HHS 21 CFR PART 1310-2011 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES《列入表的化学品和某些机器的记录与报告》.pdf

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1、136 21 CFR Ch. II (4111 Edition) Pt. 1310 PART 1310RECORDS AND RE-PORTS OF LISTED CHEMICALS AND CERTAIN MACHINES Sec. 1310.01 Definitions. 1310.02 Substances covered. 1310.03 Persons required to keep records and file reports. 1310.04 Maintenance of records. 1310.05 Reports. 1310.06 Content of record

2、s and reports. 1310.07 Proof of identity. 1310.08 Excluded transactions. 1310.09 Temporary exemption from registra-tion. 1310.10 Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act. 1310.11 Reinstatement of exemption for drug products distributed under the Food, Drug

3、and Cosmetic Act. 1310.12 Exempt chemical mixtures. 1310.13 Exemption of chemical mixtures; ap-plication. 1310.14 Removal of exemption from defini-tion of regulated transaction. 1310.15 Exempt drug products containing ephedrine and therapeutically significant quantities of another active medicinal i

4、ngredient. 1310.21 Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled sub-stances. AUTHORITY: 21 U.S.C. 802, 827(h), 830, 871(b) 890. SOURCE: 54 FR 31665, Aug. 1, 1989, unless otherwise noted. 1310.01 Definitions. Any term used in this part shall have

5、the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. 62 FR 13968, Mar. 24, 1997 1310.02 Substances covered. The following chemicals have been specifically designated by the Adminis-trator of the Drug Enforcement Admin-istration as the listed chemicals sub-

6、ject 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 oppo-site it. (a) List I chemicals (1) Anthranilic acid, its esters, and its salts 8530 (2) Benzyl cyanide.8735 (3) Ephedrine, its salts, optical iso-me

7、rs, and salts of optical isomers 8113 (4) Ergonovine and its salts 8675 (5) Ergotamine and its salts8676 (6) N-Acetylanthranilic acid, its esters, and its salts.8522 (7) Norpseudoephedrine, its salts, opti-cal isomers, and salts of optical isomers .8317 (8) Phenylacetic acid, its esters, and its sal

8、ts.8791 (9) Phenylpropanolamine, its salts, op-tical isomers, and salts of optical isomers .1225 (10) Piperidine and its salts 2704 (11) Pseudoephedrine, its salts, optical isomers, and salts of optical iso-mers8112 (12) 3,4-Methylenedioxyphenyl-2- propanone .8502 (13) Methylamine and its salts8520

9、(14) Ethylamine and its salts 8678 (15) Propionic anhydride.8328 (16) Isosafrole8704 (17) Safrole8323 (18) Piperonal8750 (19) N-Methylephedrine, its salts, opti-cal isomers, and salts of optical isomers (N-Methylephedrine) .8115 (20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of

10、optical isomers .8119 (21) Hydriodic Acid .6695 (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-hydroxy-butyric acid lactone) 2011 (25) Red phosphorus 6795 (

11、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 (28) N-phenethyl-

12、4-piperidone (NPP).8332 (29) Iodine .6699 (b) List II chemicals: (1) Acetic anhydride8519 (2) Acetone6532 (3) Benzyl chloride 8570 (4) Ethyl ether 6584 (5) Potassium permanganate 6579 (6) 2-Butanone (or Methyl Ethyl Ke-tone or MEK) 6714 (7) Toluene6594 VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 P

13、O 00000 Frm 00146 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-137 Drug Enforcement Administration, Justice 1310.03 (8) Hydrochloric acid (including anhy-drous hydrogen chlo

14、ride) 6545 (9) Sulfuric acid 6552 (10) Methyl Isobutyl Ketone (MIBK) 6715 (11) Sodium Permanganate.6588 (c) The Administrator may add or de-lete 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

15、 the final rule. (d) Any person may petition the Ad-ministrator 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 informa-tion: (1) The name and address of the peti-tioner; (2) The name of the chemical t

16、o which the petition pertains; (3) The name and address of the man-ufacturer(s) of the chemical (if known); (4) A complete statement of the facts which the petitioner believes justifies the addition or deletion of the sub-stance from paragraphs (a) or (b) of this section; (5) The date of the petitio

17、n. (f) The Administrator may require the petitioner to submit such docu-ments 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 pe-tition

