin; 5-hydroxy-N-dimethyltryptamine |
|
10 |
Mappine |
|
11 |
2, 5-Dimethoxyamphetamine |
|
12 |
Some trade or other names: |
|
13 |
2, 5-Dimethoxy-a-methylphenethylamine; 2,5-DMA |
|
14 |
4-Bromo-2, 5-Dimethoxyamphetamine |
|
15 |
Some trade or other names: |
|
16 |
4-bromo-2, 5 dimethoxy-a-methylphenethylamine; 4-bromo |
|
17 |
2,5-DMA |
|
18 |
Diethyltryptamine |
|
19 |
Some trade and other names: |
|
20 |
N,N-Diethyltryptamine; DET |
|
21 |
Dimethyltryptamine |
|
22 |
Some trade or other names: |
|
23 |
DMT |
|
24 |
4-methyl-2, 5-dimethoxyamphetamine |
|
25 |
Some trade and other names: |
|
26 |
4-methyl-2, 5-dimethoxy-a-methyl-phenethylamine |
|
27 |
DOM, STP |
|
28 |
4-methoxyamphetamine |
|
29 |
Some trade or other names: |
|
30 |
4-methoxy-a-methylphenethylamine; paramethoxy amphetamine; |
|
31 |
PMA |
|
1 |
Ibogaine |
|
2 |
Some trade and other names: |
|
3 |
7-Ethyl-6,6a,7,8,9,10,12,13 |
|
4 |
Octahydro-2-methoxy-6,9-methano-5H- |
|
5 |
pyrido (1, 2:1, 2 azepino 4, 5-b) indole |
|
6 |
tabernanthe iboga |
|
7 |
Lysergic acid diethylamide |
|
8 |
|
|
9 |
pharmaceutical-grade cannabis |
|
10 |
Mecloqualone |
|
11 |
Mescaline |
|
12 |
Peyote |
|
13 |
N-ethyl-3 piperidyl benzilate |
|
14 |
N-methyl-3 piperidyl benzilate |
|
15 |
Psilocybin |
|
16 |
Psilocyn |
|
17 |
Thiophene analog of phencyclidine |
|
18 |
Some trade or other names: |
|
19 |
1-(1-(2-thienyl)cyclohexyl) piperidine |
|
20 |
2-thienyl analog of phencyclidine; TPCP |
21 (d) Synthetic Except
as provided in subsection (2),
22 synthetic equivalents of the substances contained in the plant,
23 or in the resinous extractives of cannabis and synthetic
24 substances, derivatives, and their isomers with similar chemical
25 structure or pharmacological activity, or both, such as the
26 following, are included in schedule 1:
27 (i) /\1 cis or trans tetrahydrocannabinol, and their optical
28 isomers.
29 (ii) /\6 cis or trans tetrahydrocannabinol, and their optical
1 isomers.
2 (iii) /\3,4, cis or trans tetrahydrocannabinol, and their
3 optical isomers.
4 (e) Compounds Except
as provided in subsection (2),
5 compounds of structures of substances referred to in subdivision
6 (d), regardless of numerical designation of atomic positions, are
7 included.
8 (f) Gamma-hydroxybutyrate and any isomer, salt, or salt of
9 isomer of gamma-hydroxybutyrate.
|
10 |
Some trade and other names: |
|
11 |
Sodium oxybate |
|
12 |
4-hydroxybutanoic acid monosodium salt |
13 (g) 3,4-methylenedioxymethamphetamine.
|
14 |
Some trade and other names: |
|
15 |
Ecstasy |
|
16 |
MDMA |
17 (h) N-Benzylpiperazine
|
18 |
Some trade and other names: |
|
19 |
BZP |
|
20 |
Benzylpiperazine |
|
21 |
1-(phenylmethyl)-piperazine |
22 (i) 3-Chlorophenylpiperazine
|
1 |
Some trade and other names: |
|
2 |
MCPP |
3 (j) 1-(3-Trifluoromethylphenyl)piperazine
|
4 |
Some trade and other names: |
|
5 |
TFMPP |
6 (k) 4-Bromo-2,5-dimethoxybenzylpiperazine
|
7 |
Some trade and other names: |
|
8 |
2C-B-BZP |
9 (l) All of the following:
10 (i) (6aR,10aR)-9-(Hydroxymethyl)-6,6-dimethyl-3-(2-
11 methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol.
|
12 |
Some trade and other names: |
|
13 |
HU-210 |
14 (ii) 2-[(1R,3S)-3-hydroxycyclohexyl]-5-(2-methyloctan-2-
15 yl)phenol and its side chain homologues.
|
16 |
Some trade and other names: |
|
17 |
CP47,497 |
18 (iii) 1-pentyl-3-(1-naphthoyl)indole.
|
19 |
Some trade and other names: |
|
20 |
JWH-018 |
1 (iv) 1-butyl-3-(1-naphthoyl)indole.
|
2 |
Some trade and other names: |
|
3 |
JWH-073 |
4 (v) (2-methyl-1-propyl-1H-indol-3-yl)-1-naphthalenyl-
5 methanone.
|
6 |
Some trade and other names: |
|
7 |
JWH-015 |
8 (vi) [1-[2-(4-morpholinyl)ethyl]-1H-indol-3-yl]-1-
9 naphthalenyl-methanone.
|
10 |
Some trade and other names: |
|
11 |
JWH-200 |
12 (vii) 1-(1-pentyl-1H-indol-3-yl)-2-(2-methoxyphenyl)-
13 ethanone.
|
14 |
Some trade and other names: |
|
15 |
JWH-250 |
16 (m) Mephedrone (4-methylmethcathinone).
|
17 |
Some trade and other names: |
|
18 |
4-MMC, M-Cat, meow meow, miaow miaow, bounce, bubbles, bubble |
|
19 |
love, mad cow, plant food, drone, and neo doves |
20 (n) 4-Methyl-alpha-pyrrolidinobutyrophenone.
|
1 |
Some trade and other names: |
|
2 |
MPBP |
3 (o) Methylenedioxypyrovalerone
|
4 |
Some trade and other names: |
|
5 |
MDPV, Bath salts, charge plus, cloud nine, hurricane Charlie, |
|
6 |
ivory wave, ocean, red dove, scarface, sonic, white dove, white |
|
7 |
lightning |
8 (p) 5,6-Methylenedioxy-2-aminoindane
|
9 |
Some trade and other names: |
|
10 |
MDAI |
|
11 |
Woof-woof |
12 (q) Naphyrone (Naphthylpyrovalerone)
|
13 |
Some trade and other names: |
|
14 |
NRG-1 |
|
15 |
Rave |
16 (r) Pyrovalerone (1-(4-Methylphenyl)-2-(1-pyrrolidinyl)-1-
17 pentanone)
18 (s) Catha edulis; except as provided in subdivision (t) and
19 section 7218, all parts of the plant presently classified
20 botanically as catha edulis, whether growing or not; the leaves
21 and seeds of that plant; any extract from any part of that plant;
22 and every compound, salt, derivative, mixture, or preparation of
23 that plant or its leaves, seeds, or extracts.
|
1 |
Some trade and other names: |
|
2 |
Khat |
|
3 |
Qat |
4 (t) Cathinone.
5 (u) Salvia divinorum; except as provided in subdivision (v),
6 all parts of the plant presently classified botanically as salvia
7 divinorum, whether growing or not; the leaves and seeds of that
8 plant; any extract from any part of that plant; and every
9 compound, salt, derivative, mixture, or preparation of that plant
10 or its leaves, seeds, or extracts.
11 (v) Salvinorin A.
12 (2) Marihuana, including pharmaceutical-grade cannabis, and
13 the substances described in subsection (1)(d) and (e) are
14 schedule 2 controlled substances if they are manufactured,
15 obtained, stored, dispensed, possessed, grown, or disposed of in
16 compliance with this act and as authorized by federal authority.
17 (3) (2) For
purposes of subsection (1), "isomer" includes
18 the optical, position, and geometric isomers.
19 Sec. 7214. The following controlled substances are included
20 in schedule 2:
21 (a) Any of the following substances, except those narcotic
22 drugs listed in other schedules, whether produced directly or
23 indirectly by extraction from substances of vegetable origin, or
24 independently by means of chemical synthesis, or by combination
25 of extraction and chemical synthesis:
26 (i) Opium and opiate, and any salt, compound, derivative, or
1 preparation of opium or opiate excluding nalaxone and its salts,
2 and excluding naltrexone and its salts, but including the
3 following:
|
4 |
Raw opium Etorphine hydrochloride |
|
5 |
Opium extracts Hydrocodone |
|
6 |
Opium Fluid-extracts Hydromorphone |
|
7 |
Powdered opium Metopon |
|
8 |
Granulated opium Morphine |
|
9 |
Tincture of opium Oxycodone |
|
10 |
Codeine Oxymorphone |
|
11 |
Ethylmorphine Thebaine |
12 (ii) A salt, compound, derivative, or preparation thereof
13 which is chemically equivalent to or identical with a substance
14 referred to in this subdivision, (a), except that these
15 substances do not include the isoquinoline alkaloids of opium.
16 (iii) Opium poppy, poppy straw, and concentrate of poppy
17 straw, the crude extract of poppy straw in either liquid, solid,
18 or powder form, which contains the phenanthrene alkaloids of the
19 opium poppy.
20 (iv) Coca leaves and any salt, compound, derivative, or
21 preparation thereof which is chemically equivalent to or
22 identical with any of these substances, except that the
23 substances do not include decocainized coca leaves or extraction
24 of coca leaves which extractions do not contain cocaine or
25 ecgonine. The substances include cocaine, its salts,
26 stereoisomers, and salts of stereoisomers when the existence of
1 the salts, stereoisomers, and salts of stereoisomers is possible
2 within the specific chemical designation.
3 (b) Any of the following opiates, including their isomers,
4 esters, ethers, salts, and salts of isomers, when the existence
5 of these isomers, esters, ethers, and salts is possible within
6 the specific chemical designation:
|
7 |
Alphaprodine Fentanyl |
|
8 |
Anileridine Isomethadone |
|
9 |
Bezitramide Levomethorphan |
|
10 |
Dihydrocodeine Levorphanol |
|
11 |
Diphenoxylate Metazocine |
|
12 |
|
|
13 |
Methadone |
|
14 |
Methadone-Intermediate, 4-cyano-2dimethylamino-4, 4-diphenyl butane |
|
15 |
Moramide-Intermediate, 2-methyl-3-morpholino-1, |
|
16 |
1-diphenylpropane-carboxylic acid |
|
17 |
|
|
18 |
Pethidine |
|
19 |
Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine |
|
20 |
Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate |
|
21 |
Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4- |
|
22 |
carboxylic acid |
|
23 |
|
|
24 |
Phenazocine Racemethorphan |
|
25 |
Piminodine Racemorphan |
26 (c) Unless listed in another schedule, any material,
27 compound, mixture, or preparation which contains any quantity of
28 the following substances having potential for abuse associated
1 with a stimulant effect on the nervous system:
2 (i) Amphetamine, its salts, optical isomers, and salts of its
3 optical isomers.
4 (ii) Any substance which contains any quantity of
5 methamphetamine, including its salts, stereoisomers, and salts of
6 stereoisomers.
7 (iii) Phenmetrazine and its salts.
8 (iv) Methylphenidate and its salts.
9 (d) Any material, compound, mixture, or preparation,
10 including its salts, isomers, and salts of isomers when the
11 existence of the salts, isomers, and salts of isomers is possible
12 within the specific chemical designation as listed in schedule 2,
13 which contains any quantity of the following substances having a
14 potential for abuse associated with the depressant effect on the
15 central nervous system: methaqualone, amobarbital, pentobarbital,
16 or secobarbital; or, any compound, mixture, or preparation
17 containing amobarbital, secobarbital, pentobarbital, or any salt
18 thereof in combination with itself, with another, or with 1 or
19 more other controlled substances.
20 (e) Marihuana, but only for use as provided in sections 7335
21 and 7336.the purpose
of treating a debilitating medical condition
22 as that term is defined in section 3(b) of the Michigan medical
23 marihuana act, 2008 IL 1, MCL 333.26423, and as authorized under
24 this act.
25 Sec. 7301a. Licensing activities conducted under this part
26 are subject to sections 16201, 16203, 16299, 16303, 16305, 16307,
27 16309, and 16313 and article 8.
1 Sec. 7303. (1) A person who manufactures, distributes,
2 prescribes, or dispenses a controlled substance in this state or
3 who proposes to engage in the manufacture, distribution,
4 prescribing, or dispensing of a controlled substance in this
5 state shall obtain a license issued by the administrator in
6 accordance with the rules. A person who has been issued a
7 controlled substances license by the administrator under this
8 article and a license under article 15 shall renew the controlled
9 substances license concurrently with the renewal of the license
10 issued under article 15, and for an equal number of years.
11 (2) A person licensed by the administrator under this
12 article to manufacture, distribute, prescribe, dispense, or
13 conduct research with controlled substances may possess,
14 manufacture, distribute, prescribe, dispense, or conduct research
15 with those substances to the extent authorized by its license and
16 in conformity with the other provisions of this article.
17 (3) A license issued under this article to manufacture,
18 distribute, prescribe, or dispense pharmaceutical-grade cannabis
19 and the conduct of the licensee is subject to the additional
20 requirements of article 8.
