December 3, 2013, Introduced by Senator HUNE and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 16233, 16241, 17702, 17706, 17707, 17709,
17742, and 17748 (MCL 333.16233, 333.16241, 333.17702, 333.17706,
333.17707, 333.17709, 333.17742, and 333.17748), section 16233 as
amended by 2010 PA 382, section 16241 as amended by 1993 PA 87,
section 17702 as amended by 2012 PA 209, section 17706 as amended
by 1986 PA 304, section 17707 as amended by 1990 PA 333, section
17709 as amended by 2006 PA 672, section 17742 as added by 1987 PA
250, and section 17748 as amended by 1988 PA 462, and by adding
sections 17748a, 17748b, 17748c, and 17748d.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 16233. (1) The department may conduct an investigation
necessary to administer and enforce this article. Investigations
may include written, oral, or practical tests of a licensee's or
registrant's competency. The department may establish a special
paralegal unit to assist the department.
(2) The department may order an individual to cease and desist
from a violation of this article or article 7 or a rule promulgated
under this article or article 7.
(3) An individual ordered to cease and desist under subsection
(2) is entitled to a hearing before a hearings examiner if the
individual files a written request for a hearing within 30 days
after the effective date of the cease and desist order. The
department shall subsequently present the notice, if any, of the
individual's failure to respond to a complaint, or attend or be
represented at a hearing as described in sections 16231 and 16231a,
or the recommended findings of fact and conclusions of law to the
appropriate disciplinary subcommittee to determine whether the
order is to remain in effect or be dissolved.
(4) Upon a violation of a cease and desist order issued under
subsection (2), the department of attorney general may apply in the
circuit court to restrain and enjoin, temporarily or permanently,
an individual from further violating the cease and desist order.
(5) After consultation with the chair of the appropriate board
or task force or his or her designee, the department may summarily
suspend a license or registration if the public health, safety, or
welfare requires emergency action in accordance with section 92 of
the administrative procedures act of 1969, MCL 24.292. If a
licensee or registrant is convicted of a felony; a misdemeanor
punishable by imprisonment for a maximum term of 2 years; or a
misdemeanor involving the illegal delivery, possession, or use of a
controlled substance, the department shall find that the public
health, safety, or welfare requires emergency action and, in
accordance with section 92 of the administrative procedures act of
1969, MCL 24.292, shall summarily suspend the licensee's license or
the registrant's registration. If a licensee or registrant is
convicted of a misdemeanor involving the illegal delivery,
possession, or use of alcohol that adversely affects the licensee's
ability to practice in a safe and competent manner, the department
may find that the public health, safety, or welfare requires
emergency action and, in accordance with section 92 of the
administrative procedures act of 1969, MCL 24.292, may summarily
suspend the licensee's license or the registrant's registration.
(6) The department may summarily suspend a pharmacy license if
the department has received a notice from the United States food
and drug administration or the centers for disease control and
prevention that there is an imminent risk to the public health,
safety, or welfare and emergency action in accordance with section
92 of the administrative procedures act of 1969, MCL 24.292, is
appropriate. A suspension under this subsection remains in effect
for the duration of the emergency situation that poses a risk to
the public health, safety, or welfare. Notwithstanding any
provision of this act to the contrary, the department is not
required to conduct an investigation or consult with the board of
pharmacy to take emergency action under this subsection.
Sec. 16241. (1) After administrative disciplinary action is
final,
the department of commerce shall publish a list of the names
and
addresses of disciplined individuals. The department of
commerce
shall indicate on the list that a
final administrative
disciplinary action is subject to judicial review. The department
of
commerce shall report disciplinary
action to the department of
public
community health, the commissioner of insurance, department
of insurance and financial services, the state and federal agencies
responsible for fiscal administration of federal health care
programs, and the appropriate professional association.
(2)
Once each calendar year, the department of commerce shall
transmit to the library of Michigan sufficient copies of a
compilation of the lists required under subsection (1) for the
immediately preceding 3 calendar years. The library of Michigan
shall
distribute the compilation to each depository library in the
this
state. The department of commerce also
shall transmit the
compilation
to each county clerk in the this
state once each
calendar year.
(3)
The department of public community
health shall report the
disciplinary actions to appropriate licensed health facilities and
agencies.
The commissioner of insurance department
of insurance and
financial services shall report the disciplinary actions received
from
the department of commerce to insurance carriers providing
professional liability insurance.
