An Act To Ensure the Health and Safety of All Maine Citizens by Licensing Drug Wholesalers
Maine Legislature, Session 122, LD 1167
Committee: Business, Research and Economic Development
Sponsors: MARRACHE, DUDLEY, LERMAN, PERRY, SMITH, COWGER

Legislative Document 
No. 1167 
H.P.81O 
House of Representatives, March 8, 2005 
An Act To Ensure the Health and Safety of All Maine Citizens by 
Licensing Drug Wholesalers 
Reference to the Committee on Business, Research and Economic Development suggested 
and ordered printed. 
Presented by Representative MARRACHE of Waterville. 
1J1~ 
'1h·711D£~ 
MILLICENT M. MacFARLAND 
Clerk 
Cosponsored by Representati ves: DUCHESNE of Hudson, DUDLEY of Portland, LERMAN 
of Augusta, PERRY of Calais, SMITH of Van Buren, Senator: COWGER of Kennebec. 
Printed on recycled paper 
Be it enacted by the People of the State of Maine as follows: 
Sec. I. 32 MRSA c.lI7, sub-c. 13 is enacted to read: 
SUBCHAPTER 13 
WHOLESALE LICENSURE AND PRESCRIPTION 
MEDICATION INTEGRITY ACT 
§13841. 
Short title 
This subchapter may be known and cited as "the Wholesale 
Licensure and Prescription Medication Integrity Act. " 
§13842. 
Definitions 
As 
used in this subchapter, 
unless the context otherwise 
indicates, the following terms have the following meanings. 
1. 
Authenticate. 
"Authenticate" 
means 
to 
affirmatively 
verify before distribution of 
a 
prescription drug that each 
transaction listed on the pedigree has occurred. 
2. Facility. 
"Facility" means 
a facility of a wholesale 
drug distributor where prescription drugs are stored, handled, 
repackaged or offered for sale. 
3. Normal distribution chain. 
"Normal distribution chain" 
means a chain of custody for a prescription drug that goes from a 
manufacturer to a wholesaler to a pharmacy to a consumer. 
4. Pedigree. 
"Pedigree" means a document or electronic file 
containing 
information 
that 
records 
each 
distribution 
of 
a 
prescription 
drug, 
from 
sale 
by 
a 
manufacturer 
through 
acquisition 
and 
sale 
by 
a 
drug 
wholesaler, 
distributor 
or 
repackager 
until 
final 
sale 
to 
a 
pharmacy 
or 
other 
person 
dispensing or administering the prescription drug. 
5. Prescription drug. 
"Prescription drug" means 
a 
drug, 
including 
a 
biological 
product, 
required 
by 
federal 
law 
or 
regulation to be dispensed by a prescription, including finished 
dosage forms 
and bulk drug substances subject to the Federal 
Food, 
Drug and Cosmetic Act, 
United States Code, 
Section 
(b). 
"Prescription drug" 
does not include blood or blood 
components intended for transfusion or biological products that 
are medical devices. 
R 
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In 
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6. Repackage. 
"Repackage" means to change the container , 
wrapper 
or 
labeling of 
a 
prescription 
distribution of the prescription drug. 
drug 
to 
further 
the 
1. Repackager. 
"Repackager" means a person who repackages. 
8. Wholesale distrib]ltor. 
"Wholesale distributor" means a 
person engaged in the wholesale distribution of prescription 
drugs, including but not limited to a manufacturer. repackager, 
own label distributor, private label distributor, jobber, broker, 
warehouse, independent wholesale drug trader and retail pharmacy, 
that conducts wholesale distribution of prescription drugs. 
§13843. 
Wholesale distributor licensing 
1. Licensing. 
A wholesale distributor must be licensed by 
the board to engage in the wholesale distribution of prescription 
drugs in the State. 
If a wholesale distributor has its principal 
place of business in another state, the wholesale distributor 
must be also licensed to distribute prescription drugs in that 
state. 
A separate license must be 
obtained by 
a 
wholesale 
distributor 
for 
each facility in 
the 
State 
from 
which 
the 
wholesale distributor distributes prescription drugs. 
2. Minimum ip.fo:qnation. 
Upon application for an original 
license or renewal of a license under this section, a wholesale 
distributor shall provide to the board under oath the following 
information: 
A. 
