1、211 Drug Enforcement Administration, Justice 1315.01 1314.155 Suspension pending final order. (a) The Administrator may suspend the right to sell scheduled listed chem-ical products simultaneously with, or at any time subsequent to, the service upon the seller or distributor required to file reports
2、 under 1310.03(c) of this chapter of an order to show cause why the regulated seller or distributor should not be prohibited from selling scheduled listed chemical products, in any case where he finds that there is an imminent danger to the public health or safety. If the Administrator so suspends,
3、he shall serve with the order to show cause under 1314.150 an order of immediate suspension that shall contain a statement of his find-ings regarding the danger to public health or safety. (b) Upon service of the order of im-mediate suspension, the regulated sell-er or distributor shall, as instruct
4、ed by the Administrator: (1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the sched-uled listed chemical products in his or her possession; or (2) Place all of the scheduled listed chemical products under seal as de-scribed in Section 304 o
5、f the Act (21 U.S.C. 824(f). (c) Any suspension shall continue in effect until the conclusion of all pro-ceedings upon the prohibition, includ-ing any judicial review, unless sooner withdrawn by the Administrator or dis-solved by a court of competent juris-diction. Any regulated seller or dis-tribut
6、or whose right to sell scheduled listed chemical products is suspended under this section may request a hear-ing on the suspension at a time earlier than specified in the order to show cause under 1314.150, which request shall be granted by the Administrator, who shall fix a date for such hearing as
7、 early as reasonably possible. PART 1315IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE Subpart AGeneral Information Sec. 1315.01 Scope. 1315.02 Definitions. 1315.03 Personal use exemption. 1315.05 Applicability. Subpart BAssessment of Annual Needs 1315.11 A
8、ssessment of annual needs. 1315.13 Adjustments of assessment of annual needs. Subpart CIndividual Manufacturing Quotas 1315.21 Individual manufacturing quotas. 1315.22 Procedure for applying for individual manufacturing quotas. 1315.23 Procedure for fixing individual man-ufacturing quotas. 1315.24 I
9、nventory allowance. 1315.25 Increase in individual manufac-turing quotas. 1315.26 Reduction in individual manufac-turing quotas. 1315.27 Abandonment of quota. Subpart DProcurement and Import Quotas 1315.30 Procurement and import quotas. 1315.32 Obtaining a procurement quota. 1315.33 Power of attorne
10、y. 1315.34 Obtaining an import quota. 1315.36 Amending an import quota. Subpart EHearings 1315.50 Hearings generally. 1315.52 Purpose of hearing. 1315.54 Waiver or modification of rules. 1315.56 Request for hearing or appearance; waiver. 1315.58 Burden of proof. 1315.60 Time and place of hearing. 13
11、15.62 Final order. SOURCE: 72 FR 37448, July 10, 2007, unless otherwise noted. AUTHORITY: 21 U.S.C. 802, 821, 826, 871(b), 952. Subpart AGeneral Information 1315.01 Scope. This part specifies procedures gov-erning the establishment of an assess-ment of annual needs, procurement and VerDate Mar2010 0
12、7:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-212 21 CFR Ch. II (4111 Edition) 1315.02 manufacturing quotas pursuant to sec-ti
13、on 306 of the Act (21 U.S.C. 826), and import quotas pursuant to section 1002 of the Act (21 U.S.C. 952) for ephedrine, pseudoephedrine, and phenylpropanola-mine. 1315.02 Definitions. (a) Except as specified in paragraphs (b) and (c) of this section, any term contained in this part shall have the de
14、finition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. (b) The term net disposal means, for a stated period, the sum of paragraphs (b)(1) through (b)(3) of this section minus the sum of paragraphs (b)(4) and (b)(5) of this section: (1) The quantity of ephedrine, p
15、seudoephedrine, or phenylpropanola-mine distributed by the registrant to another person. (2) The quantity of that chemical used by the registrant in the produc-tion of (or converted by the registrant into) another chemical or product. (3) The quantity of that chemical otherwise disposed of by the re
16、gistrant. (4) The quantity of that chemical re-turned to the registrant by any pur-chaser. (5) The quantity of that chemical dis-tributed by the registrant to a reg-istered manufacturer of that chemical for purposes other than use in the pro-duction of, or conversion into, another chemical or in the
17、 manufacture of dos-age forms of that chemical. (c) Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts, optical isomers, and salts of opti-cal isomers. 1315.03 Personal use exemption. A person need not register as an im-porter, file an import declaration, and obtain an import qu
18、ota if both of the following conditions are met: (a) The person purchases scheduled listed chemical products at retail and imports them for personal use, by means of shipping through any private or commercial carrier or the Postal Service. (b) In any 30-day period, the person imports no more than 7.
