08-00
: WHOLESALE DRUG
DISTRIBUTORS OF LEGEND/CONTROLLED SUBSTANCES
08-00-0001 -DEFINITIONS
As used in this Regulation, unless the context otherwise
requires.
1.
Board means the Arkansas State Board of
Pharmacy;
2.
Person includes individual, partnership, corporation,
business firm and association;
3.
Controlled substance means those substances, drugs, or
immediate precursors listed in Schedules I through VI of the Uniform Controlled
Substances Act,
5-64-101 et seq., and
revised by the coordinator pursuant to his authority under
5-64-214
-
5-64-216;
4.
Legend drug means
a drug limited by the federal Food, Drug, and Cosmetic Act to being dispensed
by or upon a medical practitioner's prescription because the drug is:
i. Habit-forming;
ii. Toxic or having potential for
harm;
iii. Limited in its use to
use under a practitioner's supervision by the new drug application for the
drug.
a. The product label of a legend drug is
required to contain the statement "CAUTION; FEDERAL LAW PROHIBITS DISPENSING
WITHOUT A PRESCRIPTION."
b. A
legend drug includes prescription drugs subject to the requirement of the
Federal Food, Drug, and Cosmetic Act which shall be exempt if certain specified
conditions are met.
5.
Prescription drug
means controlled substances, legend drugs and veterinary legend drugs as
defined herein.
6.
Blood means whole blood collected from a single donor
and processed either for transfusion or further manufacturing.
7.
Blood component
means that part of blood separated by physical or mechanical means.
8.
Manufacturer
means anyone who is engaged in manufacturing, preparing, propagating,
compounding, processing, packaging, repackaging, or labeling of a prescription
drug.
9.
Wholesale
distribution means the distribution of prescription drugs to
persons other than consumers or patients and reverse distribution of such
drugs, but does not include:
a. Intra-company
sales;
b. The purchase or other
acquisition by a hospital or other health care entity that is a member of a
group purchasing organization or from other hospitals or health care entities
that are members of such organizations:
c. The sale, purchase or trade of a drug or
an offer to sell, purchase, or trade a drug by a charitable organization
described in Section
501(c)(3) of the
federal Internal Revenue Code to a nonprofit affiliate of the organization to
the extent otherwise permitted by law;
d. The sale, purchase, or trade of a drug or
an offer to sell, purchase, or trade a drug among hospitals or other health
care entities that are under common control; for the purposes of this
regulation common control means the power to direct or cause the direction of
the management and policies of a person or an organization whether by ownership
or stock or voting rights, by contract or otherwise;
e. The sale, purchase, or trade of a drug or
an offer to sell, purchase, or trade a drug; or the dispensing of a drug
pursuant to a prescription;
f. The
distribution of drug samples by manufacturers' representatives or distributors'
representatives; or
g. The sale,
purchase or trade of blood components intended for transfusion.
10.
Wholesale
distributor means any person engaged in wholesale distribution of
prescription drugs, including but not limited to manufacturers; repackers'
own-label distributors; private label distributors; jobbers; brokers;
warehouses, including manufacturers' and distributors' warehouses, chain drug
warehouses, and wholesale drug warehouses; independent wholesale drug traders;
prescription drug repackagers; physicians; dentists, veterinarians; birth
control and other clinics; individuals; hospital; nursing homes and their
providers; health maintenance organizations and other health care providers;
and retail and hospital pharmacies that conduct wholesale distributions. A
wholesale drug distributor shall not include any for-hire carrier or person or
entity hired solely to transport prescription drugs.
11.
Drug sample
means a unit of a prescription drug that is not intended to be sold and is
intended to promote the sale of the drug.
12.
Veterinary legend
drugs means drugs defined in
21 CFR 201.105
and bearing a label required to bear the cautionary statement, "CAUTION:
FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED
VETERINARIAN."
13. Reverse
Distribution means the receipt of prescription drugs including controlled
substances, whether received from Arkansas locations or shipped to Arkansas
locations, for the purpose of destroying the drugs or returning the drugs to
their original manufacturers or distributors.
08-00-0002 -SALES PERMIT REQUIRED.
It shall be unlawful for any person to sell or offer for sale by
advertisement, circular, letter, sign, or oral solicitation or any other means
any prescription drug unless the person holds and possesses a permit
authorizing such sale as provided by this regulation.
08-00-0003 -WHOLESALE DISTRIBUTOR-PERMIT
REQUIRED.
1. Every wholesale distributor who
shall engage in the wholesale distribution of prescription drugs, to include
without limitation, manufacturing in this state, shipping into this state or
selling or offering to sell in this state, shall register annually with the
Arkansas State Board of Pharmacy by application for a permit on a form
furnished by the Board and accompanied by a fee as defined in Regulation
01-00-0007. The Board may require a separate license for each facility directly
or indirectly owned or operated by the same business entity within this state,
or for a parent entity with divisions, subdivisions, subsidiaries, and/or
affiliate companies within this state when operations are conducted at more
than one location and there exists joint ownership and control among all the
entities.
