43-15.3 Wholesale Drug Pedigree - North Dakota Statutes

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CHAPTER 43-15.3WHOLESALE DRUG PEDIGREE43-15.3-01. Definitions. As used in this chapter, unless the context otherwise requires:1."Authentication" means to affirmatively verify before any wholesale distribution of a
prescription drug occurs that each transaction listed on the pedigree has occurred.2."Authorized distributor of record" means a wholesale distributor with whom a
manufacturerhasestablishedanongoingrelationshiptodistributethemanufacturer's prescription drug.An ongoing relationship is deemed to existbetween the wholesale distributor and a manufacturer when the wholesale
distributor, including any affiliated group of the wholesale distributor as defined in
section 1504 of the Internal Revenue Code [26 U.S.C. 1504], complies with the
following:a.The wholesale distributor has a written agreement currently in effect with the
manufacturer evidencing the ongoing relationship; andb.The wholesale distributor is listed on the manufacturer's current list of
authorized distributors of record, which is updated by the manufacturer on no
less than a monthly basis.3."Board" means the state board of pharmacy.4."Chain pharmacy warehouse" means a physical location for prescription drugs which
acts as a central warehouse and performs intracompany sales or transfers of the
drugs to a group of chain pharmacies that have the same common ownership and
control.5."Colicensed product" means a prescription drug in which two or more parties have
the right to engage in the manufacturing or marketing or in the manufacturing and
marketing of the drug.6."Drop shipment" means the sale of a prescription drug to a wholesale distributor by
the manufacturer of the prescription drug, or that manufacturer's colicensed product
partner, that manufacturer's third-party logistics provider, or that manufacturer's
exclusive distributor, under the terms of which the wholesale distributor or chain
pharmacy warehouse takes title but not physical possession of the prescription drug
and the wholesale distributor invoices the pharmacy or chain pharmacy warehouse,
or other person authorized by law to dispense or administer the drug to a patient,
and the pharmacy or chain pharmacy warehouse or other authorized person
receives delivery of the prescription drug directly from the manufacturer, or that
manufacturer's third-party logistics provider, or that manufacturer's exclusive
distributor.7."Facility" means a facility of a wholesale distributor where prescription drugs are
stored, handled, repackaged, or offered for sale.8."Manufacturer" means a person licensed or approved by the federal food and drug
administration to engage in the manufacture of drugs or devices.9."Manufacturer's exclusive distributor" means any person that contracts with a
manufacturer to provide or coordinate warehousing, distribution, or other services on
behalf of a manufacturer and which takes title to that manufacturer's prescription
drug, but which does not have general responsibility to direct the sale or disposition
of the manufacturer's prescription drug.The manufacturer's exclusive distributormust be licensed as a wholesale distributor under this chapter, and to be consideredPage No. 1part of the normal distribution channel also must be an authorized distributor of
record.10."Normal distribution channel" means a chain of custody for a prescription drug which
goes, directly or by drop shipment, from a manufacturer of the prescription drug,
from that manufacturer to that manufacturer's colicensed partner, from that
manufacturer to that manufacturer's third-party logistics provider, or from that
manufacturer to that manufacturer's exclusive distributor to:a.A pharmacy, to a patient or other designated person authorized by law to
dispense or administer the drug to a patient;b.A wholesale distributor, to a pharmacy, to a patient or other designated person
authorized by law to dispense or administer the drug to a patient;c.A wholesale distributor, to a chain pharmacy warehouse, to that chain
pharmacy warehouse's intracompany pharmacy, to a patient or other
designated person authorized by law to dispense or administer the drug to a
patient; ord.Achainpharmacywarehouse,tothechainpharmacywarehouse'sintracompany pharmacy, to a patient or other designated person authorized by
law to dispense or administer the drug to a patient.11."Pedigree" means a document or an electronic file containing information that
records each distribution of any given prescription drug.12."Prescription drug" means any drug, including any biological product, except for
blood and blood components intended for transfusion or biological products that are
also medical devices, required by federal law, including federal regulation, to be
dispensed only by a prescription, including finished dosage forms and bulk drug
substances subject to section 503(b) of the federal Food, Drug, and Cosmetic Act
[21 U.S.C. 3539(b)].13."Repackage" means repackaging or otherwise changing the container, wrapper, or
labeling to further the distribution of a prescription drug, excluding actions completed
