08-00
: WHOLESALE
DRUG DISTRIBUTORS OF LEGEND/CONTROLLED SUBSTANCES
08-00-0001
-DEFINITIONS
As used in this regulation, unless the context otherwise
requires.
(a) "Board" means the
Arkansas State Board of Pharmacy;
(b) "Person" includes individual,
partnership, corporation, business firm and association;
(c) "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;
(d) "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:
(1) Habit-forming;
(2) Toxic or having potential for
harm;
(3) Limited in its use to use
under a practitioner's supervision by the new drug application for the drug.
(i) The product label of a legend drug is
required to contain the statement "CAUTION; FEDERAL LAW PROHIBITS DISPENSING
WITHOUT A PRESCRIPTION."
(ii) 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.
(e) "Prescription drug" means controlled
substances, legend drugs and veterinary legend drugs as defined
herein.
(f) "Blood" means whole
blood collected from a single donor and processed either for transfusion or
further manufacturing.
(g) "Blood
component" means that part of blood separated by physical or mechanical means.
(h) "Manufacturers" means anyone
who is engaged in manufacturing, preparing, propagating, compounding,
processing, packaging, repackaging, or labeling of a prescription drug.
(i) "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:
(1) Intra-company sales;
(2) 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;
(3) 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;
(4) 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;
(5) 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;
(6) The
distribution of drug samples by manufacturers' representatives or distributors'
representatives; or
(7) The sale,
purchase or trade of blood components intended for
transfusion.
(j)
"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.
(k) "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.
(l)
"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."
(m) "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.(a) 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.
(b)
(1) The permit may be renewed biennially at a
renewal permit fee as defined in regulation 01-00-0007.
(2) 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.
(c)
(1)
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.
(2) A change of ownership of a wholesale
distributor occurs under, but is not limited to, the following circumstances:
(A) A change of ownership of a wholesale
distributor owned by a SOLE PROPRIETOR, is deemed to have occurred when:
(i) The business is sold and the sale becomes
final or the new owner assumes control of the wholesale distributor - which
ever occurs first.
(ii) The
proprietor enters into a partnership with another individual or business
entity.
(B) A change of
ownership of a wholesale distributor, owned by PARTNERSHIP, is deemed to have
occurred when:
(i) There is an addition or
deletion of one or more partners in a partnership to which a wholesale
distributor's license has been issued.
(ii) The business is sold and the sale
becomes final or the new owner assumes control of the wholesale distributor -
which ever occurs first.
(C) A change of ownership of a wholesale
distributor, owned by a CORPORATION, is deemed to have occurred when:
(i) 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
(ii) 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
(iii) The corporation's charter
expires or is forfeited.
(iv) The
business is sold and the sale becomes final or the new owner assumes control of
the wholesale distributor - which ever occurs first.
(D) The board may issue a limited-use
wholesale distributor license to entities that do not engage in the wholesale
distribution of prescription drugs except medical gases and may waive certain
requirements of regulation based on the limited nature of such
distribution.
(E) Each permit issued
hereunder shall be displayed by the holder thereof in a conspicuous place.
(Revised 03/14/2007)
08-00-0004
-SHIPMENT TO CERTAIN
LICENSED PROFESSIONALS(a) 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.
(b) 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(a) 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:
(1) The name, full
business address, and telephone number of the licensee;
(2) All trade or business names used by the
licensee;
(3) Addresses, telephone
numbers, and the names of contact persons for the facility used by the licensee
for the storage, handling, and distribution of prescription drugs;
(4) The type of ownership or operation (i.e.
partnership, corporation, or sole proprietorship); and
(5) The name(s) of the owner and/or operator
of the licensee, including:
(A) If a person,
the name of the person;
(B) If a
partnership, the name of each partner, and the name of the
partnership;
(C) 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;
(D) If a sole
proprietorship, the full name of the sole proprietor and the name of the
business entity.
(b) 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.
(c) Changes in any information on the
application for licensure shall be submitted to the Arkansas Board of Pharmacy
within thirty (30) days after such change.
08-00-0006
-MINIMUM
QUALIFICATIONS
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 related 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.
(a)
Facilities.
