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Martin O'Malley, Governor Ch. 353
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(H) "FACILITY" MEANS A FACILITY OF A WHOLESALE DISTRIBUTOR
WHERE PRESCRIPTION DRUGS ARE STORED, HANDLED, REPACKAGED, OR
OFFERED FOR SALE.
(I) "INTRACOMPANY SALES" MEANS A:
(1) TRANSACTION OR TRANSFER OF PRESCRIPTION DRUGS
BETWEEN A DIVISION, SUBSIDIARY, PARENT, OR AFFILIATED OR RELATED
COMPANY UNDER COMMON OWNERSHIP AND CONTROL OF A CORPORATE
ENTITY; OR
(2) TRANSACTION OR TRANSFER OF A CO-LICENSED PRODUCT
BETWEEN CO-LICENSED PARTNERS.
(J) "MANUFACTURER" MEANS A PERSON LICENSED OR APPROVED BY
THE U.S. FOOD AND DRUG ADMINISTRATION TO ENGAGE IN THE
MANUFACTURE OF PRESCRIPTION DRUGS OR PRESCRIPTION DEVICES,
CONSISTENT WITH THE DEFINITION OF "MANUFACTURER" UNDER THE U.S.
FOOD AND DRUG ADMINISTRATION'S REGULATIONS AND GUIDELINES
IMPLEMENTING THE PRESCRIPTION DRUG MARKETING ACT.
(K) "MANUFACTURER'S EXCLUSIVE DISTRIBUTOR" MEANS A PERSON
WHO:
(1) CONTRACTS WITH A MANUFACTURER TO PROVIDE OR
COORDINATE WAREHOUSING, DISTRIBUTION, OR OTHER SERVICES ON BEHALF
OF THE MANUFACTURER; AND
(2) TAKES TITLE TO THE MANUFACTURER'S PRESCRIPTION
DRUG, BUT DOES NOT HAVE GENERAL RESPONSIBILITY TO DIRECT THE SALE OR
DISPOSITION OF THE MANUFACTURER'S PRESCRIPTION DRUG.
(L) "NORMAL DISTRIBUTION CHANNEL" MEANS A CHAIN OF CUSTODY
FOR A PRESCRIPTION DRUG THAT, DIRECTLY OR BY DROP SHIPMENT, GOES:
(1) FROM:
(I) A MANUFACTURER OF THE PRESCRIPTION DRUG; OR
(II) THE MANUFACTURER'S CO-LICENSED PARTNER, THIRD
PARTY LOGISTICS PROVIDER, OR MANUFACTURER'S EXCLUSIVE DISTRIBUTOR;
AND
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- 2245 -
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