Chapter 480-7A LISTED CHEMICAL WHOLESALE DISTRIBUTOR
| (1) |
Board.
Board means the Georgia State Board of Pharmacy. |
| (2) |
Brokerage. Brokerage means
any firm or broker who arranges for the buying for resale, selling,
transferring, or otherwise arranging to distribute dangerous drugs, controlled
substances, or listed chemicals, whether or not such firm physically handles,
receives, distributes, or bills for the actual drug product. |
| (3) |
Broker. Broker means any
individual, corporation, corporation division, partnership, association, or
other entity which assists in arranging a transaction of a listed chemical by
negotiating contracts, serving as an agent or intermediary, or fulfilling a
formal obligation to complete a transaction by bringing together a buyer and
seller, a buyer and transporter, or a seller and a transporter, or by receiving
any form of compensation for so doing. |
| (4) |
DEA. DEA means the U.S.
Department of Justice Drug Enforcement Administration. |
| (5) |
Designated Representative.
Designated Representative means a person designated by a listed chemical
wholesale Distributor who will serve as the designated representative of the
listed chemical wholesale distributor with the Board and GDNA who is actively
involved in and aware of the actual daily operation of the listed chemical
wholesale distributor. |
| (6) |
Distribute or Distribution. Distribute or distribution means to sell,
offer to sell, broker, give away, transfer, whether by passage of title,
physical movement, or both; deliver or offer to deliver a listed chemical or
drug. The term does not mean to administer or dispense. |
| (7) |
Excessive. Excessive means
any sale, distribution, purchase, or transfer of a quantity of any listed
chemical by a retail store which the wholesale distributor deems or judges to
in excess of routine sales for that particular store. |
| (8) |
GBI. GBI means the Georgia
Bureau of Investigation. |
| (9) |
GDNA. GDNA means the Georgia Drugs and Narcotics Agency. |
| (10) |
Listed Chemical. Listed
Chemical means any drug or product containing a chemical defined by the Board
as a listed chemical in 480-7A-.02 and/or designated as a listed chemical by
law. |
| (11) |
Listed Chemical
Wholesale Distributor. Listed Chemical Wholesale Distributor means any
firm named under O.C.G.A. 16-13-30.3 (b.1) as a Wholesale Distributor which
sells, transfers, purchases for resale, sells for resale, or otherwise
furnishes any product containing a drug or listed chemical to a retail
outlet. |
| (12) |
Listed Chemical
Wholesale Distributor Permit. Listed Chemical Wholesale Distributor
Permit means a permit issued by the Board to a wholesale distributor to
distribute listed chemical products to retail outlets. |
| (13) |
Manufacturer. Manufacturer
means any firm which is engaged in the manufacturing, preparing, propagating,
processing, repackaging, or labeling of a dangerous drug, controlled substance,
or a listed chemical for distribution. |
| (14) |
Manufacturing Pharmacy.
Manufacturing pharmacy means a drug manufacturer who holds a manufacturing
pharmacy permit issued by the Board authorizing such firm to manufacture, but
not distribute, drugs in this state. |
| (15) |
Police Chief of a
Municipality. Police Chief of a Municipality means the Chief of Police
of a municipality located in the State of Georgia, or an officer or person
otherwise authorized by the Police Chief to act in his or her behalf in regards
to O.C.G.A. 16-13-30.3. |
| (16) |
Reportable Transaction. Reportable transaction means a report generated
regarding a transaction in which a retail store orders and receives what the
listed chemical wholesale distributor deems to be an excessive quantity of any
listed chemical products. |
| (17) |
Retail Outlet. Retail Outlet
means a grocery store, general merchandising store, drug store, or other entity
or person whose activities with listed chemicals is almost exclusively to sales
for personal use, directly to walk-in customers, in face to face transactions
by direct sales. |
| (18) |
Sheriff
of a County. Sheriff of a County means either the Sheriff of a county
located in the State of Georgia, or a deputy or person otherwise authorized by
the Sheriff to act on his or her behalf in regards to O.C.G.A.
16-13-30.3. |
| (19) |
Wholesale
Distributor. Wholesale Distributor means:
| (a) |
A firm as defined by O.C.G.A. 26-4-5(41)
and holding a wholesaler pharmacy permit issued by the Board and licensed under
O.C.G.A. 16-13-113, which authorizes a firm to distribute dangerous drugs,
controlled substances, and listed chemicals; or |
| (b) |
A firm as specified by O.C.G.A.