by the pharmacists responsible for dispensing product to the patient.14."Repackager" means a person who repackages.15."Third-party logistics provider" means anyone who contracts with a prescription drug
manufacturer to provide or coordinate warehousing, distribution, or other services on
behalf of a manufacturer, but does not take title to the prescription drug or have
general responsibility to direct the prescription drug's sale or disposition.Thethird-party logistics provider must be licensed as a wholesale distributor under this
chapter and to be considered part of the normal distribution channel must also be an
authorized distributor of record.16."Wholesale distribution" means distribution of prescription drugs to persons other
than a consumer or patient. The term does not include:a.Intracompany sales of prescription drugs, meaning any transaction or transfer
between any division, subsidiary, parent or affiliated or related company under
common ownership and control of a corporate entity, or any transaction or
transfer between colicensees of a colicensed product.b.The sale, purchase, distribution, trade, or transfer of a prescription drug or offer
to sell, purchase, distribute, trade, or transfer a prescription drug for emergency
medical reasons.Page No. 2c.Thedistributionofprescriptiondrugsamplesbymanufacturers'representatives.d.Drug returns, when conducted by a hospital, health care entity, or charitable
institution in accordance with title 21, Code of Federal Regulations, section
203.23.e.The sale of minimal quantities of prescription drugs by retail pharmacies to
licensed practitioners for office use.f.The sale, purchase, or trade of a drug; an offer to sell, purchase, or trade a
drug; or the dispensing of a drug pursuant to a prescription.g.The sale, transfer, merger, or consolidation of all or part of the business of a
pharmacy from or with another pharmacy, whether accomplished as a
purchase and sale of stock or business assets.h.The sale, purchase, distribution, trade, or transfer of a prescription drug from
one authorized distributor of record to one additional authorized distributor of
record when the manufacturer has stated in writing to the receiving authorized
distributor of record that the manufacturer is unable to supply such prescription
drug and the supplying authorized distributor of record states in writing that the
prescription drug being supplied had until that time been exclusively in the
normal distribution channel.i.The delivery of, or offer to deliver, a prescription drug by a common carrier
solely in the common carrier's usual course of business of transporting
prescription drugs, and the common carrier does not store, warehouse, or take
legal ownership of the prescription drug.j.The sale or transfer from a retail pharmacy or chain pharmacy warehouse of
expired, damaged, returned, or recalled prescription drugs to the original
manufacturer or to a third-party returns processor.17."Wholesale distributor" means anyone engaged in the wholesale distribution of
prescription drugs, including, manufacturers; repackagers; own-label distributors;
private-label distributors; jobbers; brokers; warehouses, including manufacturers'
and distributors' warehouses; manufacturer's exclusive distributors; authorized
distributors of record; drug wholesalers or distributors; independent wholesale drug
traders; specialty wholesale distributors; third-party logistics providers; retail
pharmacies that conduct wholesale distribution; and chain pharmacy warehouses
that conduct wholesale distribution. To be considered part of the normal distribution
channel such wholesale distributor must also be an authorized distributor of record.43-15.3-02.Rulemaking authority.The board shall adopt rules that conform withwholesale drug distributor licensing guidelines adopted by the federal food and drug
administration, including rules necessary to carry out the purposes of this chapter, that
incorporate and set detailed standards for meeting each of the license prerequisites set forth in
this chapter, and that establish reasonable fees to carry out this chapter.43-15.3-03.Wholesale drug distributor licensing requirement - Minimumrequirements for licensure.1.A wholesale distributor that engages in the wholesale distribution of prescription
drugs must be licensed by the board under this chapter and must be properly
licensed in any other state in which the wholesale distributor engages in the
distribution of prescription drugs before engaging in wholesale distributions of
wholesale prescription drugs in this state. However, information and qualification
requirements for licensure beyond that required by federal law or regulation do notPage No. 3apply to manufacturers distributing their own United States food and drug
administration-approveddrugs,unlessparticularrequirementsaredeemednecessary and appropriate following rulemaking.2.The board shall require the following minimum information from each wholesale
distributor applying to get a license under subsection 1:a.The name, full business address, and telephone number of the licensee.b.All trade or business names used by the licensee.c.Addresses, telephone numbers, and the names of contact persons for all