The name, full business address and telephone number of 
the applicant; 
B. 
All trade and business names used by the applicant; 
c. 
The 
name, 
address and telephone number of a 
contact 
person for every facility used by the applicant for the 
storage, handling and distribution of prescription drugs; 
D. 
The 
form 
of 
organization 
of 
the 
business 
of 
the 
applicant. 
such 
as 
sole 
proprietorship, 
partnership 
or 
corporation; 
E. 
The name of every person who has an ownership interest 
or operates the business of the applicant, including: 
(1) 
If a sole proprietorship, the full name of the 
sole proprietor and name of the business entity; 
(2) 
If a partnership, the name of the partnership as 
well as the name of every partner; or 
(3) 
If a 
corporation, 
the 
name 
and title of each 
corporate officer and director, all corporate names and 
the state of incorporation; 
F, 
A list of all licenses 
and permits 
issued to 
the 
applicant by any other sta~e that authorize the applicant to 
purchase or possess prescription drugs; 
G, 
The name of the manageI' and the next 4 highest ranking 
employees 
responsible 
foI' 
prescription 
drug 
wholesale 
operations 
of 
the 
facility 
for 
which 
the 
applicant is 
applying for a license or renewal under this section; 
H, 
The ngme Qf 
th!;! 
appli~ant ' ~ 
Q!;!~ignateQ 
r!;!pr!;!~entative 
fQr the 
fa~ility fQr which the 
appli~ant i~ applying for a 
license Qr 
r~mewal unQgr thi~ ~!;!~tionj anQ 
I, 
A sgt 
of 
fingerprints 
and 
a 
personal 
information 
statement for every person listeQ unQer paragraphs G and H 
incluQing: 
(1) 
Evgry place of resiQ!;!nce for th!;! person for the 
prgvious 7 ygarSj 
(2) 
Th!;! person's date anQ plac!;! Qf birth; 
(3) 
Evgry occupation, position of emplQyment or office 
hglQ for thg previous 7 years; 
(4) 
Thg 
principal 
business 
and 
aQQress 
of 
every 
organization in which thg pgrson hglQ a PQsition of 
employmgnt or office unQgr subparagraph 3; 
(5) 
Whether in th!;! previQus 
y!;!ars the person has 
bgen subjgct to a procegQing for the rgvocation of a 
licgnse anQ for every prQc!;!gQing listgd the nature and 
disposition of the proceeding; 
(6) 
Whether in thg previQus 
years the person has 
bgen tempQrarily or permanently enjoined by a court of 
CQmpgtgnt jurisQictiQn frQm violating statg Qr fgderal 
law rggulating the possession, control or distribution 
of 
prgscription 
Qrugs 
and 
the 
dgtails 
fQr 
!;!very 
injunctiQn listgQ; 
(7) 
A QescripUon of the 
invo-"'l...Lv-"'!;!=m'-"'e'-"n,-'t'----"o-=f'---"'-t=h~rson 
with gygry business or iuvestmgnt that manufactured, 
aCiministgrgQ, 
prgscribgQ, 
distributgd 
or 
storgd 
... 
pharmaceutical products, except for the ownership of 
stock in a publicly traded company or mutual fund: 
(8) 
Every lawsu:i, t 
in which a business or investment 
listed in subparagraph 7 was named as a party: 
(9) 
A description of every felony of which the person 
as 
an 
adult 
was 
convicted, 
regardless 
of 
whether 
adjudication of g1Jilt was withheld or the person pled 
guilty nolo contendere. 
If a conviction listed under 
this subparagraph is under 
~al, then the applicant 
must attach a copy of the notice of appeal for that 
conviction: and 
~lQ) 
A photog£2Ph of 
the person taken within the 
previous 30 days. 
If a 
change in the infoJ'-.mation required under this subsection 
occurs, the applicant shall provide the board with the updated 
information within the time required by the board by rule. 
3. Designated reRrQ~~~~~tiy~q~~lificatiQns. 
The board may 
not issue or renew a wholesale distributor license under this 
section 
unless 
the 
board 
determines 
that 
the 
designated 
representative 
under 
subsection 
2, 
paragraph 
H 
meets 
the 
following qualifications: 
.16 
A. 