All facilities at which prescription drugs are stored, warehoused,
handled, held, offered, marketed or displayed shall:
(1) Be of suitable size and construction to
facilitate cleaning, maintenance, and proper operation;
(2) Have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
(3) 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;
(4) Be maintained in a clean and orderly
condition; and
(5) Be free from
infestation by insects, rodents, birds, or vermin of any
kind.
(b) Security.
(1) All facilities used for wholesale drug
distribution shall be secure from unauthorized entry.
(A) Access from outside the premises shall be
kept to a minimum and well controlled.
(B) The outside perimeter of the premises
shall be well lighted.
(C) Entry
into areas where prescription drugs are held shall be limited to authorized
personnel.
(2) All
facilities shall be equipped with an alarm system to detect entry after hours.
This requirement shall not apply to those wholesale drug distributors of
legend/controlled substances that carry only medical gas.
(3) 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.
(c) 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 requirements in the current edition of an official
compendium.
(1) 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.
(2) Appropriate manual,
electromechanical, or electronic temperature and humidity recording equipment,
devices, and/or logs shall be utilized to document proper storage of
prescription drugs.
(3) The record
keeping requirements in section (f) of this regulation shall be followed for
all stored drugs.
(4) The
requirements of this subsection do not apply to reverse
distributors.
(d)
Examination of materials.
(1) 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.
(2) 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.
(3) The record keeping requirements in
section (f) of this regulation shall be followed for all incoming and outgoing
prescription drugs.
(e)
Returned, damaged, and outdated prescription drugs.
(1) 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.
(2) 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.
(3) 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.
(4) The record keeping requirements in
section (f) of this regulation shall be followed for all outdated, damaged,
deteriorated, misbranded, or adulterated prescription
drugs.
(f) Record keeping.
(1) 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:
(A) The source of the drugs, including the
name and principal address of the seller or transferer, and the address of the
location from which the drugs were shipped;
(B) The identity and quantity of the drugs
received and distributed or disposed of, and
(C) The dates of receipt and distribution or
other disposition of the drugs.
(2) 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 (2) years following disposition
of the drugs.
(3) 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 (2) working days
of a request by any official authorized by the Arkansas Board of Pharmacy.
(Revised 6/23/05)
08-00-0009
-WRITTEN POLICIES AND
PROCEDURES
Wholesale drag 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 ef or 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 replacement 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 drags.
This documentation shall be maintained for two (2) 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 distributors 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)
08-01
: MEDICAL EQUIPMENT, LEGEND DEVICES, AND/OR MEDICAL GAS
08-01-0001
-DEFINITIONS
(a) "Home medical equipment, legend device
and medical gas supplier" means a person, business, corporation, agency,
company, etc., licensed to supply home medical equipment, medical gases and/or
legend devices to patients on an order from medical practitioners licensed to
order, use, or administer these products and to other persons, businesses,
corporations, agencies, companies, etc., licensed to supply home medical
equipment, medical gases, and/or legend devices.
(b) "Home medical equipment services" means
the delivery, installation, maintenance, replacement, and/or instruction in the
use of medical equipment, used by a sick or disabled individual, to allow the
individual to be maintained in a noninstitutional environment.
(c) "Legend device" means a device, which
because of any potential for harmful effect or the method of its use, is not
safe - except under the supervision of a practitioner. These devices, as
approved by the Food and Drug Administration, may be labeled "Caution: Federal
(USA) law restricts this device to sale by or on the order of a
physician."
(d)
(1) "Medical equipment" means technologically
sophisticated medical devices including but not limited to:
(A) Oxygen and oxygen delivery
systems;
(B) Ventilators;
(C) Respiratory disease management
devices;
(D) Electronic and computer
driven wheelchairs and seating systems;
(E) Apnea monitors;
(F) Transcutaneous electrical nerve
stimulator (T.E.N.S.) units;
(G)
Low air loss cutaneous pressure management devices;
(H) Sequential compression devices;
(I) Neonatal home phototherapy
devices;
(J) Feeding
pumps;
(K) Electrically-powered
hospital beds;
(L) Infusion pumps;
and
(M) Patient
lifts.
