06 LC 33
1538S
The
Senate Health and Human Services Committee offered the following substitute to
HB 907:
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating
to pharmacists and pharmacies, so as to enact the "Prescription Medication
Integrity Act"; to provide for a short title; to provide for definitions; to
provide for pedigrees for prescription drugs; to provide for contingent
effectiveness; to provide for enforcement; to provide for prohibited acts; to
provide for penalties; to provide for related matters; to repeal conflicting
laws; and for other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Chapter
4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists
and pharmacies, is amended by inserting a new article at the end of such chapter
to read as follows:
"ARTICLE
11
26-4-190.
This
article shall be known and may be cited as the 'Prescription Medication
Integrity Act.'
26-4-191.
As
used in this article, the term:
(1)
'Authorized distributor of record' means a distributor with whom a manufacturer
has established an ongoing relationship to distribute the
manufactureŕs
products.
(2)
'Board' means the State Board of Pharmacy.
(3)
'Chain drug warehouse' means a physical location for prescription drugs,
devices, or both that acts as a central warehouse and performs intracompany
sales or transfers of the prescription drugs, devices, or both to a group of
chain pharmacies that have the same common ownership and control.
(4)
'Co-licensed pharmaceutical products' means pharmaceutical
products:
(A)
That have been approved by the federal Food and Drug Administration;
and
(B)
Concerning which two or more parties have the right to engage in a business
activity or occupation concerning the pharmaceutical products.
(5)
'Co-licensee' means a party to a co-licensed pharmaceutical
product.
(6)
'Drop shipment arrangement' means the physical shipment of a prescription from a
manufacturer, that
manufactureŕs
third-party logistics provider, or that
manufactureŕs
authorized distributor of record directly to a chain drug warehouse, pharmacy
buying cooperative warehouse, pharmacy, or other persons authorized under law
to dispense or administer prescription drugs but wherein the sale and title for
the prescription drug passes between a wholesale drug distributor and the party
that directly receives the prescription drug.
(7) 'Facility'
means a facility of a wholesale distributor where prescription drugs are stored,
handled, repackaged, or offered for sale.
(8)
'Manufactureŕs
exclusive distributor' means an entity that contracts with a manufacturer to
provide or coordinate warehousing, distribution, or other services for a
manufacturer and takes title to that
manufactureŕs
prescription drug.
(9)
'Normal distribution channel' means a chain of custody for a prescription drug
that goes from a manufacturer to a wholesale distributor to a pharmacy including
but not limited to:
(A)
From a manufacturer to a wholesale drug distributor, to a chain drug warehouse,
to a pharmacy affiliated with the chain drug warehouse;
(B)
From a manufacturer to a chain drug warehouse, to a pharmacy affiliated with the
chain drug warehouse;
(C)
From a manufacturer to a third-party logistics provider, to a wholesale drug
distributor, to a pharmacy;
(D)
From a manufacturer to a third-party logistics provider, to a wholesale drug
distributor, to a chain drug warehouse, to a pharmacy affiliated with the chain
drug warehouse;
(E)
From a manufacturer to a wholesale drug distributor, to a pharmacy buying
cooperative warehouse, to a pharmacy that is a member owner of the buying
cooperative operating the warehouse;
(F)
From a manufacturer to a third-party logistics provider or the
manufactureŕs
exclusive distributor, to a wholesale drug distributor, to a
pharmacy;
(G)
From a manufacturer to a third-party logistics provider or the
manufactureŕs
exclusive distributor, to a wholesale drug distributor, to a chain drug
warehouse, to a pharmacy affiliated with the chain drug warehouse;
(H)
From a manufacturer to a third-party logistics provider or the
manufactureŕs
exclusive distributor, to a wholesale drug distributor, to a pharmacy buying
cooperative warehouse, to a pharmacy that is a member owner of the buying
cooperative operating the warehouse;
(I)
From a manufacturer to a third-party logistics provider or
manufactureŕs
authorized distributor of record, to a wholesale drug distributor, to one of the
following wherein the prescription drug is delivered directly by way of a drop
shipment arrangement:
(i)
A pharmacy;
(ii)
A chain drug warehouse, to its intracompany pharmacy; or
(iii)
A pharmacy buying cooperative warehouse, to its member;
(J)
In limited situations where a documented product shortage, back order, or
emergency exists, from a manufacturer or that
manufactureŕs
third-party logistics provider or sole authorized distributor of record to an
authorized distributor of record, to one other authorized distributor of record,
to:
(i)
A pharmacy;
(ii)
A chain drug warehouse, to its intracompany pharmacy; or
(iii)
A pharmacy buying cooperative warehouse, to its member; or
(K)
As prescribed by rules adopted by the board.
