Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.07 - Minimum Requirements for Maintenance of Prescription Drug or Device Distribution Records

Current through Register Vol. 51, No. 14, July 12, 2024
A. Record
				  Keeping.
(1) A wholesale distributor shall
				  establish and maintain inventories and records of transactions regarding the
				  receipt and distribution or other disposition of prescription drugs or
				  devices.
(2) The records required
				  under §A(1) of this regulation shall include the following information:
(a) The source of the prescription drugs or
				  devices, including the:
(i) Name and principal
				  address of the seller or transferor; and
(ii) Address of the location from which the
				  prescription drugs or devices were shipped;
(b) The identity and quantity of the
				  prescription drugs or devices received and distributed or disposed
				  of;
(c) The dates of receipt and
				  distribution or other disposition of the prescription drugs or devices;
				  and
(d) The pedigrees, if required
				  by Health Occupations Article, § 12-6 C-10, Annotated Code of Maryland,
				  for prescription drugs that are wholesale distributed outside the normal
				  distribution channel.
(3) The wholesale distributor shall make
				  available inventories and records for inspection and copying by authorized
				  federal, State, or local law enforcement agency officials for a period of 3
				  years after their date of creation.
(4) The wholesale distributor shall 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:
(a) At the
				  inspection site; or
(b) So as to be
				  immediately retrievable by computer or other electronic means.
(5) Within 5 working days of a
				  request by an authorized official of a federal, State, or local law enforcement
				  agency, the wholesale distributor shall make available for inspection records
				  kept at a central location apart from the inspection site and not
				  electronically retrievable.
(6)
				  Facilities shall 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.
(7) Wholesale distributors shall 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 the Board, the FDA, and, where applicable, to the DEA.
(8) Wholesale distributors shall consider the
				  following factors when determining if there has been a significant inventory
				  loss:
(a) The schedule of the missing
				  items;
(b) The abuse or misuse
				  potential of the missing items;
(c)
				  The abuse or misuse potential in the wholesale distributor's area of the
				  missing substance;
(d) The quantity
				  missing in relation to the total quantity purchased (one tablet vs. one bottle
				  or container);
(e) Whether this is
				  the first time a potentially significant inventory loss has occurred;
(f) Whether this loss was reported to local
				  law enforcement authorities; and
(g) Whether there is a significant resale
				  value of the missing items.