(2) The term
"medical equipment" does not include:
(A)
medical equipment used or dispensed in the normal course of treating patients
by hospitals, hospices, nursing facilities, or home health agencies;
(B) medical equipment used or dispensed by
health care professionals, licensed in Arkansas - provided the professional is
practicing within the scope of that professional's practice act;
(C) upper and lower extremity prosthetics and
related orthotics; or canes, crutches, walkers, bathtub grab bars, standard
wheelchairs, commode chairs, and bath benches.
(e) "Medical gas" means those gases and
liquid oxygen intended for human consumption.
(f) "Order" means an order issued by a
licensed medical practitioner legally authorized to order medical gases and/or
legend devices.
08-01-0002
-LICENSURE REQUIRED(a) No person
or entity, subject to licensure, shall sell or rent or offer to sell or rent
directly to patients in this state any home medical equipment, legend devices,
and/or medical gases, unless the person or entity is licensed as required by
Act 1101.
The licensure requirements of this act will apply to all companies,
agencies, and other business entities that are in the business of supplying
medical equipment to patients in their home and which bill the patient or the
patient's insurance, Medicare, Medicaid, or other third-party payer for the
rent or sale of that equipment. The application for a license shall be on a
form, furnished by the Board, and shall be accompanied by payment of fee as
defined in regulation 01-00-0007. The Board shall require a separate license
for each facility directly or indirectly owned or operated, within this state,
by the same person or business entity within this state, or for a parent entity
with divisions, subdivisions, subsidiaries, and/or affiliate companies when
operations are conducted at more than one location and there exists joint
ownership and control among all the entities.
(b) Minimum Required Information for
Licensure:
(1) Applicants may apply for a
Supplier of Medical Equipment, Legend Devices, and/or Medical Gas permit using
forms provided by the Board. Entities who complete the application process and
otherwise meet the qualifications for a permit will be granted a license.
Licenses will not be granted to those who are exempt from licensure
requirements and Board regulation as provided for in ACA
17-92-903.
The Arkansas Board of Pharmacy requires the following from each applicant for a
permit as a Supplier of Medical Equipment, Legend Devices, and/or Medical Gas
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 responsible on-site manager for the facility used by
the licensee for the storage, handling, and distribution of medical equipment,
legend devices, and/or medical gas;
d. Full disclosure of the type of ownership
or operation (i.e. partnership, corporation, LLC, LLP or sole proprietorship);
and
e. The name(s) of the owner
and/or operator of the entity, including:
a. If a person, the name of the
person;
b. If a partnership, the
name of each partner, and the name of the partnership;
c. If a corporation, the name and title of
each corporate officer and director, the corporate names, and the name of the
state of incorporation, the employer identification number and the name of the
parent company, if any;
d. 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 Supplier of
Medical Equipment, Legend Devices, and/or Medical Gas each such location shall
be licensed by the Arkansas Board of Pharmacy.
(3) If the entity is located outside of
Arkansas, the name and address of the Arkansas resident agent.
(4) Copies of other licenses and permits
issued to the entity.
(5) Changes
in any information on the application for licensure shall be submitted to the
Arkansas Board of Pharmacy within thirty (30) days after such change.
(6) Copy of liability insurance for products
and services provided in the amount of $500,000 or more.
(7) A written description of the proposed
operation.
(c) Minimum
Qualifications for licensure:
The Arkansas Board of Pharmacy will consider the following factors in
determining eligibility for licensure of entities who engage in supplying home
medical equipment, medical gases, or legend devices, or any combination
thereof, to patients on an order from medical practitioners licensed to order,
use, or administer these products and to other licensed suppliers of home
medical equipment, medical gases, or legend devices or any combination
thereof.
(1) Any convictions of the
applicant under any federal, state or local laws related to the distribution of
medical equipment, legend devices, and/or medical gas.
(2) Any felony convictions of the applicant
under federal, state, or local laws;
(3) The furnishing by the applicant of false
or fraudulent material in the application;
(4) Suspension or revocation by federal,
state, or local government of any license currently or previously held by the
applicant;
(5) Compliance with
licensing requirements under previously granted licenses, if any;
(6) Compliance with the requirements to
maintain and/or make available to the Arkansas Board of Pharmacy or to federal,
state, or local law enforcement officials those records required to be
maintained by suppliers of medical equipment, legend devices, and/or medical
gas;
(7) Any other factors or
qualifications the Arkansas Board of Pharmacy considers relevant to and
consistent with the public health and safety.
