| | | Be it enacted by the People of the State of Maine as follows: |
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| | | Sec. 1. 32 MRSA c. 117, sub-c. 13 is enacted to read: |
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| | | WHOLESALE LICENSURE AND PRESCRIPTION |
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| | | This subchapter may be known and cited as "the Wholesale | | Licensure and Prescription Medication Integrity Act." |
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| | | As used in this subchapter, unless the context otherwise | | indicates, the following terms have the following meanings. |
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| | | 1. Authenticate.__"Authenticate" means to affirmatively verify | | before distribution of a prescription drug that each transaction | | listed on the pedigree has occurred. |
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| | | 2. Facility.__"Facility" means a facility of a wholesale drug | | distributor where prescription drugs are stored, handled, | | repackaged or offered for sale. |
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| | | 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. |
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| | | 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. |
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| | | 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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