facilities used by the licensee for the storage, handling, and distribution of
prescription drugs.d.The type of ownership or operation.e.The name of every owner and operator of the licensee, including:(1)If an individual, the name of the individual;(2)If a partnership, the name of each partner, and the name of the
partnership;(3)If a corporation, the name and title of each corporate officer and director,
the corporate names, and the name of the state of incorporation; and(4)If a sole proprietorship, the full name of the sole proprietor and the name
of the business entity.f.A list of all licenses and permits issued to the applicant by any other state that
authorizes the applicant to purchase or possess prescription drugs.g.The name of the applicant's designated representative for the facility, together
with the personal information statement and fingerprints, required pursuant to
subdivision h for the individual.h.Each individual required by subdivision g to provide a personal information
statement and fingerprints shall provide the following information to the state:(1)The individual's places of residence for the past seven years;(2)The individual's date and place of birth;(3)The individual's occupations, positions of employment, and offices held
during the past seven years;(4)The principal business and address of any business, corporation, or other
organization in which each office of the individual was held or in which
each occupation or position of employment was carried on;(5)Whether the individual has been, during the past seven years, the
subject of any proceeding for the revocation of any license or any
criminal violation and, if so, the nature of the proceeding and the
disposition of the proceeding;(6)Whether, during the past seven years, the individual has been enjoined,
either temporarily or permanently, by a court of competent jurisdiction
from violating any federal or state law regulating the possession, control,Page No. 4or distribution of prescription drugs or criminal violations, together with
details concerning any of those events;(7)A description of any involvement by the individual with any business,
including any investments, other than the ownership of stock in a publicly
traded company or mutual fund, during the past seven years, which
manufactured,administered,prescribed,distributed,orstoredpharmaceutical products and any lawsuits in which the businesses were
named as a party;(8)A description of any misdemeanor or felony criminal offense of which the
individual, as an adult, was found guilty, regardless of whether
adjudication of guilt was withheld or whether the individual pled guilty or
nolo contendere. If the individual indicates that a criminal conviction is
under appeal and submits a copy of the notice of appeal of that criminal
offense, the applicant must, within fifteen days after the disposition of the
appeal, submit to the state a copy of the final written order of disposition;
and(9)A photograph of the individual taken in the previous one hundred eighty
days.3.The information required under subsection 2 must be provided under oath.4.The board may not issue a wholesale distributor license to an applicant, unless the
board:a.Inspects or appoints a third party recognized by the board for the purpose of
inspecting the wholesale distribution operations of the facility before initial
licensure and continues to inspect periodically thereafter in accordance with a
schedule to be determined by the board, but not less than every three years.
Manufacturing facilities are exempt from inspection by the board if the
manufacturing facilities are currently registered with the federal food and drug
administration in accordance with section 510 of the federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301]; andb.Determinesthatthedesignatedrepresentativemeetsthefollowingqualifications:(1)Is at least twenty-one years of age;(2)Has been employed full time for at least three years in a pharmacy or
with a wholesale distributor in a capacity related to the dispensing and
distribution of, and recordkeeping relating to, prescription drugs;(3)Is employed by the applicant full time in a managerial level position;(4)Is actively involved in and aware of the actual daily operation of the
wholesale distributor;(5)Is physically present at the facility of the applicant during regular
businesshours,exceptwhentheabsenceofthedesignatedrepresentative is authorized, including sick leave and vacation leave;(6)Is serving in the capacity of a designated representative for only one
applicant at a time, except where more than one licensed wholesale
distributor is colocated in the same facility and the wholesale distributors
are members of an affiliated group, as defined in section 1504 of the
Internal Revenue Code [26 U.S.C. 1504];Page No. 5(7)Does not have any convictions under any federal, state, or local laws
relating to wholesale or retail prescription drug distribution or distribution
of controlled substances; and(8)Does not have any felony conviction under federal, state, or local laws.5.The board shall submit the fingerprints provided by an individual with a license
application for a statewide and nationwide criminal history background record check.