(4) In case of a summary suspension of a license under section
16233(5),
the department of commerce shall report the name and
address of the individual whose license has been suspended to the
department
of public community health, the commissioner of
insurance,
department of insurance and
financial services, the
state and federal agencies responsible for fiscal administration of
federal health care programs, and the appropriate professional
association. In case of a summary suspension of a license under
section 16233(6), the department shall report the name and address
of the pharmacy license that has been suspended to the department
of community health, the department of insurance and financial
services, the state and federal agencies responsible for fiscal
administration of federal health care programs, and the appropriate
professional association.
(5) A licensee or registrant whose license or registration is
revoked or suspended under this article shall give notice of the
revocation or suspension to each patient who contacts the licensee
or registrant for professional services during the term of the
revocation or suspension. The licensee or registrant may give the
notice
required under this subsection may be given orally and shall
be
given give the notice
required under this subsection at the
time
of contact.
(6) A licensee or registrant whose license or registration is
revoked or is suspended for more than 60 days under this article
shall notify in writing each patient or client to whom the licensee
or registrant rendered professional services in the licensee's or
registrant's private practice during the 120 days immediately
preceding the date of the final order imposing the revocation or
suspension and to each individual who is already scheduled for
professional services during the first 120 days after the date of
the final order imposing the revocation or suspension. The notice
shall
must be on a form provided by the licensee's or
registrant's
board
or task force and shall state, at a minimum, the name,
address, and license or registration number of the licensee or
registrant, the fact that his or her license or registration has
been revoked or suspended, the effective date of the revocation or
suspension, and the term of the revocation or suspension. Each
board or task force shall develop a notice form that meets at least
the minimum requirements of this subsection. The licensee or
registrant shall send the notice to each patient or client to whom
the licensee or registrant rendered professional services in the
licensee's or registrant's private practice during the 120 days
immediately preceding the date of the final order imposing the
revocation or suspension within 30 days after the date of the final
order imposing the revocation or suspension and shall
simultaneously transmit a copy of the notice to the department. The
licensee or registrant orally shall notify each individual who
contacts the licensee or registrant for professional services
during the first 120 days after the date of the final order
imposing the revocation or suspension. The licensee or registrant
shall also provide a copy of the notice within 10 days after the
date of the final order imposing the revocation or suspension to
his or her employer, if any, and to each hospital, if any, in which
the licensee or registrant is admitted to practice.
(7) A licensee or registrant who is reprimanded, fined, placed
on probation, or ordered to pay restitution under this article or
an applicant whose application for licensure or registration is
denied under this article shall notify his or her employer, if any,
and each hospital, if any, in which he or she is admitted to
practice, in the same manner as provided for notice of revocation
or suspension to an employer or hospital under subsection (6),
within 10 days after the date of the final order imposing the
sanction.
(8)
The department of commerce annually shall report to the
legislature and to each board and task force on disciplinary
actions
taken under this article and article 7. The report
department
shall contain, include, at
a minimum, all of the
following information in the report required under this subsection:
(a) Investigations conducted, complaints issued, and
settlements
reached by the department, of commerce, separated out
by type of complaint and health profession.
(b) Investigations and complaints closed or dismissed.
(c) Actions taken by each disciplinary subcommittee, separated
out by type of complaint, health profession, and final order
issued.
(d) Recommendations by boards and task forces.
(e) The number of extensions and delays granted by the
department that were in excess of the time limits required under
this article for each phase of the disciplinary process, and the
types of cases for which the extensions and delays were granted.
(9)
Within 2 years after the effective date of the amendatory
act
that added this subsection, the department of commerce shall
submit
a public report to the legislature on the effectiveness of
the
amendatory act that added this subsection. The report shall
include
a review and evaluation of the disciplinary process and the
reporting
requirements of this article and article 17 and
recommended
administrative or statutory changes, if any.
Sec. 17702. (1) "Agent" means an individual designated by a
prescriber to act on behalf of or at the discretion of that
prescriber as provided in section 17744.
(2) "Brand name" means the registered trademark name given to
a drug product by its manufacturer.
(3) Except as otherwise provided in subsection (4),
"compounding" means the preparation, mixing, assembling, packaging,
and labeling of a drug or device by a pharmacist under the
following circumstances:
(a) Upon the receipt of a prescription for a specific patient.