18、er of his decision and the reason therefor. The Administrator need not accept a petition if any of the require-ments prescribed in paragraph (e) of this section or requested pursuant to paragraph (f) of this section are lack-ing or are not clearly set forth as to be readily understood. If the petiti

19、oner 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 Ad-ministrator, upon his own motion, pro-poses to add or delete substances as listed chemicals as set forth in para-graph (c) of this section,

20、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 Ad

21、ministrator will con-sider any comments filed by interested persons and publish a final rule in ac-cordance with his decision in the mat-ter. 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

22、FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, July 2, 2007; 72 FR 40238, July 24, 2007 EFFECTIVE DATE NOTE: At 76 FR 17781, Mar. 31, 2011, 1310.02 was amended by adding a

23、 new paragraph (a)(30), effective May 2, 2011. For the convenience of the user, the added text is set forth as follows: 1310.02 Substances covered. * * * * * (a) * * * (30) Ergocristine and its salts 8612 * * * * * 1310.03 Persons required to keep records and file reports. (a) Each regulated person

24、who en-gages in a regulated transaction in-volving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction as specified by 1310.04 and file reports as specified by 1310.05. However, a non-regulated person who acquires list-ed chemicals for internal

25、consumption or end use and becomes a regulated person by virtue of infrequent or rare distribution of a listed chemical from inventory, shall not be required to maintain receipt records of listed chemicals under this section. (b) Each regulated person who manu-factures a List I or List II chemical s

26、hall file reports regarding such manu-facture as specified in Section 1310.05. (c) Each regulated person who en-gages in a transaction with a nonregu-lated person or who engages in an ex-port transaction that involves ephed-rine, pseudoephedrine, phenyl-propanolamine, or gamma-hydroxy-butyric acid,

27、including drug products containing these chemicals, and uses or attempts to use the Postal Service or VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00147 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking

28、permitted without license from IHS-,-,-138 21 CFR Ch. II (4111 Edition) 1310.04 any private or commercial carrier must file monthly reports of each such transaction as specified in 1310.05 of this part. 54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, 1996; 6

29、7 FR 14861, Mar. 28, 2002; 68 FR 57804, Oct. 7, 2003; 70 FR 294, Jan. 4, 2005 1310.04 Maintenance of records. (a) Every record required to be kept subject to 1310.03 for a List I chem-ical, a tableting machine, or an encap-sulating machine shall be kept by the regulated person for 2 years after the

30、date of the transaction. (b) Every record required to be kept subject to Section 1310.03 for List II chemical shall be kept by the regulated person for two years after the date of the transaction. (c) A record under this section shall be kept at the regulated persons place of business where the tran

31、saction oc-curred, except that records may be kept at a single, central location of the regulated person if the regulated per-son has notified the Administration of the intention to do so. Written notifi-cation must be submitted by registered or certified mail, return receipt re-quested, to the Spec

32、ial Agent in Charge of the DEA Divisional Office for the area in which the records are required to be kept. (d) The records required to be kept under this section shall be readily re-trievable and available for inspection and copying by authorized employees of the Administration under the provi-sion

33、s of 21 U.S.C. 880. (e) The regulated person with more than one place of business where records are required to be kept shall devise a system to detect any party purchasing from several individual lo-cations of the regulated person thereby seeking to avoid the application of the cumulative threshold

34、 or evading the requirements of the Act. (f) For those listed chemicals for which thresholds have been estab-lished, the quantitative threshold or the cumulative amount for multiple transactions within a calendar month, to be utilized in determining whether a receipt, sale, importation or expor-tati

35、on is a regulated transaction is as follows: (1) List I chemicals: (i) Except as provided in paragraph (f)(1)(ii) of this section, the following thresholds have been established for List I chemicals. Code Chemical Threshold by base weight 8522 N-Acetylanthranilic acid, its esters, and its salts 40 k

36、ilograms. 8530 Anthranilic acid, its esters, and its salts . 30 kilograms. 8256 Benzaldehyde 4 kilograms. 8735 Benzyl cyanide 1 kilogram. 8675 Ergonovine and its salts 10 grams. 8676 Ergotamine and its salts . 20 grams. 8678 Ethylamine and its salts 1 kilogram. 6695 Hydriodic acid 1.7 kilograms (or