2.
A. The permit may be renewed biennially at a
renewal permit fee as defined in Regulation 01-00-0007.
B. All permits issued under this section
shall expire on December 31, of each year. A penalty, as defined in Regulation
01-00-0007, will be charged, provided that if the renewal is unpaid by April 1,
of any year, the license shall be null and void.
3.
A. Upon
a change of ownership of a wholesale distributor, as set out herein, a new
permit shall be secured by the new owner(s). The new owner(s) can continue
operation of the wholesale distributor for fourteen (14) days after the
effective date of the change of ownership; after said fourteen (14) day period
the permit issued to the prior owner shall be void and the operation of the
wholesale distributor in Arkansas shall cease.
B. A change of ownership of a wholesale
distributor occurs under, but is not limited to, the following circumstances:
1. A change of ownership of a wholesale
distributor owned by a SOLE PROPRIETOR, is deemed to have occurred when:
a. The business is sold and the sale becomes
final or the new owner assumes control of the wholesale distributor -- which
ever occurs first.
b. The
proprietor enters into a partnership with another individual or business
entity.
2. A change of
ownership of a wholesale distributor, owned by PARTNERSHIP, is deemed to have
occurred when:
a. There is an addition or
deletion of one or more partners in a partnership to which a wholesale
distributor's license has been issued.
b. The business is sold and the sale becomes
final or the new owner assumes control of the wholesale distributor - which
ever occurs first.
3. A
change of ownership of a wholesale distributor, owned by a CORPORATION, is
deemed to have occurred when:
a. An
individual or business acquires or disposes of twenty percent (20%) of the
corporation's outstanding shares of voting stock. (This shall not apply to any
corporation the voting stock of which is actively traded on any securities
exchange or in any over the counter market); or
b. The corporation merges with another
business or corporation. (The corporation owning the wholesale distributor is
required to notify the Arkansas State Board of Pharmacy if a change of
ownership or merger occurs within the parent corporation of the corporation
which owns the wholesale distributor); or
c. The corporation's charter expires or is
forfeited.
d. The business is sold
and the sale becomes final or the new owner assumes control of the wholesale
distributor - which ever occurs first.
4. Each permit issued hereunder shall be
displayed by the holder thereof in a conspicuous
place.
08-00-0004 -SHIPMENT TO CERTAIN LICENSED
PROFESSIONALS.
1. All wholesale distributors
must, before shipping to a recipient in this state any prescription drug as
defined in this regulation, ascertain that the person to whom shipment is made
is either a licensed physician licensed by the Arkansas State Medical Board, a
licensed Doctor of Dentistry, a licensed Doctor of Veterinary Medicine, a
licensed Doctor of Podiatry Medicine, a hospital licensed by the State Board of
Health, a licensed wholesale distributor as defined in this regulation, a
licensed pharmacy licensed by the Arkansas State Board of Pharmacy, or other
entity authorized by law to purchase or possess prescription drugs.
2. No wholesale distributor shall ship any
prescription drug to any person after receiving written notice from the board
or other state or federal agency that the person no longer holds a registered
pharmacy permit or is not a licensed physician, dentist, veterinarian or
hospital.
08-00-0005
-MINIMUM REQUIRED INFORMATION FOR LICENSURE.
1. The Arkansas Board of Pharmacy requires
the following from each wholesale drug distributor as part of the initial
licensing procedure and as part of any renewal of such license:
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 the facility used by the license
for the storage, handling, and distribution of prescription drugs;
d. The type of ownership or operation (i.e.
partnership, corporation, or sole proprietorship); and
e. The name(s) of the owner and/or operator
of the licensee, including:
i. If a person,
the name of the person;
ii. If a
partnership, the name of each partner, and the name of the partnership;
iii. 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 the name of the parent company, if any;
iv. If a sole proprietorship, the
full name of the sole proprietor and the name of the business entity.
2. Where operations are
conducted at more than one location by a single wholesale distributor, each
such location shall be licensed by the Arkansas Board of Pharmacy.
3. Changes in any information on the
application for licensure shall be submitted to the Arkansas Board of Pharmacy
within 30 days after such change.
08-00-0006 -MINIMUM QUALIFICATIONS.
1. The Arkansas Board of Pharmacy will
consider the following factors in determining eligibility for licensure of
persons who engage in the wholesale distribution of prescription drugs.
a. Any convictions of the applicant under any
Federal, State, or local laws regulation to drug samples, wholesale or retail
drug distribution, or distribution of controlled substances;
b. Any felony convictions of the applicant
under Federal, State, or local laws;
c. The applicant's past experience in the
manufacture or distribution of prescription drugs, including controlled
substances;
d. The furnishing by
the applicant of false or fraudulent material in any application made in
connection with drug manufacturing or distribution;
e. Suspension or revocation by Federal,
State, or local government of any License currently or previously held by the
applicant for the manufacture or distribution of any drugs, including
controlled substances;
f.