21 (4) (3) The
following persons need not be licensed and may
22 lawfully possess controlled substances or prescription forms
23 under this article:
24 (a) An agent or employee of a licensed manufacturer,
25 distributor, prescriber, or dispenser of a controlled substance
26 if acting in the usual course of the agent's or employee's
27 business or employment.
1 (b) A common or contract carrier or warehouseman, or an
2 employee thereof, whose possession of a controlled substance or
3 prescription form is in the usual course of business or
4 employment.
5 (c) An ultimate user or agent in possession of a controlled
6 substance or prescription form pursuant to a lawful order of a
7 practitioner or in lawful possession of a schedule 5 substance.
8 (5) (4) The
administrator may waive or include by rule the
9 requirement for licensure of certain manufacturers, distributors,
10 prescribers, or dispensers, if it finds the waiver or inclusion
11 is consistent with the public health and safety.
12 (6) (5) A
separate license is required at each principal
13 place of business or professional practice where the applicant
14 manufactures, distributes, prescribes, or dispenses controlled
15 substances.
16 (7) (6) As a
requisite for licensure, the administrator may
17 inspect the establishment of a licensee or applicant for
18 licensure in accordance with the administrator's rule.
19 (8) (7) A
person licensed under this article to distribute
20 controlled substances shall report to the administrator on a
21 quarterly basis all schedule 2 controlled substances and those
22 controlled substances designated by the administrator pursuant to
23 this subsection which that
are sold to licensed practitioners and
24 retail pharmacies. The report shall be in writing and shall
25 include the name of each licensed practitioner and retail
26 pharmacy to whom the controlled substance was distributed. A
27 report under this subsection may be transmitted electronically,
1 if the transmission is ultimately reduced to writing. The
2 administrator shall designate by rule the controlled substances
3 in schedules 3 to 5 to be reported under this subsection.
4 ARTICLE 8
5 PHARMACEUTICAL-GRADE CANNABIS
6 PART 81
7 GENERAL PROVISIONS
8 Sec. 8101. (1) For purposes of this article, the words and
9 phrases defined in sections 8103 to 8107 have the meanings
10 ascribed to them in those sections.
11 (2) In addition, article 1 contains general definitions and
12 principles of construction applicable to all articles in this
13 act.
14 Sec. 8103. (1) "Applicant" means the person submitting an
15 application for a new license or license renewal under part 82
16 and includes each individual identified in the application as an
17 owner, operator, officer, director, partner, member, or manager
18 of the applicant.
19 (2) "CBD" and "CBD acid" mean cannabidiol and cannabidiol
20 acid.
21 (3) "Director" means the director of the department.
22 (4) "Eligible patient" means an individual who meets the
23 requirements of part 84 and has been issued an enhanced
24 pharmaceutical-grade cannabis registration card.
25 (5) "Enhanced pharmaceutical-grade cannabis registration
26 card" or "registration card" means the registration card issued
27 to an eligible patient under part 84.
1 (6) "Good moral character" means that term as defined in
2 section 1 of 1974 PA 381, MCL 338.41.
3 Sec. 8105. (1) "Marihuana" means that term as defined in
4 section 7106 and includes pharmaceutical-grade cannabis.
5 (2) "Medical use" means the purchase, sale, possession, use,
6 internal possession, delivery, transfer, or transportation of
7 pharmaceutical-grade cannabis or paraphernalia relating to the
8 administration of pharmaceutical-grade cannabis to treat or
9 alleviate an eligible patient's debilitating medical condition.
10 (3) "Michigan medical marihuana act" means the Michigan
11 medical marihuana act, 2008 IL 1, MCL 333.26421 to 333.26430.
12 (4) "Pharmaceutical-grade cannabis" means a grade of
13 cannabis that is cultivated for the purposes of this article;
14 that is free of chemical residues such as fungicides and
15 insecticides and is tested by validated methods to determine its
16 cannabinoid levels, specifically, THC and THC acid levels and CBD
17 and CBD acid levels and complies with the standards set forth in
18 section 8303(6) for its microbial, mycotoxin, and metal contents,
19 including heavy metals; and that meets any other necessary
20 requirements to be considered in compliance with good
21 manufacturing practices as prescribed in rules promulgated by the
22 department under this article.
23 (5) "Pharmaceutical-grade cannabis fund" or "fund" means the
24 pharmaceutical-grade cannabis fund created in section 8113.
25 (6) "Pharmaceutical-grade cannabis licensed facility" or
26 "licensed facility" means any secure entity, operation, or
27 facility at or through which pharmaceutical-grade cannabis is
1 manufactured, cultivated, and tested in this state for lawful
2 medical use as provided for in this article and the Michigan
3 medical marihuana act. Pharmaceutical-grade cannabis licensed
4 facility does not include a qualifying patient or primary
5 caregiver who possesses or cultivates marihuana in the manner
6 prescribed in the Michigan medical marihuana act or an eligible
7 patient who possesses pharmaceutical-grade cannabis in the manner
8 prescribed in this article.
9 Sec. 8107. (1) "Qualifying patient" means an individual who
10 has been issued a registry identification card as a qualifying
11 patient under the Michigan medical marihuana act.
12 (2) "THC" means delta-9-tetrahydrocannabinol and
13 tetrahydrocannabinol acid.
14 Sec. 8109. (1) A person shall not manufacture, distribute,
15 prescribe, or dispense pharmaceutical-grade cannabis without
16 first obtaining a license to manufacture, distribute, prescribe,
17 or dispense a controlled substance under article 7.
18 (2) A license issued under article 7 to manufacture,
19 distribute, prescribe, or dispense pharmaceutical-grade cannabis
20 and the conduct of a person licensed to manufacture, distribute,
21 prescribe, or dispense pharmaceutical-grade cannabis under that
22 license is subject to the additional requirements of this
23 article.
24 (3) Article 7 and this article do not apply to conduct
25 permitted under the Michigan medical marihuana act.
26 Sec. 8111. (1) Beginning on the effective date of this
27 article, the director may charge a reasonable fee for licensing,
1 registration, inspection, testing, or other activity or service
2 provided by the department under this article. The fee authorized
3 under this subsection is in addition to any fee authorized under
4 article 7. All fees permitted under this section shall be
5 delivered to the state treasurer on a monthly basis for deposit
6 in the pharmaceutical-grade cannabis fund.
7 (2) Before collecting a fee under this article, the
8 department shall develop and publish a comprehensive schedule of
9 fees. The schedule shall include a description of each activity
10 or service and the maximum fee charged for that activity or
11 service. The department shall include a statement of the rationale
12 used in determining the fees contained in the schedule. The
13 department shall revise the fee schedule from time to time so
14 that the amount of fees collected under this article does not
15 exceed the amount necessary to fund the duties of the department
16 under this article.
17 Sec. 8113. (1) The pharmaceutical-grade cannabis fund is
18 created within the state treasury. In addition to the fees
19 described in section 8111, the state treasurer may receive money
20 or other assets from any source for deposit into the fund. The
21 state treasurer shall direct the investment of the fund. The
22 state treasurer shall credit to the fund interest and earnings
23 from fund investments. Money in the fund at the close of the
24 fiscal year shall remain in the fund and shall not lapse to the
25 general fund.
26 (2) The department is the administrator of the fund for
27 auditing purposes and the department shall expend money from the
1 fund, upon appropriation, only for the direct and indirect costs
2 associated with implementing, administering, and enforcing this
3 article.
4 Sec. 8115. The department shall promulgate rules necessary
5 to carry out this article. The rules shall address, but are not
6 required to be limited to addressing, all of the following
7 subjects:
8 (a) If not specifically provided for in this article,
9 activities necessary for the compliance with or enforcement of or
10 activities that constitute a violation of this article,
11 including, but not limited to, procedures and grounds for
12 denying, suspending, or revoking a license or registration card
13 under this article.
14 (b) Instructions for local health departments and law
15 enforcement officers.
16 (c) All forms necessary or convenient for the
17 implementation, administration, and enforcement of this article.
18 (d) Activities that constitute or result in
19 misrepresentation or unfair, deceptive practices.
20 (e) Procedures and forms for issuing enhanced
21 pharmaceutical-grade cannabis registration cards.
22 (f) Regulating the manufacturing, inventory, storage,
23 disposal, and sale of pharmaceutical-grade cannabis and
24 specifying legitimate sources for obtaining seed to cultivate
25 pharmaceutical-grade cannabis.
26 (g) The quarterly reporting by licensed facilities of their
27 inventory, which shall include the number of plants under
1 cultivation, the amount of dried plant material, the amount of
2 destroyed plants, and all sales.
3 (h) Compliance with federal regulatory requirements.
4 (i) Health and sanitary requirements for licensed
5 facilities.
6 (j) Record keeping, record retention, record storage, and
7 record security requirements for pharmaceutical-grade cannabis
8 licensed facilities.
9 (k) Audit requirements for licensed facilities, which shall
10 include self reporting of inventory on a monthly basis, subject
11 to inspection by designated state and federal authorities.
12 (l) Physical security requirements for pharmaceutical-grade
13 cannabis that at a minimum include lighting and alarms.
14 (m) The reporting and transmittal of monthly sales and
15 income tax payments for licensed facilities.
16 (n) Authorization for the department of treasury to have
17 access to licensing information to ensure sales and income tax
18 payments for licensed facilities.
19 (o) Activities that constitute lawful and unlawful financial
20 arrangements between licensed facilities.
21 (p) The quantity of pharmaceutical-grade cannabis plants and
22 dried plant material that a licensed facility may possess in its
23 inventory at any time.
24 (q) Other matters necessary for the fair, impartial,
25 stringent, and comprehensive implementation, administration, and
26 enforcement of this article to protect the health, safety, and
27 welfare of the residents of this state.
1 Sec. 8117. The department shall establish a pharmaceutical-
2 grade cannabis licensed facility registry. The registry shall be
3 an online database that contains information regarding the
4 pharmaceutical-grade cannabis licensed facilities licensed under
5 part 82. Information in the database shall be made available to
6 the public.
7 Sec. 8119. By January 31 of each calendar year, the
8 department shall submit to the legislature an annual report for
9 the previous calendar year that contains all of the following
10 information:
11 (a) The total amount of fees collected under this article.
12 (b) All costs related to performing the duties of the
13 department under this article.
14 (c) Fines, suspensions, or license revocations that were
15 imposed by the department under this article.
16 (d) Any other information the department considers
17 appropriate under this article.
18 PART 81A
19 PRESCRIBING AND DISPENSING PHARMACEUTICAL-GRADE CANNABIS
20 Sec. 8151. A physician who determines that his or her
21 patient is likely to receive therapeutic or palliative benefit
22 from the use of pharmaceutical-grade cannabis to treat or
23 alleviate the patient's debilitating medical condition or
24 symptoms of the patient's debilitating medical condition may
25 recommend the issuance of an enhanced pharmaceutical-grade
26 cannabis registration card to that patient as an eligible
27 patient.
1 Sec. 8152. (1) The department may issue an enhanced
2 pharmaceutical-grade cannabis registration card to an eligible
3 patient who is recommended by a physician to obtain a
4 registration card and who properly applies for that card. Before
5 issuing a card to an eligible patient under this section, the
6 department shall determine whether the individual has previously
7 been convicted of illegally manufacturing, creating,
8 distributing, possessing, or using a controlled substance or
9 conspiring or attempting to manufacture, create, distribute,
10 possess, or use a controlled substance in this state or
11 elsewhere. If the individual has previously been convicted of
12 illegally manufacturing, creating, distributing, possessing, or
13 using a controlled substance or conspiring or attempting to
14 manufacture, create, distribute, possess, or use a controlled
15 substance in this state or elsewhere, the department shall not
16 issue a registration card to that individual.
17 (2) If an individual has a registry identification card as
18 defined in section 3 of the Michigan medical marihuana act, 2008
19 IL 1, MCL 333.26423, the department shall require the individual
20 to surrender that card before issuing the individual an enhanced
21 pharmaceutical-grade cannabis registration card under this
22 section.
23 Sec. 8153. (1) The department shall ensure that the
24 following information for each pharmaceutical-grade cannabis
25 registration card is entered into the law enforcement information
26 network:
27 (a) The card registration number.
1 (b) The name and address of the individual to whom the card
2 is issued.
3 (c) The date the card was issued.
4 (d) The name and address of the physician who authorized
5 issuance of the card.
6 (2) Subsection (1) does not authorize the department to
7 enter any information into the law enforcement information
8 network regarding the diagnosis supporting issuance of the card
9 or any medical information regarding the individual to whom the
10 card has been issued.
11 Sec. 8154. (1) Each prescription for pharmaceutical-grade
12 cannabis shall contain all of the following information:
13 (a) The date the prescription is written.
14 (b) The date the prescription is filled.
15 (c) The dosage and instructions for use, which shall include
16 the percentage of total THC and the percentage of total CBD. A
17 prescription for pharmaceutical-grade cannabis shall not allow
18 the individual to whom the prescription is issued to obtain more
19 than 2 ounces of pharmaceutical-grade cannabis within a 30-day
20 period.
21 (d) The name, address, and federal drug enforcement
22 administration number of the dispensing pharmacy and the initials
23 of the pharmacist who fills the prescription.