19、5 grams of ephedrine base, 7.5 grams of pseudoephedrine base, and 7.5 grams of phenylpropanolamine base in scheduled listed chemical products. 1315.05 Applicability. This part applies to all of the fol-lowing: (a) Persons registered to manufac-ture (including repackaging or re-labeling) or to import
20、 ephedrine, pseudoephedrine, or phenylpropanola-mine as bulk chemicals. (b) Persons registered to manufac-ture (including repackaging or re-labeling) or to import prescription and over-the-counter drug products con-taining ephedrine, pseudoephedrine, or phenylpropanolamine that may be law-fully mark
21、eted and distributed in the United States under the Federal Food, Drug, and Cosmetic Act. Subpart BAssessment of Annual Needs 1315.11 Assessment of annual needs. (a) The Administrator shall deter-mine the total quantity of ephedrine, pseudoephedrine, and phenylpropanola-mine, including drug products
22、 con-taining ephedrine, pseudoephedrine, and phenylpropanolamine, necessary to be manufactured and imported during the following calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export re-quirements, and for the establish
23、ment and maintenance of reserve stocks. (b) In making his determinations, the Administrator shall consider the fol-lowing factors: (1) Total net disposal of the chemical by all manufacturers and importers during the current and 2 preceding years; (2) Trends in the national rate of net disposal of ea
24、ch chemical; (3) Total actual (or estimated) inven-tories of the chemical and of all sub-stances manufactured from the chem-ical, and trends in inventory accumula-tion; (4) Projected demand for each chem-ical as indicated by procurement and import quotas requested pursuant to 1315.32; and (5) Other
25、factors affecting medical, scientific, research, and industrial VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00222 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,
26、-213 Drug Enforcement Administration, Justice 1315.13 needs in the United States, lawful ex-port requirements, and the establish-ment and maintenance of reserve stocks, as the Administrator finds rel-evant, including changes in the cur-rently accepted medical use in treat-ment with the chemicals or
27、the sub-stances which are manufactured from them, the economic and physical avail-ability of raw materials for use in man-ufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent un-foreseen emergencies su
28、ch as floods and fires. (c) The Administrator shall, on or be-fore May 1 of each year, publish in the FEDERAL REGISTER, general notice of an assessment of annual needs for ephedrine, pseudoephedrine, and phen-ylpropanolamine determined by him under this section. A notice of the pub-lication shall be
29、 mailed simultaneously to each person registered to manufac-ture or import the chemical. (d) The Administrator shall permit any interested person to file written comments on or objections to the pro-posed assessment of annual needs and shall designate in the notice the time during which the filings
30、may be made. (e) The Administrator may, but is not required to, hold a public 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 a notice of the hearing in the FEDERAL REGISTER. The notic
31、e shall summarize the issues to be heard and set the time for the hearing, which shall not be less than 30 days after the date of publication of the notice. (f) After consideration of any com-ments or objections, or after a hearing if one is ordered by the Administrator, the Administrator shall issu
32、e and pub-lish in the FEDERAL REGISTER the final order determining the assessment of annual needs for the chemicals. 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 notice of the publ
33、ication shall be mailed simultaneously to each person registered as a manufacturer or im-porter of the chemical. 1315.13 Adjustments of the assess-ment of annual needs. (a) The Administrator may at any time increase or reduce the assessment of annual needs for ephedrine, pseudoephedrine, or phenylpr
34、opanola-mine that has been previously fixed pursuant to 1315.11. (b) In determining to adjust the as-sessment of annual needs, the Adminis-trator shall consider the following fac-tors: (1) Changes in the demand for that chemical, changes in the national rate of net disposal of the chemical, and chan
