Md. Code Regs. 10.19.03.17

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

Section 10.19.03.17 - Transfer of Controlled Substances

A. When closing business activities, a registrant shall:

(1) Dispose of all controlled dangerous substances in accordance with Regulation .16 of this chapter; and

(2) Return the controlled substances registration certificate to the Office of Controlled Substances Administration inspector at the time of the closing inspection.

B. Change of Ownership.

(1) A Change of Ownership requires the registrant to notify the Department in writing, Attention to the Office of Controlled Substances Administration.

(2) The written notification shall be submitted:

(a) In person;

(b) By registered mail; or

(c) By certified mail with a return receipt request.

(3) The written notification must be received 14 days before the transfer occurs.

(4) The Secretary has the authority to waive the 14-day time limitation in individual instances.

(5) The written notification shall contain the following information:

(a) The name;

(b) The address;

(c) The registration number; and

(d) The authorized business activity of the:

(i) Registrant-transferor discontinuing the business; and

(ii) Registrant-transferee acquiring the business;

(e) Whether the business activities will be:

(i) Continued at the location registered by the person discontinuing business; or

(ii) Moved to another location and, if so, the address of the new location; and

(f) The date on which the transfer of controlled substances will occur.

(6) Except for transfer denials by the Secretary, the registrant-transferor may distribute, without being registered to distribute, controlled substances in the registrant-transferor's possession to the registrant-transferee in accordance with the following procedures, on the date of transfer of the controlled substances:

(a) A complete inventory of all controlled substances being transferred shall be taken and serve as the final inventory of the registranttransferor and the initial inventory of the registrant-transferee;

(b) A copy of the inventory shall be included in the records of both the transferor and transferee;

(c) A copy of the inventory shall be filed with the Department if requested by the Secretary;

(d) Transfers of Schedule I or II controlled substances shall require the use of order forms in accordance with 21 CFR §1305 ;

(e) All transferor-controlled substance records shall be transferred to the transferee; and

(f) Pursuant to 21 CFR §1304, transferors are required to make reports, which shall be marked as "Final".

Md. Code Regs. 10.19.03.17

Regulation .17 adopted effective 51:20 Md. R. 899, eff. 10/14/2024.