Sec. 10.34.22.07. Minimum Requirements for Maintenance of Prescription Drug or Device Distribution Records

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, §12-6C-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.

B. Written Policies and Procedures.

(1) A wholesale distributor shall establish, maintain, and adhere to written policies and procedures which shall be followed for:

(a) The receipt, security, storage, inventory, and distribution of prescription drugs or devices;

(b) Identifying, recording, and reporting losses or thefts; and

(c) Correcting errors and inaccuracies in inventories.

(2) A wholesale distributor shall include in the written policies and procedures the following:

(a) A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first;

(b) Procedures to be followed for adequate handling of a recall and withdrawal of a prescription drug or device due to:

(i) An action initiated at the request of the United States Food and Drug Administration or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control;

(ii) A voluntary action by the manufacturer to remove a defective or potentially defective drug or device from the market; and

(iii) An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(c) A procedure to ensure that the wholesale distributor is prepared for, protected against, and is able to handle a crisis that affects security or operation of a facility if any of the following situations occurs:

(i) Strike;

(ii) Fire;

(iii) Flood;

(iv) Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland;

(v) Terrorist activities;

(vi) Other natural disaster; or

(vii) Other situations of local, State, or national emergency;

(d) A procedure to ensure that an outdated prescription drug or device is segregated from other drugs or devices and either returned to the manufacturer or destroyed;

(e) A procedure for the disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of 3 years, and the appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and

(f) A procedure for identifying, segregating, investigating, and reporting prescription drug inventory discrepancies involving counterfeit, suspect of being counterfeit, contraband, or suspect of being contraband, in the inventory and reporting of such discrepancies within 5 business days to the Board and appropriate federal or State agency upon discovery of such discrepancies.

(3) If deviation is appropriate, a wholesale distributor may temporarily deviate from the requirement in §B(2)(a) of this regulation that the oldest approved and unexpired stock be distributed first.

(4) The wholesale distributor shall maintain documentation of the disposition of outdated prescription drugs or devices for 2 years after the disposition of the outdated prescription drugs or devices pursuant to procedures under §B(2)(d) of this regulation.

C. Responsible Individuals. A wholesale distributor shall establish and maintain a list of officers, directors, managers, the designated representative, and others in charge of wholesale distribution, storage, and handling, including:

(1) A description of their duties; and

(2) A summary of their qualifications.

D. Compliance with Federal, State, and Local Law. A wholesale distributor shall:

(1) Operate in compliance with applicable federal, State, and local laws and regulations;

(2) Permit at reasonable times and in a reasonable manner, the Board, the State Division of Drug Control, and any other authorized federal, State, and local law enforcement officials showing proper identification to:

(a) Enter and inspect the distributor's premises and delivery vehicles; and

(b) Audit and copy the distributor's records and written operating procedures; and

(3) If dealing in controlled substances:

(a) Register with the:

(i) Maryland Division of Drug Control; and

(ii) United States Drug Enforcement Administration; and

(b) Comply with all applicable federal, State, and local regulations.

E. Salvaging and Reprocessing.

(1) A wholesale distributor is subject to the provisions of applicable federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including 21 CFR Parts 207, 210, and 211, as amended.

(2) A wholesale distributor is subject to the provisions of any applicable federal, State, or local laws or regulations that relate to prescription device product salvaging or reprocessing.