(b) Upon the receipt of a prescriber's medical order for use
in the treatment of patients within the course of the prescriber's
professional practice.
(c) In anticipation of the receipt of a prescription or
medical order based on routine, regularly observed prescription or
medical order patterns.
(d) For the purpose of or incidental to research, teaching, or
chemical analysis and not for the purpose of sale or dispensing.
(4) "Compounding" does not include any of the following:
(a) The compounding of a drug product that is essentially a
copy of a commercially available product.
(b) The reconstitution, mixing, or other similar act that is
performed pursuant to the directions contained in approved labeling
provided by the manufacturer of a commercially available product.
(5) "Compounding pharmacy" means a pharmacy licensed under
this part that meets the requirements of this part to offer
compounding services.
(6)
(3) "Current selling price" means the retail
price for a
prescription drug that is available for sale from a pharmacy.
Sec.
17706. (1) "Manufacturer" means a person who that
prepares, produces, derives, propagates, compounds, processes,
packages, or repackages a drug or device salable on prescription
only, or otherwise changes the container or the labeling of a drug
or
device salable on prescription only, and who that supplies,
distributes, sells, offers for sale, barters, or otherwise disposes
of that drug or device and any other drug or device salable on
prescription only, to another person for resale, compounding, or
dispensing.
(2) "Official compendium" means the United States
pharmacopoeia and the national formulary, or the homeopathic
pharmacopoeia
of the United States, or a supplement thereof
existing
on July 1, 1983.as
applicable. If an official compendium
is revised after the effective date of the amendatory act that
added this sentence, the department shall officially take notice of
the revision. Within 30 days after taking notice of the revision,
the department, in consultation with the board, shall decide
whether the revision continues to protect the public health as it
relates to the manner that the official compendium is used in this
act. If the department, in consultation with the board, decides
that the revision continues to protect the public health, the
department may issue an order to incorporate the revision by
reference. If the department issues an order under this subsection
to incorporate the revision by reference, the department shall not
make any changes to the revision.
Sec. 17707. (1) "Personal charge" means the immediate physical
presence of a pharmacist or dispensing prescriber.
(2) "Pharmacist" means an individual licensed under this
article to engage in the practice of pharmacy.
(3) "Pharmacist in charge" or "PIC" means the pharmacist who
is responsible for compliance with this part and rules promulgated
under this part in all aspects of the practice of pharmacy
including, but not limited to, the following:
(a) The dispensing of drugs, devices, and other materials at a
pharmacy.
(b) The safe, accurate, secure, and confidential handling and
storage of drugs, devices, and protected health information. As
used in this subdivision, "handling" includes, but is not limited
to, the preparation, compounding, distributing, and dispensing of
drugs and devices.
(c) Being in full and actual charge of pharmacy personnel.
(4) (3)
"Pharmacist intern" or
"intern" means an individual
who satisfactorily completes the requirements set forth in rules
promulgated
by the board under this
part and is licensed by the
board for the purpose of obtaining instruction in the practice of
pharmacy from a preceptor approved by the board.
(5) (4)
"Pharmacy" means a
building or part of a building in
which the practice of pharmacy is conducted. For the purpose of a
duty placed on a pharmacy under this part, "pharmacy" means the
owner or operator of the pharmacy or, if appropriate, the
pharmacist in charge.
(6) (5)
"Practice of pharmacy"
means a health service, the
clinical application of which includes the encouragement of safety
and efficacy in the prescribing, dispensing, administering, and use
of drugs and related articles for the prevention of illness, and
the maintenance and management of health. Professional functions
associated with the practice of pharmacy include:
(a) The interpretation and evaluation of the prescription.
(b) Drug product selection.
(c) The compounding, dispensing, safe storage, and
distribution of drugs and devices.
(d) The maintenance of legally required records.
(e) Advising the prescriber and the patient as required as to
contents, therapeutic action, utilization, and possible adverse
reactions or interactions of drugs.
Sec. 17709. (1) "Sign" means to affix one's signature manually
to a document or to use an electronic signature when transmitting a
prescription electronically.
(2) "Sterile pharmaceutical" means a dosage form of a drug
that is free from living microbes and free from chemical or
physical contamination. As used in this subsection, "dosage form"
includes, but is not limited to, parenteral, injectable, and
ophthalmic dosage forms.
