1、125 Drug Enforcement Administration, Justice 1309.11 PART 1309REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS GENERAL INFORMATION Sec. 1309.01 Scope of part 1309. 1309.02 Definitions. 1309.03 Information; special instructions. FEES FOR REGISTRATION AND REREGI
2、STRATION 1309.11 Fee amounts. 1309.12 Time and method of payment; re-fund. REQUIREMENTS FOR REGISTRATION 1309.21 Persons required to register. 1309.22 Separate registration for inde-pendent activities. 1309.23 Separate registration for separate locations. 1309.24 Waiver of registration requirement f
3、or certain activities. 1309.25 Temporary exemption from registra-tion for chemical registration applicants. 1309.26 Exemption of law enforcement offi-cials. APPLICATION FOR REGISTRATION 1309.31 Time for application for registra-tion; expiration date. 1309.32 Application forms; contents, signa-ture.
4、1309.33 Filing of application; joint filings. 1309.34 Acceptance for filing; defective ap-plications. 1309.35 Additional information. 1309.36 Amendments to and withdrawals of applications. ACTION ON APPLICATIONS FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION 1309.41 Administrative review
5、 generally. 1309.42 Certificate of registration; denial of registration. 1309.43 Suspension or revocation of registra-tion. 1309.44 Suspension of registration pending final order. 1309.45 Extension of registration pending final order. 1309.46 Order to show cause. HEARINGS 1309.51 Hearings generally.
6、 1309.52 Purpose of hearing. 1309.53 Request for hearing or appearance; waiver. 1309.54 Burden of proof. 1309.55 Time and place of hearing. MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION 1309.61 Modification in registration. 1309.62 Termination of registration. 1309.63 Transfer of registrati
7、on. SECURITY REQUIREMENTS 1309.71 General security requirements. 1309.72 Felony conviction; employer respon-sibilities. 1309.73 Employee responsibility to report di-version. AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 877, 886a, 952, 958. SOURCE: 60 FR 32454, June 22, 1995, unles
8、s otherwise noted. GENERAL INFORMATION 1309.01 Scope of part 1309. Procedures governing the registra-tion of manufacturers, distributors, importers and exporters of List I chemicals pursuant to Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822, 823, 957 and 958) are set forth gene
9、rally by those sections and specifi-cally by the sections of this part. 1309.02 Definitions. Any term used 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 13968, Mar. 24, 1997 1309.03 Information; special instruc-tions. I
10、nformation regarding procedures under these rules and instructions supplementing these rules will be fur-nished upon request by writing to the Registration Section, Drug Enforce-ment Administration. See the Table of DEA Mailing Addresses in 1321.01 of this chapter for the current mailing ad-dress. 7
11、5 FR 10680, Mar. 9, 2010 FEES FOR REGISTRATION AND REREGISTRATION 1309.11 Fee amounts. (a) For each application for registra-tion or reregistration to manufacture the applicant shall pay an annual fee of $2,293. VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00135 Fmt 8010 Sfmt 8010 Y:SG
12、ML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-126 21 CFR Ch. II (4111 Edition) 1309.12 (b) For each application for registra-tion or reregistration to distribute, im-port, or export a List I chemic
13、al, the applicant shall pay an annual fee of $1,147. 75 FR 4980, Feb. 1, 2010 1309.12 Time and method of pay-ment; refund. (a) For each application for registra-tion or reregistration to manufacture, distribute, import, or export, the appli-cant shall pay the fee when the appli-cation for registrati
14、on or reregistra-tion is submitted for filing. (b) Payments should be made in the form of a credit card; a personal, cer-tified, or cashiers check; or a money order made payable to Drug Enforce-ment Administration. Payments made in the form of stamps, foreign currency, or third party endorsed checks
15、 will not be accepted. These ap-plication fees are not refundable. 75 FR 4980, Feb. 1, 2010 REQUIREMENTS FOR REGISTRATION 1309.21 Persons required to register. (a) Unless exempted by law or under 1309.24 through 1309.26 or 1310.12 through 1310.13 of this chapter, the fol-lowing persons must annually
16、 obtain a registration specific to the List I chemicals to be handled: (1) Every person who manufactures or imports or proposes to manufacture or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanola-mine. (2) Every person who distributes or exports or
