02-392-3 Me. Code R. § 13-9

Current through 2024-51, December 18, 2024
Section 392-3-13-9 - Permanent Closing of a Retail Pharmacy
1. Notification
A. A retail pharmacy shall notify the board of the pharmacy's permanent closing at least 14 days prior to closing. The notice shall include the name and address of the pharmacy to be closed; the date of closure; the name and address of the pharmacy acquiring the prescription inventory; and the name and address of the pharmacy acquiring the prescription files and patient profiles.
B. A retail pharmacy shall notify the DEA of the pharmacy's permanent closing at least 14 days prior to closing. The notice shall include the name, address, and DEA registration number of the pharmacy to be closed; the name, address, and DEA registration number of the pharmacy acquiring the controlled substances; and the date on which the transfer will occur.
C. A retail pharmacy shall notify the general public of the pharmacy's permanent closing at least 14 days prior to closing. The notice shall include the date of closure and the new location of the pharmacy's patient prescription files. Notice shall be given by prominent posting in a public area of the store and by display advertisement in a newspaper of general circulation in the area served by the pharmacy.
2. Closing day procedures
A. The retail pharmacy shall take a complete inventory of all controlled substances.
B. The retail pharmacy shall dispose of controlled substances as follows:
(1) If the controlled substances are being sold or given to another DEA registrant-
(a) The transfer of Schedule II controlled substances shall be made on closing day and memorialized by a properly executed DEA Form 222; and
(b) The transfer of Schedule III, IV, and V controlled substances shall be made on closing day and memorialized by invoice, with copies to each party and the board.
(2) If the controlled substances are not being sold or given to another DEA registrant, the retail pharmacy shall turn over to the board on closing day for safekeeping, at the sole expense of the pharmacy, all controlled substances in its possession, custody or control, together with appropriate inventory information. The pharmacy shall lawfully sell or dispose of these drugs within 60 days after closure. If the pharmacy fails to lawfully sell or dispose of these drugs within that time, the drugs shall be deemed forfeit to the board on the 61st day after closure without need of any action by the board. The board shall then dispose of the drugs with no compensation to the pharmacy. In the event of forfeiture as set forth herein, the retail pharmacy remains liable for all costs incurred by the board in the transportation, safekeeping and disposition of the drugs.
C. The retail pharmacy shall dispose of prescription legend drugs as follows:
(1) If the prescription legend drugs are being sold or given to another pharmacy, the bulk transfer of such drugs shall be made on closing day and memorialized by invoice, with copies to each party.
(2) If the prescription legend drugs are not being sold or given to another pharmacy, the retail pharmacy shall turn over to the board on closing day for safekeeping, at the sole expense of the drug outlet, all prescription legend drugs in its possession, custody or control, together with appropriate inventory information. The pharmacy shall lawfully sell or dispose of these drugs within 60 days after closure. If the pharmacy fails to lawfully sell or dispose of these drugs within that time, the drugs shall be deemed forfeit to the board on the 61st day after closure without need of any action by the board. The board shall then dispose of the drugs with no compensation to the pharmacy. In the event of forfeiture as set forth herein, the retail pharmacy remains liable for all costs incurred by the board in the transportation, safekeeping and disposition of the drugs.
D. Disposition of prescription files and patient profiles
(1) If the prescription files and patient profiles are being sold to another pharmacy or are being transferred to another pharmacy in the same chain, the retail pharmacy that is closing shall transfer the files and profiles on closing day. The recipient pharmacy must keep the files and profiles for the time required by Chapter 24 of the board's rules.
(2) If the prescription files and patient profiles are not being sold or transferred, the retail pharmacy shall find a pharmacy within a reasonable distance that is willing to be custodian of the records. The custodian pharmacy must keep the files and profiles for the time required by Chapter 24 of the board's rules.
E. Security. The retail pharmacy shall ensure the security of its drug supply at all times during the closing procedures.
3. Reports and Returns Due After Closing

Within 30 days after closing, the retail pharmacy shall make the following reports and returns:

A. To DEA -
(1) Name, address, and DEA number of the closed pharmacy;
(2) Return of any unused DEA Form 222s;
(3) Copy of the controlled substances inventory and all schedules; and
(4) Copies of DEA Form 222 completed pursuant to Section 8(2)(B)(1)(a) of this chapter.
B. To the board -
(1) Return of the license for the closed retail pharmacy;
(2) Report that all signs indicating the presence of the closed pharmacy have been removed;
(3) Report that all labels and blank prescriptions have been destroyed;
(4) Report that the DEA license and all unused DEA Form 222s have been returned to the DEA;
(5) Report as to the disposition of controlled substances and prescription legend drugs made pursuant to Section 8(2)(B)and (C) of this chapter; and
(6) Report as to the disposition of prescription files and patient profiles made pursuant to Section 8(2)(D) of this chapter.
4. Chemicals and Hazardous Materials

The retail pharmacy shall remove and dispose of all chemicals and hazardous materials prior to closing in accordance with the Hazardous Waste Management Rules of the Department of Environmental Protection identified in Chapter 23, Section 2(2) of the board's rules (as applicable). The pharmacy is responsible for all costs directly and indirectly incurred by the board in removing and disposing of chemicals and hazardous materials that the licensee fails to remove from the premises.

02-392 C.M.R. ch. 3, § 13-9