24 (e) The name, address, and age of the eligible patient for
25 whom the pharmaceutical-grade cannabis is prescribed.
26 Pharmaceutical-grade cannabis shall not be prescribed to an
27 individual less than 18 years of age.
1 (f) The product brand name, if a brand name is specified by
2 the prescriber.
3 (2) The department shall require the use of the electronic
4 system established under section 7333a for monitoring
5 pharmaceutical-grade cannabis dispensed under this section as a
6 schedule 2 controlled substance.
7 (3) The director shall permit access to information
8 submitted to the department under this article only to the
9 following individuals and as provided in this article:
10 (a) Employees and agents of the department authorized by the
11 director of the department.
12 (b) Employees of the department of state police authorized
13 by the administrator as defined in article 7 for the purpose of
14 cooperating and assisting a governmental agency that is
15 responsible for the enforcement of laws relating to controlled
16 substances or a prescribing physician concerning an individual
17 suspected of attempting to obtain a controlled substance by
18 fraud, deceit, or misrepresentation.
19 (c) A person with whom the department has contracted under
20 subsection (8).
21 (4) Information submitted to the department under this
22 section is confidential, but may be released to persons
23 authorized by the director to conduct research studies or to
24 other persons authorized by the director. However, subject to
25 subsection (5) and section 8153, information shall be released
26 for statistical purposes only.
27 (5) The system for retrieval of information submitted to the
1 department under this section shall be designed in all respects
2 so as to preclude improper access to information.
3 (6) Except as otherwise provided in this part, information
4 submitted to the department under this section shall be used only
5 for bona fide drug-related criminal investigatory or evidentiary
6 purposes or for investigatory or evidentiary purposes in
7 connection with the functions of 1 or more of the licensing
8 boards created in article 15.
9 (7) The identity of an individual eligible patient that is
10 submitted to the department under to this section shall be
11 removed from the system for retrieval of the information
12 described in this section and shall be destroyed and rendered
13 irretrievable not later than the end of the calendar year
14 following the year in which the information was submitted to the
15 department. However, an individual eligible patient identity that
16 is necessary for use in a specific ongoing investigation
17 conducted in accordance with this act may be retained in the
18 system until the end of the year in which the necessity for
19 retention of the identity ends.
20 (8) The department may enter into contractual agreements for
21 the administration of this section.
22 PART 82
23 FACILITY LICENSING
24 Sec. 8201. To protect the health, safety, and welfare of
25 residents of this state, the department shall license facilities
26 under this article to cultivate, manufacture, and test
27 pharmaceutical-grade cannabis in this state. The department shall
1 implement, administer, and enforce this article to ensure that a
2 safe, pure, dosage—consistent grade of pharmaceutical-grade
3 cannabis is available to eligible patients who are residents of
4 this state.
5 Sec. 8205. (1) The department shall not issue a license to
6 an applicant to operate a pharmaceutical-grade cannabis licensed
7 facility unless the department is satisfied that all of the
8 following requirements are met:
9 (a) All fees required under this article have been paid.
10 (b) The applicant will operate the licensed facility in
11 compliance with this article.
12 (c) The applicant is an adult of good moral character.
13 (d) The applicant is not delinquent in filing any tax
14 returns with a taxing agency; paying any taxes, interest, or
15 penalties; paying any judgments due to a government agency;
16 repaying government-insured student loans; or paying child
17 support.
18 (e) The applicant will not hire or contract with any
19 individual in the course of operating a licensed facility without
20 first conducting a criminal history check in the manner
21 prescribed in rules promulgated under this article.
22 (f) The premises were inspected and the inspection of the
23 premises and the operations of the applicant did not reveal any
24 reason to deny the license.
25 (g) The criminal history check conducted under subsection
26 (2) did not reveal any felony convictions.
27 (h) Any other criteria established in rules promulgated
1 under this article.
2 (2) At the time of filing an application for issuance or
3 renewal of a pharmaceutical-grade cannabis licensed facility
4 license, an applicant shall submit a set of his or her
5 fingerprints and file personal history information concerning his
6 or her qualifications for a license under this article. The
7 department shall submit the fingerprints to the department of
8 state police for the purpose of conducting fingerprint-based
9 criminal history checks. The department of state police shall
10 forward the fingerprints to the federal bureau of investigation
11 for the purpose of conducting fingerprint-based criminal history
12 checks. The department may acquire a name-based criminal history
13 check for an applicant who has twice submitted to a fingerprint-
14 based criminal history check under this part and whose
15 fingerprints are unclassifiable. An applicant who has previously
16 submitted fingerprints under this part may request that the
17 fingerprints on file be used. The department shall use the
18 information resulting from the fingerprint-based criminal history
19 check to investigate and determine whether an applicant is
20 qualified to hold a license under this article. The department
21 may verify any of the information an applicant is required to
22 submit.
23 Sec. 8209. The department may delegate the duty of
24 inspections for approval or renewal of pharmaceutical-grade
25 cannabis licensed facility licenses to a local health department
26 that has the technical and other capabilities to protect the
27 public health, safety, and welfare in this field. The delegation
1 shall not take place unless the department has first consulted
2 with an ad hoc committee that shall be appointed by the
3 department for the purpose of advising on that delegation.
4 Membership on the ad hoc committee shall include representatives
5 of the department, local public health agencies, and an
6 association that represents the pharmaceutical-grade cannabis
7 licensed facilities that would be subject to the inspections. If
8 delegated under this section, the state shall reimburse each
9 local health department the full amount of the fees collected, as
10 reimbursement for the cost of inspection, on vouchers certified
11 by the local health officer and approved by the department.
12 Sec. 8211. Not later than the thirtieth day before the
13 expiration of an annual license under this part, a person
14 operating a pharmaceutical-grade cannabis licensed facility
15 seeking relicensure shall apply for license renewal and shall pay
16 a fee as prescribed in this article. Upon compliance by an
17 applicant for license renewal with the requirements of this
18 article and payment of the license renewal fee, the department
19 shall issue a renewal license.
20 PART 83
21 PHARMACEUTICAL-GRADE CANNABIS LICENSED FACILITY OPERATIONS
22 Sec. 8301. A pharmaceutical-grade cannabis licensed facility
23 shall establish legal control of its physical location. The
24 physical location shall meet all applicable state and local
25 zoning laws.
26 Sec. 8303. (1) A pharmaceutical-grade cannabis licensed
27 facility shall notify the department in writing of the name,
1 address, and date of birth of an officer, director, partner,
2 member, manager, or employee before the individual is associated
3 with or begins working at the licensed facility. The licensed
4 facility shall obtain the individual's identification and have a
5 criminal history check conducted to determine if that individual
6 is qualified to work at or be associated with the licensed
7 facility under this article.
8 (2) A pharmaceutical-grade cannabis licensed facility shall
9 notify the department in writing within 10 days after an officer,
10 director, partner, member, manager, or employee ceases to work at
11 or otherwise be associated with the licensed facility.
12 (3) A pharmaceutical-grade cannabis licensed facility shall
13 not acquire, possess, cultivate, deliver, transfer, transport,
14 supply, sell, or dispense pharmaceutical-grade cannabis for any
15 purpose except as provided in this article.
16 (4) A pharmaceutical-grade cannabis licensed facility shall
17 not possess more than the amount of pharmaceutical-grade cannabis
18 plants or dried pharmaceutical-grade cannabis allowed in its
19 inventory as prescribed in rules promulgated under this article.
20 (5) A pharmaceutical-grade cannabis licensed facility shall
21 destroy all marihuana that it cultivates or that is otherwise in
22 its possession that is determined not to be pharmaceutical-grade
23 cannabis. A licensed facility shall keep records of its
24 activities under this subsection in order to verify its
25 compliance to the department.
26 (6) Pharmaceutical-grade cannabis shall meet the following
27 standards:
|
1 |
Microbiological |
|
2 |
Microbiological Analysis FPL Specifications |
|
3 |
Total coliforms <3 MPN/g |
|
4 |
Std. plate count aerobic <100 CFU/g |
|
5 |
Std. plate count anaerobic <100 CFU/g |
|
6 |
Escherichia coli Absent |
|
7 |
Salmonella Absent |
|
8 |
Staphylococcus aureus <100 CFU/g |
|
9 |
Yeast and molds <100 CFU/g |
|
10 |
|
|
11 |
Mycotoxins |
|
12 |
Test Specification |
|
13 |
Aflatoxin B1 <20 µg/kg of substance |
|
14 |
Aflatoxin B2 <20 µg/kg of substance |
|
15 |
Aflatoxin O1 <20 µg/kg of substance |
|
16 |
Aflatoxin O2 <20 µg/kg of substance |
|
17 |
Ochratoxin A <20 µg/kg of substance |
|
18 |
|
|
19 |
Heavy Metals |
|
20 |
Metal NHP Acceptable Limits |
|
21 |
µg/kg bw/day |
|
22 |
Arsenic <0.14 |
|
23 |
Cadmium <0.09 |
|
24 |
Lead <0.29 |
|
25 |
Mercury <0.29 |
26 (7) A licensed facility shall irradiate all pharmaceutical-
27 grade cannabis in the manner determined by the department before
28 delivering that pharmaceutical-grade cannabis to another person.
29 Sec. 8305. A pharmaceutical-grade cannabis licensed facility
1 may be a profit or nonprofit entity.
2 Sec. 8307. A pharmaceutical-grade cannabis licensed facility
3 may operate on any calendar days of the week, but shall do all of
4 the following:
5 (a) Prohibit smoking or consumption of marihuana on its
6 premises.
7 (b) Maintain all records required under this article on its
8 premises.
9 (c) Make the licensed premises available for inspection and
10 search by the department, by law enforcement officers, and by any
11 other state, federal, or local governmental agency authorized by
12 law or department rule to inspect the premises of the licensed
13 facility under this act, during regular business hours and when
14 the licensed premises are occupied by the licensee or a clerk,
15 servant, agent, or employee of the licensee. Evidence of a
16 violation of this act or rules promulgated under this act
17 discovered under this subsection may be seized and used in an
18 administrative or court proceeding.
19 Sec. 8309. In addition to the provisions of section 2946 of
20 the revised judicature act of 1961, 1961 PA 236, MCL 600.2946, in
21 a product liability action against a pharmaceutical-grade
22 cannabis licensed facility, pharmaceutical-grade cannabis is not
23 defective or unreasonably dangerous, and the pharmaceutical-grade
24 cannabis licensed facility is not liable, if the product sold was
25 tested and determined to meet the standards for pharmaceutical-
26 grade cannabis under this article.
27 PART 84
1 SALE AND DISTRIBUTION OF PHARMACEUTICAL-GRADE CANNABIS
2 Sec. 8401. (1) A pharmaceutical-grade cannabis licensed
3 facility shall not sell or otherwise distribute pharmaceutical-
4 grade cannabis except as provided in this section.
5 (2) A pharmaceutical-grade cannabis licensed facility shall
6 not sell or otherwise distribute pharmaceutical-grade cannabis
7 directly to the public.
8 (3) A pharmaceutical-grade cannabis licensed facility shall
9 sell pharmaceutical-grade cannabis only to a licensed pharmacist
10 or retail pharmacy to be dispensed only to eligible patients and
11 to other pharmaceutical-grade cannabis licensed facilities for
12 purposes provided for under this article. Pharmaceutical-grade
13 cannabis dispensed by a licensed pharmacist or retail pharmacy
14 shall have affixed upon each package and container in which the
15 cannabis is contained a label showing in legible English the name
16 and address of the manufacturer, the date the prescription is
17 filled, the dosage, including the total percentage of THC and
18 total percentage of CBD, the name of the patient, and the name
19 and address of the dispensing pharmacist.
20 (4) A pharmaceutical-grade cannabis licensed facility may
21 sell or otherwise distribute pharmaceutical-grade cannabis to
22 pharmacies for sale or distribution only to eligible patients as
23 provided in this article.
24 (5) A pharmaceutical-grade cannabis licensed facility shall
25 report to the department on a quarterly basis all quantities of
26 pharmaceutical-grade cannabis sold to licensed pharmacists,
27 retail pharmacies, and other pharmaceutical-grade cannabis
1 licensed facilities. The report shall be in writing and shall
2 include the name and address of each pharmacist, retail pharmacy,
3 and pharmaceutical-grade cannabis licensed facility to which the
4 pharmaceutical-grade cannabis is sold. A report under this sub-
5 section may be transmitted electronically, if the transmission is
6 ultimately reduced to writing.
7 PART 85
8 ENFORCEMENT
9 Sec. 8501. (1) The department shall enforce this article and
10 the applicable provisions of article 7 and shall conduct annual
11 inspections of pharmaceutical-grade cannabis licensed facilities
12 to ensure compliance with the requirements of this article and
13 article 7.
14 (2) Upon a finding that an emergency exists requiring
15 immediate action to protect the public health, safety, and
16 welfare, the department may issue an order to suspend the license
17 of a pharmaceutical-grade cannabis licensed facility without
18 notice or hearing. The order shall recite the existence of the
19 emergency and the facts supporting a determination of the need to
20 protect public health, safety, and welfare. Notwithstanding this
21 act or the administrative procedures act of 1969, the order shall
22 be effective immediately. A person to whom the order is directed
23 shall comply immediately but, on application to the department,
24 shall be afforded a hearing within 15 days. On the basis of the
25 hearing, the order of summary suspension shall be continued,
26 modified, or dissolved not later than 30 days after the hearing.
