Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.
Johnson Matthey Pharmaceutical Materials Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Informatio...
Johnson Matthey Pharmaceutical Materials Inc. has applied to be registered as a bulk manufacturer 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 April 25, 2022. Such persons may also file a written request for a hearing on the application on or before April 25, 2022.
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 November 5, 2021, Johnson Matthey Pharmaceutical Materials Inc., 25 Patton Road, Devens, Massachusetts 01434, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled substance
Drug
code
Schedule
Amphetamine
1100
II
Methylphenidate
1724
II
Nabilone
7379
II
Hydrocodone
9193
II
Levorphanol
9220
II
Thebaine
9333
II
Alfentanil
9737
II
Remifentanil
9739
II
Sufentanil
9740
II
The company plans to support its other manufacturing facilities located in West Deptford, New Jersey and Conshohocken, Pennsylvania with manufacturing and analytical testing. In reference to drug code 9333 as bulk, the company plans to manufacture a Thebaine derivative for distribution to its customers. No other activities for these drug codes are authorized for this registration.