Bulk Manufacturer of Controlled Substances Application: Eli Elsohly Laboratories
Eli Elsohly Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for fu...
Eli Elsohly Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 7, 2020. Such persons may also file a written request for a hearing on the application on or before December 7, 2020.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.33(a), this is notice that on August 17, 2020, Eli Elsohly Laboratories, 5 Industrial Park Drive, Oxford, Mississippi 38655, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled substances
Drug code
Schedule
Marihuana Extract
7350
I
Marihuana
7360
I
Tetrahydrocannabinols
7370
I
Dihydromorphone
9145
I
Amphetamine
1100
II
Methamphetamine
1105
II
Cocaine
9041
II
Codeine
9050
II
Dihydrocodeine
9120
II
Oxycodone
9143
II
Hydromorphone
9150
II
Ecgonine
9180
II
Hydrocodone
9193
II
Morphine
9300
II
Thebaine
9333
II
Oxymorphone
9652
II
The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to isolate these controlled substances from procured 7350 (marihuana extract). In reference to drug code 7360, no cultivation activities are authorized for this registration. No other activities for these drug codes are authorized for this registration.