16-13-30.3 which is authorized to distribute certain drugs or listed chemicals
as specified by paragraph (b.1) of that statute, and has been issued a chemical
wholesale distributor permit by the Board under O.C.G.A. 16-13-30.3. |
|
| (20) |
Wholesaler Pharmacy.
Wholesaler Pharmacy means a firm holding a permit issued by the Board to
distribute drugs at wholesale, not at retail, and which permit authorizes a
firm to distribute dangerous drugs, controlled substances, and listed
chemicals. A wholesaler pharmacy is not intended to be, nor should it be
considered a retail, hospital, clinic or any other type of pharmacy which has
separate permits issued by the Board. |
Drugs or chemicals which are restricted by the Board or by law
to wholesale distribution only by a firm licensed by the Board as a listed
chemical wholesale distributor or a wholesale distributor, which are also known
as listed chemicals, are as follows:
| (1) |
Pseudoephedrine or a product containing
any quantity of this drug, except as follows:
| (a) |
Pediatric products labeled pursuant to
federal regulation as primarily intended for administration to children under
12 years of age according to label instructions; and |
| (b) |
Products that the Board, upon application
of a manufacturer, exempts because the product is formulated in such a way as
to effectively prevent the conversion of the active ingredient into
methamphetamine or its salts or precursors. |
|
Chemicals listed in 480-71-.02 may only be distributed to
retail outlets by a listed chemical drug wholesale distributor licensed by the
Board, or a wholesale distributor licensed by the Board. In order for any
person or firm to conduct an act of brokerage for any dangerous drug,
controlled substance, or listed chemical which is received by retail outlet or
pharmacy in this state, regardless of where the shipment originates, such
person or firm is required to be licensed as a wholesale distributor or a
listed chemical wholesale distributor. Any manufacturer which distributes a
drug to any wholesale distributor or listed chemical wholesale distributor
located in the State of Georgia must have been issued the appropriate wholesale
distributor permit from the Board. Having been issued a manufacturing pharmacy
permit by the Board does not authorize a manufacturing firm to distribute drugs
to any firm located in this state.
| (1) |
Listed chemical
wholesale distributors that provide services within this State, whether the
listed chemical wholesale distributor is located within this State or outside
this State, shall be licensed by the Board and shall biennially renew their
permit or license with the Board using an application provided by the
Board. |
| (2) |
Where listed chemical
wholesale distribution operations are conducted at more than one location, each
such location shall be licensed by the Board. |
| (3) |
A person or firm holding a valid permit
issued by the Board and licensed as a wholesale distributor under Code Section
26-4-113 shall not be required to
obtain an additional license under this Code section; Wholesale distributors
licensed under Code Section
26-4-113 shall be subject to the
provisions of this Code section in the same manner as chemical wholesale
distributors licensed under this Code section. |
| (4) |
Licenses become null and void upon the
sale, transfer or change of mode of operation or location of the
business. |
| (5) |
The Board requires
the following and such additional information as found on an approved Board
application from each listed chemical wholesale distributor as part of the
initial licensing procedure and as part of any biennial renewal of such
license:
| (a) |
The name, trade or business
name, full business address, and telephone number of the applicant. Trade or
business names cannot be identical to that of another Board licensee. |
| (b) |
The type of ownership or operations
(i.e., partnership, corporation, or sole proprietorship). |
| (c) |
Name(s) of the owner and operator of the
licensee (if not the same person), including:
| (i) |
If a person: the name, address, and
social security number; |
| (ii) |
If a
partnership: the name, address, and social security number of each partner, and
the name of the partnership and federal employer identification
number; |
| (iii) |
If a corporation: the
name, address, social security number, and title of each corporate officer and
director, the corporate names, the name of the State of incorporation, federal
employer identification number, and the name of the parent company, if any; the
name, address, and social security number of each shareholder owning ten
percent (10%) or more of the voting stock of the corporation, including
over-the-counter stock, unless the stock is traded on a major stock exchange
and not over-the-counter; |
| (iv) |
If a
sole proprietorship: the full name, address, and social security number of the
sole proprietor, and the name and federal employer identification number of the
business entity; |
| (v) |
If a limited
liability company, the name of each member, the name of each manager, the name
of the limited liability company and federal employer identification number,
and the name of the state in which the limited liability company was organized;
and |
| (vi) |
