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10.13.02.00.htm 10.13.02.00. Title MARYLAND DEPARTMENT OF HEALTH Subtitle 13 DRUGS Chapter 02 Purchase and Distribution of Prescription Drugs and Devices Authority: Health-General Article, §21-234; Health Occupations Article, §12-6C-01(u) and 12-6C-03.1; Annotated Code of Maryland
10.13.02.01.htm 10.13.02.01. 01 Scope.. This chapter applies to the purchasing and distribution of prescription drugs and devices by the Department for public health purposes.
10.13.02.02.htm 10.13.02.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Adulterated” means a drug or device where:. a) Any part of the drug or device is filthy, putrid, or a decomposed substance; or. b) The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:i) Contaminated the drug or device with filth; or. ii) Caused the drug or device to be injurious to health..
10.13.02.03.htm 10.13.02.03. 03 Personnel.. A. The Secretary shall designate one or more Department employee representatives to be responsible for the purchase and distribution of prescription drugs and devices for public health purposes.B. A designated Department representative shall:. 1) Be a merit or contractual employee of the Department employed full time in a managerial level position;2) Be aware of and knowledgeable about the policies and procedures pertaining to the purchase and di
10.13.02.04.htm 10.13.02.04. 04 Storage and Handling.. A. Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that:1) Is constructed to facilitate:. a) Cleaning; and. b) Maintenance;. 2) Has storage areas designed to provide adequate:. a) Equipment;. b) Humidity control;. c) Lighting;. d) Sanitation;. e) Security conditions;. f) Space;. g) Temperature; and. h) Ventilation;.
10.13.02.05.htm 10.13.02.05. 05 Quarantine, Destruction, and Return of Prescription Drugs and Devices.. A. A designated Department representative shall quarantine and physically separate prescription drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs and devices until the quarantined and separated prescription drugs and devices are destroyed or returned to their supplier for disposal.B. A designated Department representative shall id
10.13.02.06.htm 10.13.02.06. 06 Record Keeping.. A designated Department representative shall:. A. Establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs and devices;B. Include the following information in the records required under §A of this regulation:. 1) The source of a prescription drug or device, including the:. a) Name and principal address of the seller or transferor; and.
10.13.02.9999.htm 10.13.02.9999. Administrative History Effective date: August 22, 2011 (38:17 Md. R. 1012).
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