(d)
(1) The
annual license renewal fee is defined in regulation 01-00-0007.
(2) All licenses issued under this act shall
expire on December 31, of each calendar year.
(3) Each application for renewal of the
license must be made on or before December 31 of each year. Penalties for late
payment are defined in regulation 01-00-0007. The license shall be considered
null and void if the fee is not paid by April 1 of each
year.
(e) Each license
issued hereunder shall be displayed by the holder thereof in a conspicuous
place.
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. (Revised 11/13/2006)
08-01-0003
-STANDARDS OF
PRACTICE(a) Written policies and
procedures must be available for review and designed to meet all the following
standards. Documentation of all staff training must be kept in each employee's
personnel file. All local, state, and federal regulatory agency policies
concerning home medical equipment and oxygen must be followed.
(1) Order intake: A home medical equipment
provider shall recognize the importance of order intake. The provider is
responsible for assuring that order intake personnel are appropriately trained
in the following:
(A) Identifying
equipment;
(B) Determining
patient/caregiver needs;
(C)
Determining referral sources needs;
(D) Knowing equipment coverage criteria based
on diagnosis;
(E) Responding
appropriately during a medical equipment emergency;
(F) Explaining service procedures;
(G) Billing third party; and
(H) Verifying insurance.
The provider must assure that only trained order intake personnel
receive referrals.
(2) Selection of appropriate equipment:
(A) When providing equipment services for a
patient, a provider shall consider: physician orders, equipment needs of the
patient, economic situation of the patient and caregiver, and requirement of
any third party payer source.
(B) A
provider shall recognize those items, which require special fitting and
evaluation. Fitting of custom items shall be performed within a reasonable time
frame by specially trained personnel.
(3) Delivery and set up - patient and
caregiver education.
(A) A provider shall
maintain trained personnel to coordinate order fulfillment and to schedule
equipment services with timely delivery. Documentation of training will be
maintained.
(B) A provider shall
assure delivery personnel are appropriately trained to:
(i) Conduct an environment/equipment
compatibility assessment.
(ii)
Appropriately and safely set up the equipment.
(iii) Instruct patient and caregivers in the
safe operation and client maintenance of the equipment.
(iv) Recognize when additional education
and/or follow-up patient compliance monitoring is
appropriate.
(C) Written
instructions must be provided to the patient/caregiver upon delivery, and
documentation of receipt of written instruction must be maintained in the
patient record.
(4)
Services during use:
(A) A provider shall
document that patients are advised of service hours and emergency service
procedures. If equipment malfunction may threaten the customer's health, access
to 24-hours-per-day, 365-days-per-year emergency service must be available for
equipment maintenance or replacement.
(B) A provider shall establish a schedule at
the time of the initial delivery for any appropriate follow-up home medical
equipment services such as periodic maintenance, supply delivery and other
related activities.
(5)
Retrieval, disinfection, and maintenance of home medical equipment
(A) A provider shall assure that
state/federal requirements for equipment disinfection are followed including
red-tagging for bio-hazards, maintaining dirty equipment isolation, equipment
cleaning and disinfection areas and procedures, and appropriate staff training
on hazard prevention.
(B) Cleaning
and disinfection solutions must be bactericidal, tuberculocidal, and
viricidal.
(C) Centers for Disease
Control universal precautions and Occupational Health Safety Administration
regulations concerning equipment handling must be followed.
(D) Create and implement a preventative
maintenance program based on manufacturers' guidelines, which include
appropriate record keeping. Trained staff must be utilized.
(6) Patient record:
(A) A supplier must maintain a record for
each customer when required by state or federal law or when a physician's order
is required.
(B) The patient record
must include an intake form and applicable physician's orders.
(C) Records should be safeguarded from loss
and kept confidential.
(D)
Documentation of proper patient/caregiver instruction must be maintained in the
patient record.
(7)
Patient rights:
(A) The patient has the right
to considerate and respectful service.
(B) The patient has the right to obtain
service without regard to race, creed, national origin, sex, age, disability,
diagnosis or religious affiliation.