(3) (2)
"Substitute" means to
dispense, without the
prescriber's authorization, a different drug in place of the drug
prescribed.
(4) "USP standards" means the pharmacopeial standards for drug
substances, dosage forms, and compounded preparations based on
designated levels of risk as published in the official compendium.
(5) (3)
"Wholesale distributor"
means a person, other than a
manufacturer, who supplies, distributes, sells, offers for sale,
barters, or otherwise disposes of, to other persons for resale,
compounding, or dispensing, a drug or device salable on
prescription only that the distributor has not prepared, produced,
derived, propagated, compounded, processed, packaged, or
repackaged, or otherwise changed the container or the labeling
thereof.of the drug or device.
Sec. 17742. (1) The board may require an applicant or the
holder of a pharmacy, manufacturer's, or wholesale distributor's
license to fully disclose the identity of each partner,
stockholder, officer, or member of the board of directors of the
pharmacy, manufacturer, or wholesale distributor, as applicable.
(2)
As used in this section and section sections 17748,
17748a, and 17768, "applicant" means a person applying for a
pharmacy, manufacturer's, or wholesale distributor's license under
this article. Applicant includes only 1 or more of the following:
(a) An individual, if the person applying is an individual.
(b) All partners, including limited partners, if the person
applying is a partnership.
(c) All stockholders, officers, and members of the board of
directors, if the person applying is a privately held corporation.
Sec.
17748. (1) A To
do business in this state, a pharmacy,
manufacturer,
or wholesale distributor, of prescription drugs,
whether
or not located in this state, but doing business in this
state,
shall must be licensed by the board in accordance with under
this
part. Licenses shall be renewed are
renewable biennially.
(2) A pharmacy
, manufacturer, or wholesale
distributor may
shall
designate an individual to be a pharmacist licensed in this
state
as the licensee pharmacist in charge for the pharmacy. ,
manufacturer,
or wholesale distributor and the licensee A
manufacturer or wholesale distributor shall designate a pharmacist
licensed in or outside of this state as the pharmacist in charge
for the manufacturer or wholesale distributor. The individual
designated as the PIC under this subsection is responsible for the
pharmacy's, manufacturer's, or wholesale distributor's compliance
with this part.
(3) A pharmacy, manufacturer, or wholesale distributor shall
report to the department a change in ownership, management,
location, or designated PIC not later than 30 days after the change
occurs.
(4) Consistent with accepted standards of professional conduct
and practice and in compliance with all applicable laws and rules,
a PIC shall do all of the following:
(a) Be responsible for the purchasing, storage, compounding,
repackaging, dispensing, and distribution of all drugs and devices.
(b) Establish policies and procedures for the employees of the
pharmacy for the procurement, storage, compounding, and dispensing
of drugs and the communication of information to the patient in
relation to drug therapy.
(c) Supervise all employees performing tasks listed in
subdivision (b) and provide oversight of the pharmacy if the
pharmacy is also licensed as a manufacturer.
(d) Supervise a nonprofessional employee of the pharmacy if
the employee's duties are related to the procurement, sale,
dispensing, or storage of drugs.
(e) Establish and supervise the method and manner for the
storing and safekeeping of drugs.
(f) Establish and supervise the recordkeeping system for the
purchase, sale, possession, storage, safekeeping, and return of
drugs.
(g) Notify the board immediately upon the knowledge that the
services of the pharmacist in charge have been or will be
terminated.
(h) Establish policies and procedures for individuals within
the pharmacy who are delegated tasks by the PIC.
(5) Except as otherwise provided in this subsection, an
applicant for a new pharmacy, manufacturer, or wholesale
distributor license under this part who is not a health
professional licensed or otherwise authorized to engage in a health
profession under this article or who is a health professional but
was licensed or otherwise authorized to engage in his or her health
profession under this article before October 1, 2008 shall submit
fingerprints in the same manner as required in section 16174 for
the purpose of a criminal history check. The board, department, and
department of state police shall comply with section 16174 for the
purpose of a criminal history check on an applicant described in
this subsection. This subsection does not apply if a criminal
history check that meets the requirements of section 16174 has been
obtained for the applicant within the 2 years preceding the date of
the application. To qualify for the exception under this
subsection, the applicant shall submit proof of the previous
criminal history check with his or her application for a new
pharmacy, manufacturer, or wholesale distributor license under this
part. If the department or board determines that the criminal
history check does not meet the requirements of section 16174 or
was not obtained within the time period prescribed, the applicant
shall comply with this subsection.
