Maryland Administrative Code

.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 pres…

.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 …

.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 comprehen…

.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…

.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 hold…

.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) …

.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 …

.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 prop…

.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 revie…

.01 Purpose. The purpose of this chapter is to establish the minimum requirements for drug acquisition records to be maintained by pharmacy permit holders.

.02 Scope. A. This chapter applies to all pharmacy permit holders in this State. B. This chapter applies to the acquisition of all prescription medication drug inventories. C. This chapter applies to a pharmacy's acquisition of drug inventory from all sources including, but not l…

.03 Minimum Requirements for Maintenance of Drug Acquisition Records. A. A pharmacy permit holder shall maintain records of all drug inventory acquisitions. B. The records maintained shall include: (1) The name and principal address of the source of the drugs; (2) The identity an…

.04 Violation and Inspection. A. A pharmacy permit holder shall make the drug inventory acquisition records required under this chapter available for inspection upon request by any federal, state, or local law enforcement agent, or any other duly authorized agent of the Board of …

.01 Scope. This chapter governs the manner in which a Maryland licensed pharmacy delivers filled prescriptions for individual patients by United States Postal Service, common carrier, or delivery service to an address within the State.

.02 Definitions. A. In this chapter, the following terms have the meaning indicated. B. Terms Defined. (1) “Delivery” means to send a prescription medication from a pharmacy by the United States Postal Service, common carrier, or delivery system to an address within the State. (2…

.03 Requirements for Packaging and Delivery of Prescription Medication. A. Packaging. Prescription medications delivered under this chapter to individuals in the State shall be: (1) Enclosed in a container that reveals to the patient any tampering of the container that occurred d…

.04 Depots. A pharmacy may not knowingly deliver prescription medications to a depot, or establish or cooperate in the establishment of a depot.

.05 Record Keeping. A. If a patient authorizes delivery of prescription medication to an agent at a location other than the pharmacy, or the patient's residence, the pharmacist shall document the authorization: (1) On the prescription; (2) In the patient profile; or (3) In anothe…

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “High-alert medication” means a medication with: (a) A significant potential for involvement in a mediation error due to the medication's name, packaging, appearance, dosin…

.02 Patient Education. A. The pharmacy permit holder shall establish methods to provide patients with information regarding the patient's role and responsibility in preventing medication errors in a manner that is reasonably likely to convey the information to the patient, and if…

.03 Pharmacy Staff Education. As part of a pharmacy permit holder's ongoing quality assurance program, the pharmacy permit holder shall: A. Ensure that each member of the pharmacy staff involved in the medication delivery system receive at least once a year, education regarding t…

.04 Ongoing Quality Assurance Program. A. A pharmacy permit holder shall establish and maintain an ongoing quality assurance program to: (1) Identify, investigate, and promote the prevention of medication errors; and (2) Establish protocols and procedures to minimize the potentia…

.01 Disclosure for Compelling Public Purpose. The custodian of records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the inf…

.02 Other Disclosures. This chapter does not prohibit or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information that the Board may otherwise disclose by law.

.01 Scope. This chapter defines the parameters under which a permit holder may allow the use of automated medication systems to facilitate the dispensing and distribution of medication.

.02 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Automated medication system” means a centralized, decentralized, or remote robotic or computerized device and that device's components designed to: (a) Distribute medicati…

.03 Limitation on Privileges to Administer. In this chapter, “privileges to administer medication” does not include privileges created by delegation from a licensed health care professional to an unlicensed health care professional.

.04 Usage Requirements for Centralized Automated Medication Systems. A. An automated medication system may only be used if: (1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter; (2) A responsible pharmacist has been de…

.05 Usage Requirements for Decentralized Automated Medication Systems. A. A decentralized automated medication system may only be used if: (1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter; (2) A responsible pharmac…

.06 Usage Requirements for Remote Automated Medication Systems. A. A remote automated medication system may only be used if: (1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter; (2) A responsible pharmacist has been d…

.07 Stocking of Automated Medication Systems. A. Selection of Medication for Stocking. A licensed pharmacist shall verify the accuracy of medications selected for stocking and replenishment of the automated medication system before the medications are stocked in the system. B. St…

.08 Return of Unused Medication. A. Single-Drug Unit Dose Packaging. (1) Automated medication systems that distribute medications in single-drug unit dose packaging may allow for return of unused medications to the system provided that: (a) The medication is returned to a designa…

.09 Education and Training. The permit holder shall ensure that individuals authorized to utilize centralized, decentralized, or remote automated medication systems receive initial and annual training regarding: A. The capabilities and limitations of the system; B. Procedures for…

.10 Quality Assurance Program. A. The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenan…

.11 Record Keeping. A. The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years. B. The records referred to in §A of this regulation shall include: (1) Maintenance record…

.12 Security. A. The responsible pharmacist shall ensure the security of the automated medication system. B. In order to restrict access to the automated medication system to authorized individuals, the responsible pharmacist shall, at a minimum: (1) Establish a clear process of …

.13 Laws and Compendial Standards. The responsible pharmacist shall ensure compliance with the laws and compendial standards for packaging and labeling.

.14 Controlled Dangerous Substances. Controlled dangerous substances shall only be dispensed and distributed in accordance with applicable State and federal statutes and regulations.

.01 Definitions. A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Amendment” means a change to: (a) A protocol or prescriber-pharmacist agreement; or (b) The parties to the prescriber-pharmacist agreement. (2) “Applicants” means physicia…

.02 Content of Protocol. A. A protocol shall: (1) Be: (a) Written; and (b) Condition or disease-state specific; and (2) Contain the following: (a) The condition that the protocol is designed to manage; (b) A list of medications that may be used under the auspices of the protocol;…

.03 Content of Prescriber-Pharmacist Agreement. A. The prescriber-pharmacist agreement shall contain the following: (1) The names and signatures of the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists authorized to act und…

.04 Requirements for Participation in Drug Therapy Management. A. In order to enter into a therapy management contract, a pharmacist: (1) Shall be licensed by and in good standing with the Board of Pharmacy; (2) Shall possess a Doctor of Pharmacy degree or equivalent training as …

.05 Guidelines for Use of Protocols. A. On receipt of specific instructions from the authorized prescriber regarding a specific patient, the pharmacist may execute the authorized prescriber’s specific instructions even if the instructions deviate from the protocol. B. The protoco…

.06 Therapy Management Contracts. A. A therapy management contract shall be signed by the: (1) Authorized prescriber or authorized prescribers involved in the management of the patient under a prescriber-pharmacist agreement; (2) Pharmacist or pharmacists involved in the manageme…

.07 Fees. A. Scope. This regulation governs authorized prescribers and pharmacists participating in drug therapy management or amendment of authorized prescribers and pharmacists that participate in the prescriber-pharmacist agreements relating to drug therapy management. B. Fees…

.01 Application for Name Change. The name of an individual or entity required to possess a pharmacy or wholesale distribution permit may be changed on a permit if: A. The permit holder submits a notice of name change to the Board within 30 days after the name change, on a form th…

.02 Application for Name Change — Fee. There is no fee for a name change under this chapter.