Importer of Controlled Substances Application: Prof Compounding CTS of Ameri
Prof Compounding CTS of Ameri has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for furt...
Prof Compounding CTS of Ameri 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 submit electronic comments on or objections to the issuance of the proposed registration on or before September 24, 2026. Such persons may also file a written request for a hearing on the application on or before September 24, 2026.
ADDRESSES:
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
www.regulations.gov
and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a
( printed page 54885)
Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on
www.regulations.gov.
If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.34(a), this is a notice that on July 7, 2026, Prof Compounding CTS of Ameri, 9901 South Wilcrest Drive, Houston, Texas 77099-5132, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
Controlled substance
Drug
code
Schedule
Morphine
9300
II
The company plans to import Morphine Sulfate USP as a narcotic raw material for domestic bulk manufacturing and supply under the ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) Program. The imported material will be used to support the strategic domestic supply of essential controlled substance Active Pharmaceutical Ingredients for national preparedness and resilience, including conversion into finished pharmaceutical products by qualified U.S. manufacturers as needed. No other activity for this drug code 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 Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
www.regulations.gov
21 CFR 1301.34(a)
21 U.S.C. 952(a)(2)