Is at least 21 years of age: 
B. 
Has been employed full time for at least 3 years in a 
pharmacy or with 
a 
wholesale distributor in a 
capacity 
related to the dispensing, distribution or record keeping of 
l2-Lescri.P..t-ion drug~ 
C. 
Has received a score of 75% or higher on an examination 
given 
by 
the 
board 
regarding 
state 
and 
federal 
laws 
governin9-the wholesale distribution of prescription dru~ 
A 
designated 
representative 
must 
take 
the 
examination 
required in this paragraph for every application for license 
or 
renewal 
filed 
under 
this 
section 
that 
names 
the 
designated representative under subsection 2, paragraph H; 
D. 
Is employed full time in a managerial position by the 
applicant; 
E. 
Is actively involved in and aware of the daily operation 
of the applicant; 
F. 
Is physically present at the facility of the applicant 
dur ing regular business hours, except when the absence of 
the designated representative is authorized for reasons such 
as sick leave or vacation leave; 
G. 
Is serving in the capacity of designated representative 
for only one applicant at a time; 
H. 
Has no convictions under any local, state or federal law 
relating 
to 
wholesale 
or 
retail 
prescription 
drug 
or 
controlled substance distribution; and 
I. 
Has 
no felony convictions under any local, state or 
federal law. 
4. Fingerprints. 
The board shall submit the fingerprints 
reQuired under subsection 2, paragraph I 
to the Department of 
Public Safety, 
Bureau of Identification for 
a state criminal 
history record check and the Federal Bureau of Investigation for 
a national criminal history record check. 
5. Bond requirement. 
An applicant under this section must 
submit to the board a bond or other eguiyalent means of security 
such as 
a letter of credit or a deposit in a trust account 
payable 
to 
the 
Wholesale 
Distributor 
Application 
Fund, 
established in subsection 6. 
The bond must secure payment of any 
fine or fee imposed by or cost incurred by the State regarding 
the license applied for under this section that the applicant 
fails to pay within 30 days after the fine, 
fee or cost is 
final. 
The State may 
make 
a 
claim on the bond or security 
reQuired under this subsection within 1 year after the license 
for which the bond or security is filed ceases to be valid. 
6. Wholesale Distributor Application Fund. 
The Wholesale 
Distributor Application Fund, a nonlapsing fund administered by 
the board, is established. 
Assets are received into the fund 
pursuant to the bonds and securities reQuired under sUbsection 
5. 
The purpose of the fund is to secure the payment of a fine, 
fee or cost levied against a licensee under this subchapter by 
the State pursuant to subsection 5. 
§13844. 
Minimum restrictions on transactions 
1. Ninety-fiye percent rule. 
In 
any calendar month, 
a 
wholesale 
distributor 
must 
sell, 
distribute, 
transfer 
or 
otherwise 
furnish 
at 
least 
95% 
of 
the 
prescriptiQn 
drugs 
possessed by the wholesale distributor to a pharmacy or other 
person dispensing Qr administering prescription drugs. 
2. 
Purchases and receipts 
from pharmacies. 
A whQlesale 
distributor may not purchase or otherwise receive a prescription 
drug 
from 
a 
pharmacy, 
except if the prescription drug 
was 
originally 
purchased 
by 
the 
pharmacy 
from 
the 
wholesale 
distributor. 
In a transaction excepted under this subsection, a 
wholesale distributor may not receive from a pharmacy an amount 
~uantity greater than was originally sold to the pharmacy by 
the wholesale distributor or pay the pharmacy an amount in cash 
or credit more than the pharmacy originally paid the wholesale 
distributor for the prescription drugs. 
3. Sale, distribution or transfer to unlicensed person. 
A 
wholesale distributor may furnish prescription drugs in the State 
only to a person licensed by the board to receive prescription 
drugs 
under 
this 
subchapter. 
A wholesale 
distributor 
shall 
verify that 
a 
person 
is 
licensed 
by 
the 
board 
to 
receive 
prescription drugs under this subchapter by contacting the board 
before the wholesale distributor distributes prescription drugs 
to the person. 
4. Premises listed on license. 
A wholesale distributor may 
deliver prescription drugs only to the premises listed on the 
license of the person receiving the prescription drugs, except 
that the wholesale distributor may deliver prescription drugs to 
an authorized agent of the person licensed to receive drugs by 
the board under this subchapter at the premises of the wholesale 
distributor if: 
A. 