17、proposes to distribute or ex-port any List I chemical, other than those List I chemicals contained in a product exempted under 1300.02(b)(28)(i)(D) of this chapter. (b) Only persons actually engaged in the activities are required to obtain a registration; related or affiliated per-sons who are not e
18、ngaged in the activi-ties are not required to be registered. (For example, a stockholder or parent corporation of a corporation distrib-uting List I chemicals is not required to obtain a registration.) (c) The registration requirements are summarized in the following table: SUMMARY OF REGISTRATION R
19、EQUIREMENTS AND LIMITATIONS Business activity Chemicals DEA forms Application fee Registration period (years) Coincident activities allowed Manufacturing List I, Drug prod-ucts containing ephedrine, pseudoephedrin-e, phenyl-propanolamine.New510 Renewal510a .$2,293 2,293 1 May distribute that chemica
20、l for which registration was issued; may not distribute any chemical for which not reg-istered. Distributing . List I, Scheduled listed chemical products.New510 Renewal510a .1,147 1,147 1 Importing List I, Drug Prod-ucts containing ephedrine, pseudoephedrin-e, phenyl-propanolamine.New510 Renewal510a
21、 .1,147 1,147 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not reg-istered. Exporting List I, Scheduled listed chemical products.New510 Renewal510a .1,147 1,147 1 VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00136 Fmt 8010
22、Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-127 Drug Enforcement Administration, Justice 1309.24 75 FR 4980, Feb. 1, 2010 1309.22 Separate registration for independent activities. (
23、a) The following groups of activities are deemed to be independent of each other: (1) Manufacturing of List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanola-mine. (2) Distributing of List I chemicals and scheduled listed chemical prod-ucts. (3) Importing List I
24、chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanola-mine. (4) Exporting List I chemicals and scheduled listed chemical products. (b) Except as provided in paragraphs (c) and (d) of this section, every person who engages in more than one group of independent activitie
25、s must obtain a separate registration for each group of activities, unless otherwise exempted by the Act or 1309.24 through 1309.26. (c) A person registered to import any List I chemical shall be authorized to distribute that List I chemical after importation, but no other chemical that the person i
26、s not registered to im-port. (d) A person registered to manufac-ture any List I chemical shall be au-thorized to distribute that List I chem-ical after manufacture, but no other chemical that the person is not reg-istered to manufacture. 75 FR 4981, Feb. 1, 2010 1309.23 Separate registration for sep
27、-arate locations. (a) A separate registration is re-quired for each principal place of busi-ness at one general physical location where List I chemicals are manufac-tured, distributed, imported, or ex-ported by a person. (b) The following locations shall be deemed to be places not subject to the reg
28、istration requirement: (1) A warehouse where List I chemi-cals are stored by or on behalf of a reg-istered person, unless such chemicals are distributed directly from such warehouse to locations other than the registered location from which the chemicals were originally delivered; and (2) An office
29、used by agents of a reg-istrant where sales of List I chemicals are solicited, made, or supervised but which neither contains such chemicals (other than chemicals for display pur-poses) nor serves as a distribution point for filling sales orders. 60 FR 32454, June 22, 1995, as amended at 75 FR 4981,
30、 Feb. 1, 2010 1309.24 Waiver of registration re-quirement for certain activities. (a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if the agent or employee is acting in the usual course of his or h
31、er business or employment. (b) The requirement of registration is waived for any person who manufac-tures or distributes a scheduled listed chemical product or other product con-taining a List I chemical that is de-scribed and included in the definition of regulated transaction in 1300.02(b)(28)(i)(
32、D) of this chapter, if that person is registered with the Ad-ministration to engage in the same ac-tivity with a controlled substance. (c) The requirement of registration is waived for any person who imports or exports a scheduled listed chemical product or other product containing a List I chemical
33、 that is described and included in the definition of regulated transaction in 1300.02(b)(28)(i)(D) of this chapter, if that person is reg-istered with the Administration to en-gage in the same activity with a con-trolled substance. (d) The requirement of registration is waived for any person who onl
