07 LC 33
2100S
The House Committee on Judiciary Non-civil offers the following substitute to SB
205:
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
12
26-4-200.
This
article shall be known and may be cited as the 'Prescription Medication
Integrity Act.'
26-4-201.
As
used in this article, the term:
(1)
'Authenticate' means to affirmatively verify before any wholesale distribution
of a prescription drug occurs that each transaction listed on the pedigree has
occurred.
(2)
'Authorized distributor of record' means a distributor with whom a manufacturer
has established an ongoing relationship to distribute the manufacturer´s
prescription drugs.
(3)
'Board' means the State Board of Pharmacy.
(4)
'Broker' has the same meaning as a third party logistics provider.
(5)
'Chain pharmacy warehouse' means a physical location for prescription drugs that
acts as a central warehouse and performs intracompany sales or transfers of such
drugs to a group of chain pharmacies that have the same common ownership or
control.
(6)
'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.
(7)
'Co-licensee' means a party to a co-licensed pharmaceutical
product.
(8)
'Distribute' means to deliver a drug or device other than by administering or
dispensing.
(9)
'Drop shipment arrangement' means the physical shipment of a prescription from a
manufacturer, that manufacturer´s co-licensee, that manufacturer´s
third-party logistics provider, or that manufacturer´s authorized
distributor of record directly to a chain pharmacy 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.
(10)
'Facility' means a facility of a wholesale distributor where prescription drugs
are stored, handled, repackaged, or offered for sale.
(11)
'Manufacturer' means a person licensed or approved by the federal Food and Drug
Administration ('FDA') to engage in the manufacture of drugs or devices,
consistent with the FDA definition of 'manufacturer' under the regulations and
interpreted guidances implementing the Prescription Drug Marketing
Act.
(12)
'Manufacturer´s 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 manufacturer´s
prescription drug.
(13)
'Normal distribution channel' means a chain of custody for a prescription drug
that goes from a manufacturer of the prescription drug (or from that
manufacturer to that manufacturer´s co-licensed partner), (or from that
manufacturer to that manufacturer´s third-party logistics provider), (or
from that manufacturer to that manufacturer´s exclusive distributor) to
(directly or by drop shipment) a wholesale distributor to a pharmacy, or to
other designated persons authorized by law to dispense or administer such drug,
including but not limited to:
(A)
From a manufacturer to a wholesale drug distributor, to a chain pharmacy
warehouse, to a pharmacy affiliated with the chain pharmacy
warehouse;
(B)
From a manufacturer to a chain pharmacy warehouse, to a pharmacy affiliated with
the chain pharmacy 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 pharmacy warehouse, to a pharmacy affiliated with the
chain pharmacy 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 pharmacy to a patient or other designated persons authorized by law to
dispense or administer such drug to a patient;
(G)
From a wholesale distributor to a pharmacy or designated persons authorized by
law to dispense or administer such drug to a patient;
(H)
From a wholesale distributor to a chain pharmacy warehouse to that chain
pharmacy warehouse´s intracompany pharmacy to a patient or other designated
persons authorized by law to dispense or administer such drug to a
patient;
(I)
From a chain pharmacy warehouse to the chain pharmacy warehouse´s
intracompany pharmacy to a patient or other designated persons authorized by law
to dispense or administer such drug to a patient;
(J)
From a manufacturer to a third-party logistics provider or the
manufacturer´s exclusive distributor, to a wholesale drug distributor, to a
pharmacy;
(K)
From a manufacturer to a third-party logistics provider or the
manufacturer´s exclusive distributor, to a wholesale drug distributor, to a
chain pharmacy warehouse, to a pharmacy affiliated with the chain pharmacy
warehouse;
(L)
From a manufacturer to a third-party logistics provider or the
manufacturer´s 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;
(M)
From a manufacturer to a third-party logistics provider or the
manufacturer´s exclusive distributor, to a wholesale drug distributor, to
designated persons authorized by law to dispense or administer such drug to a
patient;
(N)
From a manufacturer to a third-party logistics provider or manufacturer´s
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 pharmacy warehouse, to its intracompany pharmacy;
(iii)
A pharmacy buying cooperative warehouse, to its member; or
(iv)
Other designated persons authorized by law to dispense or administer such
drug;
(O)
In limited situations where a documented product shortage, back order, or
emergency exists, from a manufacturer or that manufacturer´s 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 pharmacy warehouse, to its intracompany pharmacy;
(iii)
A pharmacy buying cooperative warehouse, to its member; or
(iv)
Other designated persons authorized by law to dispense or administer such
drug;
(P)
From a manufacturer directly to a prescriber, pharmacy, or hospital system to a
patient or other designated persons authorized by law to dispense or administer
such a drug to a patient; or
(Q)
As prescribed by rules adopted by the board.
(14)
'Ongoing relationship' means an association that exists when a wholesale drug
distributor, including any member of its affiliated group, as defined in Section
1504 of the Internal Revenue Code, of which the wholesale drug distributor is a
member:
(A)
Is listed on the manufacturer´s list of authorized distributors of record,
which is updated by the manufacturer on no less than a monthly basis;
and
(B)
Has a written agreement currently in effect with the manufacturer evidencing
such ongoing relationship.