(C) Subject to applicable law, the patient
has the right to confidentiality of all information pertaining to his/her
medical equipment and service. Individuals or organizations not involved in the
patient's care may not have access to the information without the patient's
written consent.
(D) The patient has
the right to a timely response to his/her request for home medical equipment
services.
(E) The patient has the
right to select the home medical equipment supplier of his/her
choice.
(F) The patient has the
right to voice grievances without fear of termination of service or other
reprisals.
(G) The patient has the
right to expect reasonable continuity of service.
(H) The patient has the right to an
explanation of charges for equipment and supplies.
(8) Quality assurance:
(A) There is an ongoing continuous quality
improvement program designed to monitor and evaluate the quality of patient
care, improvement of patient services, if applicable, and resolution of
identified problems.
(B) Continuous
quality improvement activities are defined in a written plan.
(C) Issues monitored should be determined by
evaluating all complaints or incidents and items that are high volume, high
risk or problem prone.
(1)
Liability insurance coverage for products provided and operations of each
licensed entity is required in the amount of at least $500,000.
(b) Prohibited Practices
- The following practices are prohibited:
(1)
Patient freedom of choice:
Participation in any plan, agreement, or arrangement which eliminates
the patient's right to select a provider, licensed under this act, of their
choice shall be considered a violation of this regulation.
(2) Bribes, kickbacks and rebates:
It shall be considered a violation of this regulation for anyone to
knowingly and willfully offer, pay, solicit or receive any payment in return
for referring an individual to another person for the furnishing, or arranging
for the furnishing, of any item or service covered by this regulation.
(3) The solicitation of DME
business by providing prescribers with prescription blanks, patient order
forms, or patient order invoices with the name of any home medical equipment,
legend device, and/or medical gas provider printed thereon.
(4) A provider of home medical equipment
and/or medical gas may provide more than five percent (5%) of its annual sales
to licensed practitioners or facilities. The provider must, however, obtain a
State Wholesale Legend Drug and/or Controlled Substance Distributor Permit.
(10/13/95, amended 8/23/96, and 11/13/2006)
08-02
-WHOLESALE DISTRIBUTOR OF LIST I
CHEMICALS08-02-0001
-DEFINITIONS
As used in this regulation unless the context otherwise requires
(a) "Board" means the Arkansas State Board of
Pharmacy;
(b) "Person" includes an
individual, general or limited partnership, corporation, business firm, limited
liability company, and association;
(c) "List I chemical" means ephedrine,
pseudoephedrine, or phenylpropanolamine, or their salts, optical isomers and
salts of optical isomers, alone or in a mixture.
(d) "Manufacturer" means anyone who is
engaged in manufacturing, preparing, propagating, compounding, processing,
packaging, repackaging, or labeling of a List I chemical;
(e) "Wholesale distribution" means the
distribution of List I chemicals to persons other than consumers or patients,
but does not include entities exempt by Arkansas Code Annotated §
5-64-1006
as amended by Act 1209 of 2001.
(f)
"Wholesale distributor" means any person engaged in wholesale distribution of
List I chemicals; 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;
List I chemical repackagers; physicians; dentists, veterinarians; clinics;
individuals; hospitals; nursing homes and their providers; and retail and
hospital pharmacies that conduct wholesale distributions. A wholesale
distributor shall not include any for-hire carrier or person or entity hired
solely to transport List I chemicals.
08-02-0002
-WHOLESALE DISTRIBUTOR OF
LIST I CHEMICALS-PERMIT REQUIRED(a)
Every wholesale distributor who shall engage in the wholesale distribution of
List I chemicals to include without limitation, manufacturing in this state,
shipping in or into this state, or selling or offering to sell in this state,
if not exempt by Act 1209 of 2001, 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 permit for each facility directly or indirectly owned or
operated by the same business entity or for a parent entity with divisions,
subdivision, subsidiaries, and/or affiliate companies when operations are
conducted at more than one location and there exists joint ownership and
control among all the entities.
(b)
The permit shall be renewed as defined in regulation 01-00-0007.
(c) All permits issued under this section
shall expire as defined in regulation 01-00-0007.
(d) A change of ownership of a wholesale
distributor of List I chemicals occurs under, but is not limited to, the
following circumstances:
(1) A change of
ownership of a wholesale distributor of List I chemicals 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 of List I chemicals, 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 List I chemical wholesale
distributor's permit has been issued.
