state of michigan
100th Legislature
Regular session of 2020
Introduced by Senator
Bizon
ENROLLED SENATE BILL No. 630
AN ACT to amend
1978 PA 368, entitled “An act to protect and promote the public health; to
codify, revise, consolidate, classify, and add to the laws relating to public
health; to provide for the prevention and control of diseases and disabilities;
to provide for the classification, administration, regulation, financing, and
maintenance of personal, environmental, and other health services and
activities; to create or continue, and prescribe the powers and duties of,
departments, boards, commissions, councils, committees, task forces, and other
agencies; to prescribe the powers and duties of governmental entities and
officials; to regulate occupations, facilities, and agencies affecting the
public health; to regulate health maintenance organizations and certain third
party administrators and insurers; to provide for the imposition of a
regulatory fee; to provide for the levy of taxes against certain health
facilities or agencies; to promote the efficient and economical delivery of
health care services, to provide for the appropriate utilization of health care
facilities and services, and to provide for the closure of hospitals or
consolidation of hospitals or services; to provide for the collection and use
of data and information; to provide for the transfer of property; to provide
certain immunity from liability; to regulate and prohibit the sale and offering
for sale of drug paraphernalia under certain circumstances; to provide for the
implementation of federal law; to provide for penalties and remedies; to
provide for sanctions for violations of this act and local ordinances; to
provide for an appropriation and supplements; to repeal certain acts and parts
of acts; to repeal certain parts of this act; and to repeal certain parts of
this act on specific dates,” by amending sections 16111, 16333, 17705,
17706, 17707, 17709, 17722, 17742, 17748, 17767, and 17768 (MCL 333.16111,
333.16333, 333.17705, 333.17706, 333.17707, 333.17709, 333.17722, 333.17742,
333.17748, 333.17767, and 333.17768), section 16111 as amended by 2006 PA 392,
section 16333 as amended by 2014 PA 285, section 17705 as amended by 1986 PA
304, section 17706 as amended by 2014 PA 280, sections 17707, 17709, 17722,
17742, 17748, and 17768 as amended by 2020 PA 4, and section 17767 as amended
by 1993 PA 79, and by adding sections 17748e and 17748f.
The People of the
State of Michigan enact:
Sec.
16111. (1) This part applies to health professions, but, except for sections
16201, 16261, 16299, 16301, 16303, 16305, and 16307, does not apply to any
of the following regulated under part 177:
(a) A pharmacy.
(b) A dispensing prescriber.
(c) A drug manufacturer.
(d) A wholesale
distributor.
(e) A wholesale
distributor-broker.
(2)
Except as otherwise provided by this article, this part controls over all other
parts in this article.
(3)
A part in this article does not prohibit a licensee under another part or other
law of this state from performing activities and using designated titles
authorized by a license issued to him or her under that other part or other law
of this state.
(4)
A part in this article does not prohibit a registrant under another part or
other state law from using designated titles authorized by a registration
issued to him or her under that other part or other state law.
(5)
This article does not prohibit a licensee from advising a patient to seek
professional services or advice from another person.
Sec. 16333. Fees for a person
licensed or seeking licensure to engage in the practice of pharmacy or other
practices regulated under part 177 are as follows:
(a) Application
processing fees:
(i) Pharmacist................................................................................................................................................... $
75.00
(ii)
Pharmacy.................................................................................................................................................... 75.00
(iii)
Drug control.............................................................................................................................................. 75.00
(iv)
Manufacturer, wholesale distributor, or wholesale distributor-broker....................................... 75.00
(v)
Pharmacy technician................................................................................................................................ 75.00
(b) Examination
fees:
Jurisprudence
examination.................................................................................................................... 30.00
(c) License fees,
per year:
(i) Pharmacist................................................................................................................................................... 30.00
(ii)
Pharmacy.................................................................................................................................................... 50.00
(iii)
Drug control.............................................................................................................................................. 15.00
(iv)
Manufacturer, wholesale distributor, or wholesale distributor-broker....................................... 25.00
(v) Pharmacy
technician................................................................................................................................ 30.00
(d) Temporary license for pharmacist........................................................................................................ 25.00
(e) Limited license for pharmacist, per year............................................................................................. 15.00
(f) Temporary license for pharmacy technician........................................................................................ 15.00
(g) Limited license for pharmacy technician,
per year........................................................................... 10.00
Sec. 17705. (1) “Label” means a display of
written, printed, or graphic matter on the immediate container of a drug or
device, but does not include package liners. A requirement made by or under
authority of this part that a word, statement, or other information appear on
the label is not complied with unless the word, statement, or other information
appears on the outside container or wrapper of the retail package of the drug
or device as displayed for sale or is easily legible through an outside
container or wrapper.