Compliance with licensing requirements under previously granted licenses, if
any;
g. Compliance with the
requirements to maintain and/or make available to the State licensing authority
or to Federal, State, or local law enforcement officials those records required
to be maintained by wholesale drug distributors;
h. Any other factors or qualifications the
Arkansas Board of Pharmacy considers relevant to and consistent with the public
health and safety.
The Arkansas Board of Pharmacy reserves the right to deny a license to
an applicant if it determines that the granting of such a license would not be
in the public interest.
08-00-0007 -PERSONNEL
The licensed wholesale distributor shall employ adequate personnel with
the education and experience necessary to safely and lawfully engage in the
wholesale distribution of drugs.
08-00-0008 -MINIMUM REQUIREMENTS FOR THE
STORAGE AND HANDLING OF PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT AND
MAINTENANCE OF PRESCRIPTION DRUG DISTRIBUTION RECORDS.
The following are required for the storage and handling of prescription
drugs, and for the establishment and maintenance of prescription drug
distribution records by wholesale drug distributors and their officers, agents,
representatives, and employees.
1.
Facilities. All facilities at which prescription drugs are stored, warehoused,
handled, held, offered, marketed or displayed shall:
a. Be of suitable size and construction to
facilitate cleaning, maintenance, and proper operation;
b. Have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
c. Have a designated and clearly identified
area for storage of prescription drugs that are outdated, damaged,
deteriorated, misbranded, or adulterated, or that are in immediate or sealed
secondary containers that have been opened;
d. Be maintained in a clean and orderly
condition; and
e. Be free from
infestation by insects, rodents, birds, or vermin of any kind.
2. Security.
a. All facilities used for wholesale drug
distribution shall be secure from unauthorized entry.
i. Access from outside the premises shall be
kept to a minimum and well controlled.
ii. The outside perimeter of the premises
shall be well-lighted.
iii. Entry
into areas where prescription drugs are held shall be limited to authorized
personnel.
b. All
facilities shall be equipped with an alarm system to detect entry after
hours.
c. All facilities shall be
equipped with a security system that will provide suitable protection against
theft and diversion. When appropriate, the security system shall provide
protection against theft or diversion that is facilitated or hidden by
tampering with computers or electronic records.
3. Storage. All prescription drugs shall be
stored at appropriate temperatures and under appropriate conditions in
accordance with requirements, if any in the labeling of such drugs with
requirement in the current edition of an official compendium.
a. If no storage requirements are established
for a prescription drug, the drug may be held at "controlled" temperature, as
defined in an official compendium, to help ensure that its identity, strength,
quality, and purity are not adversely affected.
b. Appropriate manual, electromechanical, or
electronic temperature and humidity recording equipment, devices, and/or logs
shall be utilized to document proper storage of prescription drugs.
c. The record keeping requirements in
paragraph six of this section shall be followed for all stored drugs.
d. The requirements of this subsection do not
apply to Reverse Distributors.
4. Examination of materials.
a. Upon receipt, each outside shipping
container shall be visually examined for identity and to prevent the acceptance
of contaminated prescription drugs or prescription drugs that are otherwise
unfit for distribution. This examination shall be adequate to reveal container
damage that would suggest possible contamination or other damage to the
contents.
b. Each outgoing shipment
shall be carefully inspected for identity of the prescription drug products and
to ensure that there is no delivery of prescription drugs that have been
damaged in storage or held under improper conditions.
c. The record keeping requirements in
paragraph six of this section shall be followed for all incoming and outgoing
prescription drugs.
5.
Returned, Damaged, and Outdated Prescription Drugs.
a. Prescription drugs that are outdated,
damaged, deteriorated, misbranded, or adulterated shall be quarantined and
physically separated from other prescription drugs until they are destroyed or
returned to their supplier.
b. Any
prescription drugs whose immediate or sealed outer or sealed secondary
containers have been opened or used shall be identified as such, and shall be
quarantined and physically separated from other prescription drugs until they
are either destroyed or returned to the supplier.
c. If the conditions under which a
prescription drug has been returned cast doubt on the drug's safety, identity,
strength, quality, or purity, then the drug shall be destroyed, or returned to
the supplier, unless examination, testing or other investigation proves that
the drug meets appropriate standards of safety, identity, strength, quality,
and purity. In determining whether the conditions under which a drug has been
returned cast doubt on the drug's safety, identity, strength, quality, or
purity, the wholesale drug distributor shall consider, among other things, the
conditions under which the drug has been held, stored, or shipped before or
during its return and the condition of the drug and its container, carton, or
labeling, as a result of storage or shipping.
d. The record keeping requirements in
paragraph six of this section shall be followed for all outdated, damaged,
deteriorated, misbranded, or adulterated prescription drugs.