(B) The business is sold and the sale becomes
final or the new owner assumes control of the wholesale distributor of List I
chemicals - 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) A change of ownership of a wholesale
distributor of List I chemicals, owned by a
limited liability
company, is deemed to have occurred when:
(A) There is an addition or deletion of one
or more members of the limited liability company to which a List I chemical
wholesale distributor's permit has been issued;
(B) The assets of the limited liability
company devoted to or utilized in the wholesale distribution of List I
chemicals are sold and the sale becomes final or new owner assumes control of
the wholesale distribution of List I chemicals;
(C) There is dissolution of the limited
liability company.
(e)
(1) The
Board may, after notice and hearing suspend or revoke the registration of a
List I wholesale distributor, or impose other disciplinary action pursuant to
A.C.A §
17-92-315,
upon a finding of any of the following:
(A)
Violation of or failure to maintain qualification under Regulation 08-02-0001
et seq.
(B) Violation of any
federal, state, or local law or regulation regarding List I
chemicals.
(C) Revocation,
suspension, or surrender of a license or other authority issued by the Drug
Enforcement Administration as a List I wholesale distributor or to otherwise
possess, distribute or sell or offer to distribute or sell List I
chemicals
(2) The Board
shall follow the same procedures for hearings for a List I chemical wholesale
distributor as applicable to hearings for pharmacists as set forth in §
17-92-101
et seq. and Board regulations. (Revised
11/15/2003)
08-02-0003
-MINIMUM REQUIRED
INFORMATION FOR OBTAINING A PERMIT(a)
The Arkansas Board of Pharmacy requires the following from each wholesale drug
distributor of List I chemicals as part of the initial registration procedure
and as part of any renewal of such permit:
(1)
The name, full business address, and telephone number of the permit
holder;
(2) All trade or business
names used by the permit holder;
(3)
Addresses, telephone numbers, and the names of contact persons for the facility
used by the permit for the storage, handling, and distribution of List I
chemicals;
(4) The type of ownership
or operation (i.e. partnership, corporation, or sole proprietorship);
and
(5) The name(s) of the owner
and/or operator of the permit holder, including:
(A) If a person, the name of the
person;
(B) If a partnership, the
name of each partner, and the name of the partnership;
(C) 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;
(D) If a sole proprietorship, the full name
of the sole proprietor and the name of the business entity.
(E) If a limited liability company, the name
and state of organization of the limited liability company, the name of each
member and manager of the limited liability
company.
(b)
Where operations are conducted at more than one location, by a single wholesale
distributor of List I chemicals, each such location shall obtain a permit
issued by the Arkansas State Board of Pharmacy.
(c) Changes in any information on the
application for licensure shall be submitted to the Arkansas State Board of
Pharmacy within thirty (30) days after such a change.
08-02-0004
-MINIMUM
QUALIFICATIONS(a) The Arkansas State
Board of Pharmacy will consider the following factors in determining
eligibility for obtaining a permit as a Wholesale Distributor of List I
chemicals.
(1) Any convictions of the
applicant under any federal, state or local laws or regulations pertaining to
wholesale or retail drug distribution of List I chemicals, distribution of
controlled substances, or distribution of prescription drugs;
(2) Any felony convictions of the applicant
under federal, state or local laws;
(3) The applicant's past experience in the
manufacture or distribution of List I chemicals, prescription drugs, or
controlled substances;
(4) The
furnishing, by the applicant, of false or fraudulent material in any
application made in connection with manufacturing or distribution of List I
chemicals, prescription drugs, or controlled substances;
(5) Suspension or revocation by federal,
state or local government of any permit currently or previously held by the
applicant for the manufacture or distribution of any drugs or List I chemicals,
prescription drugs, or controlled substances;
(6) Compliance with registration requirements
under previously granted permits, if any;
(7) Compliance with the requirements to
maintain and/or make available to the State Board of Pharmacy or to federal,
state or local law enforcement officials those records required to be
maintained by wholesale drug distributors of List I chemicals;
(8) Any other factors or qualifications the
Arkansas Board of Pharmacy considers relevant to and consistent with the public
health and safety.