(15)
'Pedigree' means a document or electronic file containing information that
records each wholesale distribution of any given prescription drug.
(16)
'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.
(17)
'Prescription drug' means any drug (including any biological product, except for
blood and blood components intended for transfusion or biological products that
are also medical devices) required by federal law (including federal regulation)
to be dispensed only by a prescription, including finished dosage forms and bulk
drug substances subject to section 503(b) of the federal Food, Drug and Cosmetic
Act ('FFDCA').
(18)
'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.
(19)
'Repackager' means a person who repackages.
(20)
'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.
(21)
'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 manufacturers´
and distributors´ warehouses and wholesale drug warehouses; independent
wholesale drug traders; and retail and hospital pharmacies and chain pharmacy
warehouses that conduct wholesale distributions. This term shall not include
manufacturers.
(22)
'Wholesale distribution' shall not include:
(A)
Intracompany sales of prescription drugs, meaning any transaction or transfer
between any division, subsidiary, parent, or affiliated or related company under
common ownership or control of a corporate entity, except that nothing contained
herein shall be construed to prohibit the board from requiring that other
records of these transactions shall be kept in accordance with law and
regulation not found in this article;
(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, except that nothing contained herein shall be
construed to prohibit the board from requiring that other records of these
transactions shall be kept in accordance with law and regulation not found in
this article;
(C)
The distribution of prescription drug samples by manufacturers´
representatives;
(D)
Prescription drug returns when conducted by a retail pharmacy or by a hospital,
health care entity, or charitable institution in accordance with 21 C.F.R.
Section 203.23, except in cases where a pedigree is already required under the
provisions of this article, in which case any return of that prescription drug
to a wholesaler or manufacturer shall be documented on the same
pedigree;
(E)
The sale of minimal quantities of prescription drugs by retail pharmacies to
licensed practitioners for office use, except that nothing contained herein
shall be construed to prohibit the board from requiring that other records of
these transactions shall be kept in accordance with law and regulation not found
in this article;
(F)
Retail pharmacies´ delivery of prescription drugs to a patient or
patient´s 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;
(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;
(I)
Drop shipments of a prescription drug to a pharmacy, pharmacy buying cooperative
warehouse, or chain pharmacy warehouse, or other person authorized by law to
dispense or administer such drug to a patient;
(J)
The delivery of, or offer to deliver, a prescription drug by a common carrier
solely in the common carrier´s usual course of business of transporting
prescription drugs, and such common carrier does not store, warehouse, or take
legal ownership of the prescription drug;
(K)
The sale or transfer from a retail pharmacy, pharmacy buying cooperative
warehouse, or chain pharmacy warehouse of expired, damaged, returned, or
recalled prescription drugs to the original manufacturer or to a third party
returns processor; or
(L)
The sale, transfer, merger, or consolidation of all or part of the business of a
pharmacy or pharmacies from or with another pharmacy or pharmacies, whether
accomplished as a purchase and sale of stock or business assets.
26-4-202.
(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 pharmacy warehouse shall comply with the requirements
of this Code section only if the retail pharmacy or chain pharmacy warehouse
engages in wholesale distribution of prescription drugs.
(3)
The board shall conduct a study to be completed no later than July 1, 2009,
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, 2011, and may be extended by the board in one year
increments if it appears the technology is not universally available across the
entire prescription pharmaceutical supply; 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. Effective at
a date established by the board, pedigrees may be implemented through an
approved and readily available system that electronically tracks and traces the
wholesale distribution of each prescription drug starting with the sale by a
manufacturer through acquisition and sale by any wholesale distributor, until
final sale to a pharmacy or other authorized person administering or dispensing
the prescription drug. This electronic tracking system will be deemed to be
readily available only upon there being available a standardized system
originating at the manufacturer and capable of being used on a wide scale across
the entire pharmaceutical supply chain which includes manufacturers, wholesale
distributors, and pharmacies. Consideration must be given to the large-scale
implementation of this technology across the supply chain and the technology
must be proven to have no negative impact on the safety and efficacy of the
pharmaceutical product.
(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 26-4-201, 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 owner´s;
(3)
Transaction dates;
(4)
Certification that each recipient, excluding retail or hospital pharmacies, 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 at its licensed location, unless given
written authorization from the board to do otherwise, for three years from the
date of sale or transfer; and
(2)
Available for inspection, copying, or use at the licensed location upon a verbal
request by the board or its designee.
(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.
26-4-203.
(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, provided a falsified 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 calendar 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.
26-4-204.
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, including, but not limited to falsified pedigrees,
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, repackaging,
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.
26-4-205.
(a)
Notwithstanding Code Section 26-4-115, any person who engages without knowledge
in the wholesale distribution of prescription drugs, including providing a
falsified pedigree or other records, in violation of this article may be fined
not more than $10,000.00.
(b)
If a person engages in wholesale distribution of prescription drugs in violation
of this article, including providing a falsified pedigree or other records, and
acts in a grossly negligent manner in violation of this article, the person may
be punished by imprisonment for not more than 15 years, fined not more than
$50,000.00, or both.
(c)
Notwithstanding Code Section 26-4-115, any person who knowingly engages in
wholesale distribution of prescription drugs in violation of this article,
including providing a falsified pedigree or other records, shall be guilty 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.