The identity and license of the recipient is properly 
established; and 
B. 
The method of receipt is necessary for the immediate 
needs of a patient of the licensed recipient. 
5. Hospital 
ph~rmacy. A wholesale distributor may deliver 
prescription drugs to a hospital pharmacy receiving area if at 
]4 
the time of delivery a pharmacist or person authorized to receive 
the prescription drugs 
signs 
a 
receipt showing the type 
and 
quantity of 
the 
prescription 
drugs 
received. 
A 
discrepancy 
between the receipt and the type and quantity of the prescription 
drugs 
actually 
received 
must 
be 
reported 
to 
the 
wholesale 
distributor by the next business day after the delivery of the 
prescription drugs. 
6. Credit. 
A wholesale distributor may not accept payment 
for 
or 
allow the 
use 
of 
a 
person's 
or entity's credit to 
establish an account to purchase prescription drugs from a person 
other that an owner of record, chief executive officer of chief 
financial officer listed on the person's 9r entity's license from 
the board to receive prescription drugs under this subchapter. An 
account established for the purchase of prescription drugs must 
bear the name of the licensee licensed by the board to receive 
prescription drugs under this subchapter. 
§13845. 
Pedigree 
1. PQdig~~_-------A person engggrui-..in the wholesale distribution 
of a prescription drug, excluding the original manufacturer of 
the finished form of the prescription drug, 
shall provide 
a 
pedigree 
identifying 
each 
sale, 
trade 
or 
transfer 
of 
the 
prescription drug when the prescription drug leaves the normal 
distribution 
channel 
and 
is 
sold, 
traded 
or 
transferred 
to 
another person. 
If a pharmacy sells a drug to a person who is 
not the final consumer, the pharmacy shall provide to the person 
acguiring the prescription drug a pedigree. 
This subsection does 
not include a sale, trade or transfer Of 
a prescription drug 
between licensees with a 
common ownership of the prescription 
drug to meet emergency needs. 
2. Authentication. 
A person who is engaged in the wholesale 
Q.istribution of 
a 
prescription drug, 
excluding 
the 
original 
manufacturer, who possesses a pedigree for a prescription drug 
may 
not 
distribute that--prescription drug until 
the 
person 
verifies 
that 
each 
transaction 
listed 
on 
the 
pedigree 
has 
occurred. 
3. 
ContQnts. 
A 
pediqree 
must 
include 
all 
necessary 
identifying information concerning each sale in the chain of 
distribution of 
the 
prescription 
drug 
from 
the 
manufacturer 
through 
acquisition 
and 
sale 
by 
a 
wholesale 
distributor 
or 
repackager 
until 
final 
sale 
to 
a 
pharmacy 
or 
other 
person 
dispensing or administering the drug, including: 
A. 
The name of the prescription drug; 
B. 
The dosage form a,nd strength of the prescription drug; 
C. 
The size of the container; 
D. 
The number of containers; 
E. 
The IQt num&!§r of the pr§scrip!;,ion drugj 
F. 
The 
name of the manufacturer of th§ finished dQsage 
form; and 
G. 
The information in the chain of distribution, including: 
(1) 
The name, 
addres~lephone number 
and e-mail 
addr§ss if available of each owner of the prescription 
drug and each wholesale distributor who does not take 
title to the prescription drugL 
12) 
The signature of each owner of the prescription 
drug and each wholesale distributor who does not take 
title to the prescription drug; 
(3) 
The 
na,f!l~~nd address of each location from which 
the prescription drug was shipped, if different from 
the owner's name and address; 
(4) 
The transaction dates; and 
(5) 
Certification that e~ch recipient in the chain of 
distribution has authenticated the pedigree. 
4. 
R~Ji~. 
A pu:rchaser or wholesale distributor of 
a 
prescription drug must maintain the pedigree for that drug for 3 
years and make the pedigree available for inspection or removal 
upon request of an authorized law enforcement officer. 
§13846. 
Enforcement 
1. Order to 
Ce_aJi~~iJ;tl"ibuti.9n of 
pr~cription drug. 