The nationwide criminal history background record check must be conducted in the
manner provided in section 12-60-24.All costs associated with the backgroundcheck are the responsibility of the applicant.6.The board shall require every wholesale distributor applying for a license to submit a
bond of at least one hundred thousand dollars, or other equivalent means of security
acceptable to the state, including an irrevocable letter of credit or a deposit in a trust
account or financial institution, payable to a fund established by the state under
subsection 7. A chain pharmacy warehouse that is engaged only in intracompany
transfers is not subject to the bond requirement. The purpose of the bond is to
secure payment of any fines or penalties imposed by the state and any fees and
costs incurred by the state regarding that license which are authorized under state
law and which the licensee fails to pay thirty days after the fines, penalties, or costs
become final. The state may make a claim against the bond or security until one
year after the licensee's license ceases to be valid. A single bond may cover all
facilities operated by the applicant in the state. Any chain pharmacy warehouse that
is engaged only in intracompany transfers is exempt from the bond requirement.7.The board shall establish a fund in which to deposit the wholesale distributor bonds.
Money in the fund is appropriated to the board on a continuing basis.8.If a wholesale distributor distributes prescription drugs from more than one facility,
the wholesale distributor shall obtain a license for each facility.9.In accordance with each licensure renewal, the board shall send to each wholesale
distributor licensed under this section a form setting forth the information that the
wholesale distributor provided pursuant to subsection 2.Within thirty days ofreceiving the form, the wholesale distributor must identify and state under oath to the
state licensing authority all changes or corrections to the information that was
provided under subsection 2.Changes in, or corrections to, any information insubsection 2 must be submitted to the board as required by that authority. The
board may suspend, revoke, or refuse to renew the license of a wholesale distributor
if the board determines that the wholesale distributor no longer qualifies for the
license issued under this section.10.The designated representative identified pursuant to subdivision g of subsection 2
must receive and complete continuing training in applicable federal and state laws
governing wholesale distribution of prescription drugs.11.Information provided under subdivision h of subsection 2 may not be disclosed to
any person other than a government agency that needs the information for licensing
or monitoring purposes.43-15.3-04. Requirements to distribute prescription drugs.1.A person may not engage in wholesale distributions of prescription drugs without,
after December 31, 2007, obtaining and maintaining accreditation or certification
from the national association of boards of pharmacy's verified accredited wholesale
distributor or an accreditation body approved by the board under subsection 4,
obtaining and maintaining a license issued by the board, and paying any reasonablePage No. 6fee required by the board. By action of the board, the deadline may be extended
through December 31, 2008.2.The board may not issue or renew the license of a wholesale drug distributor that
does not comply with this chapter. The board shall require a separate license for
each facility or location where wholesale distribution operations are conducted. An
agent or employee of any licensed wholesale drug distributor does not need a
license and may lawfully possess pharmaceutical drugs when acting in the usual
course of business or employment. The issuance of a license under this chapter
does not affect tax liability imposed by the tax department on any wholesale drug
distributor.3.The board may adopt rules that permit out-of-state wholesale drug distributors to
obtain a license on the basis of reciprocity if an out-of-state wholesale drug
distributor possesses a valid license granted by another state and the legal
standards for licensure in the other state are comparable to the standards under this
chapter and the other state extends reciprocity to wholesale drug distributors
licensed in this state. However, if the requirements for licensure under this chapter
are more restrictive than the standards of the other state, the out-of-state wholesale
drug distributor must comply with the additional requirements of this chapter to
obtain a license under this chapter.4.The board may adopt rules to approve an accreditation body to evaluate a wholesale
drug distributor's operations to determine compliance with professional standards,
this chapter and any other applicable law, and perform inspections of each facility