(10)
'Ongoing relationship' means an association that exists when a wholesale drug
distributor, including any affiliated group, as defined in Section 1504 of the
Internal Revenue Code, of which the wholesale drug distributor is a member (i)
is listed on the
manufactureŕs
list and the list is updated monthly; or (ii) has a written agreement currently
in effect with the manufacturer.
(11)
'Pedigree' means a document or electronic file containing information that
records each transaction of a prescription drug from sale by a pharmaceutical
manufacturer, to acquisition and sale by any wholesale distributor or
repackager, to final sale to a pharmacy or other person dispensing or
administering the prescription drug.
(12)
'Pharmacy buying cooperative warehouse' means a permanent physical location that
acts as a central warehouse for drugs and from which sales of drugs are made to
a group of pharmacies that are member owners of the buying cooperative operating
the warehouse. Pharmacy buying cooperative warehouses must be licensed as
wholesale distributors.
(13)
'Prescription drug' means a drug which, under federal law, is required, prior to
being dispensed or delivered, to be labeled with either of the following
statements: 'Caution: federal law prohibits dispensing without prescription' or
'Caution: federal law restricts this drug to use by, or on the order of, a
licensed veterinarian'; or a drug which is required by any applicable federal or
state law or rule to be dispensed pursuant only to a prescription drug order or
is restricted to use by practitioners only; or a controlled substance as defined
in paragraph (6) of Code Section 26-4-5 or a dangerous drug as defined in
paragraph (7) of Code Section 26-4-5.
(14)
'Repackage' means repackaging or otherwise changing the container, wrapper, or
labeling to further the distribution of a prescription drug; provided, however,
that this shall not apply to pharmacists in the dispensing of prescription drugs
to the patient.
(15)
'Repackager' means a person who repackages.
(16)
'Third-party logistics provider' means an entity that provides or coordinates
warehousing, distribution, or other services on behalf of a manufacturer but
does not take title to a drug or have general responsibility to direct the sale
or other disposition of the drug.
(17)
'Wholesale distributor' means any person engaged in wholesale distribution of
drugs, including but not limited to repackagers; own label distributors; private
label distributors; jobbers; brokers; warehouses, including
manufacturerś
and
distributorś
warehouses and wholesale drug warehouses; independent wholesale drug traders;
and retail and hospital pharmacies and chain drug warehouses that conduct
wholesale distributions. This term shall not include manufacturers.
(18)
'Wholesale distribution' shall not include:
(A)
Intracompany sales of prescription drugs by a chain drug warehouse, meaning any
transaction or transfer between any division, subsidiary, parent, or affiliated
or related company under common ownership and control of a corporate entity;
(B)
The sale, purchase, distribution, trade, or transfer of a prescription drug or
offer to sell, purchase, distribute, trade, or transfer a prescription drug for
emergency medical reasons including transfers of a prescription drug from retail
pharmacy to retail pharmacy;
(C)
The distribution of prescription drug samples by
manufacturerś
representatives;
(D)
Prescription drug returns when conducted by a hospital, health care entity,
retail pharmacy, or charitable institution in accordance with 21 C.F.R. Section
203.23;
(E)
The sale of minimal quantities of prescription drugs by retail pharmacies to
licensed practitioners for office use;
(F)
Retail
pharmacieś
delivery of prescription drugs to a patient or
patient́s
agent pursuant to the lawful order of a licensed practitioner;
(G)
The distribution of prescription drugs by third-party logistics providers
working under contract of a prescription drug manufacturer; or
(H)(i)
The distribution by a manufacturer of the finished form of a prescription drug
it manufactures; or
(ii)
The distribution by a co-licensee of the finished form of a prescription drug if
that co-licensee distributes that drug as a co-licensed product.
26-4-192.
(a)(1)
Each person who is engaged in wholesale distribution of prescription drugs shall
establish and maintain inventories and records of all transactions regarding the
receipt and distribution or other disposition of the prescription drugs. These
records shall include pedigrees for all prescription drugs which are not
distributed through the normal distribution channel in accordance with rules and
regulations adopted by the board.
(2)
A retail pharmacy or chain drug warehouse shall comply with the requirements of
this Code section only if the retail pharmacy or chain drug warehouse engages in
wholesale distribution of prescription drugs.
(3)
The board shall conduct a study to be completed no later than January 1, 2007,
which shall include consultation with manufacturers, distributors, and
pharmacies responsible for the sale and distribution of prescription drug
products in this state. Based on the results of the study, the board shall
establish a mandated implementation date for electronic pedigrees which shall be
no sooner than December 31, 2007; provided, however, that no provision of this
article shall be effective until such time as the General Assembly appropriates
reasonable funds for administration of this article.
