Md. Code Regs. 10.34.22.10

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.22.10 - Required Information and Procedures for Ceasing to Operate

A. If a wholesale distributor is located in another state, a wholesale distributor anticipating ceasing to operate in Maryland shall return the permit to the Board within 10 days of ceasing to operate in Maryland.

B. Procedures for Wholesale Distributors Located in this State for Ceasing to Operate.

(1) Notification.

(a) At least 30 days before a wholesale distributor's anticipated date of ceasing to operate, the wholesale distributor shall notify the Board in writing, by certified mail, return receipt requested, or hand delivered to the Board's office, of the day on which the wholesale distributor will cease to operate.

(b) A wholesale distributor shall:

(i) Notify drug and device suppliers that supply prescription drugs and devices to the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate;

(ii) Notify manufacturers, wholesale distributors, licensed pharmacies and authorized prescribers that receive prescription drugs and devices from the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate; and

(iii) Comply with applicable federal regulations.

(2) The wholesale distributor shall submit to and pass a closing inspection conducted by the Board.

(3) With the exception of controlled dangerous substances, the wholesale distributor shall dispose of prescription drugs or devices in stock by one or more of the following means:

(a) Returning the prescription drugs or devices to a distributor or manufacturer;

(b) Transferring the prescription drugs or devices to another wholesale distributor, licensed pharmacy, authorized prescriber, or other person or entity approved by the Board; or

(c) Destroying in accordance with this regulation.

(4) Disposition of Controlled Dangerous Substances. The wholesale distributor shall comply with the procedures set forth in this regulation in addition to those set forth in COMAR 10.19.03.10 governing the transfer, return or disposal of controlled dangerous substances.

(5) At the closing inspection, the wholesale distributor shall provide to the Board the following:

(a) The exact date on which the wholesale distributor ceased to operate;

(b) A copy of the inventory of prescription drugs or devices disposed of, transferred, or returned.

(c) The names, addresses, telephone numbers, and Drug Enforcement Administration registration numbers, if applicable, of the persons or business entities to whom prescription drugs or devices in stock were returned or transferred under this regulation;

(d) The wholesale distributor permit;

(e) If prescription drugs or devices are destroyed pursuant to this regulation, a letter, signed under oath by the wholesale distributor, stating the:

(i) Date, place and manner in which the prescription drugs or devices were destroyed;

(ii) Names, addresses, and telephone numbers of the persons responsible for destroying the prescription drugs or devices; and

(iii) Name, dosage unit, and quantity of each type of prescription drug or device destroyed; and

(f) If any pedigrees or other documents are transferred, a letter, signed under oath by the wholesale distributor, stating:

(i) The date, time, place to which and manner in which the pedigrees or other documents were transferred; and

(ii) The names, addresses, and telephone numbers of the persons responsible for transferring the pedigrees or other documents.

(6) At the closing inspection, the wholesale distributor shall provide to the Division of Drug Control the following pertaining to controlled dangerous substances:

(a) The exact date on which the wholesale distributor ceased to operate;

(b) A copy of the closing inventory of controlled dangerous substances required by the Drug Enforcement Administration.

(c) The names, addresses, telephone numbers, Drug Enforcement Administration registration numbers, Division of Drug Control registration numbers, and Board permit numbers, if applicable, of the persons or business entities to whom controlled dangerous substances in stock were returned or transferred under this regulation; and

(d) The State Department of Health and Mental Hygiene Controlled Dangerous Substance Registration for cancellation.

Md. Code Regs. 10.34.22.10

Regulations .10, adopted effective 41:10 Md. R. 561, eff.7/1/2014