(b) The
applicant shall be registered with the Drug Enforcement Administration (DEA) as
a retail distributor of List I Chemicals and said registration shall be in good
standing.
(c) The Arkansas Board of
Pharmacy reserves the right to deny a permit to an applicant if it determines
that the granting of such a permit would not be in the public interest.
(Revised 11/15/2003)
08-02-0005
-PERSONNEL
The wholesale distributor of List I chemicals that is issued a permit
by the Board of Pharmacy shall employ adequate personnel with the education and
experience necessary to safely and lawfully engage in the wholesale
distribution of List I chemicals.
08-02-0006
-MINIMUM REQUIREMENTS FOR
THE STORAGE AND HANDLING OF LIST I CHEMICALS
The following are required for the storage and handling of List
chemicals, by wholesale drug distributors and their officers, agents,
representatives, and employees.
(a)
Facilities.
All facilities at which List I chemicals are stored, warehoused,
handled, held, offered, marketed or displayed shall:
(1) Be of suitable size and construction to
facilitate cleaning, maintenance, and proper operation;
(2) Have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
(3) Have a designated and clearly identified
area for storage of List I chemicals that are outdated, damaged, deteriorated,
misbranded, or adulterated, or that are in immediate or sealed secondary
containers that have been opened;
(4) Be maintained in a clean and orderly
condition; and
(5) Be free from
infestation by insects, rodents, birds, or vermin of any
kind.
(b) Security.
(1) All facilities used for wholesale drug
distribution shall be secure from unauthorized entry.
(A) Access from outside the premises shall be
kept to a minimum and well controlled.
(B) The outside perimeter of the premises
shall be well lighted.
(C) Entry
into areas where List I chemicals are held shall be limited to authorized
personnel.
(2) All
facilities shall be equipped with an alarm system to detect entry after
hours.
(3) 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.
(c) Storage.
All List I chemicals shall be stored at appropriate temperatures and
under appropriate conditions in accordance with requirements, if any, in the
labeling of such List I chemicals with requirement in the current edition of an
official compendium.
(1) If no storage
requirements are established for the List I chemical, the chemical 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.
(2) Appropriate manual,
electromechanical, or electronic temperature and humidity recording equipment,
devices, and/or logs shall be utilized to document proper storage of List I
chemicals.
(d) Examination
of materials.
(1) Upon receipt, each outside
shipping container shall be visually examined for identity and to prevent the
acceptance of contaminated List I chemicals 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.
(2) Each outgoing shipment
shall be carefully inspected for identity of the List I chemical products and
to ensure that there is no delivery of List I chemicals that have been damaged
in storage or held under improper conditions.
(e) Returned, damaged, and out-dated List I
chemicals.
(1) List I chemicals that are
outdated, damaged, deteriorated, misbranded, or adulterated shall be
quarantined and physically separated from other List I chemicals until they are
destroyed or returned to their supplier.
(2) Any List I chemicals 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 List I chemicals until they are either destroyed or returned to the
supplier.
(3) If the conditions
under which a List I chemical has been returned cast doubt on the product's
safety, identity, strength, quality, or purity, then the product shall be
destroyed, or returned to the supplier, unless examination, testing or other
investigation proves that the product meets appropriate standards of safety,
identity, strength, quality, and purity. In determining whether the conditions
under which a List I chemical has been returned cast doubt on the product's
safety, identity, strength, quality, or purity, the wholesale distributor of
List I chemicals shall consider, among other things, the conditions under which
the List I chemical has been held, stored, or shipped before or during its
return and the condition of the product and its container, carton, or labeling,
as a result of storage or shipping.
08-02-0007
-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 maintaining a permit
under this regulation. The Board, in its discretion, may accept a satisfactory
inspection by a state agency of another state which the Board determines to be
comparable to that made by the Arkansas State Board of
Pharmacy.
08-02-0008
-SUSPICIOUS ORDERS FOR LIST I CHEMICALS
Wholesale Distributors of List 1 chemicals should use their best
judgment in identifying suspicious orders. The wholesalers should use the
following criteria in order to identify suspicious orders:
(a) All Levels/All Chemicals
(1) New customer or unfamiliar representative
or established customer who begins ordering List 1 chemicals.
