HHS 21 CFR PART 1302-2011 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES《管制物质的标签和包装要求》.pdf

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1、55 Drug Enforcement Administration, Justice 1302.05 PART 1302LABELING AND PACK-AGING REQUIREMENTS FOR CONTROLLED SUBSTANCES Sec. 1302.01 Scope of part 1302. 1302.02 Definitions. 1302.03 Symbol required; exceptions. 1302.04 Location and size of symbol on label and labeling. 1302.05 Effective dates of

2、 labeling require-ments. 1302.06 Sealing of controlled substances. 1302.07 Labeling and packaging require-ments for imported and exported sub-stances. AUTHORITY: 21 U.S.C. 821, 825, 871(b), 958(e). SOURCE: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973

3、. 1302.01 Scope of part 1302. Requirements governing the labeling and packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d) are set forth generally by those sections and specifically by the sections of this part. 36 FR 13386, July 21, 1971. Red

4、esignated at 38 FR 26609, Sept. 24, 1973 1302.02 Definitions. Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. 62 FR 13958, Mar. 24, 1997 1302.03 Symbol required; exceptions. (a) Each commercial container of a

5、 controlled substance (except for a con-trolled substance excepted by the Ad-ministrator pursuant to 1308.31 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is list-ed. Each such commercial container, if it otherwise has no labe

6、l, must bear a label complying with the requirement of this part. (b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the sym-bol designating the schedule in which such controlled substance is listed. (c) The following symbols shall des-ignate the sche

7、dule corresponding thereto: Schedule Schedule I CI or CI. Schedule II . CII or CII. Schedule III CIII or CIII. Schedule IV . CIV or CIV. Schedule V CV or CV. The word schedule need not be used. No distinction need be made between narcotic and nonnarcotic substances. (d) The symbol is not required on

8、 a carton or wrapper in which a commer-cial container is held if the symbol is easily legible through such carton or wrapper. (e) The symbol is not required on a commercial container too small or oth-erwise unable to accommodate a label, if the symbol is printed on the box or package from which the

9、commercial container is removed upon dispensing to an ultimate user. (f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled sub-stance being utilized in clinical re-search involving blind and double blind studies. 36 FR 7785, Apr. 24, 1971, as amende

10、d at 36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 1302.04 Location and size of symbol on label and labeling. The symbol shall be prominently lo-cated on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed t

11、o dispensers of any con-trolled substance. The symbol on labels shall be clear and large enough to af-ford easy identification of the schedule of the controlled substance upon in-spection without removal from the dis-pensers shelf. The symbol on all other labeling shall be clear and large enough to

12、afford prompt identification of the controlled substance upon in-spection of the labeling. 62 FR 13958, Mar. 24, 1997 1302.05 Effective dates of labeling re-quirements. All labels on commercial containers of, and all labeling of, a controlled sub-stance which either is transferred to another schedul

13、e or is added to any VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00065 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-56 21 CFR Ch. II (4111 Edition) 1302.06 sc

14、hedule shall comply with the require-ments of 1302.03, on or before the ef-fective date established in the final order for the transfer or addition. 62 FR 13958, Mar. 24, 1997 1302.06 Sealing of controlled sub-stances. On each bottle, multiple dose vial, or other commercial container of any controll

15、ed substance, there shall be se-curely affixed to the stopper, cap, lid, covering, or wrapper or such container a seal to disclose upon inspection any tampering or opening of the container. 62 FR 13958, Mar. 24, 1997 1302.07 Labeling and packaging re-quirements for imported and ex-ported substances.

16、 (a) The symbol requirements of 1302.031302.05 apply to every com-mercial container containing, and to all labeling of, controlled substances imported into the jurisdiction of and/or the customs territory of the United States. (b) The symbol requirements of 1302.031302.05 do not apply to any commerc

17、ial containers containing, or any labeling of, a controlled substance intended for export from the jurisdic-tion of the United States. (c) The sealing requirements of 1302.06 apply to every bottle, multiple dose vial, or other commercial con-tainer of any controlled substance list-ed in schedule I o

18、r II, or any narcotic controlled substance listed in schedule III or IV, imported into, exported from, or intended for export from, the juris-diction of and/or the customs territory of the United States. 62 FR 13958, Mar. 24, 1997 PART 1303QUOTAS GENERAL INFORMATION Sec. 1303.01 Scope of part 1303.

19、1303.02 Definitions. AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS 1303.11 Aggregate production quotas. 1303.12 Procurement quotas. 1303.13 Adjustments of aggregate produc-tion quotas. INDIVIDUAL MANUFACTURING QUOTAS 1303.21 Individual manufacturing quotas. 1303.22 Procedure for applying for individua

20、l manufacturing quotas. 1303.23 Procedure for fixing individual man-ufacturing quotas. 1303.24 Inventory allowance. 1303.25 Increase in individual manufac-turing quotas. 1303.26 Reduction in individual manufac-turing quotas. 1303.27 Abandonment of quota. HEARINGS 1303.31 Hearings generally. 1303.32

21、Purpose of hearing. 1303.33 Waiver or modification of rules. 1303.34 Request for hearing or appearance; waiver. 1303.35 Burden of proof. 1303.36 Time and place of hearing. 1303.37 Final order. AUTHORITY: 21 U.S.C. 821, 826, 871(b). GENERAL INFORMATION 1303.01 Scope of part 1303. Procedures governing

22、 the establish-ment of production and manufacturing quotas on basic classes of controlled substances listed in schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) are governed generally by that section and specifically by the sections of this part. 36 FR 7786, Apr. 24, 1971. Redesi

23、gnated at 38 FR 26609, Sept. 24, 1973 1303.02 Definitions. Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. 62 FR 13958, Mar. 24, 1997 AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS 1303.11 Aggregate production q

24、uotas. (a) The Administrator shall deter-mine the total quantity of each basic class of controlled substance listed in Schedule I or II necessary to be manu-factured during the following calendar year to provide for the estimated med-ical, scientific, research and industrial needs of the United Stat

25、es, for lawful export requirements, and for the estab-lishment and maintenance of reserve stocks. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00066 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-