Sec. 17748a. (1) Beginning on the effective date of this
section, an applicant for a new pharmacy license for a pharmacy
that will provide compounding services shall submit verification of
current accreditation through a national accrediting organization
approved by the board or verify the pharmacy is in the
accreditation process. The department shall not issue a license to
a pharmacy described in this subsection that is not accredited
unless the applicant demonstrates compliance with USP standards.
(2) By 1 year after the effective date of this section, a
pharmacy that is licensed on the effective date of this section and
that provides compounding services shall be accredited by a
national accrediting organization approved by the board or be in
compliance with USP standards in a manner determined by the board.
(3) Notwithstanding any provision of part 161 to the contrary,
a pharmacy that provides compounding services shall submit with a
license renewal application verification of current accreditation
or compliance with USP standards, as applicable.
(4) A pharmacy that provides compounding services shall comply
with requirements of the United States food and drug administration
applicable to the compounding services.
(5) A pharmacy shall notify the department of a complaint
regarding compounding activities filed by another state in which
the pharmacy is licensed for violations of that state's pharmacy
laws, an investigation by federal authorities regarding violations
of federal law, or an investigation by any agency into violations
of accreditation standards within 30 days of knowledge of the
complaint or investigation.
(6) A pharmacist shall maintain a record of a compounded
sterile pharmaceutical in the same manner and for the same
retention period as prescribed in rules for other prescription
records. The pharmacist shall include, but is not limited to
including, all of the following information in the record required
under this subsection:
(a) The name, strength, quantity, and dosage form of the
compounded pharmaceutical.
(b) The formula to compound that includes mixing instructions,
all ingredients and their quantities, and any additional
information needed to prepare the compounded pharmaceutical.
(c) The prescription number or assigned internal
identification number.
(d) The date of preparation.
(e) The manufacturer and lot number of each ingredient.
(f) The expiration or beyond-use date.
(g) The name of the person who prepared the compounded
pharmaceutical.
(h) The name of the pharmacist who approved the compounded
pharmaceutical.
(7) A pharmacist shall not offer excess compounded
pharmaceuticals to other pharmacies for resale. A compounding
pharmacy shall not distribute samples of a compounded
pharmaceutical to a health professional.
(8) A compounding pharmacy may advertise or otherwise promote
the fact that they provide compounding services.
(9) Based on the existence of a health professional/patient
relationship and the presentation of a valid prescription, or in
anticipation of the receipt of a prescription based on routine,
regularly observed prescription patterns, a pharmacist may compound
for a patient a nonsterile or sterile pharmaceutical that is not
commercially available in the marketplace.
(10) Notwithstanding any provision of this act to the
contrary, a person shall not compound and manufacture drug products
or allow the compounding and manufacturing of drug products at the
same location.
(11) The department, in consultation with the board, may
promulgate rules regarding conditions, good compounding practices,
and facilities for the compounding of nonsterile and sterile
pharmaceuticals.
Sec. 17748b. (1) Except as otherwise provided in this
subsection, a pharmacist or pharmacy shall not compound nonsterile
or sterile pharmaceuticals for a prescriber or health facility or
agency licensed under article 17 to administer to the prescriber's,
facility's, or agency's patients without a prescription. Upon
application by a pharmacist or compounding pharmacy, the department
may authorize the pharmacist or compounding pharmacy to compound
nonsterile or sterile pharmaceuticals for a prescriber or health
facility or agency licensed under article 17 to administer to the
prescriber's, facility's, or agency's patients in limited
quantities without a prescription. This subsection does not apply
to the compounding of topical nonsterile pharmaceuticals. The
department shall prescribe the form of the application for use
under this subsection, which application must include at least all
of the following information:
(a) The name and license number of the pharmacist or pharmacy
requesting authorization to compound under this subsection.
(b) The name of the specific prescriber or health facility or
agency that is requesting compounded pharmaceuticals and an
affidavit from the prescriber or designated agent of the health
facility or agency attesting to the need and that the compounded
pharmaceuticals are only for patients located in this state or in
states immediately adjacent to this state.
(c) The pharmaceuticals to be compounded and the reason for
the need to compound the pharmaceuticals.
