Md. Code Regs. 10.34.03.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.03.02 - 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

(iii) Drug procurement; and

(b) Located in the same building or pavilion as the other institutional pharmacy.

(1-1) "Direct supervision" means that a licensed pharmacist is physically available to supervise the performance of delegated pharmacy acts.

(1-2) "Director of pharmacy" means a pharmacist who is responsible for the pharmacy services provided by an institutional pharmacy in compliance with appropriate State and federal laws and regulations.

(2) "Dispense" or "dispensing" means the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient's agent and which entails the:

(a) Interpretation of an authorized prescriber's prescription for a drug or device;

(b) Selection and labeling of the drug or device prescribed pursuant to that prescription; and

(c) Measuring and packaging of the prescribed drug or device in accordance with State and federal laws.

(3) Distribute.

(a) "Distribute" means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Title 12, Annotated Code of Maryland, prior to administration of the provided drug or device to the patient pursuant to a prescription issued by an authorized prescriber.

(b) "Distribute" does not include the operations of a person who holds a permit issued under Health Occupations Article, §12"6C"03, Annotated Code of Maryland.

(4) "Drug" means a prescription or non-prescription medication or other material used in the diagnosis or treatment of injury, illness, or disease.

(5) "Drug recall" means the recall of a drug by a manufacturer or the U.S. Food and Drug Administration (FDA) in the event that there is a reasonable possibility that the use of or exposure to an affected product may cause either:

(a) Adverse effects on health; or

(b) Death.

(6) "Emergency drug supply" means a process for supplying drugs which:

(a) May be required for the emergency need of a patient; and

(b) Is not available from an authorized source in a timely manner.

(7) "Institutional facility" or "institution" means an entity other than a comprehensive care facility, assisted living facility, developmental disabilities facility, or correctional facility whose primary purpose is to provide a physical environment for patients to obtain inpatient, outpatient, or emergency care, except for urgent care facilities that are not part of an institution.

(8) "Institutional medication protocol" means a course of therapy including drug treatment predetermined and documented by the institution and the generally accepted medical practice for proper completion of a particular therapeutic or diagnostic intervention ordered by an authorized prescriber and which allows the pharmacist to execute the protocol.

(9) "Institutional pharmacy" means a pharmacy which:

(a) Provides services to an acute care, rehabilitation, transitional care, chronic care, or mental health hospital;

(b) Engages in compounding, distributing, or dispensing of drugs;

(c) May provide nondispensing functions as described in Regulation .16 of this chapter; and

(d) Has been issued a pharmacy permit pursuant to Health Occupations Article, §§12-401 and 12-403(c), Annotated Code of Maryland.

(10) "Licensed pharmacist" means an individual who is licensed by the Board to practice pharmacy.

(11) "Medication order" means a patient-specific order entered on the chart or a medical record of a patient by an authorized prescriber or the authorized prescriber.s designee for a drug or device that is transmitted in writing, verbally or by electronic means and includes the:

(a) Date ordered;

(b) Drug name;

(c) Dosage;

(d) Dosage form;

(e) Patient name with second identifier such as date of birth or medical record number;

(f) Route of administration;

(g) Administration instructions, if appropriate; and

(h) Signature, if appropriate, of an:

(i) Authorized prescriber, as defined in Health Occupations Article, §12-101(b), Annotated Code of Maryland; or

(ii) Individual permitted to practice medicine without a license as defined in Health Occupations Article, §14-302, Annotated Code of Maryland.

(12) "Order-sets" means predefined orders, including medication orders, that are based on an institutionally approved protocol.

(12-1) "Pavilion" means a detached or semidetached part of a hospital devoted to a special use.

(13) Pharmaceutical care.

(a) "Pharmaceutical care" means the provision of a patient's drug regimen for the purpose of:

(i) Achieving definite outcomes related to the cure or prevention of a disease;

(ii) Elimination or reduction of a patient's symptoms; or

(iii) Arresting or slowing of a disease process by identifying, resolving, or preventing actual or potential drug therapy problems.

(b) "Pharmaceutical care" may include patient counseling and providing information to licensed and certified health care providers.

(14) "Prescription Drug.

(a) "Prescription drug" means any drug required by federal law or regulation to be dispensed only by a prescription.

(b) "Prescription drug" includes:

(i) A biological product; and

(ii) Finished dosage forms and bulk drug substances subject to § 503(b) of the Federal Food, Drug and Cosmetic Act.

(c) "Prescription drug" does not include blood and blood components intended for transfusion or biological products that are also medical devices.

(15) "Second identifier" means a reliable method to:

(a) Identify a patient for whom service or treatment is intended; and

(b) Match the service or treatment intended to the patient.

(16) "Verbal order" means a medication order from an authorized prescriber which is received by an authorized licensed practitioner using appropriate read back procedures that is subsequently recorded in the patient's chart and countersigned by the prescriber within a time period required by the institution.

(17) "Written order" means a medication order that is recorded as a written document by an authorized prescriber.

Md. Code Regs. 10.34.03.02