Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices 44405 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–865] 

Bulk Manufacturer of Controlled 

Substances Application: Bulk 

Manufacturer of Marihuana: PA 

Options for Wellness, Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is providing 

notice of an application it has received 

from an entity applying to be registered 

to manufacture in bulk basic class(es) of 

controlled substances listed in schedule 

I. DEA intends to evaluate this and other 

pending applications according to its 

regulations governing the program of 

growing marihuana for scientific and 

medical research under DEA 

registration. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefor, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before October 12, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. To ensure proper handling of 

comments, please reference Docket No. 

DEA–865 in all correspondence, 

including attachments. 

SUPPLEMENTARY INFORMATION: The 

Controlled Substances Act (CSA) 

prohibits the cultivation and 

distribution of marihuana except by 

persons who are registered under the 

CSA to do so for lawful purposes. In 

accordance with the purposes specified 

in 21 CFR 1301.33(a), DEA is providing 

notice that the entity identified below 

has applied for registration as a bulk 

manufacturer of schedule I controlled 

substances. In response, registered bulk 

manufacturers of the affected basic 

class(es), and applicants therefor, may 

file written comments on or objections 

of the requested registration, as 

provided in this notice. This notice does 

not constitute any evaluation or 

determination of the merits of the 

application submitted. 

The applicant plans to manufacture 

bulk active pharmaceutical ingredients 

(APIs) for product development and 

distribution to DEA registered 

researchers. If the application for 

registration is granted, the registrant 

would not be authorized to conduct 

other activity under this registration 

aside from those coincident activities 

specifically authorized by DEA 

regulations. DEA will evaluate the 

application for registration as a bulk 

manufacturer for compliance with all 

applicable laws, treaties, and 

regulations and to ensure adequate 

safeguards against diversion are in 

place. 

As this applicant has applied to 

become registered as a bulk 

manufacturer of marihuana, the 

application will be evaluated under the 

criteria of 21 U.S.C. 823(a). DEA will 

conduct this evaluation in the manner 

described in the rule published at 85 FR 

82333 on December 18, 2020, and 

reflected in DEA regulations at 21 CFR 

part 1318. 

In accordance with 21 CFR 

1301.33(a), DEA is providing notice that 

on May 26, 2021, PA Options for 

Wellness, Inc., 4711 Queen Avenue, 

Suite 201, Harrisburg, Pennsylvania 

17109–3125, applied to be registered as 

a bulk manufacturer of the following 

basic class(es) of controlled substances: 

Controlled substance Drug 

code Schedule 

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

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

Tetrahydrocannabinols .... 7370 I 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2021–17171 Filed 8–11–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–878] 

Importer of Controlled Substances 

Application: Epic Pharma, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Epic Pharma, LLC. has 

applied to be registered as an importer 

of basic class(es) of controlled 

substance(s). Refer to Supplementary 

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 September 13, 2021. Such 

persons may also file a written request 

for a hearing on the application on or 

before September 13, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing must 

be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All requests for a 

hearing should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on July 7, 2021, Epic 

Pharma, LLC., 22715 North Conduit 

Avenue, Laurelton, New York 11413, 

applied to be registered as an importer 

of the following basic class(es) of 

controlled substance(s): 

Controlled substance Drug 

code Schedule 

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

The company plans to import the 

listed controlled substance for research 

and development purposes. 

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 Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2021–17182 Filed 8–11–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–875] 

Importer of Controlled Substances 

Application: Globyz Pharma, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Globyz Pharma, LLC. has 

applied to be registered as an importer 

of basic class(es) of controlled 

substance(s). Refer to Supplementary 

Information listed below for further 

drug information. 


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