34、y distrib-utes a prescription drug product con-taining a List I chemical that is regu-lated pursuant to 1300.02(b)(28)(i)(D) of this chapter. (e) The requirement of registration is waived for any person whose activities with respect to List I chemicals are limited to the distribution of red phos-pho
35、rus, white phosphorus, or hypophosphorous acid (and its salts) to another location operated by the same firm solely for internal end-use, or an EPA or State licensed waste treatment VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00137 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DS
36、K5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-128 21 CFR Ch. II (4111 Edition) 1309.25 or disposal firm for the purpose of waste disposal. (f) The requirement of registration is waived for any person whose distribu-tion of red
37、phosphorus or white phos-phorus is limited solely to residual quantities of chemical returned to the producer, in reusable rail cars and intermodal tank containers which con-form to International Standards Orga-nization specifications (with capacities greater than or equal to 2,500 gallons in a sing
38、le container). (g) The requirement of registration is waived for any person whose activities with respect to List I chemicals are limited solely to the distribution of Lugols Solution (consisting of 5 per-cent iodine and 10 percent potassium iodide in an aqueous solution) in origi-nal manufacturers
39、packaging of one fluid ounce (30 ml) or less. (h) The requirement of registration is waived for any manufacturer of a List I chemical, if that chemical is pro-duced solely for internal consumption by the manufacturer and there is no subsequent distribution or exportation of the List I chemical. (i)
40、If any person exempted under paragraph (b), (c), (d), (e), or (f) of this section also engages in the distribu-tion, importation, or exportation of a List I chemical, other than as de-scribed in such paragraph, the person shall obtain a registration for the ac-tivities, as required by 1309.21. (j) T
41、he Administrator may, upon finding that continuation of the waiver would not be in the public interest, suspend or revoke a waiver granted under paragraph (b), (c), (d), (e), or (f) of this section pursuant to the proce-dures set forth in 1309.43 through 1309.46 and 1309.51 through 1309.55. In consi
42、dering the revocation or suspen-sion of a persons waiver granted pur-suant to paragraph (b) or (c) of this section, the Administrator shall also consider whether action to revoke or suspend the persons controlled sub-stance registration pursuant to section 304 of the Act (21 U.S.C. 824) is war-rante
43、d. (k) Any person exempted from the registration requirement under this section must comply with the security requirements set forth in 1309.71 through 1309.73 and the recordkeeping and reporting requirements set forth under Parts 1310, 1313, 1314, and 1315 of this chapter. 75 FR 4981, Feb. 1, 2010
44、1309.25 Temporary exemption from registration for chemical registra-tion applicants. (a) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export a combination ephedrine prod-uct is temporarily exempted from the registration requirement
45、, provided that the person submits a proper appli-cation for registration on or before July 12, 1997. The exemption will re-main in effect for each person who has made such application until the Ad-ministration has approved or denied that application. This exemption ap-plies only to registration; al
46、l other chemical control requirements set forth in this part 1309 and parts 1310, and 1313 of this chapter remain in full force and effect. (b) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export a pseudoephedrine or phenyl-propano
47、lamine drug product is tempo-rarily exempted from the registration requirement, provided that the person submits a proper application for reg-istration on or before October 3, 1997. The exemption will remain in effect for each person who has made such appli-cation until the Administration has ap-pro
48、ved or denied that application. This exemption applies only to registration; all other chemical control require-ments set forth in this part 1309 and parts 1310 and 1313 of this chapter re-main in full force and effect. (c) Each person required by sections 302 or 1007 of the Act (21 U.S.C. 822 or 95
49、7) to obtain a registration to manu-facture or import prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanola-mine is temporarily exempted from the registration requirement, provided that the person submits a proper appli-cation for registration on or before March 3, 2010. The exemption will re-main in effect for each person who has made such application until the Ad-ministration has
