Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.37 - Pharmacy Permit Holder Requirements - Wholesale Distribution and Nonresident Pharmacy Operations
Section 10.34.37.04 - Requirements for Nonresident Pharmacy Operations
Universal Citation: MD Code Reg 10.34.37.04
Current through Register Vol. 51, No. 19, September 20, 2024
A. A Maryland licensed pharmacist may not be employed by more than one nonresident pharmacy at a time.
B. A nonresident pharmacy shall:
(1) Hold a pharmacy permit issued by the
Board;
(2) Have a pharmacist on
staff who is:
(a) Licensed by the
Board;
(b) Designated as the
pharmacist responsible for providing pharmaceutical services to patients in the
State; and
(c) Regularly available
on-site as needed to meet Maryland patient's needs;
(3) Designate another Maryland licensed
pharmacist as the pharmacist on staff within 60 days upon the loss of the
current designated pharmacist on staff;
(4) Be located and equipped so that the
pharmacy may be operated without endangering the public health or
safety;
(5) Maintain at all times a
current reference library that is appropriate to meet the needs of:
(a) The practice specialty of that pharmacy;
and
(b) The consumers the pharmacy
serves;
(6) Comply with
the regulations adopted by the Board establishing the types of texts required
to be included in the reference libraries in each of the various practice
specialty pharmacies;
(7) Maintain
at all times the minimum professional and technical equipment and sanitary
appliances that are necessary in a pharmacy to:
(a) Prepare and dispense prescriptions
properly; and
(b) Otherwise operate
a pharmacy;
(8) Be
equipped with the minimum equipment and appliances specified by the Board under
this regulation;
(9) Be kept in a
clean and orderly manner;
(10)
Store all prescription or nonprescription drugs or devices properly and safely
as set forth in COMAR
10.34.22.06;
(11) On an annual basis and within 30 days
after a change of office, corporate officer, or pharmacist, disclose to the
Board the location, names, and titles of all principal corporate officers and
all pharmacists who are dispensing prescriptions for drugs or devices to
persons in this State;
(12) Comply
with all lawful directions and requests for information from the regulatory or
licensing agency of the state in which it is located and all requests for
information made by the Board pursuant to this regulation;
(13) Maintain at all times a valid, unexpired
permit to conduct a pharmacy in compliance with the laws of the state in which
it is located;
(14) Maintain
records of prescription drugs or devices dispensed to patients in this State so
that the records are readily retrievable;
(15) During the pharmacy's regular hours of
operation, but not less than 6 days a week, and for a minimum of 40 hours per
week, provide a toll-free telephone service to facilitate communication between
patients in this State and a pharmacist or an individual who:
(a) Has access to the patient's prescription
records; and
(b) Is required to
refer patients in the State to the responsible pharmacist licensed in the
State, as appropriate;
(16) Disclose the pharmacy's toll-free
telephone number on a label affixed to each container of drugs or
devices;
(17) Comply with the laws
of this State relating to the confidentiality of prescription records if there
are no laws relating to the confidentiality of prescription records in the
state in which the nonresident pharmacy is located;
(18) With regard to a prescription drug that
is delivered in this State by the United States Postal Service, a common
carrier, or a delivery service and is not personally hand delivered directly to
a patient or to the agent of the patient at the residence of the patient or at
another location designated by the patient:
(a) Provide a general written notice in each
shipment of a prescription drug that alerts a consumer that, under certain
circumstances, a medication's effectiveness may be affected by exposure to
extremes of heat, cold, or humidity; and
(b) Provide a specific written notice in each
shipment of a prescription drug that provides a consumer with a toll-free or
local consumer access telephone number accessible during regular hours of
operation, which is designed to respond to consumer questions pertaining to
medications;
(19)
Provide information regarding the process for resolving incorrectly filled
prescriptions in accordance with existing regulations by:
(a) Posting a sign that is conspicuously
positioned and readable by consumers at the point where prescription drugs are
dispensed to consumers; or
(b)
Including written information regarding the process with each prescription
dispensed; and
(20) If
dispensing compounded sterile preparations to patients in the State, comply
with:
(a) USP standards; and
(b) COMAR 10.34.19.
C. A nonresident pharmacy may not:
(1) Offer pharmaceutical services under any
term or condition that tends to interfere with or impair the free and complete
exercise of professional pharmaceutical judgment or skill;
(2) Make any agreement that denies a patient
a free choice of pharmacist or pharmacy services;
(3) Participate in any activity that is a
ground for Board action against:
(a) A
licensed pharmacist under Health Occupations Article, §12-313, Annotated
Code of Maryland;
(b) A registered
pharmacy technician under Health Occupations Article, §12-6B-09,
Annotated Code of Maryland; or
(c)
A registered pharmacy intern under Health Occupations Article, §12-6D-11,
Annotated Code of Maryland; or
(4) Allow an unauthorized individual to
represent that the individual is a pharmacist, a registered pharmacy intern, or
registered pharmacy technician.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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