The 
board may order a manufacturer, wholesale distributor or retailer 
to immediately cease distribution of a prescription drug if the 
board finds that there is a reasonable probability that: 
.16 
A. 
A wholesale distributor of the prescription drug has: 
(1) 
Knowingly violated a provision of this subchapter; 
or 
(2) 
Falsified 
a 
pedigree 
or 
knowingly 
sold, 
distributed, 
transferred, 
manufactured, 
repackaged, 
handled 
or 
held 
a 
counterfeit 
prescription 
drug 
intended for human use; 
B. 
The 
prescription drug 
could 
cause 
serious, 
adverse 
health consequences or death; and 
C. 
Other measures to protect the public health, safety or 
welfare would result in unreasonable delay. 
2. Hearing. 
An order under subsection 1 must provide to the 
person subject to 
th~rder an opportunity for 
an 
informal 
hear ing on the actions required by the order no later than 10 
days after the date of the order. 
After a hearing held under 
this subsection, if the board determines that inadequate grounds 
exist to support the actions required by the order, the board 
must vacate the order. 
§13841. 
Prohibited acts 
1. 
Prohibited act~. 
A persQn may not perform, cause to be 
performed, 
aid 
or 
abet 
any 
violation 
of 
this 
subchapter, 
including the following acts: 
A. 
Pr9vi.9ing the __ Q9_ard-<-_~tnot;ll.e..~Qrf,icial of the State or a 
federal official with false or fraudulent records or making 
false or fraudulent stQtements regarding a matter within the 
provisions of this subchapter: 
]0 
B. 
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: 
C. 
Adulterating, 
misbranding 
or 
counterfeiting 
a 
prescription drug: 
D. 
Manufactur,i.Jlg, 
repacka-9'iJl,gJ 
selling, 
transferrin~ 
delivering, holding or offering for sale a prescription drug 
that is adulterated, misbranded, counterfeited, suspected of 
being counterfeited or otherwise upfit for distribution: 
E. 
Receiving 
a 
prescription 
misbranded, 
stolen, 
obtained 
counterfeited 
or 
suspected 
of 
delivering or offering to deliver 
drug that is 
adulterated, 
by 
fraud 
or 
deceit, 
being 
counterfei ted 
and 
the prescription drug: and 
F. 
Altering, 
mutilating, 
destroying, 
obliterating 
or 
removing the whole or part of the label of a prescription 
drug or any other act that misbrands a prescription drug. 
2. Penalties. 
Notwiths.!&p.ging __ tpe provisions of Title 17-A, 
section 1301, a violation of this subchapter is a Class B offense 
for which a fine of up to $50,000 may be adjudged, unless the 
State proves that the person in violation of this subchapter 
knowingly violated tb-is sub_G_haptELCL __ !..n 
whJcb.~_~lJe viol_~tiQn 
]8 
is a Class A offense for which a penalty of no more that $500,000 
may be adjudged. 
§13848. 
Examination 
The board 
sl1al~..Y_~lop an examini3.tion regarding state and 
federal laws governing the wholesale distribution of prescription 
drugs that is to be taken by a designated representative pursuant 
to section l3843~section 3, paragra~~ 
§13849. Rules 
.. 
The board shall adopt rules to carry out the purposes of 
this subchapter no later than 90 days after the effective date of 
this subchapter. 
Rules adopted pursuant to this subsection are 
major 
substantive rules 
as 
defined in Title 
5, 
chapter 
375, 
subchapter 2-A. 
B 
SUMMARY 
This 
bill 
creates 
a 
licensing 
distributors of prescription drugs to 
Board 
of 
Pharmacy. 
Provisions 
of 
include: 
1. 
Definitions; 
structure 
for 
be regulated by 
this 
licensing 
wholesale 
the Maine 
structure 
2. 
Licensing requirements 
for wholesale distributors of 
prescription drugs; 
2B 
3. 
Restrictions on transactions for wholesale distributors 
of prescription drugs; 
4. 
Requirements for pedigrees for prescription drugs; 
5. 
Enforcement 
and 
Pharmacy 
to 
issue 
an 
prescription drug; and 
authority 
order 
to 
for 
cease 
the 
Maine 
Board 
distribution 
of 
of 
a 
6. 
Prohibited acts 
and penalties for violations of the 
provisions of this bill .