(2) “Labeling”
means the labels and other written, printed, or graphic matter on a drug or
device or its container or wrapper, or accompanying the drug or device.
(3) “License” in
addition to the definition in section 16106 means a pharmacy license, drug
control license, or a manufacturer, wholesale distributor, or wholesale distributor-broker
of drugs or devices license.
Sec. 17706. (1) “Manufacturer”
means a person 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 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.
Manufacturer does not include a pharmacy unless the pharmacy meets the
requirements described in section 17748f.
(2)
“Official compendium” means the United States Pharmacopoeia and the National
Formulary, or the Homeopathic
Pharmacopoeia of the United States, as
applicable. If an official compendium is revised after September 30,
2014, 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) “Parent pharmacy” means a pharmacy that
operates a remote pharmacy through a telepharmacy system.
(2) “Personal charge” means
the immediate physical presence of a pharmacist or dispensing prescriber.
(3) “Pharmacist” means an
individual licensed under this article to engage in the practice of pharmacy.
(4) “Pharmacist in charge” or
“PIC” means the pharmacist who is designated by a pharmacy, manufacturer,
wholesale distributor, or wholesale distributor-broker as its pharmacist in charge under section 17748(2).
(5) “Pharmacist intern” or “intern”
means an individual who satisfactorily completes the requirements set forth in
rules promulgated by the department in consultation with the board and is
licensed by the board for the purpose of obtaining instruction in the practice
of pharmacy from a preceptor approved by the board.
(6) “Pharmacy” means a
facility or part of a facility that is licensed under this part to dispense
prescription drugs or prepare prescription drugs for delivery or distribution.
Pharmacy does not include the office of a dispensing prescriber or an automated
device. 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.
(7) “Pharmacy technician”
means an individual who is required to hold a health profession subfield
license under this part to serve as a pharmacy technician.
(8) “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. Practice of pharmacy
includes the direct or indirect provision of professional functions and
services associated with the practice of pharmacy. Professional functions
associated with the practice of pharmacy include the following:
(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 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) “Substitute” means to
dispense, without the prescriber’s authorization, a different drug in place of
the drug prescribed.
(4) “Surveillance system”
means a real-time, continuous audio and visual camera system that connects a
pharmacist at a parent pharmacy with a remote pharmacy for the purposes of
providing oversight and security surveillance.
(5) “Telepharmacy system”
means an interoperable computer system that meets all of the following
requirements:
(a) Shares real-time data and
uses a real-time audio and video link to connect a pharmacist at a parent
pharmacy with a remote pharmacy operated by the parent pharmacy.
(b) Uses a camera that is of
sufficient quality and resolution to allow a pharmacist at a parent pharmacy
who is reviewing a prescription to visually identify the markings on tablets
and capsules at the remote pharmacy.
(6) “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.
(7) “Wholesale distributor”
means a person, other than a manufacturer or wholesale distributor-broker, that 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 of the drug or device. A wholesale distributor
does not include a pharmacy unless the pharmacy meets the requirements of
section 17748f.
(8) “Wholesale
distributor-broker” means a person that meets both of the following:
(a) The person
facilitates the delivery or trade of a drug or device salable on prescription
only, other than a controlled substance, between pharmacies, or between a
pharmacy and a qualified pharmacy as that term is defined in section 17748e,
for the purpose of filling a prescription for an identified patient.