27 Sec. 8503. (1) In addition to any other penalties prescribed
1 or remedies provided in this article, article 7, and article 15,
2 the department may, on its own motion or on receipt of a
3 complaint, and after an investigation and a hearing before an
4 administrative law judge at which the pharmaceutical-grade
5 cannabis licensed facility licensee is afforded an opportunity to
6 be heard, suspend or revoke a facility license issued under this
7 article. The department may suspend or revoke a license for any
8 violation by the licensee, a board member, an agent, or an
9 employee of the licensed facility or of any of the terms,
10 conditions, or provisions of the license issued by the
11 department. The department may administer oaths and issue
12 subpoenas to require the presence of persons and the production
13 of papers, books, and records necessary to the determination of
14 any hearing that the department is authorized to conduct.
15 (2) The department shall provide notice of suspension or
16 revocation, as well as any required notice of a hearing, by
17 mailing the same in writing to the licensed facility at the
18 address contained in the license. If a license is suspended or
19 revoked, no part of the fees paid for the license under this
20 article or under article 7 shall be returned to the licensee. The
21 department may summarily suspend a license without notice pending
22 any prosecution, investigation, or public hearing. Nothing in
23 this section shall prevent the summary suspension of a license
24 for a temporary period of not more than 15 days.
25 Sec. 8505. In any licensing hearing held by the department
26 under this article, a person shall not refuse, upon request of
27 the department, to testify or provide other information on the
1 grounds of self-incrimination. Any testimony or other information
2 produced in the hearing and any information directly or
3 indirectly derived from the testimony or other information shall
4 not be used against the person in any criminal prosecution based
5 on a violation of this article except a prosecution for perjury
6 committed while testifying. Continued refusal to testify or
7 provide other information is grounds for the suspension or
8 revocation of a license or registration card issued under this
9 article.
10 Sec. 8507. (1) The owner, operator, or agent of a
11 pharmaceutical-grade cannabis licensed facility who knowingly
12 violates this article or who establishes or operates a
13 pharmaceutical-grade cannabis licensed facility in violation of
14 this article is guilty of a crime as follows:
15 (a) Except as provided in subdivisions (b) and (c), the
16 person is guilty of a misdemeanor punishable by imprisonment for
17 not more than 90 days or a fine of not more than $10,000.00, or
18 both.
19 (b) Except as provided in subdivision (c), if the person has
20 1 prior conviction for violating this article, the person is
21 guilty of a misdemeanor punishable by imprisonment for not more
22 than 180 days or a fine of not more than $50,000.00, or both.
23 (c) If the person has 2 or more prior convictions for
24 violating this article, or intentionally violates this article,
25 the person is guilty of a misdemeanor punishable by imprisonment
26 for not more than 2 years or a fine of not more than $100,000.00,
27 or both.
1 (2) Subsection (1) does not prohibit the person from being
2 charged with, convicted of, or sentenced for any other violation
3 of law committed by the person while violating this section.
4 Sec. 8509. Except as otherwise provided in this article, a
5 pharmaceutical-grade cannabis licensed facility that has been
6 issued a license under this article, or any owner, operator,
7 officer, director, partner, member, manager, or employee of the
8 licensed facility, is not subject to arrest, prosecution, or
9 penalty in any manner, or denied any right or privilege,
10 including, but not limited to, civil penalty or disciplinary
11 action by a business or occupational or professional licensing
12 board or bureau, for the cultivation, distribution, and sale of
13 pharmaceutical-grade cannabis under this article for use by
14 eligible patients in the manner prescribed in this article.
15 Sec. 8511. Except as otherwise provided in this section, a
16 local governmental unit shall not enact or enforce an ordinance
17 regarding pharmaceutical-grade cannabis licensed facilities. A
18 local governmental unit may limit the number of pharmaceutical-
19 grade cannabis licensed facilities that may operate in the local
20 governmental unit and may enact reasonable zoning regulations
21 applicable to pharmaceutical-grade cannabis licensed facilities
22 based on local government zoning, health, and safety laws for the
23 cultivation, distribution, and sale of pharmaceutical-grade
24 cannabis.
25 Sec. 16169. (1) If an individual employed by or under
26 contract to the department has reasonable cause to believe that a
27 health professional may be impaired, the individual shall
1 transmit the information to the committee either orally or in
2 writing. Upon receipt of the information, the committee shall
3 request the program consultant described in section 16168 to
4 determine whether or not the health professional may be impaired.
5 (2) If, based on the information received by the department
6 under section 16168(2), the department determines that the health
7 professional involved may be a threat to the public health,
8 safety, or welfare and has violated this article, or
article 7,
9
or article 8 or the rules promulgated
under this article, or
10 article 7, or article 8, the department may proceed under
11 sections 16211 and 16231.
12 Sec. 16170a. (1) The identity of an individual submitting
13 information to the committee or the department regarding the
14 suspected impairment of a health professional is confidential.
15 (2) The identity of a health professional who participates
16 in the health professional recovery program is confidential and
17 is not subject to disclosure under discovery or subpoena or the
18 freedom of information act, Act No. 442 of the Public Acts of
19 1976, being sections 15.231 to 15.246 of the Michigan Compiled
20 Laws, 1976 PA 442,
MCL 15.231 to 15.246, unless the health
21 professional fails to satisfactorily participate in and complete
22 a treatment plan prescribed under the health professional
23 recovery program or violates section 16170(3).
24 (3) If a health professional successfully participates in
25 and completes a treatment plan prescribed under the health
26 professional recovery program, as determined by the committee,
27 the department shall destroy all records pertaining to the
1 impairment of the health professional, including records
2 pertaining to the health professional's participation in the
3 treatment plan, upon the expiration of 5 years after the date of
4 the committee's determination. This subsection does not apply to
5 records pertaining to a violation of this article, or
article 7,
6
or article 8 or a rule promulgated
under this article, or article
7 7, or article 8.
8 Sec. 16174. (1) An individual who is licensed or registered
9 under this article shall meet all of the following requirements:
10 (a) Be 18 or more years of age.
11 (b) Be of good moral character.
12 (c) Have a specific education or experience in the health
13 profession or in a health profession subfield or health
14 profession specialty field of the health profession, or training
15 equivalent, or both, as prescribed by this article or rules of a
16 board necessary to promote safe and competent practice and
17 informed consumer choice.
18 (d) Have a working knowledge of the English language as
19 determined in accordance with minimum standards established for
20 that purpose by the department.
21 (e) Pay the appropriate fees as prescribed in this article.
22 (2) In addition to the requirements of subsection (1), an
23 applicant for licensure, registration, specialty certification,
24 or a health profession specialty subfield license under this
25 article shall meet all of the following requirements:
26 (a) Establish that disciplinary proceedings before a similar
27 licensure, registration, or specialty licensure or specialty
1 certification board of this or any other state, of the United
2 States military, of the federal government, or of another country
3 are not pending against the applicant.
4 (b) Establish that if sanctions have been imposed against
5 the applicant by a similar licensure, registration, or specialty
6 licensure or specialty certification board of this or any other
7 state, of the United States military, of the federal government,
8 or of another country based upon grounds that are substantially
9 similar to those set forth in this article, or
article 7, or
10
article 8 or the rules promulgated
under this article, or article
11 7, or article 8, as determined by the board or task force to
12 which the applicant applies, the sanctions are not in force at
13 the time of application. This subdivision does not apply to an
14 application for licensure that the board may grant under section
15 17011(4) or 17511(2).
16 (c) File with the board or task force a written, signed
17 consent to the release of information regarding a disciplinary
18 investigation involving the applicant conducted by a similar
19 licensure, registration, or specialty licensure or specialty
20 certification board of this or any other state, of the United
21 States military, of the federal government, or of another
22 country.
23 (3) Beginning October 1, 2008, an applicant for initial
24 licensure or registration shall submit his or her fingerprints to
25 the department of state police to have a criminal history check
26 conducted and request that the department of state police forward
27 his or her fingerprints to the federal bureau of investigation
1 for a national criminal history check. The department of state
2 police shall conduct a criminal history check and request the
3 federal bureau of investigation to make a determination of the
4 existence of any national criminal history pertaining to the
5 applicant. The department of state police shall provide the
6 department with a written report of the criminal history check if
7 the criminal history check contains any criminal history record
8 information. The department of state police shall forward the
9 results of the federal bureau of investigation determination to
10 the department within 30 days after the request is made. The
11 department shall notify the board and the applicant in writing of
12 the type of crime disclosed on the federal bureau of
13 investigation determination without disclosing the details of the
14 crime. The department of state police may charge a reasonable fee
15 to cover the cost of conducting the criminal history check. The
16 criminal history record information obtained under this
17 subsection shall be used only for the purpose of evaluating an
18 applicant's qualifications for licensure or registration for
19 which he or she has applied. A member of the board shall not
20 disclose the report or its contents to any person who is not
21 directly involved in evaluating the applicant's qualifications
22 for licensure or registration. Information obtained under this
23 subsection is confidential, is not subject to disclosure under
24 the freedom of information act, 1976 PA 442, MCL 15.231 to
25 15.246, and shall not be disclosed to any person except for
26 purposes of this section or for law enforcement purposes.
27 (4) Before granting a license, registration, specialty
1 certification, or a health profession specialty field license to
2 an applicant, the board or task force to which the applicant
3 applies may do 1 of the following:
4 (a) Make an independent inquiry into the applicant's
5 compliance with the requirements described in subsection (2). If
6 subsection (2)(b) applies to an application for licensure and a
7 licensure or registration board or task force determines under
8 subsection (2)(b) that sanctions have been imposed and are in
9 force at the time of application, the board or task force shall
10 not grant a license or registration or specialty certification or
11 health profession specialty field license to the applicant.
12 (b) Require the applicant to secure from a national
13 association or federation of state professional licensing boards
14 certification of compliance with the requirements described in
15 subsection (2). If an application is for licensure that the board
16 may grant under section 17011(4) or 17511(2), the applicant is
17 not required to secure the certification of compliance with
18 respect to the requirements described in subsection (2)(b).
19 (5) If, after issuing a license, registration, specialty
20 certification, or health profession specialty field license, a
21 board or task force or the department determines that sanctions
22 have been imposed against the licensee or registrant by a similar
23 licensure or registration or specialty licensure or specialty
24 certification board as described in subsection (2)(b), the
25 disciplinary subcommittee may impose appropriate sanctions upon
26 the licensee or registrant. The licensee or registrant may
27 request a show cause hearing before a hearing examiner to
1 demonstrate why the sanctions should not be imposed.
2 (6) An applicant for licensure, registration, specialty
3 certification, or a health profession specialty field license who
4 is or has been licensed, registered, or certified in a health
5 profession or specialty by another state or country shall
6 disclose that fact on the application form.
7 Sec. 16192. (1) A licensee or registrant shall report to the
8 department a change in name or mailing address not later than 30
9 days after the change occurs.
10 (2) The department may serve a notice of hearing or a
11 complaint on an applicant, licensee, or registrant in an action
12 or proceeding for a violation of this article, or
article 7, or
13
article 8 or a rule promulgated under
this article, or article 7,
14 or article 8 by regular mail and by certified mail, return
15 receipt requested, to the applicant's, licensee's, or
16 registrant's last known address, by serving the notice on the
17 applicant, licensee, or registrant, or by making a reasonable
18 attempt to serve the notice on the applicant, licensee, or
19 registrant. For purposes of this subsection, if service is by
20 mail, service is effective 3 days after the date of mailing, and
21 nondelivery does not affect the validity of the service if the
22 nondelivery was caused by the refusal of the applicant, licensee,
23 or registrant to accept service.
24 (3) A license or registration is not transferable.
25 Sec. 16216. (1) The chair of each board or task force shall
26 appoint 1 or more disciplinary subcommittees for that board or
27 task force. A disciplinary subcommittee for a board or task force
1 shall consist of 2 public members and 3 professional members from
2 the board or task force. The chair of a board or task force shall
3 not serve as a member of a disciplinary subcommittee.
4 (2) A final decision of the disciplinary subcommittee
5 finding a violation of this article, or article 7, or article 8
6 shall be by a majority vote of the members appointed and serving
7 on the disciplinary subcommittee.
8 (3) A final decision of the disciplinary subcommittee
9 imposing a sanction under this article, or article 7, or article
10 8 or a final decision of the disciplinary subcommittee other than
11 a final decision described in subsection (2) requires a majority
12 vote of the members appointed and serving on the disciplinary
13 subcommittee with an affirmative vote by at least 1 public
14 member.
15 (4) The chairperson of each disciplinary subcommittee shall
16 be a public member and shall be appointed by the chair of the
17 board or task force.
18 Sec. 16221. The department may investigate activities
19 related to the practice of a health profession by a licensee, a
20 registrant, or an applicant for licensure or registration. The
21 department may hold hearings, administer oaths, and order the
22 taking of relevant testimony and shall report its findings to the
23 appropriate disciplinary subcommittee. The disciplinary
24 subcommittee shall proceed under section 16226 if it finds that 1
25 or more of the following grounds exist:
26 (a) A violation of general duty, consisting of negligence or
27 failure to exercise due care, including negligent delegation to
1 or supervision of employees or other individuals, whether or not
2 injury results, or any conduct, practice, or condition that
3 impairs, or may impair, the ability to safely and skillfully
4 practice the health profession.