37、1 liter by vol-ume). 8704 Isosafrole . 4 kilograms. 8520 Methylamine and its salts . 1 kilogram. 8502 3,4Methylenedioxyphenyl-2-propanone 4 kilograms. 8115 NMethylephedrine, its salts, optical isomers, and salts of optical iso-mers.1 kilogram. 8119 NMethylpseudoephedrine, its salts, optical isomers,

38、 and salts of opti-cal isomers.1 kilogram. 6724 Nitroethane 2.5 kilograms. 8317 Norpseudoephedrine, its salts, optical isomers, and salts of optical iso-mers.2.5 kilograms. 8791 Phenylacetic acid, its esters, and its salts 1 kilogram. 2704 Piperidine and its salts 500 grams. 8750 Piperonal (also cal

39、led heliotropine) . 4 kilograms. 8328 Propionic anhydride . 1 gram. 8323 Safrole . 4 kilograms. (ii) For List I chemicals that are con-tained in scheduled listed chemical products as defined in 1300.02(b)(34)(i) of this chapter, the thresholds estab-lished in paragraph (g) of this section apply only

40、 to non-retail distribution, VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00148 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-139 Drug Enforcement Administratio

41、n, Justice 1310.04 import, and export. Sales of these prod-ucts at retail are subject to the re-quirements of part 1314 of this chapter. (2) List II Chemicals: (i) Imports and Exports Chemical Threshold by volume Threshold by weight (A) Acetic anhydride . 250 gallons . 1,023 kilograms. (B) Acetone .

42、 500 gallons . 1,500 kilograms. (C) Benzyl chloride . N/A 4 kilograms. (D) Ethyl ether . 500 gallons . 1,364 kilograms. (E) Potassium permanganate . N/A 500 kilograms. (F) 2-Butanone (MEK) 500 gallons . 1,455 kilograms. (G) Toluene . 500 gallons . 1,591 kilograms. (H) Sodium permanganate . N/A 500 k

43、ilograms (ii) Domestic Sales Chemical Threshold by volume Threshold by weight (A) Acetic anhydride . 250 gallons . 1,023 kilograms. (B) Acetone . 50 gallons . 150 kilograms. (C) Benzyl chloride . N/A 1 kilogram. (D) Ethyl ether . 50 gallons . 135.8 kilograms. (E) Potassium permanganate . N/A 55 kilo

44、grams. (F) 2-Butanone (MEK) 50 gallons . 145 kilograms. (G) Toluene . 50 gallons . 159 kilograms. (H) Anhydrous Hydrogen chloride N/A 0.0 kilograms. (I) Sodium permanganate . N/A 55 kilograms (iii) The cumulative threshold is not applicable to domestic sales of Ace-tone, 2-Butanone (MEK), and Toluen

45、e. (iv) Exports, Transshipments and International Transactions to Des-ignated Countries as Set Forth in 1310.08(b). Chemical Threshold by volume Threshold by weight (A) Hydrochloric acid 50 gallons (1) Anhydrous Hydrogen chlo-ride. 27 kilograms. (B) Sulfuric acid 50 gallons (v) Export and Internatio

46、nal Trans-actions to Designated Countries, and Importations for Transshipment or Transfer to Designated Countries Chemical Threshold by volume Threshold by weight (A) Methyl Isobutyl Ketone (MIBK).500 gallons . 1523 kilograms. (B) Reserved. (g) For listed chemicals for which no thresholds have been

47、established, the size of the transaction is not a factor in determining whether the trans-action meets the definition of a regu-lated transaction as set forth in 1300.02(b)(28) of this chapter. All such transactions, regardless of size, are subject to recordkeeping and reporting requirements as set

48、forth in this part and notification provisions as set forth in part 1313 of this chapter. (1) Listed chemicals for which no thresholds have been established: (i) Ephedrine, its salts, optical iso-mers, and salts of optical isomers; (ii) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)- f

49、uranone; 1,2-Butanolide; 1,4- Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone) (iii) Hypophosphorous acid and its salts (including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite, and sodium hypophosphite) (iv) Iodine (v) N-phenethyl-4-piperidone (NPP) (vi) Pseudoephedrine, its salts, opti-cal isomers, and salts of optical iso-mers (vii)