and location where wholesale distribution operations are conducted by the wholesale
drug distributor.43-15.3-05. Restrictions on transactions.1.A wholesale distributor shall receive prescription drug returns or exchanges from a
pharmacy or chain pharmacy warehouse under the terms and conditions of the
agreement between the wholesale distributor and the pharmacy or between the
wholesale distributor and the chain pharmacy warehouse, including the returns of
expired, damaged, and recalled pharmaceutical product to either the original
manufacturer or a third-party returns processor, and the returns or exchanges are
not subject to the pedigree requirement of section 43-15.3-06 if they are exempt
from pedigree under the federal food and drug administration's currently applicable
guidance for the federal Prescription Drug Marketing Act of 1987 [Pub. L. 100-293;
102 Stat. 95]. Wholesale distributors and pharmacies must ensure that the aspects
of this operation are secure and do not permit the entry of adulterated and
counterfeit product.2.A manufacturer or wholesale distributor shall furnish prescription drugs only to a
person licensed by the appropriate state licensing authorities.Before furnishingprescription drugs to a person not known to the manufacturer or wholesale
distributor, the manufacturer or wholesale distributor shall affirmatively verify that the
person is legally authorized to receive the prescription drugs by contacting the
appropriate state licensing authorities.3.Prescription drugs furnished by a manufacturer or wholesale distributor may be
delivered only to the premises listed on the license. The manufacturer or wholesale
distributor may furnish prescription drugs to an individual or agent of that individual
at the premises of the manufacturer or wholesale distributor if:a.The identity and authorization of the recipient are properly established; andb.This method of receipt is employed only to meet the immediate needs of a
particular patient of the authorized individual.Page No. 74.Prescription drugs may be furnished to a hospital pharmacy receiving area if a
pharmacist or authorized receiving personnel signs, at the time of delivery, a receipt
showing the type and quantity of the prescription drug so received. Any discrepancy
between receipt and the type and quantity of the prescription drug actually received
must be reported to the delivering manufacturer or wholesale distributor by the next
business day after the delivery to the pharmacy receiving area.5.A manufacturer or wholesale distributor may not accept payment for or allow the use
of a person's credit to establish an account for the purchase of prescription drugs
from any individual other than the owner of record, the chief executive officer, or the
chief financial officer listed on the license of an individual legally authorized to
receive prescription drugs. Any account established for the purchase of prescription
drugs must bear the name of the licensee.43-15.3-06. Pedigree.1.Each person who is engaged in wholesale distribution of prescription drugs,
including repackagers but excluding the original manufacturer of the finished form of
the prescription drug which leave or have ever left the normal distribution channel,
before each wholesale distribution of the drug, must provide a pedigree to the
person who receives the drug.a.A retail pharmacy or chain pharmacy warehouse must comply with the
requirements of this section only if the pharmacy or chain pharmacy warehouse
engages in wholesale distribution of prescription drugs.b.The board shall determine by July 1, 2009, a targeted implementation date for
electronic track and trace pedigree technology.The determination must bebased on consultation with manufacturers, distributors, and pharmacies
responsible for the sale and distribution of prescription drug products in this
state.Afterconsultationwithinterestedstakeholdersandbeforeimplementation of the electronic track and trace pedigree technology, the board
must determine that the technology is universally available across the entire
prescription pharmaceutical supply chain.The implementation date for themandated electronic track and trace pedigree technology may not be before
July 1, 2010, and may be extended by the board in one-year increments if it
appears the technology is not universally available across the entire
prescription pharmaceutical supply chain.2.Each person engaged in the wholesale distribution of a prescription drug, including a
repackager but excluding the original manufacturer of the finished form of the
prescription drug, that is provided a pedigree for a prescription drug and attempts to
further distribute that prescription drug shall verify affirmatively before any
distribution of a prescription drug occurs that each transaction listed on the pedigree
