HHS 21 CFR PART 1303-2011 QUOTAS《配额》.pdf

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1、56 21 CFR Ch. II (4111 Edition) 1302.06 schedule 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

2、other commercial container of any controlled 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-quireme

3、nts for imported and ex-ported substances. (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

4、1302.031302.05 do not apply to any commercial 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 co

5、ntrolled substance list-ed in schedule I or 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 INF

6、ORMATION Sec. 1303.01 Scope of part 1303. 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. 13

7、03.22 Procedure for applying for individual 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. HEA

8、RINGS 1303.31 Hearings generally. 1303.32 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 1303.0

9、1 Scope of part 1303. Procedures governing 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 th

10、is part. 36 FR 7786, Apr. 24, 1971. Redesignated 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 PROCURE

11、MENT QUOTAS 1303.11 Aggregate production quotas. (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, resear

12、ch and industrial needs of the United States, 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 fo

13、r ResaleNo reproduction or networking permitted without license from IHS-,-,-57 Drug Enforcement Administration, Justice 1303.12 (b) In making his determinations, the Administrator shall consider the fol-lowing factors: (1) Total net disposal of the class by all manufacturers during the current and

14、2 preceding years; (2) Trends in the national rate of net disposal of the class; (3) Total actual (or estimated) inven-tories of the class and of all substances manufactured from the class, and trends in inventory accumulation; (4) Projected demand for such class as indicated by procurement quotas r

15、e-quested pursuant to 1303.12; and (5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Adminis-trator finds relevant, including changes in the currently accepted med-ical use in treatment with the class or the su

16、bstances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory pur-poses, yield and stability problems, po-tential disruptions to production (in-cluding possible labor strikes), and re-cent unforeseen emergencies such as fl

17、oods and fires. (c) The Administrator shall, on or be-fore May 1 of each year, publish in the FEDERAL REGISTER, general notice of an aggregate production quota for any basic class determined by him under this section. A copy of said notice shall be mailed simultaneously to each per-son registered as

18、 a bulk manufacturer of the basic class. The Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice the time during which such filings may be made. The Adminis-trator may, but shall not be required to, hold a publi

19、c hearing on one or more issues raised by the comments and objections filed with him. In the event the Administrator decides to hold such a hearing, he shall publish notice of the hearing in the FEDERAL REGISTER, which notice shall summa-rize the issues to be heard and shall set the time for the hea

20、ring which shall nnt be less than 30 days after the date of publication of the notice. After con-sideration of any comments or objec-tions, or after a hearing if one is or-dered by the Administrator, the Ad-ministrator shall issue and publish in the FEDERAL REGISTER his final order determining the a

21、ggregate production quota for the basic class of controlled substance. The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. A copy of said order shall be mailed simultaneously to each person

22、 registered as a bulk manufac-turer of the basic class. 36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973 1303.12 Procurement quotas. (a) In order to determine the esti-mated needs for, and to insure an ade-quate and uninterrupted supply

23、of, basic classes of controlled substances listed in Schedules I and II (except raw opium being imported by the registrant pursuant to an import permit) the Ad-ministrator shall issue procurement quotas authorizing persons to procure and use quantities of each basic class of such substances for the

24、purpose of manufacturing such class into dosage forms or into other substances. (b) Any person who is registered to manufacture controlled substances listed in any schedule and who desires to use during the next calendar year any basic class of controlled substances listed in Schedule I or II (excep

25、t raw opium being imported by the registrant pursuant to an import permit) for pur-poses of manufacturing, shall apply on DEA Form 250 for a procurement quota for such basic class. A separate applica-tion must be made for each basic class desired to be procured or used. The ap-plicant shall state wh

26、ether he intends to manufacture the basic class himself or purchase it from another manufac-turer. The applicant shall state sepa-rately each purpose for which the basic class is desired, the quantity desired for that purpose during the next cal-endar year, and the quantities used and estimated to b

27、e used, if any, for that purpose during the current and pre-ceding 2 calendar years. If the purpose is to manufacture the basic class into dosage form, the applicant shall state the official name, common or usual name, chemical name, or brand name VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 000

28、00 Frm 00067 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-58 21 CFR Ch. II (4111 Edition) 1303.12 of that form. If the purpose is to manu-facture another substance, the appl

29、i-cant shall state the official name, com-mon or usual name, chemical name, or brand name of the substance, and, if a controlled substance listed in any schedule, the schedule number and Ad-ministration Controlled Substances Code Number, as set forth in part 1308 of this chapter, of the substance. I

