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10.34.03.00.htm 10.34.03.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 34 BOARD OF PHARMACY Chapter 03 Institutional Pharmacy Authority: Health Occupations Article, §12-205, Annotated Code of Maryland
10.34.03.01.htm 10.34.03.01. 01 Scope.. This chapter applies to:. A. A permit holder that operates a pharmacy that services an inpatient setting; and. B. A person or entity that holds a pharmacy permit and operates a pharmacy in or for an institutional facility.
10.34.03.02.htm 10.34.03.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Decentralized pharmacy” means an institutional pharmacy which provides services for the population of an institutional facility and is:a) Dependent on another institutional pharmacy for:. i) Administrative control;. ii) Staffing with a licensed pharmacist physically available on site in the decentralized pharmacy to supervise the performance of delegated pharmacy acts; and
10.34.03.03.htm 10.34.03.03. 03 Issuance of Permits.. A. An institutional pharmacy shall obtain required permits in compliance with State and federal laws and regulations.B. An institutional pharmacy shall:. 1) Staff a pharmacist at each decentralized pharmacy site within the building or pavilion in which it is located; and2) List decentralized pharmacy sites within the building in which it is located, on the initial application, or on the renewal application;C. A decentralized pharmacy that meets the definit
10.34.03.04.htm 10.34.03.04. 04 Policies and Procedures.. A. The director of pharmacy shall establish and operate under a policies and procedures manual which:1) Complies with this chapter;. 2) Defines the scope and method of pharmacy services provided to the patients of the institutional facility;3) Determines when personnel may have access to the pharmacy area;. 4) Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;5) Includes:.
10.34.03.05.htm 10.34.03.05. 05 Personnel.. A. The permit holder shall appoint a licensed pharmacist as director of pharmacy who shall:. 1) Be in full and actual charge of the pharmacy and its personnel;. 2) 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; and3) Review the policies and procedures of the pharmacy annually and revise them as necessary..
10.34.03.06.htm 10.34.03.06. 06 Security.. A. If a pharmacist is not present within the pharmacy, the pharmacist shall lock and secure the pharmacy and any of its decentralized areas that contain pharmaceuticals before leaving the pharmacy or the decentralized area.B. Thedirector of pharmacy shall establish policies and procedures for emergency access to the pharmacy or any of its decentralized areas.C. Security Requirements. Entry into an institutional pharmacy area where prescription drugs or devi
10.34.03.07.htm 10.34.03.07. 07 Physical Requirements and Equipment.. A. The institutional pharmacy shall have floor space, shelving, and equipment to ensure that drugs and supplies within the institutional pharmacy are properly stored and prepared with respect to sanitation, temperature, light, ventilation, moisture control, segregation, and security.B. The institutional pharmacy shall have professional and technical equipment, supplies, and adequate physical facilities for proper compounding, disp
10.34.03.08.htm 10.34.03.08. 08 Responsibilities of Director of Pharmacy.. The director of pharmacy or designee shall:. A. Be responsible for the safe and efficient dispensing, control, security, and accountability of drugs;B. Work in cooperation with the other professional staff of the institutional facility with respect to the duties listed in this regulation and in ordering, administering, and controlling drug products and materials, including prescription blanks;C. Supervise the preparat
10.34.03.09.htm 10.34.03.09. 09 Medication Packaging ― Record Keeping.. A. A licensed pharmacist shall verify the selection of medication to be packaged and verify the completed packaging of medication performed by a registered pharmacy technician for the following:1) Accuracy;. 2) Completeness:. 3) Appropriateness; and. 4) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.B. Packaging from the Manufacturer’s Original Container. The pharmacy shall
10.34.03.10.htm 10.34.03.10. 10 Labeling for Use Outside the Institutional Facility.. A. The director of pharmacy or designee shall ensure that the labels on drugs dispensed for use outside the facility by an institutional pharmacy to clinics, ambulatory patients, or other patients about to be discharged meet the requirements of Health Occupations Article, §12-505, Annotated Code of Maryland.B. The director of pharmacy or designee shall ensure that the labels contain other information that
10.34.03.11.htm 10.34.03.11. 11 Drug Dispensing ― Emergency Supplies and Procedures.. A. The director of pharmacy shall participate in the development and maintenance of the formulary for emergency drugs and supplies that are maintained throughout the institutional facility.B. The director of pharmacy or designee shall, in conjunction with the medical staff of the institutional facility, develop and implement written policies and procedures to ensure compliance with the provisions of this regulation.