5 (b) Personal disqualifications, consisting of 1 or more of
6 the following:
7 (i) Incompetence.
8 (ii) Subject to sections 16165 to 16170a, substance use
9 disorder as defined in section 100d of the mental health code,
10 1974 PA 258, MCL 330.1100d.
11 (iii) Mental or physical inability reasonably related to and
12 adversely affecting the licensee's ability to practice in a safe
13 and competent manner.
14 (iv) Declaration of mental incompetence by a court of
15 competent jurisdiction.
16 (v) Conviction of a misdemeanor punishable by imprisonment
17 for a maximum term of 2 years; a misdemeanor involving the
18 illegal delivery, possession, or use of a controlled substance;
19 or a felony. A certified copy of the court record is conclusive
20 evidence of the conviction.
21 (vi) Lack of good moral character.
22 (vii) Conviction of a criminal offense under section 520e or
23 520g of the Michigan penal code, 1931 PA 328, MCL 750.520e and
24 750.520g. A certified copy of the court record is conclusive
25 evidence of the conviction.
26 (viii) Conviction of a violation of section 492a of the
27 Michigan penal code, 1931 PA 328, MCL 750.492a. A certified copy
1 of the court record is conclusive evidence of the conviction.
2 (ix) Conviction of a misdemeanor or felony involving fraud in
3 obtaining or attempting to obtain fees related to the practice of
4 a health profession. A certified copy of the court record is
5 conclusive evidence of the conviction.
6 (x) Final adverse administrative action by a licensure,
7 registration, disciplinary, or certification board involving the
8 holder of, or an applicant for, a license or registration
9 regulated by another state or a territory of the United States,
10 by the United States military, by the federal government, or by
11 another country. A certified copy of the record of the board is
12 conclusive evidence of the final action.
13 (xi) Conviction of a misdemeanor that is reasonably related
14 to or that adversely affects the licensee's ability to practice
15 in a safe and competent manner. A certified copy of the court
16 record is conclusive evidence of the conviction.
17 (xii) Conviction of a violation of section 430 of the
18 Michigan penal code, 1931 PA 328, MCL 750.430. A certified copy
19 of the court record is conclusive evidence of the conviction.
20 (xiii) Conviction of a criminal offense under section 520b,
21 520c, 520d, or 520f of the Michigan penal code, 1931 PA 328, MCL
22 750.520b, 750.520c, 750.520d, and 750.520f. A certified copy of
23 the court record is conclusive evidence of the conviction.
24 (c) Prohibited acts, consisting of 1 or more of the
25 following:
26 (i) Fraud or deceit in obtaining or renewing a license or
27 registration.
1 (ii) Permitting a license or registration to be used by an
2 unauthorized person.
3 (iii) Practice outside the scope of a license.
4 (iv) Obtaining, possessing, or attempting to obtain or
5 possess a controlled substance as defined in section 7104 or a
6 drug as defined in section 7105 without lawful authority; or
7 selling, prescribing, giving away, or administering drugs for
8 other than lawful diagnostic or therapeutic purposes.
9 (d) Unethical business practices, consisting of 1 or more of
10 the following:
11 (i) False or misleading advertising.
12 (ii) Dividing fees for referral of patients or accepting
13 kickbacks on medical or surgical services, appliances, or
14 medications purchased by or in behalf of patients.
15 (iii) Fraud or deceit in obtaining or attempting to obtain
16 third party reimbursement.
17 (e) Unprofessional conduct, consisting of 1 or more of the
18 following:
19 (i) Misrepresentation to a consumer or patient or in
20 obtaining or attempting to obtain third party reimbursement in
21 the course of professional practice.
22 (ii) Betrayal of a professional confidence.
23 (iii) Promotion for personal gain of an unnecessary drug,
24 device, treatment, procedure, or service.
25 (iv) Either of the following:
26 (A) A requirement by a licensee other than a physician that
27 an individual purchase or secure a drug, device, treatment,
1 procedure, or service from another person, place, facility, or
2 business in which the licensee has a financial interest.
3 (B) A referral by a physician for a designated health
4 service that violates 42 USC 1395nn or a regulation promulgated
5 under that section. For purposes of this subdivision, 42 USC
6 1395nn and the regulations promulgated under that section as they
7 exist on June 3, 2002 are incorporated by reference. A
8 disciplinary subcommittee shall apply 42 USC 1395nn and the
9 regulations promulgated under that section regardless of the
10 source of payment for the designated health service referred and
11 rendered. If 42 USC 1395nn or a regulation promulgated under that
12 section is revised after June 3, 2002, the department shall
13 officially take notice of the revision. Within 30 days after
14 taking notice of the revision, the department shall decide
15 whether or not the revision pertains to referral by physicians
16 for designated health services and continues to protect the
17 public from inappropriate referrals by physicians. If the
18 department decides that the revision does both of those things,
19 the department may promulgate rules to incorporate the revision
20 by reference. If the department does promulgate rules to
21 incorporate the revision by reference, the department shall not
22 make any changes to the revision. As used in this sub-
23 subparagraph, "designated health service" means that term as
24 defined in 42 USC 1395nn and the regulations promulgated under
25 that section and "physician" means that term as defined in
26 sections 17001 and 17501.
27 (v) For a physician who makes referrals pursuant to 42 USC
1 1395nn or a regulation promulgated under that section, refusing
2 to accept a reasonable proportion of patients eligible for
3 Medicaid and refusing to accept payment from Medicaid or Medicare
4 as payment in full for a treatment, procedure, or service for
5 which the physician refers the individual and in which the
6 physician has a financial interest. A physician who owns all or
7 part of a facility in which he or she provides surgical services
8 is not subject to this subparagraph if a referred surgical
9 procedure he or she performs in the facility is not reimbursed at
10 a minimum of the appropriate Medicaid or Medicare outpatient fee
11 schedule, including the combined technical and professional
12 components.
13 (f) Beginning June 3, 2003, the department of consumer and
14 industry services shall prepare the first of 3 annual reports on
15 the effect of 2002 PA 402 on access to care for the uninsured and
16 Medicaid patients. The department shall report on the number of
17 referrals by licensees of uninsured and Medicaid patients to
18 purchase or secure a drug, device, treatment, procedure, or
19 service from another person, place, facility, or business in
20 which the licensee has a financial interest.
21 (g) Failure to report a change of name or mailing address
22 within 30 days after the change occurs.
23 (h) A violation, or aiding or abetting in a violation, of
24 this article or of a rule promulgated under this article.
25 (i) Failure to comply with a subpoena issued pursuant to
26 this part, failure to respond to a complaint issued under this
27 article, or article 7, or article 8, failure to
appear at a
1 compliance conference or an administrative hearing, or failure to
2 report under section 16222 or 16223.
3 (j) Failure to pay an installment of an assessment levied
4 under the insurance code of 1956, 1956 PA 218, MCL 500.100 to
5 500.8302, within 60 days after notice by the appropriate board.
6 (k) A violation of section 17013 or 17513.
7 (l) Failure to meet 1 or more of the requirements for
8 licensure or registration under section 16174.
9 (m) A violation of section 17015, 17015a, 17017, 17515, or
10 17517.
11 (n) A violation of section 17016 or 17516.
12 (o) Failure to comply with section 9206(3).
13 (p) A violation of section 5654 or 5655.
14 (q) A violation of section 16274.
15 (r) A violation of section 17020 or 17520.
16 (s) A violation of the medical records access act, 2004 PA
17 47, MCL 333.26261 to 333.26271.
18 (t) A violation of section 17764(2).
19 Sec. 16222. (1) A licensee or registrant having who has
20 knowledge that another licensee or registrant has committed a
21 violation under section 16221, or article 7, or article 8 or a
22 rule promulgated under article 7 or article 8 shall report the
23 conduct and the name of the subject of the report to the
24 department. Information obtained by the department under this
25 subsection is confidential and is subject to sections 16238 and
26 16244. Failure of a licensee or registrant to make a report under
27 this subsection does not give rise to a civil cause of action for
1 damages against the licensee or registrant, but the licensee or
2 registrant is subject to administrative action under sections
3 16221 and 16226. This subsection does not apply to a licensee or
4 registrant who obtains the knowledge of a violation while
5 providing professional services to the licensee or registrant to
6 whom the knowledge applies, who is serving on a duly constituted
7 ethics or peer review committee of a professional association, or
8 who is serving on a committee assigned a professional review
9 function in a health facility or agency.
10 (2) Unless the licensee or registrant making the a report
11 under subsection (1) otherwise agrees in writing, the identity of
12 the licensee or registrant making the report shall remain
13 confidential unless disciplinary proceedings under this part are
14 initiated against the subject of the report and the licensee or
15 registrant making the report is required to testify in the
16 proceedings.
17 (3) A licensee or registrant shall notify the department of
18 a criminal conviction or a disciplinary licensing or registration
19 action taken by another state against the licensee or registrant
20 within 30 days after the date of the conviction or action. This
21 subsection includes, but is not limited to, a disciplinary action
22 that is stayed pending appeal.
23 Sec. 16226. (1) After finding the existence of 1 or more of
24 the grounds for disciplinary subcommittee action listed in
25 section 16221, a disciplinary subcommittee shall impose 1 or more
26 of the following sanctions for each violation:
|
1 |
Violations of Section 16221 |
Sanctions |
|
2 |
Subdivision (a), (b)(ii), |
Probation, limitation, denial, |
|
3 |
(b)(iv), (b)(vi), or |
suspension, revocation, |
|
4 |
(b)(vii) |
restitution, community service, |
|
5 |
|
or fine. |
|
6 |
|
|
|
7 |
Subdivision (b)(viii) |
Revocation or denial. |
|
8 |
|
|
|
9 |
Subdivision (b)(i), |
Limitation, suspension, |
|
10 |
(b)(iii), (b)(v), |
revocation, denial, |
|
11 |
(b)(ix), (b)(x), |
probation, restitution, |
|
12 |
(b)(xi), or (b)(xii) |
community service, or fine. |
|
13 |
|
|
|
14 |
Subdivision (b)(xiii) |
Probation, limitation, denial, |
|
15 |
|
suspension, revocation, |
|
16 |
|
restitution, community service, |
|
17 |
|
fine, or, subject to subsection |
|
18 |
|
(5), permanent revocation. |
|
19 |
|
|
|
20 |
|
|
|
21 |
Subdivision (c)(i) |
Denial, revocation, suspension, |
|
22 |
|
probation, limitation, community |
|
23 |
|
service, or fine. |
|
24 |
|
|
|
25 |
Subdivision (c)(ii) |
Denial, suspension, revocation, |
|
26 |
|
restitution, community service, |
|
27 |
|
or fine. |
|
28 |
|
|
|
29 |
Subdivision (c)(iii) |
Probation, denial, suspension, |
|
30 |
|
revocation, restitution, |
|
31 |
|
community service, or fine. |
|
1 |
|
|
|
2 |
Subdivision (c)(iv) |
Fine, probation, denial, |
|
3 |
or (d)(iii) |
suspension, revocation, community |
|
4 |
|
service, or restitution. |
|
5 |
|
|
|
6 |
Subdivision (d)(i) |
Reprimand, fine, probation, |
|
7 |
or (d)(ii) |
community service, denial, |
|
8 |
|
or restitution. |
|
9 |
|
|
|
10 |
Subdivision (e)(i) |
Reprimand, fine, probation, |
|
11 |
|
limitation, suspension, community |
|
12 |
|
service, denial, or restitution. |
|
13 |
|
|
|
14 |
Subdivision (e)(ii) |
Reprimand, probation, |
|
15 |
or (i) |
suspension, restitution, |
|
16 |
|
community service, denial, or |
|
17 |
|
fine. |
|
18 |
|
|
|
19 |
Subdivision (e)(iii), |
Reprimand, fine, probation, |
|
20 |
(e)(iv), or (e)(v) |
suspension, revocation, |
|
21 |
|
limitation, community service, |
|
22 |
|
denial, or restitution. |
|
23 |
|
|
|
24 |
Subdivision (g) |
Reprimand or fine. |
|
25 |
|
|
|
26 |
Subdivision (h) or (s) |
Reprimand, probation, denial, |
|
27 |
|
suspension, revocation, |
|
28 |
|
limitation, restitution, |
|
29 |
|
community service, or fine. |
|
30 |
|
|
|
31 |
Subdivision (j) |
Suspension or fine. |
|
1 |
|
|
|
2 |
Subdivision (k), (p), |
Reprimand or fine. |
|
3 |
or (r) |
|
|
4 |
|
|
|
5 |
Subdivision (l) |
Reprimand, denial, or |
|
6 |
|
limitation. |
|
7 |
|
|
|
8 |
Subdivision (m) or (o) |
Denial, revocation, restitution, |
|
9 |
|
probation, suspension, |
|
10 |
|
limitation, reprimand, or fine. |
|
11 |
|
|
|
12 |
Subdivision (n) |
Revocation or denial. |
|
13 |
|
|
|
14 |
Subdivision (q) |
Revocation. |
|
15 |
|
|
|
16 |
Subdivision (t) |
Revocation, fine, and |
|
17 |
|
restitution. |
18 (2) Determination of sanctions for violations under this
19 section shall be made by a disciplinary subcommittee. If, during
20 judicial review, the court of appeals determines that a final
21 decision or order of a disciplinary subcommittee prejudices
22 substantial rights of the petitioner for 1 or more of the grounds
23 listed in section 106 of the administrative procedures act of
24 1969, 1969 PA 306, MCL 24.306, and holds that the final decision
25 or order is unlawful and is to be set aside, the court shall
26 state on the record the reasons for the holding and may remand
27 the case to the disciplinary subcommittee for further
28 consideration.
