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

Current through Register Vol. 51, No. 14, July 12, 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.