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10.34.36.00.htm 10.34.36.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 34 BOARD OF PHARMACY Chapter 36 Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes Authority: Health-Occupations Article, §12-205, 12-301, 12-401, 12-403, 12-501, and 12-503―12-506, Annotated Code of Maryland
10.34.36.01.htm 10.34.36.01. 01 Scope.. This chapter applies to pharmacies and licensed pharmacists serving assisted living programs or group homes as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for assisted living programs or group homes.
10.34.36.02.htm 10.34.36.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) Assisted Living Program.. a) "Assisted living program" means a residential or facility-based program that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services 24 hours a day, 7 days a week, to meet the needs of individuals who are unable to perform, or who need assistance in performing, t
10.34.36.03.htm 10.34.36.03. 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 residents of the assisted living program or group home;C. Determines under what circumstances 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;
10.34.36.04.htm 10.34.36.04. 04 Personnel.. A. The permit holder shall appoint a responsible pharmacist who shall:. 1) Be responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title;2) Be responsible for reviewing the policies and procedures manual of the pharmacy annually and revising it as necessary;3) Be responsible for the safe and efficient dispe
10.34.36.05.htm 10.34.36.05. 05 Physical Requirements.. A. Storage. The permit holder 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) Segregation; and. 6) Security.. B. Equipment and Materials.. 1) The permit holder or designee shall ensure that the pharmacy contains as appropriate to the level
10.34.36.06.htm 10.34.36.06. 06 Medication and Device Distribution and Pharmaceutical Services.. A. The responsible pharmacist shall be accountable for, at a minimum:. 1) The preparation of medications compounded in the pharmacy as applicable;. 2) The proper preparation, storage, and distribution of compounded sterile preparations according to COMAR 10.34.19 to the extent that the functions are performed at the pharmacy;3) The packaging and labeling of medications;. 4) Records of transaction
10.34.36.07.htm 10.34.36.07. 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 approved packaging.B. A licensed pharmacist shall ensure that labeling of the medication container includes the:.
10.34.36.08.htm 10.34.36.08. 08 Labeling of Resident Medications.. A. A licensed pharmacist shall ensure that medications dispensed by the pharmacy and intended for use within an assisted living program or group home 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 resident, patient, or consumer, as appropriate;. 5) Name, quantity, and strength of the drug;.
10.34.36.09.htm 10.34.36.09. 09 Drug Control and Accountability.. A. 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) A licensed pharmacist determines that procedures are in place that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim pe
10.34.36.10.htm 10.34.36.10. 10 Quality Management.. A. The responsible pharmacist, in cooperation with the appropriate committee of the assisted living program, shall develop procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter and COMAR 10.07.14.29 where appropriate.B. The responsible pharmacist, in cooperation with the appropriate committee of the group home, if applicable, may develop pr
10.34.36.9999.htm 10.34.36.9999. Administrative History Effective date: June 15, 2013 (40:9 Md. R. 789).
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