Current through Register Vol. 51, No. 19, September 20, 2024
A designated Department representative shall:
A. Establish and maintain inventories and
records of transactions regarding the receipt and distribution or other
disposition of prescription drugs and devices;
B. Include the following information in the
records required under §A of this regulation:
(1) The source of a prescription drug or
device, including the:
(a) Name and principal
address of the seller or transferor; and
(b) Address of the location from which a
prescription drug or device was shipped;
(2) The identity and quantity of the
prescription drugs and devices received and distributed or disposed
of;
(3) The dates of receipt and
distribution or other disposition of the prescription drugs and devices;
and
(4) If required by Health
Occupations Article, § 12-6 C-10, Annotated Code of Maryland, the
pedigrees for prescription drugs that are wholesale distributed outside the
normal distribution channel;
C. Establish, maintain, and adhere to written
policies and procedures addressing the:
(1)
Receipt, security, storage, inventory, and distribution of prescription drugs
and devices;
(2) Identifying,
recording, and reporting of losses or thefts; and
(3) Correcting of errors and inaccuracies in
inventories;
D. Include
in the written policies and procedures established according to §C of this
regulation the following:
(1) A procedure by
which the oldest approved and unexpired stock of a prescription drug or device
is distributed first;
(2)
Procedures to be followed for handling a recall and withdrawal of a
prescription drug or device due to:
(a) An
action initiated at the request of the United States Food and Drug
Administration (FDA) or other federal, State, or local law enforcement or other
government agency, including the Maryland Division of Drug Control;
(b) A voluntary action by the manufacturer to
remove a defective or potentially defective prescription drug or device from
the market; and
(c) An action
undertaken to promote public health and safety by replacing existing
merchandise with an improved product or new package design;
(3) A procedure to ensure that the
Department is prepared for, protected against, and able to handle a crisis that
affects security or operation of a facility if any of the following situations
occur:
(a) Strike;
(b) Fire;
(c) Flood;
(d) Catastrophic health emergency as defined
in Public Safety Article, § 14-3 A-01, Annotated Code of
Maryland;
(e) Terrorist
activities;
(f) Natural disaster;
or
(g) Other situations of local,
State, or national emergency;
(4) A procedure to ensure that outdated
prescription drugs and devices are segregated from other prescription drugs and
devices and either returned to the manufacturer or destroyed;
(5) A procedure for:
(a) The disposing and destruction of
containers, labels, and packaging to ensure that the containers, labels, and
packaging cannot be used in counterfeiting activities; and
(b) Appropriate witnessing of the destruction
of any labels, packaging, immediate containers, or containers in accordance
with applicable federal and State requirements; and
(6) A procedure for:
(a) Identifying, investigating, and reporting
prescription drug inventory discrepancies involving counterfeiting, suspicion
of counterfeiting, contraband, or suspicion of contraband; and
(b) Upon discovery, the reporting of a
discrepancy within 5 business days to the Board;
E. Make available inventories and
records for inspection and copying by authorized federal or State law
enforcement agency officials for a period of 3 years after the date of creation
of the inventories and records;
F.
Keep the records described in this regulation readily available for inspection
by authorized federal, State, or local law enforcement agency officials during
the retention period, either:
(1) At the
inspection site; or
(2) So as to be
immediately retrievable by computer or other electronic means;
G. Within 5 working days of a
request by an authorized official of a federal, State, or local law enforcement
agency, make available for inspection records kept at a central location apart
from the inspection site and not electronically retrievable;
H. Establish and maintain procedures for
reporting counterfeit and contraband or suspected counterfeit and contraband
drugs or devices or counterfeiting and contraband or suspected counterfeiting
and contraband activities to the Board and the FDA;
I. Maintain a system for the mandatory
reporting of significant inventory losses of prescription drugs and devices
where it is known or suspected that diversion is occurring to:
(1) The Board;
(2) The FDA; and
(3) Where applicable, the U.S. Drug
Enforcement Administration; and
J. Consider the following factors when
determining if there has been a significant inventory loss:
(1) The schedule of the missing
items;
(2) The abuse or misuse
potential of the missing items;
(3)
The abuse or misuse potential in the Department's area of the missing
substance;
(4) The quantity missing
in relation to the total quantity purchased, for example, one tablet per
one bottle or container;
(5) Whether this is the first time a
potentially significant inventory loss has occurred;
(6) Whether this loss was reported to local
law enforcement authorities; and
(7) Whether there is a significant resale
value of the missing items.
