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21 C.F.R. § 1310.02   Substances covered.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES

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§ 1310.02   Substances covered.

The following chemicals have been specifically designated by the Administrator of the Drug Enforcement Administration as the listed chemicals subject to the provisions of this part and parts 1309 and 1313 of this chapter. Each chemical has been assigned the DEA Chemical Code Number set forth opposite it.

(a) List I chemicals

(1) Anthranilic acid, its esters, and its salts8530 (2) Benzyl cyanide8735 (3) Ephedrine, its salts, optical isomers, and salts of optical isomers8113 (4) Ergonovine and its salts8675 (5) Ergotamine and its salts8676 (6) N-Acetylanthranilic acid, its esters, and its salts8522 (7) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers8317 (8) Phenylacetic acid, its esters, and its salts8791 (9) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers1225 (10) Piperidine and its salts2704 (11) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers8112 (12) 3,4-Methylenedioxyphenyl-2-propanone8502 (13) Methylamine and its salts8520 (14) Ethylamine and its salts8678 (15) Propionic anhydride8328 (16) Isosafrole8704 (17) Safrole8323 (18) Piperonal8750 (19) N-Methylephedrine, its salts, optical isomers, and salts of optical isomers (N-Methylephedrine)8115 (20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers8119 (21) Hydriodic Acid6695 (22) Benzaldehyde8256 (23) Nitroethane6724(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone)2011(25) Red phosphorus6795(26) White phosphorus (Other names: Yellow Phosphorus)6796(27) Hypophosphorous acid and its salts (Including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite and sodium hypophosphite)6797

(b) List II chemicals:

(1) Acetic anhydride8519 (2) Acetone6532 (3) Benzyl chloride8570 (4) Ethyl ether6584 (5) Potassium permanganate6579 (6) 2-Butanone (or Methyl Ethyl Ketone or MEK)6714 (7) Toluene6594 (8) Hydrochloric acid (including anhydrous hydrogen chloride)6545(9) Sulfuric acid6552 (10) Methyl Isobutyl Ketone (MIBK)6715(11) Iodine6699

(c) The Administrator may add or delete a substance as a listed chemical by publishing a final rule in the Federal Register following a proposal which shall be published at least 30 days prior to the final rule.

(d) Any person may petition the Administrator to have any substance added or deleted from paragraphs (a) or (b) of this section.

(e) Any petition under this section shall contain the following information:

(1) The name and address of the petitioner;

(2) The name of the chemical to which the petition pertains;

(3) The name and address of the manufacturer(s) of the chemical (if known);

(4) A complete statement of the facts which the petitioner believes justifies the addition or deletion of the substance from paragraphs (a) or (b) of this section;

(5) The date of the petition.

(f) The Administrator may require the petitioner to submit such documents or written statements of fact relevant to the petition as he deems necessary in making a determination.

(g) Within a reasonable period of time after the receipt of the petition, the Administrator shall notify the petitioner of his decision and the reason therefor. The Administrator need not accept a petition if any of the requirements prescribed in paragraph (e) of this section or requested pursuant to paragraph (f) of this section are lacking or are not clearly set forth as to be readily understood. If the petitioner desires, he may amend and resubmit the petition to meet the requirements of paragraphs (e) and (f) of this section.

(h) If a petition is granted or the Administrator, upon his own motion, proposes to add or delete substances as listed chemicals as set forth in paragraph (c) of this section, he shall issue and publish in the Federal Register a proposal to add or delete a substance as a listed chemical. The Administrator shall permit any interested person to file written comments regarding the proposal within 30 days of the date of publication of his order in the Federal Register. The Administrator will consider any comments filed by interested persons and publish a final rule in accordance with his decision in the matter.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001]

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