29 (3) A disciplinary subcommittee may impose a fine of up to,
1 but not exceeding, $250,000.00 for a violation of section
2 16221(a) or (b).
3 (4) A disciplinary subcommittee may require a licensee or
4 registrant or an applicant for licensure or registration who has
5 violated this article, or article 7, or article 8 or a rule
6 promulgated under this article, or article 7, or article 8 to
7 satisfactorily complete an educational program, a training
8 program, or a treatment program, a mental, physical, or
9 professional competence examination, or a combination of those
10 programs and examinations.
11 (5) A disciplinary subcommittee shall not impose the
12 sanction of permanent revocation for a violation of section
13 16221(b)(xiii) unless the violation occurred while the licensee or
14 registrant was acting within the health profession for which he
15 or she was licensed or registered.
16 Sec. 16231. (1) A person or governmental entity who that
17 believes that a violation of this article, or article 7, or
18
article 8 or a rule promulgated under
this article, or article 7,
19 or article 8 exists may make an allegation of that fact to the
20 department in writing.
21 (2) If, upon reviewing an application or an allegation or a
22 licensee's file under section 16211(4), the department determines
23 there is a reasonable basis to believe the existence of a
24 violation of this article, or article 7, or article 8 or a rule
25 promulgated under this article, or article 7, or article 8, the
26 department, with the authorization of the chair of the
27 appropriate board or task force or his or her designee, shall
1 investigate. If the chair or his or her designee fails to grant
2 or deny authorization within 7 days after receipt of a request
3 for authorization, the department shall investigate.
4 (3) Upon the receipt of information reported pursuant to
5 section 16243(2) that indicates 3 or more malpractice
6 settlements, awards, or judgments against a licensee in a period
7 of 5 consecutive years or 1 or more malpractice settlements,
8 awards, or judgments against a licensee totaling more than
9 $200,000.00 in a period of 5 consecutive years, whether or not a
10 judgment or award is stayed pending appeal, the department shall
11 investigate.
12 (4) At any time during an investigation or following the
13 issuance of a complaint, the department may schedule a compliance
14 conference pursuant to under
section 92 of the administrative
15 procedures act of 1969, MCL 24.292. The conference may include
16 the applicant, licensee, registrant, or individual, the
17 applicant's, licensee's, registrant's, or individual's attorney,
18 1 member of the department's staff, and any other individuals
19 approved by the department. One member of the appropriate board
20 or task force who is not a member of the disciplinary
21 subcommittee with jurisdiction over the matter may attend the
22 conference and provide such assistance as needed. At the
23 compliance conference, the department shall attempt to reach
24 agreement. If an agreement is reached, the department shall
25 submit a written statement outlining the terms of the agreement,
26 or a stipulation and final order, if applicable, or a request for
27 dismissal to the appropriate disciplinary subcommittee for
1 approval. If the agreement or stipulation and final order or
2 request for dismissal is rejected by the disciplinary
3 subcommittee, or if no agreement is reached, a hearing before a
4 hearings examiner shall be scheduled. A party shall not make a
5 transcript of the compliance conference. All records and
6 documents of a compliance conference held before a complaint is
7 issued are subject to section 16238.
8 (5) Within 90 days after an investigation is initiated under
9 subsection (2) or (3), the department shall do 1 or more of the
10 following:
11 (a) Issue a formal complaint.
12 (b) Conduct a compliance conference under subsection (4).
13 (c) Issue a summary suspension.
14 (d) Issue a cease and desist order.
15 (e) Dismiss the complaint.
16 (f) Place in the complaint file not more than 1 written
17 extension of not more than 30 days to take action under this
18 subsection.
19 (6) Unless the person submitting the allegation under
20 subsection (1) otherwise agrees in writing, the department shall
21 keep the identity of a person submitting the allegation
22 confidential until disciplinary proceedings under this part are
23 initiated against the subject of the allegation and the person
24 making the allegation is required to testify in the proceedings.
25 (7) The department shall serve a complaint pursuant to under
26 section 16192. The department shall include in the complaint a
27 notice that the applicant, licensee, registrant, or individual
1 who is the subject of the complaint has 30 days from the date of
2 receipt to respond in writing to the complaint.
3 (8) The department shall treat the failure of the applicant,
4 licensee, registrant, or individual to respond to the complaint
5 within the 30-day period set forth in subsection (7) as an
6 admission of the allegations contained in the complaint. The
7 department shall notify the appropriate disciplinary subcommittee
8 of the individual's failure to respond and shall forward a copy
9 of the complaint to that disciplinary subcommittee. The
10 disciplinary subcommittee may then impose an appropriate sanction
11 under this article, or article 7, or article 8.
12 Sec. 16231a. (1) If an agreement is not reached at a
13 compliance conference held under section 16231(4), or if an
14 agreement is reached but is rejected by a disciplinary
15 subcommittee and the parties do not reach a new agreement, the
16 department shall hold a hearing before a hearings examiner
17 employed by or under contract to the department. If an agreement
18 is reached but is rejected by the disciplinary subcommittee, the
19 department shall not hold another compliance conference, but may
20 continue to try and reach a new agreement. The hearings examiner
21 shall conduct the hearing within 60 days after the compliance
22 conference at which an agreement is not reached or after the
23 agreement is rejected by the disciplinary subcommittee, unless a
24 new agreement is reached and approved by the disciplinary
25 subcommittee. One member of the appropriate board or task force
26 who is not a member of the disciplinary subcommittee with
27 jurisdiction over the matter may attend the hearing and provide
1 such assistance as needed.
2 (2) The hearings examiner shall determine if there are
3 grounds for disciplinary action under section 16221 or if the
4 applicant, licensee, or registrant has violated this article, or
5 article 7, or article 8 or the rules promulgated under this
6 article, or article 7, or article 8. The hearings
examiner shall
7 prepare recommended findings of fact and conclusions of law for
8 transmittal to the appropriate disciplinary subcommittee. The
9 hearings examiner shall not recommend or impose penalties.
10 (3) The applicant, licensee, or registrant who is the
11 subject of the complaint or the department of attorney general
12 may request and be granted not more than 1 continuance by the
13 hearings examiner for good cause shown.
14 (4) The applicant, licensee, or registrant may be
15 represented at the hearing by legal counsel. The department shall
16 be represented at the hearing by an assistant attorney general
17 from the department of attorney general. The assistant attorney
18 general shall not be the same individual assigned by the
19 department of attorney general to provide legal counsel to the
20 board or the special assistant attorney general described in
21 section 16237.
22 (5) Unless a continuance has been granted under subsection
23 (3), failure of an applicant, licensee, or registrant to appear
24 or be represented at a scheduled hearing shall be treated by the
25 hearings examiner as a default and an admission of the
26 allegations contained in the complaint. The hearings examiner
27 shall notify the appropriate disciplinary subcommittee of the
1 individual's failure to appear and forward a copy of the
2 complaint and any other relevant records to the disciplinary
3 subcommittee. The disciplinary subcommittee may then impose an
4 appropriate sanction under any
combination of this article, or
5 article 7, or both.article
8.
6 Sec. 16232. (1) The department shall provide an opportunity
7 for a hearing in connection with the denial, reclassification,
8 limitation, reinstatement, suspension, or revocation of a license
9 or a proceeding to reprimand, fine, order community service or
10 restitution, or place a licensee on probation.
11 (2) The department shall provide an opportunity for a
12 hearing in connection with the denial, limitation, suspension,
13 revocation, or reinstatement of a registration or a proceeding to
14 reprimand, fine, order community service or restitution, or place
15 a registrant on probation.
16 (3) A disciplinary subcommittee shall meet within 60 days
17 after receipt of the recommended findings of fact and conclusions
18 of law from a hearings examiner to impose a penalty.
19 (4) Only the department shall promulgate rules governing
20 hearings under this article, or article 7, article 8 and related
21 preliminary proceedings.
22 Sec. 16233. (1) The department may conduct an investigation
23 necessary to administer and enforce this article. Investigations
24 may include written, oral, or practical tests of a licensee's or
25 registrant's competency. The department may establish a special
26 paralegal unit to assist the department.
27 (2) The department may order an individual to cease and
1 desist from a violation of this article, or article 7, or article
2
8 or a rule promulgated under this
article, or article 7, or
3 article 8.
4 (3) An individual ordered to cease and desist under
5 subsection (2) is entitled to a hearing before a hearings
6 examiner if the individual files a written request for a hearing
7 within 30 days after the effective date of the cease and desist
8 order. The department shall subsequently present the notice, if
9 any, of the individual's failure to respond to a complaint, or
10 attend or be represented at a hearing as described in sections
11 16231 and 16231a, or the recommended findings of fact and
12 conclusions of law to the appropriate disciplinary subcommittee
13 to determine whether the order is to remain in effect or be
14 dissolved.
15 (4) Upon a violation of a cease and desist order issued
16 under subsection (2), the department of attorney general may
17 apply in the circuit court to restrain and enjoin, temporarily or
18 permanently, an individual from further violating the cease and
19 desist order.
20 (5) After consultation with the chair of the appropriate
21 board or task force or his or her designee, the department may
22 summarily suspend a license or registration if the public health,
23 safety, or welfare requires emergency action in accordance with
24 section 92 of the administrative procedures act of 1969, MCL
25 24.292. If a licensee or registrant is convicted of a felony; a
26 misdemeanor punishable by imprisonment for a maximum term of 2
27 years; or a misdemeanor involving the illegal delivery,
1 possession, or use of a controlled substance, the department
2 shall find that the public health, safety, or welfare requires
3 emergency action and, in accordance with section 92 of the
4 administrative procedures act of 1969, MCL 24.292, shall
5 summarily suspend the licensee's license or the registrant's
6 registration. If a licensee or registrant is convicted of a
7 misdemeanor involving the illegal delivery, possession, or use of
8 alcohol that adversely affects the licensee's ability to practice
9 in a safe and competent manner, the department may find that the
10 public health, safety, or welfare requires emergency action and,
11 in accordance with section 92 of the administrative procedures
12 act of 1969, MCL 24.292, may summarily suspend the licensee's
13 license or the registrant's registration.
14 Sec. 16237. (1) In imposing a penalty under section
15 16232(3), a disciplinary subcommittee shall review the
16 recommended findings of fact and conclusions of law of the
17 hearings examiner.
18 (2) The department of attorney general may assign an
19 independent special assistant attorney general who is under
20 contract to the department of attorney general and is not a
21 member of the state classified civil service to advise the
22 disciplinary subcommittees on matters of law and provide other
23 legal assistance as necessary. A special assistant attorney
24 general assigned to the disciplinary subcommittees under this
25 subsection shall not be the same individual who represented the
26 department before a hearings examiner under section 16231a(4).
27 (3) In reviewing the recommended findings of fact and
1 conclusions of law of the hearings examiner and the record of the
2 hearing, a disciplinary subcommittee may request the hearings
3 examiner to take additional testimony or evidence on a specific
4 issue or may revise the recommended findings of fact and
5 conclusions of law as determined necessary by the disciplinary
6 subcommittee, or both. A disciplinary subcommittee shall not
7 conduct its own investigation or take its own additional
8 testimony or evidence under this subsection.
9 (4) If a disciplinary subcommittee finds that a
10 preponderance of the evidence supports the recommended findings
11 of fact and conclusions of law of the hearings examiner
12 indicating that grounds exist for disciplinary action, the
13 disciplinary subcommittee shall impose an appropriate sanction
14 under any combination of this article, or article 7, or both.
15 article 8. If the disciplinary subcommittee finds that a
16 preponderance of the evidence does not support the findings of
17 fact and conclusions of law of the hearings examiner indicating
18 that grounds exist for disciplinary action, the disciplinary
19 subcommittee shall dismiss the complaint. A disciplinary
20 subcommittee shall report final action taken by it in writing to
21 the appropriate board or task force.
22 (5) The compliance conference, the hearing before the
23 hearings examiner, and final disciplinary subcommittee action
24 shall be completed within 1 year after the department initiates
25 an investigation under section 16231(2) or (3). The department
26 shall note in its annual report any exceptions to the 1-year
27 requirement.
1 (6) A final decision of a disciplinary subcommittee rendered
2 after the effective date of the amendatory act that added this
3 section but before January 1, 1995 may be appealed only in the
4 manner provided in sections 103 to 106 of the administrative
5 procedures act of 1969, being sections 24.303 to 24.306 of the
6 Michigan Compiled Laws. 1969
PA 306, MCL 24.301 to 24.306. A
7 final decision of a disciplinary subcommittee rendered on or
8 after January 1, 1995 may be appealed only to the court of
9 appeals. An appeal filed under this subsection is by right.