6. Record keeping.
a. Wholesale drug distributors shall
establish and maintain inventories and records of all transactions regarding
the receipt and distribution or other disposition of prescription drugs. These
records shall include the following information:
i. The source of the drugs, including the
name and principal address of the seller or transfer or, and the address of the
location from which the drugs were shipped;
ii. The identity and quantity of the drugs
received and distributed or disposed of, and
iii. The dates of receipt and distribution or
other disposition of the drugs.
b. Inventories and records shall be made
available for inspection and photocopying by any official authorized by the
Arkansas Board of pharmacy for a period of two years following disposition of
the drugs.
c. Records described in
this regulation that are kept at the inspection site or that can be immediately
retrieved by computer or other electronic means shall be readily available for
authorized inspection during the retention period. Records kept at a central
location apart from the inspection site and not electronically retrievable
shall be made available for inspection within two working days of a request by
any official authorized by the Arkansas Board of Pharmacy.
08-00-0009 -WRITTEN POLICIES AND
PROCEDURES.
Wholesale drug distributors shall establish, maintain, and adhere to
written policies and procedures, which shall be followed for the receipt,
security, storage, inventory, and distribution of prescription drugs, including
policies and procedures for identifying, recording, and reporting losses or
thefts, and for correcting all errors and inaccuracies in inventories.
Wholesale drug distributors shall include in their written policies and
procedures the following:
A. A
procedure whereby the oldest approved stock of a prescription drug product is
distributed first. The procedure may permit deviation from this requirement if
such deviation is temporary and appropriate.
B. A procedure to be followed for handling
recalls and withdrawals of prescription drugs. Such procedure shall be adequate
to deal with recalls and withdrawals due to:
1. Any action initiated at the request of the
Food and Drug Administration or other Federal, State, or local law enforcement
of other government agency, including the Arkansas Board of Pharmacy;
2. Any voluntary action by the manufacturer
to remove defective or potentially defective drugs from the market;
or
3. Any action undertaken to
promote public health and safety by replacing of existing merchandise with an
improved product or new package design.
C. A procedure to ensure that wholesale drug
distributors prepare for, protect against, and handle any crisis that affects
security or operation of any facility in the event of strike, fire, flood, or
other natural disaster, or other situations of local, State, or national
emergency.
D. A procedure to ensure
that any outdated prescription drugs shall be segregated from other drugs and
either returned to the manufacturer or destroyed. This procedure shall provide
for written documentation of the disposition of outdated prescription drugs.
This documentation shall be maintained for two years after disposition of the
outdated drug.
08-00-0010
-RESPONSIBLE PERSONS.
Wholesale drug distributors shall establish and maintain lists of
officers, directors, managers, and other persons in charge of wholesale drug
distribution, storage, and handling, including a description of their duties
and a summary of their qualifications.
08-00-0011 -COMPLIANCE WITH FEDERAL, STATE,
AND LOCAL LAWS.
Wholesale drug distributors shall operate in compliance with applicable
Federal, State, and local laws and regulations.
Wholesale drug distributions that deal in controlled substances shall
register with the appropriate State Controlled substance authority and with the
Drug Enforcement Administration (DEA), and shall comply with all applicable
State, local, and DEA regulations.
08-00-0012 -SALVAGING AND REPROCESSING.
Wholesale drug distributors shall be subject to the provisions of any
applicable Federal, State, or local laws or regulations that relate to
prescription drug product salvaging or reprocessing, including Chapter
21,
parts 207, 210d, 211 of the Code of Federal Regulations.
08-00-0013 -APPLICABILITY.
Nothing in this regulation shall apply to the sale of chemicals or
poisons for use for non medical purposes or for uses as insecticides or
biologies or medicine used for the cure, mitigation, or prevention of disease
of animals or fowl or for agricultural uses which comply with the requirements
of the Federal Food, Drug, and Cosmetic Act and all amendments thereto UNLESS
THOSE PRODUCTS ARE PRESCRIPTION DRUGS UNDER THIS REGULATION.
08-00-0014 -INSPECTION OF PREMISES AND
RECORDS.
The Board may conduct inspections upon all premises, including delivery
vehicles, Purporting or appearing to be used by a person licensed under this
regulation. The Board, in its discretion, may accept a satisfactory inspection
by the United States Food and Drug Administration (USFDA) or a state agency of
another state which the Board determines to be comparable to that made by USFDA
or the Arkansas Board of Pharmacy. 6/22/84 (Revised 6/20/91, 6/23/96, and
8/23/96).