(d) The anticipated quantities of pharmaceuticals to be
compounded each month and the frequency of the need to compound
before receipt of a prescription or documentation supporting the
anticipated quantities.
(e) The conditions of operation including practices consistent
with USP standards and requirements for third-party testing.
(2) A pharmacist or compounding pharmacy that is authorized to
compound nonsterile or sterile pharmaceuticals for a prescriber or
health facility or agency under subsection (1) shall do all of the
following:
(a) Maintain complete and accurate records on a monthly basis
of requests from and pharmaceuticals compounded for each prescriber
or health facility or agency.
(b) Provide the information described in subdivision (a) to
the department as specified in rules or upon request.
(3) The authorization granted under subsection (1) is for a 1-
year period and is subject to renewal by the department. The
department may, without prior notice to the pharmacist or pharmacy,
physically inspect the facility where the compounding of nonsterile
or sterile pharmaceuticals occurs.
(4) The department shall not authorize a pharmacist or
compounding pharmacy to compound nonsterile or sterile
pharmaceuticals without a prescription if the pharmacist or
pharmacy is under investigation, is in the process of being
disciplined, or is in a disciplinary status.
(5) Except as otherwise provided in this subsection, the
department may immediately revoke the authorization granted under
subsection (1) if there is a confirmed deviation or violation of
the compounding process or if an adverse event associated with a
compounded nonsterile or sterile pharmaceutical is detected. If the
health, safety, and welfare of the public are not in immediate
jeopardy, the department shall provide at least 30 days' notice of
the revocation of authorization under this subsection.
(6) A pharmacy or pharmacist authorized to compound
pharmaceuticals under this section that becomes aware of an adverse
event associated with a compounded pharmaceutical shall report the
adverse event to the department not later than 10 calendar days
after becoming aware of the adverse event.
(7) The department shall post and maintain a list of
pharmacies and pharmacists who are authorized to compound
pharmaceuticals under this section on its internet website.
(8) A prescriber or health facility or agency that obtains
compounded pharmaceuticals under this section shall not redispense
or sell the compounded pharmaceutical to a patient, a prescriber,
or health facility or agency.
Sec. 17748c. A pharmacist shall not compound a pharmaceutical
that is commercially available unless all of the following
requirements are met:
(a) The commercially available pharmaceutical is modified to
produce a significant difference, in the professional judgment of
the prescriber, between the compounded pharmaceutical for the
patient and the comparable commercially available pharmaceutical.
(b) The commercially available pharmaceutical is not available
from normal distribution channels in a timely manner to meet the
patient's needs and the dispensing of the compounded pharmaceutical
has been approved by the prescriber and the patient. A pharmacist
who compounds a commercially available pharmaceutical as provided
in this subdivision shall maintain documentation of the reason for
the compounding.
Sec. 17748d. (1) Except as otherwise provided in this section,
a person that violates section 17748a or 17748b is guilty of a
misdemeanor.
(2) Except as otherwise provided in this section, a person
that knowingly or willfully violates section 17748a or 17748b or a
person that falsifies prescriptions in order to compound a
pharmaceutical in bulk is guilty of a felony punishable by
imprisonment for not more than 2 years or a fine of not more than
$1,000.00, or both.
(3) Except as otherwise provided in this section, a person
that knowingly or willfully violates section 17748a or 17748b or a
person that falsifies prescriptions in order to compound a
pharmaceutical in bulk, which activity results in personal injury,
is guilty of a felony punishable by imprisonment for not more than
4 years or a fine of not more than $4,000.00, or both.
(4) A person that knowingly or willfully violates section
17748a or 17748b or a person that falsifies prescriptions in order
to compound a pharmaceutical in bulk, which activity results in
serious impairment of a body function, is guilty of a felony
punishable by imprisonment for not more than 5 years or a fine of
not more than $5,000.00, or both. As used in this subsection,
"serious impairment of a body function" means that term as defined
in section 58c of the Michigan vehicle code, 1949 PA 300, MCL
257.58c.
(5) A person that knowingly or willfully violates section
17748a or 17748b or a person that falsifies prescriptions in order
to compound a pharmaceutical in bulk, which activity results in
death, is guilty of a felony punishable by imprisonment for not
more than 15 years or a fine of not more than $20,000,00, or both.
(6) The state attorney general or local prosecutor is
authorized to advance and prosecute criminal charges described in
this section.