10 Sec. 16241. (1) After administrative disciplinary action is
11 final, the department of commerce shall publish a list of the
12 names and addresses of disciplined individuals. The department of
13 commerce shall indicate on the list that a final administrative
14 disciplinary action is subject to judicial review. The department
15 of commerce shall report
disciplinary action to the department of
16 public health, the commissioner director of the department of
17 insurance and financial services, the state and federal agencies
18 responsible for fiscal administration of federal health care
19 programs, and the appropriate professional association.
20 (2) Once each calendar year, the department of commerce
21 shall transmit to the library of Michigan sufficient copies of a
22 compilation of the lists required under subsection (1) for the
23 immediately preceding 3 calendar years. The library of Michigan
24 shall distribute the compilation to each depository library in
25 the this state. The department of commerce also shall also
26 transmit the compilation to each county clerk in the this state
27 once each calendar year.
1 (3) The department of public community health shall report
2 the disciplinary actions to appropriate licensed health
3 facilities and agencies. The commissioner director of the
4 department of insurance and financial services shall report the
5 disciplinary actions received from the department of commerce to
6 insurance carriers providing professional liability insurance.
7 (4) In case of a summary suspension of a license under
8 section 16233(5), the department of commerce shall report the
9 name and address of the individual whose license has been
10 suspended to the department of public community health, the
11 commissioner director
of the department of insurance and
12 financial services, the state and federal agencies responsible
13 for fiscal administration of federal health care programs, and
14 the appropriate professional association.
15 (5) A licensee or registrant whose license or registration
16 is revoked or suspended under this article shall give notice of
17 the revocation or suspension to each patient who contacts the
18 licensee or registrant for professional services during the term
19 of the revocation or suspension. The notice required under this
20 subsection may be given orally and shall be given at the time of
21 contact.
22 (6) A licensee or registrant whose license or registration
23 is revoked or is suspended for more than 60 days under this
24 article shall notify in writing each patient or client to whom
25 the licensee or registrant rendered professional services in the
26 licensee's or registrant's private practice during the 120 days
27 immediately preceding the date of the final order imposing the
1 revocation or suspension and to each individual who is already
2 scheduled for professional services during the first 120 days
3 after the date of the final order imposing the revocation or
4 suspension. The notice shall be on a form provided by the
5 licensee's or registrant's board or task force and shall state,
6 at a minimum, the name, address, and license or registration
7 number of the licensee or registrant, the fact that his or her
8 license or registration has been revoked or suspended, the
9 effective date of the revocation or suspension, and the term of
10 the revocation or suspension. Each board or task force shall
11 develop a notice form that meets at least the minimum
12 requirements of this subsection. The licensee or registrant shall
13 send the notice to each patient or client to whom the licensee or
14 registrant rendered professional services in the licensee's or
15 registrant's private practice during the 120 days immediately
16 preceding the date of the final order imposing the revocation or
17 suspension within 30 days after the date of the final order
18 imposing the revocation or suspension and shall simultaneously
19 transmit a copy of the notice to the department. The licensee or
20 registrant orally shall notify each individual who contacts the
21 licensee or registrant for professional services during the first
22 120 days after the date of the final order imposing the
23 revocation or suspension. The licensee or registrant shall also
24 provide a copy of the notice within 10 days after the date of the
25 final order imposing the revocation or suspension to his or her
26 employer, if any, and to each hospital, if any, in which the
27 licensee or registrant is admitted to practice.
1 (7) A licensee or registrant who is reprimanded, fined,
2 placed on probation, or ordered to pay restitution under this
3 article or an applicant whose application for licensure or
4 registration is denied under this article shall notify his or her
5 employer, if any, and each hospital, if any, in which he or she
6 is admitted to practice, in the same manner as provided for
7 notice of revocation or suspension to an employer or hospital
8 under subsection (6), within 10 days after the date of the final
9 order imposing the sanction.
10 (8) The department of commerce shall annually
shall report
11 to the legislature and to each board and task force on
12 disciplinary actions taken under this article, and
article 7, and
13 article 8. The report shall contain, at a minimum, all of the
14 following information:
15 (a) Investigations conducted, complaints issued, and
16 settlements reached by the department, of commerce, separated
out
17 by type of complaint and health profession.
18 (b) Investigations and complaints closed or dismissed.
19 (c) Actions taken by each disciplinary subcommittee,
20 separated out by type of complaint, health profession, and final
21 order issued.
22 (d) Recommendations by boards and task forces.
23 (e) The number of extensions and delays granted by the
24 department that were in excess of the time limits required under
25 this article for each phase of the disciplinary process, and the
26 types of cases for which the extensions and delays were granted.
27 (9) Within 2 years after the effective date of the
1 amendatory act that added this subsection, the department of
2 commerce shall submit a public report to the legislature on the
3 effectiveness of the amendatory act that added this subsection.
4 The report shall include a review and evaluation of the
5 disciplinary process and the reporting requirements of this
6 article and article 17 and recommended administrative or
7 statutory changes, if any.
8 Sec. 16245. (1) Except as otherwise provided in this
9 section, an individual whose license is limited, suspended, or
10 revoked under this part may apply to his or her board or task
11 force for a reinstatement of a revoked or suspended license or
12 reclassification of a limited license pursuant to section 16247
13 or 16249.
14 (2) Except as otherwise provided in this section, an
15 individual whose registration is suspended or revoked under this
16 part may apply to his or her board for a reinstatement of a
17 suspended or revoked registration pursuant to section 16248.
18 (3) A board or task force shall reinstate a license or
19 registration suspended for grounds stated in section 16221(j)
20 upon payment of the installment.
21 (4) Except as otherwise provided in this subsection, in case
22 of a revoked license or registration, an applicant shall not
23 apply for reinstatement before the expiration of 3 years after
24 the effective date of the revocation. In the case of a license or
25 registration that was revoked for a violation of section
26 16221(b)(vii) or (xiii), a violation of section 16221(c)(iv)
27 consisting of a felony conviction, any other felony conviction
1 involving a controlled substance, or a violation of section
2 16221(q), an applicant shall not apply for reinstatement before
3 the expiration of 5 years after the effective date of the
4 revocation. In the case of a license or registration that was
5 permanently revoked for a violation of section 16221(b)(xiii), the
6 former licensee or registrant is ineligible for reinstatement.
7 The department shall return an application for reinstatement
8 received before the expiration of the applicable time period
9 under this subsection or if the applicant is ineligible for
10 reinstatement under this subsection.
11 (5) The department shall provide an opportunity for a
12 hearing before final rejection of an application for
13 reinstatement unless the application is returned because the
14 applicant is ineligible for reinstatement under subsection (4).
15 (6) Based upon the recommendation of the disciplinary
16 subcommittee for each health profession, the department shall
17 adopt guidelines to establish specific criteria to be met by an
18 applicant for reinstatement under this article, or
article 7, or
19 article 8. The criteria may include corrective measures or
20 remedial education as a condition of reinstatement. If a board or
21 task force, in reinstating a license or registration, deviates
22 from the guidelines adopted under this subsection, the board or
23 task force shall state the reason for the deviation on the
24 record.
25 (7) An individual who seeks reinstatement or
26 reclassification of a license or registration pursuant to this
27 section shall pay the application processing fee as a
1 reinstatement or reclassification fee. If approved for
2 reinstatement or reclassification, the individual shall pay the
3 per year license or registration fee for the applicable license
4 or registration period.
5 (8) An individual who seeks reinstatement of a revoked or
6 suspended license or reclassification of a limited license
7 pursuant to under this section shall have a criminal history
8 check conducted in accordance with section 16174 and submit a
9 copy of the results of the criminal history check to the board
10 with his or her application for reinstatement or
11 reclassification.
12 Sec. 16315. (1) The health professions regulatory fund is
13 established in the state treasury. Except as otherwise provided
14 in this section, the state treasurer shall credit the fees
15 collected under sections 16319 to 16349 to the health professions
16 regulatory fund. The money in the health professions regulatory
17 fund shall be expended only as provided in subsection (5).
18 (2) The state treasurer shall direct the investment of the
19 health professions regulatory fund. Interest and earnings from
20 health professions regulatory fund investment shall be credited
21 to the health professions regulatory fund.
22 (3) The unencumbered balance in the health professions
23 regulatory fund at the close of the fiscal year shall remain in
24 the health professions regulatory fund and shall not revert to
25 the general fund.
26 (4) The health professions regulatory fund may receive gifts
27 and devises and other money as provided by law.
1 (5) The department of community health shall use the
health
2 professions regulatory fund to carry out its powers and duties
3 under this article, and article 7, and article 8, including,
but
4 not limited to, reimbursing the department of attorney general
5 for the reasonable cost of services provided to the department of
6 community health under this
article, and article 7, and article
7
8. For the fiscal year ending
September 30, 2007 only, subject to
8 appropriations by the legislature and approval by the governor,
9 the department of community health may also use the health
10 professions regulatory fund to support health information
11 technology initiatives.
12 (6) The nurse professional fund is established in the state
13 treasury. Of the money that is attributable to per-year license
14 fees collected under section 16327, the state treasurer shall
15 credit $8.00 of each individual annual license fee collected to
16 the nurse professional fund. The money in the nurse professional
17 fund shall be expended only as provided in subsection (9).
18 (7) The state treasurer shall direct the investment of the
19 nurse professional fund, and shall credit interest and earnings
20 from the investment to the nurse professional fund. The nurse
21 professional fund may receive gifts and devises and other money
22 as provided by law.
23 (8) The unencumbered balance in the nurse professional fund
24 at the close of the fiscal year shall remain in the nurse
25 professional fund and shall not revert to the general fund.
26 (9) The department of community health shall use the nurse
27 professional fund each fiscal year only as follows:
1 (a) To promote safe patient care in all nursing practice
2 environments.
3 (b) To advance the safe practice of the nursing profession.
4 (c) To assure a continuous supply of high-quality direct
5 care nurses, nursing faculty, and nursing education programs.
6 (d) To operate a nursing scholarship program.
7 (10) The pain management education and controlled substances
8 electronic monitoring and antidiversion fund is established in
9 the state treasury.
10 (11) The state treasurer shall direct the investment of the
11 pain management education and controlled substances electronic
12 monitoring and antidiversion fund. Interest and earnings from
13 investment of the pain management education and controlled
14 substances electronic monitoring and antidiversion fund shall be
15 credited to the pain management education and controlled
16 substances electronic monitoring and antidiversion fund.
17 (12) The unencumbered balance in the pain management
18 education and controlled substances electronic monitoring and
19 antidiversion fund at the close of the fiscal year shall remain
20 in the pain management education and controlled substances
21 electronic monitoring and antidiversion fund and shall not revert
22 to the general fund. The pain management education and controlled
23 substances electronic monitoring and antidiversion fund may
24 receive gifts and devises and other money as provided by law.
25 Twenty dollars of the license fee received by the department of
26 community health under
section 16319 shall be deposited with the
27 state treasurer to the credit of the pain management education
1 and controlled substances electronic monitoring and antidiversion
2 fund. The department shall use the pain management education and
3 controlled substances electronic monitoring and antidiversion
4 fund only in connection with programs relating to pain management
5 education for health professionals, preventing the diversion of
6 controlled substances, and development and maintenance of the
7 electronic monitoring system for controlled substances data
8 required by section 7333a.
9 Sec. 17754. (1) Except as otherwise provided under article
10 7, article 8, and the federal act, a prescription may be
11 transmitted electronically as long as if the
prescription is
12 transmitted in compliance with the health insurance portability
13 and accountability act of 1996, Public Law 104-191, or
14 regulations promulgated under that act, 45 CFR parts 160 and 164,
15 by a prescriber or his or her agent and the data are not altered
16 or modified in the transmission process. The electronically
17 transmitted prescription shall include all of the following
18 information:
19 (a) The name, address, and telephone number of the
20 prescriber.
21 (b) The full name of the patient for whom the prescription
22 is issued.
23 (c) An electronic signature or other identifier that
24 specifically identifies and authenticates the prescriber or his
25 or her agent.
26 (d) The time and date of the transmission.
27 (e) The identity of the pharmacy intended to receive the
1 transmission.
2 (f) Any other information required by the federal act or
3 state law.
4 (2) The electronic equipment or system utilized in the
5 transmission and communication of prescriptions shall provide
6 adequate confidentiality safeguards and be maintained to protect
7 patient confidentiality as required under any applicable federal
8 and state law and to ensure against unauthorized access. The
9 electronic transmission of a prescription shall be communicated
10 in a retrievable, recognizable form acceptable to the intended
11 recipient. The electronic form utilized in the transmission of a
12 prescription shall not include "dispense as written" or "d.a.w."
13 as the default setting.
14 (3) Prior to Before
dispensing a prescription that is
15 electronically transmitted, the pharmacist shall exercise
16 professional judgment regarding the accuracy, validity, and
17 authenticity of the transmitted prescription.
18 (4) An electronically transmitted prescription that meets
19 the requirements of this section is the original prescription.
20 Sec. 17768. (1) In a manner consistent with part 161, the
21 disciplinary subcommittee may fine, reprimand, or place on
22 probation, a person licensed under this part, or deny, limit,
23 suspend, or revoke a person's license or order restitution or
24 community service for a violation of this part or rules
25 promulgated under this part.
