Maryland Administrative Code

.14 Probation and Violation of Probation. A. If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation that the Board considers appropriate, including: (1) Re-education or completion of approved courses; (2) Payment of a fine; (3) Prac…

.15 Reinstatement. A. A registrant or licensee shall petition the Board for a lifting of the suspension of a registration, license, or permit or a reinstatement following revocation or surrender of a registration, license, or permit. B. The Board may reinstate a registration, lic…

.01 Scope. This chapter applies to: A. Applicants for licensure as a pharmacist; and B. Internship programs for student pharmacists for which credit may be allowed toward licensure.

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Foreign school or college of pharmacy” means a school or college of pharmacy that is not located in any state of the United …

.03 Licensure Examinations. A. Examination Eligibility. (1) An applicant may be approved by the Board to take Exam I upon satisfactory proof that the applicant has graduated, or is expected to graduate at the completion of the immediate semester, from a school or college of pharm…

.04 Internship Program or Training Required. An applicant shall complete one of the following as a prerequisite to Board licensure: A. 1,000 hours of a school-supervised professional experience program conducted by a school of pharmacy accredited by the American Council of Pharma…

.05 Partial or Non-Pharmacy-School-Supervised Program of Internship. A. Applicants may complete the requirement for internship training by having at least 1,560 hours of full-time training as a registered pharmacy intern, under the direct supervision of licensed pharmacists. B. T…

.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.

.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 institutio…

.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 i…

.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) Det…

.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 …

.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. The director of pharmacy shall establis…

.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,…

.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 facilit…

.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) Approp…

.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 mee…

.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 de…

.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) Institutio…

.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 …

.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 d…

.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 de…

.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 …

.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 en…

.01 Scope. This chapter governs the: A. Transfer of prescriptions for non-controlled dangerous substances between pharmacies; B. Filling of prescriptions at one pharmacy pursuant to the request of staff of a second pharmacy; and C. Preparation of medication for stock and investig…

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Outsourcing” means the transmitting of a prescription order from a primary pharmacy to a secondary pharmacy that prepares the prescription. (2) “Patient specific” means a …

.03 Permanent Transfer of a Prescription Between Pharmacies. A pharmacist from a primary pharmacy may permanently transfer a prescription order to a secondary pharmacy to be dispensed to a specific patient if the pharmacist transferring the prescription from the primary pharmacy …

.04 Refilling of Permanently Transferred Prescriptions. A. A pharmacist at the primary pharmacy may not refill a prescription that has been permanently transferred to a secondary pharmacy. B. The use of unified prescription records by more than one pharmacy through a computerized…

.05 Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer. The pharmacist at the secondary pharmacy who receives a permanently transferred prescription document is responsible for maintaining documentation in a readily retrievable and identifiable ma…

.06 Transfers of Prescription for Controlled Dangerous Substances. A pharmacist may transfer a prescription for a controlled dangerous substance in accordance with federal law. Cross References 10.34.04.10C

.07 Outsourcing of a Prescription Order. A pharmacist from a primary pharmacy may transmit a prescription order to a secondary pharmacy for preparation and final dispensing to a specific patient or for return to the primary pharmacy for final dispensing to a specific patient if: …

.08 Documentation by the Secondary Pharmacy when a Prescription Order is Outsourced. The permit holder at the secondary pharmacy is responsible for maintaining documentation in a readily retrievable and identifiable manner, which includes: A. That the prescription order was trans…

.09 Preparation of Stock and Investigational Medications. A. A pharmacist may provide medication for use as stock medication for a licensed health care facility in accordance with applicable laws, if the pharmacy providing the medication also serves as the primary provider of pat…

.10 Permit and Quality Assurance. A. The permit holder of a pharmacy which prepares patient specific prescriptions as a secondary pharmacy such that these prescriptions account for 5 percent or more of the pharmacy's total number of prescriptions filled shall submit to the Board …

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Emergency” means an event such as a fire, water leak, electrical failure, public disaster, or catastrophe which may impact the prescription area. (2) “Means of access” mea…

.02 Prescription Area. A. The pharmacy permit holder shall: (1) Ensure that the prescription area: (a) Maintains temperature and ventilation at levels that do not affect the prescription drugs or devices stored in the area; and (b) Permits reasonable communication between the pha…

.03 Pharmacy Operation. A. A pharmacist shall be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation. B. If the prescription area is not open the same hours as the establishment, the pharmacy permit holder shall prominently…

.04 Records. A. A pharmacy permit holder shall: (1) Prevent unauthorized disclosure or loss by securing all patient records; (2) Designate personnel with authorized access to computerized patient records; and (3) Maintain current computerized records in a manner which permits rec…

.05 Security Responsibility. A. The pharmacy permit holder is responsible for ensuring that pharmacists, employees, and others who enter the pharmacy: (1) Know and abide by the requirements of this chapter; (2) Maintain those measures necessary to ensure this chapter’s enforcemen…

.01 Scope. This chapter applies to each pharmacist, pharmacy intern, and pharmacy technician licensed or registered by the Maryland Board of Pharmacy.

.02 Definitions. A. In these regulations, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Mailing address” means the address the pharmacist or pharmacy technician specifies that the Board use when communicatin…

.03 Mailing Address. A. Each licensed pharmacist, pharmacy intern, and registered pharmacy technician shall report to the Board the pharmacist’s, pharmacy intern’s, or pharmacy technician’s current mailing address on the pharmacist’s, pharmacy intern’s, or pharmacy technician’s b…

.04 Place of Employment. A. This regulation applies only to pharmacists, pharmacy interns, and pharmacy technicians employed in Maryland. B. Each licensed pharmacist, registered pharmacy intern, and registered pharmacy technician shall report to the Board the pharmacist’s, pharma…

.05 Grounds for Disciplinary Action. A. A pharmacist’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information shall constitute grounds for action under Health Occupa…

.01 Definitions. A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Material safety data sheets” means a list of hazardous chemicals that provides detailed information on each hazardous chemical, including its potential hazardous effects, its phys…

.01-1 Equipment. A pharmacy shall have the following equipment to carry out the practice of pharmacy in Maryland: A. If applicable, a Class A prescription balance and weights, or a prescription balance with equivalent or superior sensitivity to a Class A prescription balance; and…

.02 Additional Equipment. The pharmacy shall maintain additional equipment to enable it to prepare and dispense prescriptions properly consistent with its scope of practice.