Nebraska
State Statutes (as of
4/17/07)
Wholesale Drug Distributor Licensing Act
Contact: Nebr. Health & Human Services System
Becky.WisellPh@hhss.ne.gov or (402)
471-2115
___________________________________________________________________
Section 71-7427
Act, how cited.
Sections
71-7427 to 71-7463 shall be known and may be cited as the Wholesale Drug
Distributor Licensing Act.
Source:
Laws 1992, LB 1019, ? 1
R.S.1943, (2003), ? 71-7401
Laws 2006, LB 994, ? 1.
Section 71-7428
Definitions, where found.
For
purposes of the Wholesale Drug Distributor Licensing Act, the definitions found
in sections 71-7429 to 71-7446 apply.
Source:
Laws 1992, LB 1019, � 2
R.S.1943, (2003), � 71-7402
Laws 2006, LB 994, � 2.
Section 71-7429
Blood, defined.
Blood
means whole blood collected from a single donor and processed either for
transfusion or further manufacturing.
Source:
Laws 1992, LB 1019, � 3
R.S.1943, (2003), � 71-7403
Laws 2006, LB 994, � 3.
Section 71-7430
Blood component, defined.
Blood
component means that part of blood separated by physical or mechanical means.
Source:
Laws 1992, LB 1019, � 4
R.S.1943, (2003), � 71-7404
Laws 2006, LB 994, � 4.
Section 71-7431
Board, defined.
Board
means the Board of Pharmacy.
Source:
Laws 1992, LB 1019, � 5
Laws 1999, LB 828, � 176
R.S.1943, (2003), � 71-7405
Laws 2006, LB 994, � 5.
Section 71-7432
Chain pharmacy warehouse, defined.
Chain
pharmacy warehouse means a facility utilized as a central warehouse for intracompany sales or transfers of prescription drugs or
devices by two or more pharmacies operating under common ownership or common
control.
Source:
Laws 2006, LB 994, ? 6.
Section 71-7433
Common control, defined.
Common
control means that the power to direct or cause the direction of the management
and policies of a person or an organization by ownership of stock or voting
rights, by contract, or otherwise is held by the same person or persons.
Source:
Laws 1992, LB 1019, ? 6
R.S.1943, (2003), ? 71-7406
Laws 2006, LB 994, ? 7.
Section 71-7434
Department, defined.
Department
means the Department of Health and Human Services Regulation and Licensure.
Source:
Laws 1992, LB 1019, � 7
Laws 1996, LB 1044, � 778
R.S.1943, (2003), � 71-7407
Laws 2006, LB 994, � 8.
Section 71-7435
Drug sample, defined.
Drug
sample means a unit of a prescription drug intended to promote the sale of the
drug and not intended to be sold.
Source:
Laws 1992, LB 1019, � 8
R.S.1943, (2003), � 71-7408
Laws 2006, LB 994, � 9.
Section 71-7436
Emergency medical reasons, defined.
Emergency
medical reasons means the alleviation of a temporary shortage by transfers of
prescription drugs between any of the following: (1) Holders of pharmacy
licenses, (2) health care practitioner facilities as defined in section 71-414,
(3) hospitals as defined in section 71-419, and (4) practitioners as defined in
section 71-1,142.
Source:
Laws 1992, LB 1019, � 9
Laws 1998, LB 1073, � 157
Laws 2001, LB 398, � 82
R.S.1943, (2003), � 71-7409
Laws 2006, LB 994, � 10.
Section 71-7437
Facility, defined.
Facility
means a physical structure utilized by a wholesale drug distributor for the
storage, handling, or repackaging of prescription drugs or the offering of
prescription drugs for sale.
Source:
Laws 2006, LB 994, ? 11.
Section 71-7438
Manufacturer, defined.
Manufacturer
means any entity engaged in manufacturing, preparing, propagating, compounding,
processing, packaging, repackaging, or labeling a prescription drug.
Source:
Laws 1992, LB 1019, � 10
R.S.1943, (2003), � 71-7410
Laws 2006, LB 994, � 12.
Section 71-7439
Normal distribution chain, defined.
(1) Normal
distribution chain means the transfer of a prescription drug or the co-licensed
product of the original manufacturer of the finished form of a prescription
drug along a chain of custody directly from the manufacturer or co-licensee of
such drug to a patient or ultimate consumer of such drug.
