21 CFR 1313.12 - Requirement of authorization to import.
(a) Each regulated person who imports a listed chemical that meets or exceeds the threshold quantities identified in § 1310.04(f) or is a listed chemical for which no threshold has been established as identified in § 1310.04(g) of this chapter, shall notify the Administrator of the importation not later than 15 days before the transaction is to take place.
(b) A completed DEA Form 486 must be received by the Import/Export Unit, Drug Enforcement Administration, not later than 15 days prior to the importation. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. A copy of the completed DEA Form 486 may be transmitted directly to the Drug Enforcement Administration through electronic facsimile media not later than 15 days prior to the importation.
(c) The 15-day advance notification requirement for listed chemical imports may be waived for the following:
(1) Any importation that meets both of the following requirements:
(i) The regulated person has satisfied the requirements for reporting to the Administration as a regular importer of the listed chemicals.
(ii) The importer intends to transfer the listed chemicals to a person who is a regular customer for the chemical, as defined in § 1300.02 of this chapter.
(2) A specific listed chemical, as set forth in paragraph (f) of this section, for which the Administrator determines that advance notification is not necessary for effective chemical diversion control.
(d) For imports where advance notification is waived pursuant to paragraph (c)(1) of this section, the DEA Form 486 must be received by the Drug Enforcement Administration, Import/Export Unit, on or before the date of importation through use of the mailing address listed in § 1313.12(b) or through use of electronic facsimile media.
(e) For importations where advance notification is waived pursuant to paragraph (c)(2) of this section no DEA Form 486 is required; however, the regulated person shall submit quarterly reports to the Import/Export Unit, Drug Enforcement Administration, no later than the 15th day of the month following the end of each quarter. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The report shall contain the following information regarding each individual importation:
(1) The name of the listed chemical;
(2) The quantity and date imported;
(3) The name and full business address of the supplier;
(4) The foreign port of embarkation; and
(5) The port of entry.
(f) The 15 day advance notification requirement set forth in paragraph (a) has been waived for imports of the following listed chemicals:
(2) 2-Butanone (or Methyl Ethyl Ketone or MEK).