has occurred.3.The pedigree must:a.Include all necessary identifying information concerning each sale in the chain
of distribution of the product from the manufacturer, or the manufacturer's
third-party logistics provider, colicensed product partner, or manufacturer's
exclusive distributor, through acquisition and sale by any wholesale distributor
or repackager, until final sale to a pharmacy or other person dispensing or
administering the drug.At minimum, the necessary chain of distributioninformation must include:(1)The name, address, telephone number, and if available, the e-mail
address, of each owner of the prescription drug, and each wholesale
distributor of the prescription drug;Page No. 8(2)The name and address of each location from which the product was
shipped, if different from the owner's;(3)The transaction dates; and(4)A certification that each recipient has authenticated the pedigree.b.At minimum, the pedigree must also include the:(1)Name of the prescription drug;(2)Dosage form and strength of the prescription drug;(3)Size of the container;(4)Number of containers;(5)Lot number of the prescription drug;(6)Name of the manufacturer of the finished dosage form; and(7)National drug code (NDC) number.4.Each pedigree or electronic file must be:a.Maintained by the purchaser and the wholesale distributor for three years from
the date of sale or transfer; andb.Available for inspection or use within five business days upon a request of an
authorized officer of the law or the board.5.The board shall adopt rules and a form relating to the requirements of this section.43-15.3-07. Order to cease distribution.1.The board shall issue an order requiring the appropriate person, including the
distributors or retailers of the drug, to immediately cease distribution of the drug
within the state if the board finds that there is a reasonable probability that:a.A wholesale distributor, other than a manufacturer, has violated a provision in
this chapter or falsifiedapedigreeorsold,distributed,transferred,manufactured, repackaged, handled, or held a counterfeit prescription drug
intended for human use;b.The prescription drug at issue as a result of a violation in subdivision a could
cause serious, adverse health consequences or death; andc.Other procedures would result in unreasonable delay.2.An order under subsection 1 must provide the individual subject to the order with an
opportunity for an informal hearing, to be held not later than ten days after the date
of the issuance of the order, on the actions required by the order. If, after providing
an opportunity for such a hearing, the board determines that inadequate grounds
exist to support the actions required by the order, the board shall vacate the order.43-15.3-08. Prohibited acts - Penalty.Page No. 91.Except as otherwise provided under section 43-15.3-09, it is a class B misdemeanor
for a person to perform or cause the performance of or aid and abet any of the
following acts in this state:a.Failing to obtain a license under this chapter or operating without a valid license
when a license is required by this chapter.b.If the requirements of subsection 1 of section 43-15.3-05 are applicable and are
not met, purchasing or otherwise receiving a prescription drug from a
pharmacy.c.If a state license is required under subsection 2 of section 43-15.3-05, selling,
distributing, or transferring a prescription drug to a person that is not authorized
under the law of the jurisdiction in which the person receives the prescription
drug to receive the prescription drug.d.Failing to deliver prescription drugs to specified premises, as required by
subsection 3 of section 43-15.3-05.e.Accepting payment or credit for the sale of prescription drugs in violation of
subsection 5 of section 43-15.3-05.f.Failing to maintain or provide pedigrees as required by this chapter.g.Failing to obtain, pass, or authenticate a pedigree, as required by this chapter.h.Providing the board or any of the board's representatives or any federal official
with false or fraudulent records or making false or fraudulent statements
regarding any matter within the provisions of this chapter.i.Obtaining or attempting to obtain a prescription drug by fraud, deceit,
misrepresentation, or engaging in misrepresentation or fraud in the distribution
of a prescription drug.j.Except for the wholesale distribution by manufacturers of a prescription drug
that has been delivered into commerce pursuant to an application approved
under federal law by the federal food and drug administration, manufacturing,
repacking, selling, transferring, delivering, holding, or offering for sale any
prescription drug that is adulterated, misbranded, counterfeit, suspected of
being counterfeit, or has otherwise been rendered unfit for distribution.k.Except for the wholesale distribution by a manufacturer of a prescription drug
that has been delivered into commerce under an application approved under
