Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.03 - Inpatient Institutional Pharmacy
Section 10.34.03.02 - Definitions
Universal Citation: MD Code Reg 10.34.03.02
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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