Any other relevant
information that the Board requires. |
|
| (d) |
Name(s), address(es), telephone
number(s), date(s) of birth of a person(s) to serve as the designated
representative(s) for listed chemicals and additional information as
required. |
| (e) |
A non-refundable
application and/or renewal fee as determined by the Board and set forth in the
fee schedule. |
|
| (6) |
By
submitting an application for licensure as a listed chemical wholesale
distributor, said applicant consents to a criminal background check of the
applicant, all personnel involved in the operations of the listed chemical
wholesale distributor, all shareholders involved in operations, and anyone
owning or being involved in operations to determine if an applicant or others
associated with the ownership, management, or operations of the listed chemical
wholesale distributor has committed criminal acts that would constitute grounds
for denial of licensure. The background check will be conducted in compliance
with any applicable state laws, at the applicant's expense, and will be
sufficient to include all states of residence since the person has been an
adult. |
| (7) |
Each facility which
engages in listed chemical wholesale distribution must undergo an inspection on
behalf of the Board by an agent with the GDNA for the purpose of inspecting the
in-state listed chemical wholesale distribution operations prior to initial
licensure and periodically thereafter in accordance with a schedule to be
determined by the Board but no less than once every three (3) years. |
| (8) |
Each facility which is located outside
the State and engages in listed chemical wholesale distribution must undergo a
background investigation by GDNA on behalf of the Board and be approved by the
GDNA prior to being approved for licensure, and as necessary submit to an
inspection by either GDNA or an agent contracted with by GDNA. |
| (1) |
An application
for a license or permit provided for in this chapter may be denied by the Board
for reasons including, but not limited to:
| (a) |
Furnishing false or fraudulent material information in any application filed
under this rule or Chapter 13 of Title 16; |
| (b) |
Being convicted of a crime under any
state or federal law; |
| (c) |
Having
his or her federal registration suspended or revoked to manufacture,
distribute, or dispense controlled substances or listed chemicals; |
| (d) |
Violating the provisions of Chapter 4 of
Title 26 or Chapter 13 of Title 16; |
| (e) |
Being located in a place of
residence; |
| (f) |
Failing to maintain
effective controls against the diversion of products containing listed
chemicals to unauthorized persons or entities; and/or |
| (g) |
Any other factors or qualifications
provided by law or that the Board considers relevant to and consistent with the
public health and safety. |
|
| (1) |
Listed chemical wholesale distributors
and other wholesale distributors shall, at a minimum, maintain records
regarding the distribution of listed chemicals as follows:
| (a) |
Produce and maintain, for a minimum of
three years from the date of the transaction, inventories and records of all
transactions regarding the receipt, sale, credit, transfer, disposition, and
distribution of all listed chemicals to any firm, person, or retail outlet
located in this State. Inventories and records shall be made available for
inspection and photocopying by any authorized agent of any State or federal
agency for a period of three (3) years following their creation date. |
| (b) |
Records described in this section 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 an authorized
official of any State and federal governmental agency charged with enforcement
of these rules. |
| (c) |
Maintain an up
to date list of firms, persons or retail outlets with whom they do business in
regards to listed chemicals. |
|
| (2) |
Listed chemical wholesale distributors
and other wholesale distributors shall, at a minimum, maintain and provide
documents and reports regarding the distribution of listed chemicals as
follows:
| (a) |
Supply a copy of their Board
issued permit to any firm, person, or retail outlet in this state which has
received, purchased, or gained access to any product containing a listed
chemical. |
| (b) |
Supply each firm,
person, or retail outlet with a copy of all records involving sales, credits,
transfers or the like whenever such transaction involves a product containing a
listed chemical. |
| (c) |
Report to GDNA
of shortages or losses of listed chemicals within seven (7) business
days. |
| (d) |
Within seven days, notify
the GDNA of any purchases of a product containing a listed chemical from the
listed chemical wholesale distributor which the wholesaler judges to be
excessive, or have knowledge or suspicion of said purchases being used in the
unlawful manufacture of a controlled substance or file with the GDNA any
reportable transaction. A reportable transaction should be sent to the
attention of the Director of the GDNA. Such reports should be sent to GDNA
located at 40 Pryor Street, SW - Suite 2000 in Atlanta, Georgia
30303. |
| (e) |
Upon verbal or written
request from the GDNA, the GBI, or the sheriff of a county or the police chief
of a municipality located in this state, submit reports to account for the
