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.
08-02-0006 -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area for storage of List I Chemicals that are outdated, damaged, deteriorated,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:
