Importer of Controlled Substances Application: Aspen API, Inc.

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Aspen API, Inc. has applied to be registered as an importer 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 August 9, 2021. Such persons may also file a written request for a hearing on the application on or before August 9, 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 request 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 May 5, 2021, Aspen API, Inc., 2136 Wolf Road, Des Plaines, Illinois 60018, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substance as a bulk active pharmaceutical ingredient (API) for distribution to manufacturers of finished dosage prescription drugs. 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 the Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.