transactions of any listed chemicals with persons or firms located within this
state; such transactions shall include all sales, distribution, or transactions
dealing with products containing a listed chemical; All such records shall be
submitted by the distributor within two working days. |
|
| (3) |
Any and all retail outlets or persons
receiving a listed chemical product from a licensed listed chemical wholesale
distributor, licensed by this State, are required to maintain records of all
such transactions for a minimum of three years, and upon request, by law
enforcement officials, are required to provide such records for review within
five business days, with failure to provide such records accounting for the
presence of such products shall result in the embargo or seizure of such
products. |
| (4) |
Changes in any
information required on the initial application shall be submitted to the Board
no less than 30 days prior to such change. |
The following are required for the shipping, transporting,
storage and handling of listed chemicals, and for the establishment and
maintenance of listed chemical wholesale distribution records by listed
chemical wholesale distributors and other wholesale distributors and their
officers, agents, representatives, and employees:
| (1) |
All facilities at which listed chemicals
are received, stored, warehoused, handled, held, offered, marketed, displayed,
or transported from shall:
| (a) |
Be of suitable
construction to ensure that all listed chemicals in the facilities are
maintained in accordance with official compendium standards, such as
USP/NF; |
| (b) |
Be of suitable size and
construction to facilitate cleaning, maintenance, and proper listed chemical
wholesale distribution operations; |
| (c) |
Have adequate storage areas to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions; |
| (d) |
Have a quarantine area for storage of
listed chemicals that are outdated, damaged, deteriorated, misbranded,
adulterated, otherwise unfit for distribution, or that are in immediate or
sealed secondary containers that have been opened; |
| (e) |
Be maintained in a clean and orderly
condition; and |
| (f) |
Be free from
infestation of any kind. |
| (g) |
Shall
be a commercial location and not a personal dwelling or residence. |
| (h) |
Shall be duly registered with the DEA and
in compliance with all applicable laws and rules for the storage, distribution,
shipping, handling, and transporting of listed chemicals. |
|
| (1) |
All facilities
used for listed chemical wholesale distribution shall be secure from
unauthorized entry:
| (a) |
Access from outside
the premises shall be kept to a minimum and be well-controlled; |
| (b) |
The outside perimeter of the premises
shall be well-lighted; |
| (c) |
Entry
into areas where listed 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. |
| (4) |
All facilities shall be equipped with
inventory management and control systems that protect against and detect and
document any instances of theft, diversion, or counterfeiting. |
| (5) |
Listed chemical wholesale distributors
should possess and maintain in good working order technology and equipment that
allows the listed chemical wholesale distributor to authenticate, track, and
trace listed chemicals. The technology and equipment shall satisfy any
standards set by the Board for such technology and equipment. The technology
and equipment shall be used, as required by the Board, to conduct "for cause"
and random tracking, tracing, and authentication of listed chemicals. |
| (6) |
Listed chemical wholesale distributors
shall employ, train, and document the training of personnel in the proper use
of such technology and equipment. |
| (7) |
All facilities shall be equipped with
security systems to protect the integrity and confidentiality of data and
documents and make such data and documents readily available to the Board and
other state and federal law enforcement officials. |
All listed chemicals shall be stored at appropriate
temperatures and under appropriate conditions in accordance with requirements,
if any, in the labeling of such listed chemicals, or with requirements in the
current edition of an official compendium such as the USP/NF.
| (1) |
If no storage requirements are
established for a listed chemical, the listed chemical may be held at
"controlled" room temperature, as defined in an official compendium such as
USP/NF, 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, and/or logs shall be utilized to document proper storage of listed
chemicals. |
| (3) |
Packaging of the
listed chemicals should be in accordance with an official compendium such as
USP/NF and identify any compromise in the integrity of the listed chemicals due
to tampering or adverse storage conditions. |
| (4) |
The record-keeping requirements in
480-7A-.06 shall be followed for the listed chemical wholesale distribution of
all listed chemicals. |
| (1) |
Any drug or device that is outdated,
damaged, deteriorated, misbranded, adulterated, or otherwise deemed unfit for
human consumption shall be quarantined and physically separated from other
listed chemicals until they are returned to either the manufacturer or
wholesale distributor from which it was acquired or destroyed.