(2) Normal
distribution chain includes transfers of a prescription drug or co-licensed
product:
(a) From a
manufacturer or co-licensee to a wholesale drug distributor, to a pharmacy, and
then to a patient or a patient's agent;
(b) From a
manufacturer or co-licensee to a wholesale drug distributor, to a pharmacy, to
a health care practitioner, health care practitioner facility, or hospital, and
then to a patient or a patient's agent;
(c) From a
manufacturer or co-licensee to a wholesale drug distributor, to a chain
pharmacy warehouse, to a pharmacy affiliated with the chain pharmacy warehouse,
and then to a patient or a patient's agent;
(d) From a
manufacturer or co-licensee to a chain pharmacy warehouse, to a pharmacy
affiliated with the chain pharmacy warehouse, and then to a patient or a
patient's agent; or
(e) Recognized in rules and regulations adopted and
promulgated by the department.
(3) For
purposes of this section, co-licensed products means prescription drugs that
have been approved by the federal Food and Drug Administration and are the
subject of an arrangement by which two or more parties have the right to engage
in a business activity or occupation concerning such drugs.
Source:
Laws 2006, LB 994, ? 13.
Section 71-7440
Pedigree, defined.
Pedigree
means a written or electronic documentation of every transfer of a prescription
drug as provided in sections 71-7455 and 71-7456.
Source:
Laws 2006, LB 994, ? 14.
Section 71-7441
Prescription drug, defined.
Prescription
drug means any human drug required by federal law or regulation to be dispensed
only by prescription, including finished dosage forms and active ingredients
subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act, as such section existed on August 1, 2006.
Source:
Laws 1992, LB 1019, � 11
R.S.1943, (2003), � 71-7411
Laws 2006, LB 994, � 15.
Section 71-7442
Repackage, defined.
Repackage
means repackaging or otherwise changing the container, wrapper, or labeling of
a prescription drug to facilitate the wholesale distribution of such drug.
Source:
Laws 2006, LB 994, ? 16.
Section 71-7443
Repackager,
defined.
Repackager means a person who repackages.
Source:
Laws 2006, LB 994, ? 17.
Section 71-7444
Wholesale drug distribution, defined.
(1)
Wholesale drug distribution means the distribution of prescription drugs to a
person other than a consumer or patient.
(2)
Wholesale drug distribution does not include:
(a) Intracompany sales of prescription drugs, including any
transaction or transfer between any division, subsidiary, or parent company and
an affiliated or related company under common ownership or common control;
(b) The
sale, purchase, or trade of or an offer to sell, purchase, or trade a prescription
drug by a charitable organization described in section 501(c)(3) of the
Internal Revenue Code, a state, a political subdivision, or any other
governmental agency to a nonprofit affiliate of the organization, to the extent
otherwise permitted by law;
(c) The
sale, purchase, or trade of or an offer to sell, purchase, or trade a
prescription drug among hospitals or other health care entities operating under
common ownership or common control;
(d) The
sale, purchase, or trade of or an offer to sell, purchase, or trade a
prescription drug for emergency medical reasons;
(e) The
sale, purchase, or trade of, an offer to sell, purchase, or trade, or the
dispensing of a prescription drug pursuant to a prescription;
(f) The
distribution of drug samples by representatives of a manufacturer or of a
wholesale drug distributor;
(g) The
sale, purchase, or trade of blood and blood components intended for
transfusion; or
(h) The
delivery of or the offer to deliver a prescription drug by a common carrier
solely in the usual course of business of transporting such drugs as a common
carrier if the common carrier does not store, warehouse, or take legal
ownership of such drugs.
Source:
Laws 1992, LB 1019, � 12
Laws 1995, LB 574, � 60
R.S.1943, (2003), � 71-7412
Laws 2006, LB 994, � 18.
Section 71-7445
Wholesale drug distributor, defined.
(1)
Wholesale drug distributor means any person or entity engaged in wholesale drug
distribution in this state, including manufacturers, repackagers,
own-label distributors, jobbers, private-label distributors, brokers,
warehouses including manufacturer and distributor warehouses, chain pharmacy
warehouses, and wholesale drug warehouses, wholesale medical gas distributors,
independent wholesale drug traders, and retail pharmacies that engage in
wholesale drug distribution in this state.
(2)
Wholesale drug distributor does not include a common carrier or other person or
entity hired solely to transport prescription drugs if the common carrier,
person, or entity does not store, warehouse, or take legal ownership of such
drugs.
Source:
Laws 1992, LB 1019, � 13
R.S.1943, (2003), � 71-7413
Laws 2006, LB 994, � 19.
Section 71-7446
Wholesale medical gas distributor, defined.
Wholesale
medical gas distributor means any person engaged in the wholesale drug
distribution of medical gases provided to suppliers or other entities licensed
or otherwise authorized to use, administer, or distribute such gases.