35、ges in the rate of net disposal of the chemical by registrants holding in-dividual manufacturing or import quotas for that chemical; (2) Whether any increased demand for that chemical, the national and/or changes in individual rates of net dis-posal of that chemical are temporary, short term, or lon
36、g term; (3) Whether any increased demand for that chemical can be met through ex-isting inventories, increased individual manufacturing quotas, or increased im-portation, without increasing the as-sessment of annual needs, taking into account production delays and the probability that other individu
37、al man-ufacturing quotas may be suspended pursuant to 1315.24(b); (4) Whether any decreased demand for that chemical will result in exces-sive inventory accumulation by all per-sons registered to handle that chemical (including manufacturers, distributors, importers, and exporters), notwith-standing
38、 the possibility that individual manufacturing quotas may be sus-pended pursuant to 1315.24(b) or aban-doned pursuant to 1315.27; (5) Other factors affecting medical, scientific, research, industrial, and im-portation needs in the United States, lawful export requirements, and re-serve stocks, as th
39、e Administrator finds relevant, including changes in the currently accepted medical use in treatment with the chemical or the substances that are manufactured from it, the economic and physical avail-ability of raw materials for use in man-ufacturing and for inventory purposes, yield and stability p
40、roblems, potential disruptions to production (including VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00223 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-214 21
41、CFR Ch. II (4111 Edition) 1315.21 possible labor strikes), and recent un-foreseen emergencies such as floods and fires. (c) In the event that the Adminis-trator determines to increase or reduce the assessment of annual needs for a chemical, the Administrator shall pub-lish in the FEDERAL REGISTER ge
42、neral notice of an adjustment in the assess-ment of annual needs for that chemical as determined under this section. A no-tice of the publication shall be mailed simultaneously to each person reg-istered as a manufacturer or importer of the chemical. (d) The Administrator shall permit any interested
43、 person to file written comments on or objections to the pro-posal and shall designate in the notice the time during which such filings may be made. (e) The Administrator may, but is not required to, hold a public hearing on one or more issues raised by the comments and objections filed with him. In
44、 the event the Administrator decides to hold such a hearing, he shall publish a notice of the hearing in the FEDERAL REGISTER. The notice shall summarize the issues to be heard and set the time for the hearing, which shall not be less than 10 days after the date of publication of the notice. (f) Aft
45、er consideration of any com-ments or objections, or after a hearing if one is ordered by the Administrator, the Administrator shall issue and pub-lish in the FEDERAL REGISTER the final order determining the assessment of annual needs for the chemical. The order shall include the findings of fact and
46、 conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. A notice of the publication shall be mailed simultaneously to each person registered as a manufacturer or im-porter of the chemical. Subpart CIndividual Manufacturing Quotas 1315.21 Ind
47、ividual manufacturing quotas. The Administrator shall, on or before July 1 of each year, fix for and issue to each person registered to manufacture in bulk ephedrine, pseudoephedrine, or phenylpropanolamine who applies for a manufacturing quota an individual manufacturing quota authorizing that pers
48、on to manufacture during the next calendar year a quantity of that chem-ical. Any manufacturing quota fixed and issued by the Administrator is sub-ject to his authority to reduce or limit it at a later date pursuant to 1315.26 and to his authority to revoke or sus-pend it at any time pursuant to 130
49、1.36, 1309.43, 1309.44, or 1309.45 of this chapter. 1315.22 Procedure for applying for individual manufacturing quotas. Any person who is registered to man-ufacture ephedrine, pseudoephedrine, or phenylpropanolamine and who de-sires to manufacture a quantity of the chemical must apply on DEA Form 189 for a manufacturing quota for the quantity of the chemical. Copies of DEA Form 189 may be obtained from the Office of Diversion Control Web site, and must
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