Regulation .17 Transfer of Controlled Substances.
Regulation .17 Transfer of Controlled Substances.LinkCopy Citation
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 registrant-transferor 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”.