10.34.03.12.htm 10.34.03.12. 12 Drug Dispensing ― Prescribers' Orders.. A. Drugs may be dispensed from the institutional pharmacy only in response to medication orders issued by prescribers who have been authorized to do so by law and by the governing body of the institution.B. Documentation.. 1) Institutional Medication Protocols.. a) The pharmacist may dispense, or make available, drugs for an approved institutional medication protocol if conditions designated by the institutionb) The director of pharma
10.34.03.13.htm 10.34.03.13. 13 Controlled Dangerous Substances.. A. Drug Accountability.. 1) The director of pharmacy is responsible for establishing procedures and maintaining adequate written or electronic records regarding dispensing and accountability of controlled dangerous substances which specify at least the following:a) Name and strength of the drug;. b) Dose;. c) Dosage form;. d) Prescriber;. e) Patient name with second identifier;. f) Date and time of administration; and.
10.34.03.14.htm 10.34.03.14. 14 Drug Recalls.. A. The director of pharmacy or designee shall develop and implement a drug recall procedure that can be readily activated to assure that drugs which have been recalled are returned to the pharmacy for proper disposition.B. If a recall has been initiated for a drug that has been purchased by the institution, the director of pharmacy or designee shall issue a notice in a timely manner informing affected departments of the institution that the
10.34.03.15.htm 10.34.03.15. 15 Adverse Drug Events.. A. The director of pharmacy or designee shall participate in the appropriate committee or committees to establish procedures to report and record adverse drug events including medication errors and adverse drug reactions.B. The director of pharmacy or designee shall immediately report adverse drug events to the prescriber, or the prescriber's designee, and make a written or electronic report to the appropriate committee or committees, as dete
10.34.03.16.htm 10.34.03.16. 16 Pharmaceutical Care Functions of the Pharmacist.. The pharmacist shall be available as necessary to provide pharmaceutical care to individual patients including, but not limited to:A. Participating in decisions about medication use for patients including decisions not to use medication therapy as well as judgments about:1) Medication selection;. 2) Dosages;. 3) Routes and methods of administration;. 4) Medication therapy monitoring; and.
10.34.03.17.htm 10.34.03.17. 17 Requirements for a Decentralized Pharmacy.. A. A decentralized pharmacy is subject to:. 1) Health Occupations Article, Title 12, Annotated Code of Maryland;. 2) This subtitle; and. 3) Other applicable State and federal laws and regulations.. B. A decentralized pharmacy shall ensure that a licensed pharmacist is immediately available on the premises of the decentralized pharmacy to:1) Supervise pharmacy operations; and. 2) Provide the final check for preparing medicatio
10.34.03.9999.htm 10.34.03.9999. Administrative History Effective date: November 6, 1995 (22:22 Md. R. 1666) ―. Chapter revised effective October 1, 2011 (38:19 Md. R. 1147). Regulation .02B amended effective May 31, 2014 (40:19 Md. R. 1547). Regulation .03 amended effective May 31, 2014 (40:19 Md. R. 1547). Regulation .06C amended effective May 31, 2014 (40:19 Md. R. 1547). Regulation .12B amended effective May 31, 2014 (40:19 Md. R. 1547). Regulation .17 adopted effective May 31, 2014 (40:19 Md. R. 1547).
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