(b) The person
does not take possession or ownership of a drug or device salable on
prescription only or coordinate warehousing of the drug or device.
Sec. 17722. In addition to
the functions set forth in part 161, except as otherwise provided in this part,
the board shall do the following:
(a)
Regulate, control, and inspect the character and standard of pharmacy practice
and of drugs and devices manufactured, distributed, prescribed, dispensed,
administered, or issued in this state and procure samples and limit or prevent
the sale of drugs and devices that do not comply with this part.
(b)
Prescribe minimum criteria for the use of professional and technical equipment
and references in the compounding and dispensing of drugs and devices.
(c)
Grant a pharmacy license for each separate place of practice in which the
compounding or dispensing of prescription drugs or devices, or both, or the
receiving of prescription orders in this state is to be conducted.
(d)
Grant a drug control license for the place of practice of a dispensing
prescriber who meets the requirements for the license.
(e)
Grant a license to a manufacturer, wholesale distributor, or wholesale distributor-broker that meets the requirements for the license.
Sec. 17742. (1) The board may
require an applicant or the holder of a pharmacy, manufacturer’s, wholesale
distributor’s, or wholesale distributor-broker’s license to fully disclose the identity of each
partner, stockholder, officer, or member of the board of directors of the
pharmacy, manufacturer, wholesale distributor, or wholesale
distributor-broker, as applicable.
(2)
As used in this section and sections 17742a, 17748, 17748a, 17748e, and
17768, “applicant” means a person applying for a pharmacy, manufacturer’s,
wholesale distributor’s, or
wholesale distributor-broker’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) Except for a qualified pharmacy as that term
is defined in section 17748e, to do business in
this state, a pharmacy, manufacturer, wholesale distributor, or
wholesale distributor-broker, whether or not
located in this state, must be licensed 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 are renewable biennially.
(2)
Except for a remote pharmacy, a pharmacy shall designate a pharmacist licensed
in this state as the pharmacist in charge for the pharmacy. For a remote
pharmacy, the pharmacist designated as the pharmacist in charge of the parent
pharmacy shall also serve as the pharmacist in charge of the remote pharmacy.
Except as otherwise provided in this subsection, a manufacturer shall designate
a pharmacist licensed in or outside of this state as the pharmacist in charge
for the manufacturer or, if the manufacturer does not hold a license as a
pharmacy, shall designate an employee with the appropriate education or
experience, or both, to assume responsibility for compliance with licensing
requirements as facility manager for the manufacturer. Except as otherwise
provided in this subsection, a wholesale distributor or wholesale distributor-broker shall designate a pharmacist licensed in or outside of
this state as the pharmacist in charge for the wholesale distributor or
wholesale distributor-broker or shall designate
an employee with the appropriate education or experience, or both, to assume
responsibility for compliance with licensing requirements as facility manager
for the wholesale distributor or wholesale distributor-broker. The pharmacy, manufacturer, wholesale distributor, or wholesale distributor-broker and the individual designated as the PIC or facility
manager under this subsection are jointly responsible for the pharmacy’s,
manufacturer’s, wholesale distributor’s, or
wholesale distributor-broker’s compliance with
this part and rules promulgated under this part. A person that is a
manufacturer, wholesale distributor, or wholesale distributor-broker with respect to a device salable on prescription only
but not with respect to any drug salable on prescription only is exempt from
this subsection.
(3) Subject to this
subsection, a pharmacist may be designated as the PIC for not more than 3
pharmacies, including remote pharmacies. 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 unless he or she is serving as the PIC of a remote
pharmacy. The PIC of a remote pharmacy is not required to be physically present
at the remote pharmacy to satisfy the hour requirement described in this
subsection, but may satisfy the requirement through the use of a telepharmacy
system. The pharmacy and the PIC shall maintain appropriate records and
demonstrate compliance with this subsection on the request of the board or its
designee.
(4) A pharmacy, manufacturer,
wholesale distributor, or wholesale distributor-broker shall report to the department a change in ownership,
management, location, or its PIC or facility manager designated under
subsection (2) not later than 30 days after the change occurs.