26 (2) In addition to the grounds set forth in subsection (1),
27 and in a manner consistent with part 161, the board may fine,
1 reprimand, or place on probation a person licensed under this
2 part, or deny, limit, suspend, or revoke a license issued under
3 this part or order restitution or community service if the board
4 finds that any of the following categories apply to an applicant
5 or a partner, officer, or member of the board of directors of a
6 pharmacy, manufacturer, or wholesale distributor licensed under
7 this part or a stockholder of a pharmacy, manufacturer, or
8 wholesale distributor which is a privately held corporation
9 licensed under this part:
10 (a) The applicant or other person described in this
11 subsection lacks good moral character.
12 (b) Subject to subsection (3), the applicant or other person
13 described in this subsection has been convicted of a misdemeanor
14 or a felony under a state or federal law relating to a controlled
15 substance or the practice of pharmacy.
16 (c) The applicant or other person described in this
17 subsection has furnished false or fraudulent material information
18 or has knowingly omitted material information in an application
19 filed under this part.
20 (d) The applicant or other person described in this
21 subsection has previously maintained a financial interest in a
22 pharmacy, manufacturer, or wholesale distributor which has been
23 denied a license or federal registration, has had its license or
24 federal registration limited, suspended, or revoked, or been
25 subject to any other criminal, civil, or administrative penalty.
26 (e) The applicant or other person described in this
27 subsection is not in compliance with article 7 or article 8 or
1 the rules promulgated under article 7 or article 8.
2 (3) Except for a conviction for a misdemeanor under section
3 7404 (2)(d) 7404(2)(d)
or a local ordinance that is
substantially
4 similar to section 7404 (2)(d), 7404(2)(d), the reference to
a
5 misdemeanor in subsection (2)(b) applies only to a conviction for
6 a misdemeanor that is directly related to the manufacture,
7 delivery, possession, possession with intent to manufacture or
8 deliver, use, distribution, prescription, or dispensing of a
9 controlled substance. Subsection (2)(b) does not apply to a
10 conviction for a misdemeanor based upon an unintentional error or
11 omission involving a clerical or record-keeping function.
12 Sec. 17775. (1) This section and section 17776 shall be
13 known and may be referred to as the "program for utilization of
14 unused prescription drugs".
15 (2) As used in this section and section 17776:
16 (a) "Board" means the Michigan board of pharmacy created
17 under section 17721.
18 (b) "Cancer drug" means that term as defined in section
19 17780.
20 (c) "Charitable clinic" means a charitable nonprofit
21 corporation or facility that meets all of the following
22 requirements:
23 (i) Is organized as a not-for-profit corporation pursuant to
24 the nonprofit corporation act, 1982 PA 162, MCL 450.2101 to
25 450.3192.
26 (ii) Holds a valid exemption from federal income taxation
27 issued pursuant to under
section 501(a) of the internal revenue
1 code of 1986, 26 USC 501.
2 (iii) Is listed as an exempt organization under section 501(c)
3 of the internal revenue code of 1986, 26 USC 501.
4 (iv) Is organized under or operated as a part of a health
5 facility or agency licensed under article 17.
6 (v) Provides on an outpatient basis for a period of less
7 than 24 consecutive hours to persons not residing or confined at
8 the facility advice, counseling, diagnosis, treatment, surgery,
9 care, or services relating to the preservation or maintenance of
10 health.
11 (vi) Has a licensed pharmacy.
12 (d) "Eligible facility" means a medical institution as that
13 term is defined in R 338.486 of the Michigan administrative code.
14 (e) "Eligible participant" means an individual who meets all
15 of the following requirements:
16 (i) Is a resident of this state.
17 (ii) Is eligible to receive medicaid or medicare or has no
18 health insurance and otherwise lacks reasonable means to purchase
19 prescription drugs, as prescribed in rules promulgated under this
20 section.
21 (f) "Health professional" means any of the following
22 individuals licensed and authorized to prescribe and dispense
23 drugs or to provide medical, dental, or other health-related
24 diagnoses, care, or treatment within the scope of his or her
25 professional license:
26 (i) A physician licensed to practice medicine or osteopathic
27 medicine and surgery under part 170 or 175.
1 (ii) A physician's assistant licensed under part 170, 175, or
2 180.
3 (iii) A dentist licensed under part 166.
4 (iv) An optometrist licensed under part 174.
5 (v) A pharmacist licensed under this part.
6 (vi) A podiatrist licensed under part 180.
7 (g) "Program" means the statewide unused prescription drug
8 repository and distribution program known as the program for
9 utilization of unused prescription drugs that is established
10 under this section.
11 (3) The board shall establish, implement, and administer a
12 statewide unused prescription drug repository and distribution
13 program consistent with public health and safety through which
14 unused or donated prescription drugs, other than controlled
15 substances, may be transferred from an eligible facility or
16 manufacturer to a pharmacy or a charitable clinic that elects to
17 participate in the program. The program is created to dispense
18 unused or donated prescription drugs, other than controlled
19 substances, to eligible participants and to provide for the
20 destruction and disposal of prescription drugs or other
21 medications that are ineligible for dispensing under the program.
22 (4) Participation in the program by an eligible facility,
23 manufacturer, pharmacy, or charitable clinic is voluntary.
24 Nothing in this section or section 17776 requires any eligible
25 facility, manufacturer, pharmacy, or charitable clinic to
26 participate in the program.
27 (5) Pharmacies, health professionals, and charitable clinics
1 that participate in the program shall use the following criteria
2 in accepting unused or donated prescription drugs from eligible
3 facilities or manufacturers for use in the program:
4 (a) Only prescription drugs in their original sealed,
5 tamper-evident, and unopened unit dose packaging may be accepted
6 for dispensing. However, prescription drugs packaged in single-
7 unit dose packaging may be accepted for dispensing even if the
8 outside packaging is open as long as the single-unit dose
9 packaging is unopened.
10 (b) The following shall not be accepted for dispensing:
11 (i) Expired prescription drugs.
12 (ii) Controlled substances as defined in article 7 or article
13 8 or by federal law.
14 (iii) Drugs that have been held outside of a health
15 professional's control where sanitation and security cannot be
16 assured.
17 (iv) Drugs that can only be dispensed to a patient registered
18 with the drug's manufacturer under federal food and drug
19 administration requirements.
20 (c) A prescription drug shall not be accepted for dispensing
21 if the person accepting the drug has reason to believe that the
22 drug is adulterated.
23 (d) Subject to the limitations prescribed in this
24 subsection, unused or donated prescription drugs dispensed for
25 purposes of a medical assistance program or drug product donation
26 program may be accepted for dispensing under the program.
27 (e) Any additional criteria established in rules promulgated
1 under this section.
2 (6) A pharmacy or charitable clinic that meets the
3 eligibility requirements for participation in the program and any
4 rules promulgated under this section may do any of the following:
5 (a) Dispense prescription drugs accepted under the program
6 to eligible participants.
7 (b) If established by rule under this section, charge
8 eligible participants who receive prescription drugs under the
9 program a handling fee for the service.
10 (7) A pharmacy or charitable clinic that participates in the
11 program and accepts prescription drugs for the program shall do
12 all of the following:
13 (a) Comply with all applicable federal laws and regulations
14 and state laws and rules related to the storage and distribution
15 of harmful drugs.
16 (b) Inspect all accepted prescription drugs before
17 dispensing the prescription drugs to determine that the drugs are
18 not adulterated.
19 (c) Dispense prescription drugs only pursuant to a
20 prescription issued by a health professional.
21 (8) A pharmacy, health professional, or charitable clinic
22 that accepts prescription drugs under the program shall not
23 resell the prescription drugs. Receipt of a fee from an eligible
24 participant, if established in rules promulgated under this
25 section, or reimbursement from a governmental agency to a
26 charitable clinic does not constitute resale of prescription
27 drugs under this subsection.
1 (9) For purposes of the lawful donation, acceptance, or
2 dispensing of prescription drugs under the program, the following
3 persons that are in compliance with the program, this section and
4 section 17776, and any rules promulgated under this section and
5 in the absence of bad faith or gross negligence are not subject
6 to criminal or civil liability for injury other than death, or
7 loss to person or property, or professional disciplinary action:
8 (a) The board.
9 (b) The department.
10 (c) An eligible facility or manufacturer that donates
11 prescription drugs to the program.
12 (d) A manufacturer or its representative that directly
13 donates prescription drugs in professional samples to a
14 charitable clinic under the program.
15 (e) A pharmacy, charitable clinic, or health professional
16 that accepts or dispenses prescription drugs for the program.
17 (f) A pharmacy or charitable clinic that employs a health
18 professional who accepts prescription drugs for the program and
19 who may legally dispense prescription drugs under this part.
20 (10) A manufacturer is not, in the absence of bad faith,
21 subject to criminal prosecution or liability in tort or other
22 civil action for injury, death, or loss to person or property for
23 matters related to the donation, acceptance, or dispensing of a
24 prescription drug manufactured by the manufacturer that is
25 donated by any person under the program, including, but not
26 limited to, liability for failure to transfer or communicate
27 product or consumer information or the expiration date of the
1 donated prescription drug.
2 (11) Subject to subsection (12), the department, in
3 consultation with the board, shall promulgate rules under the
4 administrative procedures act of 1969 and establish procedures
5 necessary to establish, implement, and administer the program.
6 The board shall provide technical assistance to eligible
7 facilities, manufacturers, pharmacies, and charitable clinics
8 that participate in the program.
9 (12) The department, in consultation with the board, shall
10 promulgate emergency rules under the administrative procedures
11 act of 1969 on or before the expiration of 6 months after the
12 effective date of this section September 28, 2013 to
establish,
13 implement, and administer the program. The department, in
14 consultation with the board, shall promulgate permanent rules
15 pursuant to under the administrative procedures act of 1969 as
16 soon as practical after emergency rules have been promulgated
17 under this subsection. The department and the board shall include
18 all of the following in rules promulgated under this section:
19 (a) Eligibility criteria for pharmacies and charitable
20 clinics authorized to accept and dispense prescription drugs for
21 the program.
22 (b) Eligibility criteria for eligible participants.
23 (c) Establishment of a A list of prescription drugs
that are
24 not eligible for acceptance and dispensing under the program.
25 (d) Standards and procedures for transfer, transportation,
26 acceptance, safe storage, security, and dispensing of
27 prescription drugs.
1 (e) A process for seeking input from the department of human
2 services and the department of community health in establishing
3 provisions that affect eligible facilities.
4 (f) A process for seeking input from the department of human
5 services and the department of community health in establishing
6 provisions that affect mental health and substance abuse clients.
7 (g) Standards and procedures for inspecting accepted
8 prescription drugs to ensure that the prescription drugs meet the
9 requirements of the program and to ensure that, in the
10 professional judgment of the pharmacist, the prescription drugs
11 meet all federal and state standards for product integrity.
12 (h) Procedures for the destruction and environmentally sound
13 disposal of prescription drugs or other medications that are
14 accepted and that are ineligible for dispensing under the
15 program.
16 (i) Procedures for verifying whether the charitable clinic,
17 pharmacy, pharmacist, or other health professionals participating
18 in the program are licensed and in good standing with the
19 applicable licensing board.
20 (j) Establishment of standards Standards for acceptance of
21 unused or donated prescription drugs from eligible facilities.
22 (k) Establishment of standards Standards for the acceptance
23 by a pharmacy, health professional, or charitable clinic that
24 participates in the program from any person of a prescription
25 drug or any other medication that is ineligible for dispensing
26 under the program for destruction and disposal.
27 (l) Any other standards and procedures the department, in
1 consultation with the board, considers appropriate or necessary
2 to establish, implement, and administer the program.
3 (13) Pursuant to the rules promulgated and standards and
4 procedures established for the program under this section, a
5 resident of an eligible facility or the representative or
6 guardian of a resident of an eligible facility may donate unused
7 prescription drugs for dispensing to eligible participants under
8 the program.
9 (14) Pursuant to rules promulgated and standards and
10 procedures established for the program under this section, a
11 person may deliver to a pharmacy, health professional, or
12 charitable clinic that participates in the program a prescription
13 drug or any other medication that is ineligible for dispensing
14 under the program for destruction and disposal.
15 (15) This section and section 17776 do not impair or
16 supersede the provisions regarding the cancer drug repository
17 program established in section 17780. If any provision of this
18 section or section 17776 conflicts with a provision of section
19 17780 with regard to a cancer drug, section 17780 controls.
20 Sec. 20176a. (1) A health facility or agency shall not
21 discharge or discipline, threaten to discharge or discipline, or
22 otherwise discriminate against an employee regarding the
23 employee's compensation, terms, conditions, location, or
24 privileges of employment because the employee or an individual
25 acting on behalf of the employee does either or both of the
26 following:
27 (a) In good faith reports or intends to report, verbally or
1 in writing, the malpractice of a health professional or a
2 violation of this article, article 7, article 8, or article 15 or
3 a rule promulgated under this article, article 7, article 8, or
4 article 15.
5 (b) Acts as an expert witness in a civil action involving
6 medical malpractice or in an administrative action.
7 (2) In addition to the sanctions set forth in section 20165,
8 a health facility or agency that violates subsection (1) is
9 subject to an administrative fine of not more than $10,000.00 for
10 each violation.
11 Enacting section 1. Sections 7335 and 7336 of the public
12 health code, 1978 PA 368, MCL 333.7335 and 333.7336, are
13 repealed.