2020-09706. Bulk Manufacturer of Controlled Substances Application: Purisys, LLC

ACTION:

Notice of application.

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 July 6, 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 January 30, 2020, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:

Controlled substance	Drug code	Schedule
Amphetamine	1100	II
Lisdexamfetamine	1205	II
Cathinone	1235	I
Methylphenidate	1724	II
Morphine-N-Oxide	9307	I
Normophine	9313	I
Oripavine	9330	II
Thebaine	9333	II
Opium Tincture	9630	II
Oxymorphone	9652	II
Noroxymorphone	9668	II
Alfentanil	9737	II
Sufentanil	9740	II
Carfentanil	9743	II
Tapentadol	9780	II
Fentanyl	9801	II

The company plans to manufacture the above-listed controlled substances to produce active pharmaceutical ingredients (API) for their prescription drug products and manufacture analytical reference standards for distribution to customers. The company also plans to use these substances for lab scale research and development activities.

William T. McDermott,

Assistant Administrator.