43570 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric Acid ... 2010 I 

Marihuana Extract .................... 7350 I 

Marihuana ................................ 7360 I 

The company plans to import finished 

dosage unit products containing gammahydroxybutryic acid and cannabis 

extracts for clinical trial studies. 

These cannabis extracts compounds 

are listed under drug code 7350. No 

other activity for these drug codes is 

authorized for this registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of FDA approved or nonapproved finished dosage forms for 

commercial sale. 

Dated: September 11, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–19833 Filed 9–15–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Bulk Manufacturer of Controlled 

Substances Application: Specgx LLC 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.33(a) on 

or before November 17, 2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.33(a), this is notice that on August 

9, 2017, Specgx LLC, 3600 North 

Second Street, Saint Louis, Missouri 

63147 applied to be registered as a bulk 

manufacturer of the following basic 

classes of controlled substances: 

Controlled substance Drug code Schedule 

Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I 

Tetrahydrocannabinols .................................................................................................................................................... 7370 I 

Codeine-N-oxide .............................................................................................................................................................. 9053 I 

Dihydromorphine ............................................................................................................................................................. 9145 I 

Difenoxin .......................................................................................................................................................................... 9168 I 

Morphine-N-oxide ............................................................................................................................................................ 9307 I 

Normorphine .................................................................................................................................................................... 9313 I 

Norlevorphanol ................................................................................................................................................................ 9634 I 

Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................... 9821 I 

Butyryl Fentanyl ............................................................................................................................................................... 9822 I 

Amphetamine ................................................................................................................................................................... 1100 II 

Methamphetamine ........................................................................................................................................................... 1105 II 

Lisdexamfetamine ............................................................................................................................................................ 1205 II 

Methylphenidate .............................................................................................................................................................. 1724 II 

Nabilone ........................................................................................................................................................................... 7379 II 

4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II 

Codeine ........................................................................................................................................................................... 9050 II 

Dihydrocodeine ................................................................................................................................................................ 9120 II 

Oxycodone ....................................................................................................................................................................... 9143 II 

Hydromorphone ............................................................................................................................................................... 9150 II 

Diphenoxylate .................................................................................................................................................................. 9170 II 

Ecgonine .......................................................................................................................................................................... 9180 II 

Hydrocodone ................................................................................................................................................................... 9193 II 

Levorphanol ..................................................................................................................................................................... 9220 II 

Meperidine ....................................................................................................................................................................... 9230 II 

Methadone ....................................................................................................................................................................... 9250 II 

Methadone intermediate .................................................................................................................................................. 9254 II 

Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. 9273 II 

Morphine .......................................................................................................................................................................... 9300 II 

Oripavine ......................................................................................................................................................................... 9330 II 

Thebaine .......................................................................................................................................................................... 9333 II 

Opium tincture ................................................................................................................................................................. 9630 II 

Opium, powdered ............................................................................................................................................................ 9639 II 

Oxymorphone .................................................................................................................................................................. 9652 II 

Noroxymorphone ............................................................................................................................................................. 9668 II 

Alfentanil .......................................................................................................................................................................... 9737 II 

Remifentanil ..................................................................................................................................................................... 9739 II 

Sufentanil ......................................................................................................................................................................... 9740 II 

Tapentadol ....................................................................................................................................................................... 9780 II 

Fentanyl ........................................................................................................................................................................... 9801 II 


sradovich on DSKBBY8HB2PROD with NOTICES
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices 43571 

The company plans to manufacture 

bulk active pharmaceutical ingredients 

(APIs) for distribution to its customers. 

Dated: September 13, 2017 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–19786 Filed 9–15–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Specgx LLC 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.34(a) on 

or before October 18, 2017. Such 

persons may also file a written request 

for a hearing on the application 

pursuant to 21 CFR 1301.43 on or before 

October 18, 2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for hearing must be 

sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All request for hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/LJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.34(a), this is notice that on August 

9, 2017, Specgx LLC, 3600 North 

Second Street, Saint Louis, Missouri 

63147 applied to be registered as an 

importer of the following basic classes 

of controlled substances: 

Controlled substance Drug 

code Schedule 

Marihuana ....................... 7360 I 

Phenylacetone ................ 8501 II 

Coca Leaves .................. 9040 II 

Opium, raw ..................... 9600 II 

Poppy Straw Concentrate.9670 II 

The company plans to import the 

listed controlled substances to bulk 

manufacture into Active Pharmaceutical 

Ingredients for distribution to its 

customers. In reference to drug code 

7360 (marihuana) the company plans to 

import a synthetic cannabidiol. No other 

activity for this drug code is authorized 

for this registration. Placement of these 

drug codes onto the company’s 

registration does not translate into 

automatic approval of subsequent 

permit applications to import controlled 

substances. Approval of permit 

applications will occur only when the 

registrant’s business activity is 

consistent with what is authorized 

under 21 U.S.C. 952(a)(2). Authorization 

will not extend to the import of FDA 

approved or non-approved finished 

dosage forms for commercial sale. 

Dated: September 11, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–19784 Filed 9–15–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Bulk Manufacturer of Controlled 

Substances Application: Halo 

Pharmaceutical, Inc. 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.33(a) on 

or before November 17, 2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.33(a), this is notice that on July 11, 

2017, Halo Pharmaceutical, Inc., 30 

North Jefferson Road, Whippany, New 

Jersey 07981 applied to be registered as 

a bulk manufacturer the following basic 

classes of controlled substances: 

Controlled substance Drug 

code Schedule 

Dihydromorphine .......... 9145 I 

Hydromorphone ............ 9150 II 

The company plans to manufacture 

Hydromorphone (9150) for distribution 

to its customers. Dihydromorphine 

(9145) is an intermediate in the 

manufacture of Hydromorphone and is 

not for commercial distribution. 

Dated: September 11, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–19834 Filed 9–15–17; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Unither Manufacturing 

LLC 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.34(a) on 

or before October 18, 2017. Such 

persons may also file a written request 


sradovich on DSKBBY8HB2PROD with NOTICES