LD 1167
pg. 7
Page 6 of 10 An Act To Ensure the Health and Safety of All Maine Citizens by Licensing Drug ... Page 8 of 10
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LR 1797
Item 1

 
§13845.__Pedigree

 
1. Pedigree.__A person engaged 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
acquiring 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
distribution 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. Contents.__A pedigree 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 and strength of the prescription drug;

 
C.__The size of the container;

 
D.__The number of containers;

 
E.__The lot number of the prescription drug;

 
F.__The name of the manufacturer of the finished dosage
form; and

 
G.__The information in the chain of distribution, including:

 
(1)__The name, address, telephone number and e-mail
address if available of each owner of the prescription
drug and each wholesale distributor who does not take
title to the prescription drug;


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