(5) A pharmacist designated
as the PIC for a pharmacy shall supervise the practice of pharmacy for the
pharmacy. 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.
(c) Establishment and
supervision of the method and manner for 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 subsection (8), fingerprints for the following individuals must be
submitted with an application for a new pharmacy, manufacturer, wholesale
distributor, or wholesale distributor-broker license in the same manner as required in section
16174 for the purpose of a criminal history check:
(a) If the application is
from an individual, 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,
fingerprints for that individual.
(b) If the application is
from a partnership, fingerprints for all partners and any individual who will
manage the day-to-day operations of the new pharmacy, manufacturer, wholesale
distributor, or wholesale
distributor-broker.
(c) If the application is
from a privately held corporation, fingerprints for any individual who will
manage the day-to-day operations of the new pharmacy, manufacturer, or
wholesale distributor. This subdivision only applies to a privately held
corporation that in the aggregate owns fewer than 75 pharmacies, manufacturers,
wholesale distributors, or wholesale distributor-brokers on the date the corporation submits its license
application.
(7) The board, department,
and department of state police shall conduct the criminal history check on the
individuals described in subsection (6) in the same manner as described in
section 16174.
(8) Subsection (6) does not
apply if a criminal history check that meets the requirements of section 16174
has been obtained for the individuals described in subsection (6) within the 2
years preceding the date of the application for a new pharmacy, manufacturer,
wholesale distributor, or wholesale distributor-broker license under this part. To qualify for the exception
under this subsection, an applicant shall submit proof of the previous criminal
history check for each individual described in subsection (6), as applicable,
with the application for a new pharmacy, manufacturer, wholesale distributor, or wholesale distributor-broker license under this part. If the department or board
determines that a criminal history check for an individual described in
subsection (6) does not meet the requirements of section 16174 or was not
obtained within the time period prescribed, fingerprints must be submitted for
the individual as required under subsection (6).
(9) 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, and the 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.
17748e. (1) An out-of-state pharmacy that is not licensed under this part as a
pharmacy may deliver or trade a drug or device salable on prescription only to
a person located in this state only if the out-of-state pharmacy meets both of
the following requirements:
(a) The out-of-state pharmacy holds a license
in good standing as a pharmacy from the state in which it is located.
(b) The out-of-state pharmacy uses a wholesale
distributor-broker that is licensed in this state to facilitate the
transaction.
(2) Except as otherwise provided in this part,
a pharmacy that is using a wholesale distributor-broker shall only deliver or
trade a drug or device salable on prescription only that it receives from 1 or
more of the following:
(a) A manufacturer.
(b) A wholesale distributor.
(c) Subject to subsection (3), a pharmacy.
(d) Subject to subsection (3), a qualified
pharmacy.
(3) A drug salable on prescription only must
not be delivered or traded between pharmacies, or between a pharmacy and a
qualified pharmacy that is using a wholesale distributor-broker, unless all of
the following are met:
(a) The pharmacy or qualified pharmacy from
which the drug is being obtained receives a request for the drug that
identifies the drug’s brand name or generic name, lot number, expiration date,
quality, quantity, and size.
(b) The drug is approved by the United States
Food and Drug Administration.
(c) The drug is not expired at the time of the
delivery or trade.
(d) The drug is not a controlled substance.
(e) Before delivering or trading the drug, the
pharmacy or qualified pharmacy from which the drug is being obtained confirms
with the pharmacy or qualified pharmacy receiving the drug that the drug is
available for delivery or trade.
(f) The pharmacy or qualified pharmacy from
which the drug is being obtained includes with the drug a packaging checklist,
confirming that the drug being delivered or traded matches the information
identified on the request described in subdivision (a).
(g) The drug is delivered or traded in the
original manufacturer’s packaging, whether sealed or unsealed, with the drug’s
national drug code, lot number, and expiration date conspicuously identified on
the packaging. If the original manufacturer’s packaging is unsealed at the time
of the delivery or trade, the delivery or trade may include a quantity of the
drug that is less than the quantity contained in the original manufacturer’s
packaging. However, the pharmacies, or the pharmacy and qualified pharmacy,
shall not trade or deliver more than 1 unsealed or partial quantity of the
drug during any consecutive 90-day period.