| (a) |
When listed chemicals are adulterated, or
misbranded, notice of the adulteration, or misbranding shall be provided to the
Board and manufacturer or wholesale distributor from which it was acquired
within three (3) business days. |
| (b) |
Any listed chemical returned to a manufacturer or wholesale distributor shall
be kept under proper conditions for storage, handling, and shipping,
transporting, and documentation showing that proper conditions were maintained
is provided to the manufacturer or wholesale distributor to which the drugs are
returned. |
|
| (2) |
Any listed
chemical whose immediate or sealed outer or secondary containers or labeling
are adulterated or misbranded shall be quarantined and physically separated
from other listed chemicals until they are returned to either the manufacturer
or wholesale distributor from which it was acquired or destroyed.
| (a) |
When the immediate or sealed outer or
secondary containers or Labeling of any listed chemical are adulterated or
misbranded notice of the adulteration or misbranding shall be provided to the
Board and manufacturer or wholesale distributor from which it was acquired
within three (3) business days. |
|
| (3) |
Any listed chemical that has been opened,
outdated, or used, shall be identified as such, and shall be quarantined and
physically separated from other drugs or devices until they are returned to the
manufacturer or wholesale Distributor from which acquired or destroyed via
distribution to a reverse distributor. |
| (4) |
The record-keeping requirements in
480-7A-.06 of this rule shall be followed for all outdated, damaged,
deteriorated, misbranded, or adulterated listed chemicals, as provided by law,
and such action shall be consistent with relating the drugs. |
A license issued to a listed chemical wholesale distributor
pursuant to this part may be subject to revocation, fines, suspension, or
otherwise disciplined as provided by law, for reasons, including but not
limited to the following:
| (1) |
The
permit or license holder being convicted or being arrested, charged and
sentenced for violations of Federal, State, or local laws and/or regulations
relating the drugs. |
| (2) |
Violating
any of the provisions of any applicable Board laws or rules. |
| (3) |
If any owner, officer, designated
representative, or other significant person employed by the permit holder has:
| (a) |
Furnished false or fraudulent material
information in any application filed under this Code section; |
| (b) |
Been convicted of a crime under any state
or federal law; |
| (c) |
Had his or her
federal registration suspended or revoked to manufacture, distribute, or
dispense controlled substances or listed chemicals; |
| (d) |
Violated the provisions of Chapter 4 of
Title 26 or Chapter 13 of Title 16; |
| (e) |
Failed to maintain effective controls
against the diversion of listed chemical products to unauthorized persons or
entities. |
| (f) |
Failed to comply with
the reporting requirements of this chapter; or |
| (g) |
Made a false statement in a report or
record required by this chapter or State law. |
|
| (4) |
The adulteration or misbranding of any
listed chemical; |
| (5) |
The receipt of
any listed chemical that is adulterated, misbranded, stolen, obtained by fraud
or deceit, or the delivery or proffered delivery of such chemical for
distribution. |
| (6) |
The alteration,
mutilation, destruction, forging, obliteration, or removal of the whole or any
part of the labeling of a listed chemical or the commission of any other act
with respect to a listed chemical that results in the listed chemical being
misbranded; |
| (7) |
Failing to maintain
records to verify the sale, transfer, or distribution of any and all chemical
products to a firm, person or retail outlet in this State. |
| (8) |
Failing to maintain or provide records or
submit to an inspection as required by any Rule or laws of this
State; |
| (9) |
Providing the Board or
any of its representatives or any state or federal official with false or
fraudulent records or making false or fraudulent statements regarding any
matter within the provisions of any rule or law of this State. |
| (10) |
Failing to obtain a license or operating
without a valid permit or license when a permit or license is
required; |
| (11) |
Obtaining or
attempting to obtain a listed chemical by fraud, deceit, misrepresentation or
engaging in misrepresentation or fraud in the distribution of a listed
chemical; |
| (12) |
Failing to report
any violations of the rules or law regarding listed chemicals. |
Notwithstanding any other provision of this chapter, no person
shall be required to obtain a license or permit for the sale, receipt,
transfer, or possession of a listed chemical product when:
| (a) |
Such lawful distribution takes place in
the usual course of business between agents or employees of a single regulated
person or entity; or |
| (b) |
A listed
chemical product is delivered to or by a common or contract carrier for
carriage in the lawful and usual course of the business of the common or
contract carrier or to or by a warehouseman for storage in the lawful and usual
course of the business of the warehouseman. |
