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Ch. 352
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Martin O'Malley, Governor
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(V) AN AUTHORIZED DISTRIBUTOR OF RECORD TO
ANOTHER AUTHORIZED DISTRIBUTOR OF RECORD SOLELY FOR DISTRIBUTION
TO AN OFFICE-BASED HEALTH CARE PRACTITIONER AUTHORIZED BY LAW TO
DISPENSE OR ADMINISTER THE PRESCRIPTION DRUG TO A PATIENT.
(M) "ONGOING RELATIONSHIP" MEANS A RELATIONSHIP THAT EXISTS
BETWEEN A WHOLESALE DISTRIBUTOR, INCLUDING ANY AFFILIATED GROUP OF
THE WHOLESALE DISTRIBUTOR, AS DEFINED IN § 1504 OF THE INTERNAL
REVENUE CODE, AND A MANUFACTURER WHEN THE WHOLESALE DISTRIBUTOR;
(1) HAS A WRITTEN AGREEMENT CURRENTLY IN EFFECT WITH
THE MANUFACTURER EVIDENCING THE ONGOING RELATIONSHIP; AND
(2) IS LISTED ON THE MANUFACTURER'S CURRENT LIST OF
AUTHORIZED DISTRIBUTORS OF RECORD.
(N) "PEDIGREE" MEANS A DOCUMENT OR ELECTRONIC FILE
CONTAINING INFORMATION THAT RECORDS EACH WHOLESALE DISTRIBUTION
OF A PRESCRIPTION DRUG.
(O) "PHARMACY WAREHOUSE" MEANS A PHYSICAL LOCATION FOR
STORAGE OF PRESCRIPTION DRUGS THAT:
(1) SERVES AS A CENTRAL WAREHOUSE; AND
(2) PERFORMS INTRACOMPANY SALES OR TRANSFERS OF THE
PRESCRIPTION DRUGS TO A GROUP OF PHARMACIES THAT ARE UNDER COMMON
OWNERSHIP AND CONTROL WITH THE PHARMACY WAREHOUSE.
(P) (1) "PRESCRIPTION DRUG" MEANS ANY DRUG REQUIRED BY
FEDERAL LAW OR REGULATION TO BE DISPENSED ONLY BY A PRESCRIPTION.
(2) "PRESCRIPTION DRUG" INCLUDES:
(I) A BIOLOGICAL PRODUCT; AND
(II) FINISHED DOSAGE FORMS AND BULK DRUG
SUBSTANCES SUBJECT TO § 503(B) OF THE FEDERAL FOOD, DRUG, AND
COSMETIC ACT.
(3) "PRESCRIPTION DRUG" DOES NOT INCLUDE BLOOD AND
BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR BIOLOGICAL PRODUCTS
THAT ARE ALSO MEDICAL DEVICES.
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- 2217 -
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