HOUSE SUBSTITUTE FOR

SB-0704, As Passed House, June 12, 2014

SENATE BILL NO. 704

A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 16233, 16241, 17702, 17704, 17706, 17707,

17709, 17742, and 17748 (MCL 333.16233, 333.16241, 333.17702,

333.17704, 333.17706, 333.17707, 333.17709, 333.17742, and

333.17748), sections 16233 and 16241 as amended by 2013 PA 268,

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, article 7, or article 8 or a rule

promulgated under this article, article 7, or article 8.

(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 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 shall report

disciplinary action to the department of ~~public~~ community health,

the ~~director of 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.

(2) Once each calendar year, the department 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 this state. The

department shall also transmit the compilation to each county clerk

in this state once each calendar year.

(3) The department of community health shall report the

disciplinary actions to appropriate licensed health facilities and

agencies. The ~~director of the~~ department of insurance and financial

services shall report the disciplinary actions received from the

department to insurance carriers providing professional liability

insurance.

(4) In case of a summary suspension of a license under section

16233(5), the department shall report the name and address of the

individual whose license has been suspended to the department of

community health, the ~~director of 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. 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 shall annually report to the legislature

and to each board and task force on disciplinary actions taken

under this article, article 7, and article 8. 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, separated out by type of

complaint and health profession.

(b) Investigations and complaints closed or dismissed.

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.

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 medical or dental order from a

prescriber or agent for use in the treatment of patients within the

course of the prescriber's professional practice.

medical or dental order based on routine, regularly observed

prescription or medical or dental 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) Except as provided in section 17748c, 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.

products.

(5) "Compounding pharmacy" means a pharmacy that is licensed

under this part and is authorized to offer compounding services

under sections 17748, 17748a, and 17748b.

(6) ~~(3)~~ "Current selling price" means the retail price for a

prescription drug that is available for sale from a pharmacy.

Sec. 17704. (1) "Federal act" means the federal food, drug,

and cosmetic act, ~~of 1938, 21 U.S.C. 301 to 392.~~21 USC 301 to 399f.

(2) "Food and drug administration" or "FDA" means the United

States food and drug administration.

(3) ~~(2)~~ "Generic name" means the established or official name

of a drug or drug product.

(4) ~~(3)~~ "Harmful drug" means a drug intended for use by human

beings ~~which~~ that is harmful because of its toxicity, habit-forming

nature, or other potential adverse effect; , the method of its use;

, or the collateral measures necessary to its safe and effective

use , and ~~which~~ that is designated as harmful by ~~the board~~

~~according to~~ a rule promulgated under this part.

(5) ~~(4)~~ "Internship" means an educational program of

professional and practical experience for an intern.

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.

(3) "Outsourcing facility" means that term as defined in 21

USC 353b.

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 designated by a pharmacy, manufacturer, or wholesale distributor

as its pharmacist in charge under section 17748(2).

(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

person to which the pharmacy license is issued, unless otherwise

specifically provided.

(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.

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 essentially free from living microbes and chemical or

physical contamination to the point at which it poses no present

risk to the patient, in accordance with USP standards. 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.

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. To do business in this state, a person that provides

compounding services must be licensed as a pharmacy or manufacturer

under this part and, if a pharmacy, authorized to provide

compounding services under this section and sections 17748a and

17748b. To do business in this state, an outsourcing facility must

be licensed as a pharmacy 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 is~~ 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 pharmacy,

manufacturer, or wholesale distributor and the individual

designated as the PIC under this subsection are jointly responsible

for the pharmacy's, manufacturer's, or wholesale distributor's

compliance with this part and rules promulgated under this part.

(3) Subject to this subsection, a pharmacist may be designated

as the PIC for more than 1 pharmacy. A PIC described in this

subsection shall work an average of at least 8 hours per week at

each pharmacy for which he or she is the PIC. The pharmacy and the

PIC shall maintain appropriate records and demonstrate compliance

with this subsection upon the request of the board or its designee.

(4) 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.

(5) A pharmacist in charge shall supervise the practice of

pharmacy for the pharmacy in which he or she has been designated

the PIC. The duties of the PIC include, but are not limited to, the

following:

(a) Supervision of all activities of pharmacy employees as

they relate to the practice of pharmacy including the purchasing,

storage, compounding, repackaging, dispensing, and distribution of

drugs and devices to ensure that those activities are performed in

compliance with this part and the rules promulgated under this

part.

(b) Enforcement and oversight of policies and procedures

applicable to 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.

storage and safekeeping of pharmaceuticals, including maintenance

of security provisions to be used when the pharmacy is closed.

(d) Establishment and supervision of the record-keeping system

for the purchase, sale, delivery, possession, storage, and

safekeeping of drugs and devices.

(e) Establishment of policies and procedures for individuals

who are delegated responsibilities for any of the tasks described

in this subsection by the PIC.

(6) 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.

(7) If, as authorized or required under this article, the

department inspects or investigates an applicant for a new pharmacy

license for a pharmacy that will provide compounding services or a

compounding pharmacy, which applicant or compounding pharmacy is

located outside of this state, the applicant or compounding

pharmacy shall reimburse the department for its expenses incurred

in carrying out its authority or duty to inspect or investigate the

applicant or licensee under this article.

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 for sterile pharmaceuticals

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 in a manner determined by the board.

(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 for sterile pharmaceuticals must

be accredited by a national accrediting organization approved by

the board, be verified by the board as being in the accreditation

process, 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 for sterile

pharmaceuticals shall submit with a license renewal application

verification of current accreditation or compliance with USP

standards, as applicable.

(4) A person that provides services consistent with an

outsourcing facility shall comply with requirements of the FDA

applicable to compounding services for sterile pharmaceuticals.

(5) A pharmacy shall notify the department of a complaint

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 regarding compounding activities within 30 days of

knowledge of the complaint or investigation.

(6) Except for distribution within a hospital or another

health care entity under common control when regulated by federal

law, 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.

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 or complimentary starter

doses 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 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, unless the

pharmaceutical compounded by the pharmacist or pharmacy complies

with the most recent guidance on pharmacy compounding of human drug

products under 21 USC 353a. 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.

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 sterility 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 2-

year period consistent with the 2-year license cycle of the

pharmacy. 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 directly related to

sterility or integrity of the product and 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 attributed to the integrity of the product of a compounded

pharmaceutical shall report the adverse event to the department not

later than 10 calendar days after becoming aware of the adverse

event. For purposes of this subsection, an adverse event does not

include an isolated allergic reaction to a substance included in

the compound if the allergic reaction is treated and relieved with

standard protocol.

(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. The

department shall update the list required under this subsection at

least quarterly.

(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. Except for pharmaceuticals on the Michigan

pharmaceutical product list maintained by the department of

community health, a pharmacist shall not compound a pharmaceutical

that is commercially available unless 1 of the following

requirements is 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 county prosecutor may bring

and prosecute criminal charges described in this section.

Enacting section 1. This amendatory act takes effect 90 days

after the date it is enacted into law.