Md. Code Regs. 10.13.02.06

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.13.02.06 - Record Keeping

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.

Md. Code Regs. 10.13.02.06