Bill Text: MI SB0630 | 2019-2020 | 100th Legislature | Engrossed
Bill Title: Health: pharmaceuticals; wholesale distributor-broker license; create. Amends secs. 16111, 16333, 17705, 17706, 17707, 17709, 17722, 17742, 17748, 17767 & 17768 of 1978 PA 368 (MCL 333.16111 et. seq.) & adds secs. 17748e & 17748f.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Passed) 2020-07-22 - Assigned Pa 0142'20 With Immediate Effect [SB0630 Detail]
Download: Michigan-2019-SB0630-Engrossed.html
Substitute For
SENATE BILL NO. 630
A bill to amend 1978 PA 368, entitled
"Public health code,"
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:
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Sec. 16111. (1) This part applies to health
professions, but,
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except
for sections 16201, 16261, 16299, 16301, 16303, 16305, and 16307, 16309, and 16313, does not apply to a any of the following regulated under part 177:
(a)
A pharmacy. ,
(b)
A dispensing prescriber. , or
(c)
A drug manufacturer. or wholesaler who is regulated by part 177.
(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 shall 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................................. |
$ |
20.00 75.00 |
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|
(ii) |
Pharmacy................................... |
35.00 75.00 |
|
(iii) |
Drug control............................... |
20.00 75.00 |
|
(iv) |
Manufacturer, or wholesalerwholesale distributor, or wholesale distributor-broker................. |
50.00 75.00 |
|
(v) |
Pharmacy technician........................ |
25.00 75.00 |
|
(b) |
Examination fees: |
|
|
|
Jurisprudence examination.................. |
30.00 |
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(c) |
License fees, per year: |
|
|
(i) |
Pharmacist................................. |
30.00 |
|
(ii) |
Pharmacy................................... |
50.00 |
|
(iii) |
Drug control............................... |
15.00 |
|
(iv) |
Manufacturer, or wholesalerwholesale 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
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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, or 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 Pharmacopoeia and the national formulary, National Formulary, or the homeopathic pharmacopoeia Homeopathic Pharmacopoeia of the United
States, as applicable. If an official compendium is revised after the effective date of the
amendatory act that added this sentence, 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
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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, or 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
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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,
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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 , who 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.
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(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, or a wholesale
distributor, of prescription drugs who or wholesale distributor-
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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, or 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, or 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, or 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) To Except for a
qualified pharmacy as that term is defined in section 17748e, to do
business in this state, a pharmacy, manufacturer, or 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
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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, or 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, or wholesale
distributor's, or wholesale distributor-broker's compliance
with this part and rules promulgated under this part. A person that is a
manufacturer, or 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
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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 upon on the request of the board or its
designee.
(4) A pharmacy,
manufacturer, or 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.
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(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, or 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, or 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
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corporation
that in the aggregate owns fewer than 75 pharmacies, manufacturers, or 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, or 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, or 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
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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.
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(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
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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
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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
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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.
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(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, and wholesalers 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
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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, or wholesale distributor, or wholesale
distributor-broker licensed under this part; a stockholder of a
pharmacy, manufacturer, or wholesale
distributor, or wholesale distributor-broker that is a
privately held corporation licensed under this part; or a facility manager for
a manufacturer, or 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, or wholesale
distributor, or wholesale distributor-broker that has
been denied a license or federal registration, has had its license
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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.