Source:
Laws 2006, LB 994, ? 20.
Section 71-7447
Wholesale drug distributor; licenses; requirements; exemptions.
(1) No
person or entity may act as a wholesale drug distributor in this state without
first obtaining a wholesale drug distributor license from the department. The
department shall issue a license to any applicant that satisfies the
requirements for licensure under the Wholesale Drug Distributor Licensing Act.
Manufacturers are exempt from any licensing and other requirements of the act
to the extent not required by federal law or regulation except for those
requirements deemed necessary and appropriate under rules and regulations
adopted and promulgated by the department.
(2)
Wholesale medical gas distributors shall be exempt from any licensing and other
requirements of the Wholesale Drug Distributor Licensing Act to the extent not
required under federal law but shall be licensed as wholesale drug distributors
by the department for the limited purpose of engaging in the wholesale
distribution of medical gases upon application to the department, payment of a
licensure fee, and inspection of the applicant's facility by the department,
except that the applicant may submit and the department may accept an
inspection accepted in another state or an inspection conducted by a nationally
recognized accreditation program approved by the board. For purposes of such
licensure, wholesale medical gas distributors shall only be required to provide
information required under subdivisions (1)(a) through
(1)(c) of section 71-7448.
(3) The
Wholesale Drug Distributor Licensing Act does not apply to:
(a) An
agent or employee of a licensed wholesale drug distributor who possesses drug
samples when such agent or employee is acting in the usual course of his or her
business or employment; or
(b) Any
person who (i) engages in a wholesale transaction
relating to the manufacture, distribution, sale, transfer, or delivery of
medical gases the gross dollar value of which does not exceed five percent of
the total retail sales of medical gases by such person during the immediately
preceding calendar year and (ii) has either a pharmacy permit or license or a
drug dispensing permit or delegated dispensing permit.
Source:
Laws 1992, LB 1019, � 17
Laws 1997, LB 752, � 198
Laws 2001, LB 398, � 84
Laws 2003, LB 242, � 148
R.S.1943, (2003), � 71-7417
Laws 2006, LB 994, � 21.
Section 71-7448
License; application; contents; examination; criminal history record
information check; waiver.
(1) Every
applicant for an initial or renewal license as a wholesale drug distributor
shall file a written application with the department. The application shall be
accompanied by the fee established by the department under section 71-7450 and
proof of bond or other security required under section 71-7452 and shall
include the following information:
(a) The
applicant's name, business address, type of business entity, and telephone
number. If the applicant is a partnership, the application shall include the name
of each partner and the name of the partnership. If the applicant is a
corporation, the application shall include the name and title of each corporate
officer and director, all corporate names of the applicant, and the applicant's
state of incorporation. If the applicant is a sole proprietorship, the
application shall include the name of the sole proprietor and name of the
proprietorship;
(b) All
trade or business names used by the applicant;
(c) The
addresses and telephone numbers of all facilities used by the applicant for the
storage, handling, and wholesale distribution of prescription drugs and the
names of persons in charge of such facilities. A separate license shall be
obtained for each such facility;
(d) A
listing of all licenses, permits, or other similar documentation issued to the
applicant in any other state authorizing the applicant to purchase or possess
prescription drugs;
(e) The
names and addresses of the owner and manager of the applicant's wholesale drug
distribution facilities, a designated representative at each such facility, and
all managerial employees at each such facility; and
(f) Other
information as required by the department, including affirmative evidence of
the applicant's ability to comply with the Wholesale Drug Distributor Licensing
Act and rules and regulations adopted and promulgated under the act.
(2) The
department may require persons listed on the application to pass an examination
approved by the department on laws pertaining to the wholesale distribution of
prescription drugs.
(3) The
application shall include the applicant's social security number if the
applicant is an individual. The social security number shall not be a public
record and may only be used by the department for administrative purposes.
(4) The
application shall be signed by (a) the owner, if the applicant is an individual
or partnership, (b) the member, if the applicant is a limited liability company
with only one member, or two of its members, if the applicant is a limited
liability company with two or more members, or (c) two of its officers, if the
applicant is a corporation.
(5) The
designated representative and the supervisor of the designated representative
of a wholesale drug distributor and each owner with greater than a ten percent
interest in the wholesale drug distributor, if the wholesale drug distributor
is a nonpublicly held company, shall be subject to a
criminal history record information check and shall provide the department or
the designated agent of the department with a complete set of fingerprints for
such purpose if his or her fingerprints are not already on file for such
purpose. The department or the designated agent of the department shall forward
such fingerprints to the Nebraska State Patrol to be submitted to the Federal Bureau
of Investigation for a national criminal history record information check. Such
persons shall authorize the release of the results of such criminal history
record information check to the department, and the applicant shall pay the
actual cost of such fingerprinting and such criminal history record information
check.
