Comments, objections and requests for hearings must be filed by Aug. 22.
The Drug Enforcement Administration has received applications from five U.S. companies seeking to import controlled substances.
Catalent Pharma Solutions LLC of Philadelphia applied to be registered as an importer of gamma hydroxybutyric acid. According to the application, the company plans to import finished dosage unit products for clinical trials, research and analytical activities.
Fisher Clinical Services of Breinigsville, Pa., applied to import psilocybine for clinical trials.
Fresenius Kabi USA LLC, Grand Island, N.Y., applied to be an importer of remifentanil. According to the Federal Reigster, the company plans to import remifentanil for narcotic material for bulk manufacture.
Shertech Laboratories LLC of Duncan, S.C., applied to import cocaine. According to the application, the company plans to import synthetic derivatives of the controlled substance in bulk form to conduct clinical trials.
VHG Labs doing business as LGC Standards, Manchester, N.H., applied to be registered as an importer of more than 80 controlled substances, including amobarbital, dihydrocodeine, ethylmorphine, heroin, mephedrone, mescaline, methamphetamine, morphine, pentobarbital and psilocin.
According to the Federal Register, the company plans to import analytical reference standards for distribution to its customers for research and analytical purposes.
Registered bulk manufacturers of the affected basic classes may file written comments on or objections to the issuance of the proposed registration on or before Aug. 22. Written requests for hearings on the applications also are due Aug. 22.
Written comments should be sent to Drug Enforcement Administration, Attention DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, VA 22152.
Requests for hearings must be sent to the Drug Enforcement Administration, Attention Administrator, 8701 Morrissette Drive, Springfield, VA 22152.
Applications filed to import controlled substances