30、f the purpose is to manufacture another basic class of controlled substance list-ed in Schedule I or II, the applicant shall also state the quantity of the other basic class which the applicant has applied to manufacture pursuant to 1303.22 and the quantity of the first basic class necessary to manu

31、facture a specified unit of the second basic class. DEA Form 250 shall be filed on or be-fore April 1 of the year preceding the calendar year for which the procure-ment quota is being applied. Copies of DEA Form 250 may be obtained from, and shall be filed with, the Drug and Chemical Evaluation Sect

32、ion, Drug En-forcement Administration. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing address. (c) The Administrator shall, on or be-fore July 1 of the year preceding the calendar year during which the quota shall be effective, issue to each quali-fied appl

33、icant a procurement quota au-thorizing him to procure and use: (1) All quantities of such class nec-essary to manufacture all quantities of other basic classes of controlled sub-stances listed in Schedules I and II which the applicant is authorized to manufacture pursuant to 1303.23; and (2) Such ot

34、her quantities of such class as the applicant has applied to procure and use and are consistent with his past use, his estimated needs, and the total quantity of such class that will be produced. (d) Any person to whom a procure-ment quota has been issued may at any time request an adjustment in the

35、 quota by applying to the Adminis-trator with a statement showing the need for the adjustment. Such applica-tion shall be filed with the Drug (2) Any person who is registered or authorized to conduct chemical anal-ysis with controlled substances (for controlled substances to be used in such analysis

36、 only); and (3) Any person who is registered to conduct research with a basic class of controlled substance listed in Schedule I or II and who is authorized to manu-facture a quantity of such class pursu-ant to 1301.13 of this chapter. (f) Any person to whom a procure-ment quota has been issued, aut

37、hor-izing that person to procure and use a quantity of a basic class of controlled substances listed in Schedules I or II during the current calendar year, shall, at or before the time of giving an order to another manufacturer requiring the distribution of a quantity of such basic class, certify in

38、 writing to such other manufacturer that the quantity of such basic class ordered does not exceed the persons unused and available procure-ment quota of such basic class for the current calendar year. The written cer-tification shall be executed by the same individual who signed the DEA Form 222 tra

39、nsmitting the order. Man-ufacturers shall not fill an order from persons required to apply for a procure-ment quota under paragraph (b) of this section unless the order is accompanied by a certification as required under this section. The certification required by this section shall contain the fol-

40、lowing: The date of the certification; the name and address of the bulk man-ufacturer to whom the certification is directed; a reference to the number of the DEA Form 222 to which the certifi-cation applies; the name of the person VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00068 Fmt

41、8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-59 Drug Enforcement Administration, Justice 1303.13 giving the order to which the certifi-cation applies; the name of the basic clas

42、s specified in the DEA Form 222 to which the certification applies; the ap-propriate schedule within which is list-ed the basic class specified in the DEA Form 222 to which the certification ap-plies; a statement that the quantity (expressed in grams) of the basic class specified in the DEA Form 222

43、 to which the certification applies does not ex-ceed the unused and available procure-ment quota of such basic class, issued to the person giving the order, for the current calendar year; and the signa-ture of the individual who signed the DEA Form 222 to which the certifi-cation applies. 36 FR 7786

44、, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 EDITORIAL NOTE: For FEDERAL REGISTER ci-tations affecting 1303.12, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. 1303.13 Adjustments of aggregate production quo

45、tas. (a) The Administrator may at any time increase or reduce the aggregate production quota for a basic class of controlled substance listed in Schedule I or II which he has previously fixed pursuant to 1303.11. (b) In determining to adjust the ag-gregate production quota, the Adminis-trator shall

46、consider the following fac-tors: (1) Changes in the demand for that class, changes in the national rate of net disposal of the class, and changes in the rate of net disposal of the class by registrants holding individual man-ufacturing quotas for that class; (2) Whether any increased demand for that

47、 class, the national and/or indi-vidual rates of net disposal of that class are temporary, short term, or long term; (3) Whether any increased demand for that class can be met through existing inventories, increased individual man-ufacturing quotas, or increased impor-tation, without increasing the

48、aggre-gate production quota, taking into ac-count production delays and the prob-ability that other individual manufac-turing quotas may be suspended pursu-ant to 1303.24(b); (4) Whether any decreased demand for that class will result in excessive inventory accumulation by all persons registered to

49、handle that class (includ-ing manufacturers, distributors, practi-tioners, importers, and exporters), not-withstanding the possibility that indi-vidual manufacturing quotas may be suspended pursuant to 1303.24(b) or abandoned pursuant to 1303.27; (5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Adminis-trator finds relevant, including changes in the curr