(6) The
department may waive certain requirements under this section upon proof
satisfactory to the department that such requirements are duplicative of other
requirements of law or regulation and that the granting of such exemption will
not endanger the public safety.
Source:
Laws 2006, LB 994, ? 22.
Section 71-7449
Designated representative; information required.
Each
designated representative named under subdivision (1)(e)
of section 71-7448 shall provide the following information prior to the
issuance of an initial or renewal license under such section:
(1) The
designated representative's places of residence for the immediately preceding
seven years;
(2) The
designated representative's date and place of birth;
(3) All
occupations, positions of employment, and offices held by the designated
representative during the immediately preceding seven years and the principal
businesses and the addresses of any business, corporation, or other
organization in which such occupations, positions, or offices were held;
(4)
Whether the designated representative has been, at any time during the immediately
preceding seven years, the subject of any proceeding for the revocation of any
license and, if so, the nature of the proceeding and its disposition;
(5)
Whether the designated representative has been, at any time during the
immediately preceding seven years, either temporarily or permanently enjoined
by a court of competent jurisdiction from violations of any federal or state
law regulating the possession, control, or distribution of prescription drugs,
and, if so, the details of such order;
(6) A
description of any involvement by the designated representative during the
immediately preceding seven years, other than the ownership of stock in a
publicly traded company or mutual fund, with any business which manufactured,
administered, distributed, or stored prescription drugs and any lawsuits in
which such businesses were named as a party;
(7)
Whether the designated representative has ever been convicted of any felony and
details relating to such conviction; and
(8) A
photograph of the designated representative taken within the immediately
preceding thirty days.
Source:
Laws 2006, LB 994, ? 23.
Section 71-7450
Fees.
(1)
Licensure activities under the Wholesale Drug Distributor Licensing Act shall
be funded by license fees. An applicant for an initial or renewal license under
the act shall pay a license fee as provided in this section.
(2)
License fees shall include (a) a base fee of fifty dollars and (b) an additional
fee of not more than five hundred dollars based on variable costs to the
department of inspections and of receiving and investigating complaints, other
similar direct and indirect costs, and other relevant factors as determined by
the department.
(3) If the
licensure application is denied, the license fee shall be returned to the
applicant, except that the department may retain up to twenty-five dollars as
an administrative fee and may retain the entire license fee if an inspection
has been completed prior to such denial.
(4) The
department shall also collect a fee for reinstatement of a license that has
lapsed or has been suspended or revoked. The department shall collect a fee of
ten dollars for a duplicate original license.
(5) The
department shall remit all license fees collected under this section to the
State Treasurer for credit to the Department of Health and Human Services
Regulation and Licensure Cash Fund. License fees collected under this section
shall only be used for activities related to the licensure of wholesale drug
distributors.
Source:
Laws 2006, LB 994, ? 24.
Section 71-7451
License; term; renewal.
A
wholesale drug distributor license shall expire on July 1 of each year and may
be renewed. The license shall not be transferable. The department shall mail an
application for renewal to each licensee not later than June 1 of each year. If
an application for renewal is received from the licensee after July 1, the
department may impose a late fee and shall refuse to issue the license until
such late fee and renewal fee are paid. Failure to receive an application for
renewal shall not relieve the licensee from the late fee imposed by this
section.
Source:
Laws 1992, LB 1019, � 20
Laws 2001, LB 398, � 85
Laws 2003, LB 242, � 150
R.S.1943, (2003), � 71-7420
Laws 2006, LB 994, � 25.
Section 71-7452
Bond or other security.
An
applicant for an initial or renewal license as a wholesale drug distributor
shall submit to the department proof of a bond of not less than one hundred
thousand dollars or other equivalent means of security acceptable to the
department. The bond or other security shall be given for the purpose of
securing payment of any fines or other penalties imposed by the department and
any fees or costs incurred by the department relating to such applicant as
authorized under the Wholesale Drug Distributor Licensing Act or rules and
regulations adopted and promulgated under the act which remain unpaid by the
applicant within thirty days after such fines, penalties, and costs become
final. The department may make a claim against such bond or security until one
year after the expiration of the license issued to the applicant under the act.
Source:
Laws 2006, LB 994, ? 26.
Section 71-7453
Department; inspections; procedures; fees.