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Notice

Importer of Controlled Substances Application: United States Pharmacopeial Convention

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ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before August 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 25, 2017.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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SUPPLEMENTARY INFORMATION:

The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.34(a), this is notice that on February 15, 2017, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered as an importer of the following basic classes of controlled substances:

Controlled substanceDrug codeSchedule
Cathinone1235I
Methaqualone2565I
Lysergic acid diethylamide7315I
Marihuana7360I
Tetrahydrocannabinols7370I
4-Methyl-2,5-dimethoxyamphetamine7395I
3,4-Methylenedioxyamphetamine7400I
4-Methoxyamphetamine7411I
Codeine-N-oxide9053I
Difenoxin9168I
Heroin9200I
Morphine-N-oxide9307I
Normethadone9635I
Methamphetamine1105II
Phenmetrazine1631II
Methylphenidate1724II
Amobarbital2125II
Pentobarbital2270II
Secobarbital2315II
Glutethimide2550II
Phencyclidine7471II
4-Anilino-N-phenethyl-4-piperidine (ANPP)8333II
Phenylacetone8501II
Alphaprodine9010II
Anileridine9020II
Cocaine9041II
Dihydrocodeine9120II
Diphenoxylate9170II
Levomethorphan9210II
Levorphanol9220II
Meperidine9230II
Dextropropoxyphene, bulk (non-dosage forms)9273II
Thebaine9333II
Noroxymorphone9668II
Alfentanil9737II
Sufentanil9740II

The company plans to import the listed controlled substances in bulk powder form from foreign sources for the manufacture of analytical reference standards for sale to their customers.

The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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 FDA approved or non-approved finished dosage forms for commercial sale.

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Dated: July 20, 2017.

Demetra Ashley,

Acting Assistant Administrator.

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[FR Doc. 2017-15693 Filed 7-25-17; 8:45 am]

BILLING CODE 4410-09-P