(b)
Each person in possession of a pedigree for a prescription drug who is engaged
in the wholesale distribution of a prescription drug, including repackagers but
excluding the original manufacturer of the finished form of the prescription
drug and any entity engaged in the activities listed in paragraph (9) of Code
Section 26-4-191, and who attempts to further distribute that prescription drug
shall affirmatively verify before any distribution of a prescription drug occurs
that each transaction listed on the pedigree has occurred.
(c)
The pedigree shall include all necessary identifying information concerning each
sale in the chain of distribution of the product from the manufacturer, to
acquisition and sale by any wholesale distributor or repackager, and to final
sale to a pharmacy or other person dispensing or administering the prescription
drug. At a minimum, the pedigree shall include:
(1)
The name, address, telephone number, and, if available, e-mail address of each
owner of the prescription drug and each wholesale distributor of the
prescription drug;
(2)
The name and address of each location from which the prescription drug was
shipped, if different from the
owneŕs;
(3)
Transaction dates;
(4)
Certification that each recipient has authenticated the pedigree;
(5)
The name of the prescription drug;
(6)
Dosage form and strength of the prescription drug;
(7)
Size of the container;
(8)
Number of containers;
(9)
Lot number of the prescription drug; and
(10)
The name of the manufacturer of the finished dosage form.
(d)
Each pedigree shall be:
(1)
Maintained by the wholesale distributor for three years from the date of sale or
transfer; and
(2)
Available for inspection or use upon a request by the board.
(e)
The board shall adopt rules and regulations, including a standard form, relating
to the requirements of this article no later than 90 days after the effective
date of this article.
(f)
Pharmacies licensed pursuant to this chapter shall not be required to possess or
maintain any pedigree issued pursuant to this Code section.
26-4-193.
(a)
If the board finds that there is a reasonable probability that:
(1)
A wholesale distributor, other than a manufacturer, has:
(A)
Violated a provision of this article; or
(B)
Falsified a pedigree, or sold, distributed, transferred, manufactured,
repackaged, handled, or held a counterfeit prescription drug intended for human
use;
(2)
The prescription drug at issue in subparagraph (B) of paragraph (1) of this
subsection could cause serious, adverse health consequences or death; and
(3)
Other procedures would result in unreasonable delay,
the
board shall issue an order requiring the appropriate person including the
distributors or retailers of the prescription drug to immediately cease
distribution of the prescription drug in or to this state.
(b)
An order under subsection (a) of this Code section shall provide the person
subject to the order with an opportunity for an informal hearing, to be held not
later than ten days after the date of the issuance of the order, on the actions
required by the order. If, after such a hearing, the board determines that
inadequate grounds exist to support the actions required by the order, the board
shall vacate the order.
26-4-194.
It
shall be unlawful for a person to perform or cause the performance of or aid and
abet any of the following acts in this state:
(1)
Selling, distributing, or transferring a prescription drug to a person that is
not authorized to receive the prescription drug under the law of the
jurisdiction in which the person receives the prescription drug;
(2)
Failing to maintain or provide pedigrees as required by the board;
(3)
Failing to obtain, transfer, or authenticate a pedigree as required by the
board;
(4)
Providing the board or any of its representatives or any federal official with
false or fraudulent records or making false or fraudulent statements regarding
any matter within the provisions of this article;
(5)
Obtaining or attempting to obtain a prescription drug by fraud, deceit, or
misrepresentation or engaging in misrepresentation or fraud in the distribution
of a prescription drug; and
(6)
Except for the wholesale distribution by manufacturers of a prescription drug
that has been delivered into commerce pursuant to an application approved under
federal law by the Food and Drug Administration, the manufacturing, repacking,
selling, transferring, delivering, holding, or offering for sale of any
prescription drug that is adulterated, misbranded, counterfeit, suspected of
being counterfeit, or has otherwise been rendered unfit for
distribution.
26-4-195.
(a)
Notwithstanding Code Section 26-4-115, any person who engages in the wholesale
distribution of prescription drugs in violation of this article shall be guilty
of a felony and, upon conviction thereof, shall be punished by imprisonment for
not more than 15 years, by fine not to exceed $50,000.00, or both.
(b)
Notwithstanding Code Section 26-4-115, any person who knowingly engages in
wholesale distribution of prescription drugs in violation of this article shall
be gulity of a felony and, upon conviction thereof, shall be punished by
imprisonment for not more than 25 years, by fine not to exceed $500,000.00, or
both."
SECTION
2.
All
laws and parts of laws in conflict with this Act are repealed.