federal law by the federal food and drug administration, adulterating,
misbranding, or counterfeiting any prescription drug.l.Receiving any prescription drug that is adulterated, misbranded, stolen,
obtained by fraud or deceit, counterfeit, or suspected of being counterfeit, and
the delivery or proffered delivery of such drug for pay or otherwise.m.Altering, mutilating, destroying, obliterating, or removing the whole or any part
of the labeling of a prescription drug or the commission of any other act with
respect to a prescription drug that results in the prescription drug being
misbranded.2.The prohibited acts in subsection 1 do not include a prescription drug manufacturer
or agent of a prescription drug manufacturer obtaining or attempting to obtain a
prescription drug for the sole purpose of testing the prescription drug for authenticity.Page No. 1043-15.3-09. Penalties.1.The board may impose the following sanctions if, after a hearing under
chapter 28-32, the board finds that a person has violated section 43-15.3-08:a.Revoke the wholesale drug distributor's license issued under this chapter if the
person is a wholesale drug distributor; orb.Assess a civil penalty against the person. A civil penalty assessed may not
exceed ten thousand dollars per violation.2.The board, upon a showing of a violation of this chapter, may revoke, suspend, or
limit a license issued under this chapter after a proceeding under chapter 28-32.
After a proceeding under chapter 28-32, the board may assess a civil penalty
against a licensed wholesale drug distributor of not more than ten thousand dollars
for each occurrence. If the licensed wholesale drug distributor fails to pay the civil
penalty within the time specified by the board, the board may suspend the license
without additional proceedings.3.Upon application by the board, a court may grant an injunction, a restraining order,
or other order to enjoin a person from offering to engage or engaging in the
performance of any practices for which a permit or license is required by any
applicable federal or state law including this chapter, upon a showing that the
practices were or are likely to be performed or offered to be performed without a
permit or license. An action brought under this subsection must be commenced
either in the county where the conduct occurred or is likely to occur or in the county
in the state where the defendant resides. An action brought under this subsection is
in addition to any other penalty provided by law and may be brought concurrently
with other actions to enforce this chapter.4.A person that knowingly purchases or receives a prescription drug through any
source other than a person licensed under this chapter, including a wholesale
distributor, manufacturer, pharmacy distributor, or pharmacy commits a class A
misdemeanor.A subsequent unrelated violation of this subsection is a class Cfelony.5.A person who knowingly or intentionally engages in the wholesale distribution of a
prescription drug without a license issued under this chapter commits a class C
felony. A person is guilty of a class C felony if that person engages in the wholesale
distribution of a prescription drug and with intent to defraud or deceive fails to obtain
or deliver to another person a complete and accurate required pedigree concerning
a prescription drug before obtaining the prescription drug from another person or
transferring the prescription drug to another person or falsely swears or certifies that
the person has authenticated any documents to the wholesale distribution of
prescription drugs.6.A person is guilty of a class C felony if that person engages in the wholesale
distribution of a prescription drug and knowingly or intentionally:a.Destroys, alters, conceals, or fails to maintain a complete and accurate
required pedigree concerning a prescription drug in the person's possession;b.Purchases or receives prescription drugs from a person not authorized to
distribute prescription drugs in wholesale distribution;c.Sells, barters, brokers, or transfers a prescription drug to a person not
authorized to purchase the prescription drug in the jurisdiction in which the
person receives the prescription drug in a wholesale distribution;Page No. 11d.Forges, counterfeits, or falsely creates a pedigree;e.Falsely represents a factual matter contained in a pedigree; orf.Fails to record material information required to be recorded in a pedigree.7.A person is guilty of a class C felony if that person engages in the wholesale
distribution of a prescription drug and possesses a required pedigree concerning a
prescription drug, knowingly or intentionally fails to authenticate the matters
contained in the pedigree as required, and distributes or attempts to further distribute
the prescription drug.Page No. 12Document Outlinechapter 43-15.3 wholesale drug pedigree