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10.34.23.00.htm 10.34.23.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 34 BOARD OF PHARMACY Chapter 23 Pharmaceutical Services to Patients in Comprehensive Care Facilities Authority: Health Occupations Article, §12-205, 12-301, 12-401, 12-403, 12-501, 12-503, 12-504, 12-505, 12-506, and 12-6B-01, Annotated Code of Maryland
10.34.23.01.htm 10.34.23.01. 01 Scope.. This chapter applies to pharmacies and licensed pharmacists serving comprehensive care facilities as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for these facilities.
10.34.23.02.htm 10.34.23.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Chart order” means a lawful order entered on the chart or a medical record of a patient of a comprehensive care facility by an authorized prescriber or the authorized prescriber’s designated agent for a drug or device.2) Comprehensive Care Facility.. a) “Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age
10.34.23.03.htm 10.34.23.03. 03 Policies and Procedures.. The permit holder shall establish and operate under a policies and procedures manual which:. A. Complies with this chapter;. B. Defines the scope and method of pharmacy services provided to the patients of the comprehensive care facility;C. Determines when personnel may have access to the pharmacy area;. D. Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;1) Labeling requirements
10.34.23.04.htm 10.34.23.04. 04 Personnel.. A. Director of Pharmacy. The permit holder shall appoint a licensed pharmacist as director of pharmacy who is:1) Licensed to engage in the practice of pharmacy in Maryland;. 2) Knowledgeable in, and thoroughly familiar with, the specialized functions of comprehensive care facility pharmaceutical services;3) Responsible for and in full and actual charge of the pharmacy and its personnel;. 4) Responsible for the operations of the pharmacy and for compliance with t
10.34.23.05.htm 10.34.23.05. 05 Physical Requirements.. A. Storage. The director of pharmacy or designee shall ensure that medications and supplies within the pharmacy are properly stored according to the manufacturer’s specifications and State and federal laws and regulations with respect to:1) Sanitation;. 2) Temperature;. 3) Light;. 4) Ventilation;. 5) Moisture control;. 6) Segregation; and. 7) Security.. B. Equipment and Materials..
10.34.23.06.htm 10.34.23.06. 06 Medication and Device Distribution and Pharmaceutical Services.. A. The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder.B. The director of pharmacy or designee shall work in cooperation with the professional staff of the comprehensive care facil1) Meeting the responsibilities set forth in §C of this regulation; and.
10.34.23.07.htm 10.34.23.07. 07 Medication Packaging.. A. A licensed pharmacist shall verify the:. 1) Selection of medication to be packaged; and. 2) Completed packaging of medication performed by registered pharmacy technicians for the following:. a) Accuracy;. b) Completeness;. c) Appropriateness; and. d) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia apprB. The licensed pharmacist shall ensure that labeling of the medication container includes the:.
10.34.23.08.htm 10.34.23.08. 08 Labeling of Patient Medications.. A. The director of pharmacy or designee shall ensure that medications dispensed by the pharmacy and intended for use within the comprehensive care facility are dispensed in appropriate containers and are labeled with the:1) Name and address of the pharmacy;. 2) Date of dispensing;. 3) Prescription number assigned by the pharmacy;. 4) Name of the patient;. 5) Name, quantity, and strength of the drug;. 6) Name of the prescriber;.
10.34.23.09.htm 10.34.23.09. 09 Drug Control and Accountability.. A. The director of pharmacy or designee shall develop a process for the pharmacy to be notified of medications which have been discontinued.B. Medications may be accepted for return if:. 1) The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device;2) The licensed pharmacist determines that the returned medication has been handled in a manner whic
10.34.23.10.htm 10.34.23.10. 10 Quality Management.. The director of pharmacy or designee, in cooperation with the pharmaceutical services committee of the comprehensive care facility, shall be responsible for developing procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter.
10.34.23.9999.htm 10.34.23.9999. Administrative History Effective date: October 7, 1996 (23:20 Md. R. 1424) ―. Chapter revised effective June 1, 2011 (38:11 Md. R. 671). Regulation .03E amended effective September 16, 2013 (40:18 Md. R. 1479). Regulation .07D, E amended effective April 2, 2012 (39:6 Md. R. 408). Regulation .08B amended effective April 2, 2012 (39:6 Md. R. 408). Regulation .09G amended effective September 16, 2013 (40:18 Md. R. 1479).
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