(h) If 1 of the pharmacies involved in the
delivery or trade is a qualified pharmacy, the delivery or trade is intended to
fill a prescription for an identified patient.
(4) A wholesale distributor-broker is not
liable in a civil action for personal injury or death resulting from a drug or
device salable on prescription only that was delivered or traded by a pharmacy
or qualified pharmacy under this section, regardless of whether the wholesale
distributor-broker is subject to disciplinary action under this part, if the
wholesale distributor-broker’s conduct does not amount to gross negligence as
that term is defined in section 7 of 1964 PA 170, MCL 691.1407.
(5) To receive a license as a wholesale
distributor-broker under this part, an applicant shall meet the requirements
for licensure established by the department in consultation with the board by
rule. The rules must require the applicant to demonstrate to the satisfaction
of the board that, at the time of the application for initial licensure, the
applicant facilitates deliveries or trades for at least 50 qualified pharmacies
that are each licensed in good standing in their state of licensure. If the
number of qualified pharmacies described in this subsection with which a
wholesale distributor-broker facilitates deliveries and trades falls below 50,
the wholesale distributor-broker may continue to do business in this state.
However, a wholesale distributor-broker seeking renewal of its license shall,
in addition to meeting any requirements for renewal under section 16201,
demonstrate to the satisfaction of the board that the wholesale distributor-broker
facilitates deliveries and trades for at least 50 qualified pharmacies at the
time of license renewal.
(6) A wholesale distributor-broker shall
provide a transaction history, transaction statement, or transaction
information to a pharmacy purchasing a drug or device from a pharmacy or
qualified pharmacy through the wholesale distributor-broker under this section
if any of the following are met:
(a) A transaction history, transaction
statement, or transaction information is required under the drug supply chain
security act, Public Law 113-54.
(b) The qualified pharmacy provided the
transaction history, transaction statement, or transaction information to the
wholesale distributor-broker, and the wholesale distributer-broker receives a
request for the document from the purchasing pharmacy. A wholesale
distributor-broker that receives a document described in this subdivision shall
retain the document for at least 7 years.
(7) A wholesale distributor-broker that
receives notification from a pharmacy or qualified pharmacy that a delivery or
trade facilitated by the wholesale distributor-broker involved a drug or device
salable on prescription only that is a suspect product or illegitimate product
shall immediately notify each of the following:
(a) The department.
(b) The United States Food and Drug
Administration.
(c) Each pharmacy that received the product
from the pharmacy or qualified pharmacy.
(8) Before facilitating the delivery or trade
of a drug or device salable on prescription only to a pharmacy, the wholesale
distributor-broker shall notify the pharmacy, in writing, that the wholesale
distributor-broker will not examine the drug or device for quality or accuracy
before the pharmacy receives the drug or device.
(9) A wholesale distributor-broker shall not
facilitate a delivery or trade of a drug or device salable on prescription only
between a pharmacy and a qualified pharmacy unless both of the following are
met:
(a) The pharmacy’s or qualified pharmacy’s
license is in good standing in its state of licensure at the time of the
delivery or trade and the wholesale distributor-broker has no knowledge of
pending disciplinary action against the pharmacy or qualified pharmacy in its
state of licensure.
(b) The wholesale distributor-broker has, for
the quarter in which the delivery or trade will occur, received from the
pharmacy and qualified pharmacy a signed attestation that the pharmacy or
qualified pharmacy holds a license in good standing in its state of licensure
and that the pharmacy or qualified pharmacy is in compliance with all
applicable federal and state laws. The wholesale distributor-broker shall make
an attestation received under this subdivision available to the department on
the department’s request.
(10) A wholesale distributor-broker shall
cooperate with the department if the department is investigating a transaction
involving the wholesale distributor-broker or a qualified pharmacy with which
the wholesale distributor-broker facilitates transactions.