(2) Customers who don't seem to know industry
practice or who fail to provide reasons for an order at variance with accepted
legitimate industry practice.
(3)
Customer whose communications are not prepared or conducted in a professional
business manner.
(4) Customer who
provides evasive responses to any questions or is unable to supply information
as to whether chemicals are for domestic use or for export.
(5) Customer who has difficulty pronouncing
chemical names.
(6) New customers
who don't seem to know federal or state government regulations.
(7) Customer whose stated use of List 1
chemicals is incompatible with destination country's commercial activities or
consignee's line of business.
(8)
Customers who want predominantly or only regulated chemicals.
(9) Customers who want multiple regulated or
surveillance list products, particularly if in contrast to customary use and
practice.
(10) Customer who is vague
or resists providing information about the firm's address, telephone number,
and reason for seeking that chemical.
(11) Customer who provides false or
suspicious addresses, telephone numbers, or references.
(12) Customer who is vague or will not
furnish references for credit purposes.
(13) Customer who refuses or is reluctant to
establish a credit account or provide purchase order information.
(14) Customer who prefers to pay by cashiers
check, postal money order, etc.
(15)
Customer who desires to pay cash.
(16) Customer who wants to pick up the
chemicals outside of normal practice in the suppliers experience.
(17) Customer with little or no business
background available.
(18) An
established customer who deviates from previous orders or ordering
methods.
(19) Customers who want
airfreight or express delivery.
(20)
Customers who want chemicals shipped to post office boxes or an address other
than their usual business address, (i.e. residence address)
(21) Customer using a freight forwarder as
ultimate consignee.
(22) Customer
who requests unusual methods of delivery or routes of shipment.
(23) Customer who provides unusual shipping,
labeling, or packaging instructions.
(24) Customer who requests the use of
intermediate consignees whose location or business is incompatible with the
purported end users nature of business or location.
(25) Above threshold hydrochloride gas or
iodine sales to a non-commercial customer.
(b) Distributor (non-retail) of regulated
over-the-counter products
(1) Customers who
don't want to tell you what area they will resell into.
(2) Customers who don't want to tell you in
what volumes they will resell.
(3)
Customers who refuse to tell you who their customers are.
(4) Customers who don't have limits on
resales.
(5) Customers who push to
buy more than your sales limit.
(6)
Customers who repeatedly buy your sales limit at the shortest interval you
set.
(7) Customers who don't know
what his or her customers' limits are on individual resales.
(8) Customers who resell to non-traditional
outlets for regulated over-the-counter products, (i.e. hair salons, head shops,
drug paraphernalia stores, liquor stores, record stores, video
shops.)
(9) Customers who resell
large volumes into "independent convenience store" market.
(10) Any customer who asks for large bottle
sizes, 60 count or higher.
(11)
Customers who buy only the largest size available.
(12) Customers that don't sell other
pharmaceutical products or appear to sell those other products in token
amounts.
(13) Any customer that
resells multiple cases that flow through to individual retail
outlets.
(14) New customers who want
to sell regulated over-the-counter products into California, Arizona, Nevada,
Oregon, Utah, Washington, New Mexico, Texas, Kansas, Missouri, or
Arkansas.
(15) Any customer who
wants to sell to an outlet relocated from California, Missouri, or Kansas to
any of the states identified in the prior sentence.
(16) Any customer who wants to export,
particularly to Mexico, Canada, or Southeast Asia.
(17) Customers who will not provide you with
evidence of registration with the Drug Enforcement Administration (DEA)(Or have
applied by Nov. 13, 1995 for single entity ephedrine; pseudoephedrine, and
phenylpropanolamine products.)
(18)
Customers who will not provide you with evidence of applicable state
registrations/licenses.
(19)
Customers who sell mail order and who don't report sales to the DEA monthly.
(Note they must also be registered.)
(20) Nominal retail customers who sell above
the federal, "retail" 24 gram individual sale limits.
(c) Wholesale drug distribution indicators
(1) Individual pharmacies that intend to
export.
(2) Individual pharmacies or
chains that won't set a voluntary limit for individual sales at some fraction
of the Federal limit to qualify as retail outlet.
(3) Pharmacies that stock large shelf volumes
in stores that have repeated thefts or other sales problems.
(6/21/2001)