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Martin O'Malley, Governor
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Ch. 352
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(II) EDUCATION AND EXPERIENCE REQUIREMENTS FOR
PERSONNEL EMPLOYED IN POSITIONS RESPONSIBLE FOR CARRYING OUT THE
DUTIES:
1. REFERENCED IN ITEM (I) OF THIS ITEM; OR
2. RELATED TO STATE PERMIT REQUIREMENTS
UNDER THIS SUBTITLE.
12-6C-08.
INFORMATION PROVIDED BY A WHOLESALE DISTRIBUTOR OR AN
APPLICANT FOR A WHOLESALE DISTRIBUTOR PERMIT UNDER THIS SUBTITLE
MAY NOT BE DISCLOSED TO ANY PERSON OR ENTITY EXCEPT A STATE
LICENSING OR PERMITTING AUTHORITY, STATE BOARD, OR GOVERNMENT
AGENCY THAT NEEDS THE INFORMATION FOR LICENSING, PERMITTING,
MONITORING, OR LAW ENFORCEMENT PURPOSES.
12-6C-09.
(A) (1) A WHOLESALE DISTRIBUTOR SHALL RECEIVE PRESCRIPTION
DRUG RETURNS OR EXCHANGES FROM A PHARMACY OR PHARMACY WAREHOUSE
ACCORDING TO THE TERMS AND CONDITIONS OF THE AGREEMENT BETWEEN
THE WHOLESALE DISTRIBUTOR AND THE PHARMACY OR PHARMACY
WAREHOUSE.
(2) RETURNS OF EXPIRED, DAMAGED, RECALLED, OR OTHERWISE
NONSALEABLE PRESCRIPTION DRUGS SHALL BE DISTRIBUTED BY THE
RECEIVING WHOLESALE DISTRIBUTOR ONLY TO EITHER THE ORIGINAL
MANUFACTURER OR A THIRD PARTY RETURNS PROCESSOR.
(3) RETURNS OR EXCHANGES OF PRESCRIPTION DRUGS,
SALEABLE OR OTHERWISE, INCLUDING ANY REDISTRIBUTION BY A RECEIVING
WHOLESALER, ARE NOT SUBJECT TO THE PEDIGREE REQUIREMENTS OF §
12-6C-10 OF THIS SUBTITLE IF THEY ARE EXEMPT FROM THE PEDIGREE
REQUIREMENT OF THE U.S. FOOD AND DRUG ADMINISTRATION'S CURRENTLY
APPLICABLE PRESCRIPTION DRUG MARKETING ACT GUIDELINES.
(4) WHOLESALE DISTRIBUTORS AND PHARMACIES SHALL BE
ACCOUNTABLE FOR:
(I) ADMINISTERING THEIR RETURNS PROCESS; AND
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- 2231 -
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