(11) As used in this section:
(a) “Illegitimate product” means that term as
defined in 21 USC 360eee.
(b) “Out-of-state pharmacy” means a facility
or part of a facility that is located outside of this state and that dispenses
prescription drugs or prepares prescription drugs for delivery or distribution
under the laws of the state in which it is located.
(c) “Qualified pharmacy” means an out-of-state
pharmacy that meets the requirements described in subsection (1).
(d) “Suspect product” means that term as
defined in 21 USC 360eee.
(e) “Transaction history” means that term as
defined in 21 USC 360eee.
(f) “Transaction information” means that term
as defined in 21 USC 360eee.
(g) “Transaction statement” means that term as
defined in 21 USC 360eee.
Sec.
17748f. (1) A pharmacy shall obtain a license as a wholesale distributor under
this part if the total number of dosage units of all prescription drugs
distributed by the pharmacy to a person during any consecutive 12-month period
is more than 5% of the total number of dosage units of prescription drugs
distributed and dispensed by the pharmacy during the same 12-month period.
(2) A pharmacy shall obtain a license as a
manufacturer under this part if, during any consecutive 12-month period, the
total number of dosage units of all prescription drugs that are prepared or
compounded by the pharmacy for the resale, compounding, or dispensing by
another person is more than 5% of the total number of dosage units of
prescription drugs prepared by the pharmacy during the same 12-month period.
Sec. 17767. The board may promulgate rules and make
determinations necessary or appropriate to the licensing of pharmacists, drugs,
dispensers, manufacturers, wholesale
distributors, and wholesale distributor-brokers under
this part.
Sec. 17768. (1) In a manner consistent with part 161,
the disciplinary subcommittee may fine, reprimand, or place on probation a
person licensed under this part, may deny, limit, suspend, or revoke a person’s
license, or may order restitution or community service for a violation of this
part or rules promulgated under this part.
(2)
In addition to the grounds set forth in subsection (1), and in a manner
consistent with part 161, the board may fine, reprimand, or place on probation
a person licensed under this part, may deny, limit, suspend, or revoke a
license issued under this part, or may order restitution or community service
if the board finds that any of the following apply to an applicant; a partner,
officer, or member of the board of directors of a pharmacy, manufacturer, wholesale
distributor, or wholesale distributor-broker licensed under this part; a stockholder of a pharmacy,
manufacturer, wholesale distributor, or
wholesale distributor-broker that is a privately
held corporation licensed under this part; or a facility manager for a
manufacturer, wholesale distributor, or wholesale distributor-broker designated under section 17748(2):
(a)
The applicant or other person described in this subsection lacks good moral
character.
(b)
Subject to subsection (3), the applicant or other person described in this
subsection has been convicted of a misdemeanor or a felony under a state or
federal law relating to a controlled substance or the practice of pharmacy.
(c)
The applicant or other person described in this subsection has furnished false
or fraudulent material information or has knowingly omitted material
information in an application filed under this part.
(d)
The applicant or other person described in this subsection has maintained a
financial interest in a pharmacy, manufacturer, wholesale distributor, or
wholesale distributor-broker that has been
denied a license or federal registration, has had its license or federal
registration limited, suspended, or revoked, or has been subject to any other
criminal, civil, or administrative penalty.
(e)
The applicant or other person described in this subsection is not in compliance
with article 7 or article 8 or the rules promulgated under article 7 or article
8.
(f)
The applicant or other person described in this subsection has violated section
17748.
(3)
Except for a conviction for a misdemeanor under section 7404(2)(d) or a local
ordinance that is substantially similar to section 7404(2)(d), the reference to
a misdemeanor in subsection (2)(b) applies only to a conviction for a misdemeanor
that is directly related to the manufacture, delivery, possession, possession
with intent to manufacture or deliver, use, distribution, prescription, or
dispensing of a controlled substance. Subsection (2)(b) does not apply to a
conviction for a misdemeanor based on an unintentional error or omission
involving a clerical or record-keeping function.
Secretary of the Senate
Clerk of the House of Representatives
Approved___________________________________________
____________________________________________________
Governor