LD 1167
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LD 1167 Title Page An Act To Ensure the Health and Safety of All Maine Citizens by Licensing Drug ... Page 2 of 10
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LR 1797
Item 1

 
Be it enacted by the People of the State of Maine as follows:

 
Sec. 1. 32 MRSA c. 117, 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, 21 United States Code, Section
503(b).__"Prescription drug" does not include blood or blood
components intended for transfusion or biological products that
are medical devices.


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