08-02-0001
-DEFINITIONS
As used in this Regulation, unless the context otherwise
requires
1.
Board means the Arkansas State Board of
Pharmacy;
2.
Person includes individual, general or limited
partnership, corporation, business firm, limited liability company, and
association;
3.
List I
Chemical means ephedrine, pseudoephedrine, or phenylpropanolamine,
or their salts, optical isomers and salts of optical isomers, alone or in a
mixture.
4.
Manufacturer means anyone who is engaged in
manufacturing, preparing, propagating, compounding, processing, packaging,
repackaging, or labeling of a List I Chemical;
5.
Wholesale
Distribution means the distribution of List 1 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.
6.
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.
1. 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.
2. The permit shall be
renewed as defined in Regulation 01-00-0007.
3. All permits issued under this section
shall expire as defined in Regulation 01-00-0007.
4. A change of ownership of a wholesale
distributor of List I Chemicals occurs under, but is not limited to, the
following circumstances:
A. 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.
B. 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.
C. 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.
D. 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.
08-02-0003 -MIINIMUM REQUIRED INFORMATION FOR
OBTAINING A PERMIT
1. 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:
A. The name, full
business address, and telephone number of the permit holder;
B. All trade or business names used by the
permit holder;
C. 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;
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 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 LLC, the name of each member and manager of
the LLC.
2.
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.
3. Changes in any information on the
application for licensure shall be submitted to the Arkansas State Board of
Pharmacy within 30 days after such a change.
08-02-0004 -MINIMUM QUALIFICATIONS
1. 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.
A. 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;
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 List I Chemicals, prescription drugs, or
controlled substances;
D. 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;
E. 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;
F. Compliance with registration requirements
under previously granted permits, if any;
G. 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;
H. Any other factors or qualifications the
Arkansas Board of Pharmacy considers relevant to and consistent with the public
health and safety.
2. 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.
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.
1.
Facilities. All facilities at which List I Chemicals 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 List I Chemicals 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.
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.
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 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.
a. If no storage requirements are established
for the List I Chemicals, the chemicals 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 List I Chemicals.
4. Examination of materials.
a. 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.
b. 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.
5. Returned, Damaged, and Outdated List I
Chemicals.
a. 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.
b. Any List I Chemical 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.
c. 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.
08-02-0008
-SUSPICIOUS ORDERS FOR LIST 1 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:
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.
DISTRIBUTOR (Non-Retail) REGULATED OTC 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 customers limits are on individual resales.
8. Customers who resell to non-traditional
outlets for regulated OTC 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 OTC 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 DEA. (Or having applied by the following
deadlines: 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 mal order and who don't report sales to DEA monthly. (Note
they must also be registered.)
20.
Nominal retail customers who sell above the Federal, "Retial," 24 GM individual
sale limits.
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 self volumes
in stores that have repeated thefts or other sales problems.
NOTICE
On Thursday, June 21, 2000, at 10:00 a.m., the Arkansas State Board of
Pharmacy will hold a public hearing at Arlington Hotel, Central Avenue at
Fountain Street, Hot Springs, Arkansas. The Board will consider the adoption of
the following: