Registration of manufacturers, distributors, and dispensers of controlled substances (21 CFR 1301.01-1301.93)

22 21 CFR Ch. II (4–1–16 Edition) Pt. 1301 PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CON TROLLED SUBSTANCES GENERAL INFORMATION Sec. 1301.01 Scope of this part 1301. 1301.02 Definitions. 1301.03 Information; special instructions. REGISTRATION 1301.11 Persons required to register; require ment of modification of registration au thorizing activity as an online phar macy. 1301.12 Separate registrations for separate locations. 1301.13 Application for registration; time for application; expiration date; registra tion for independent activities; applica tion forms, fees, contents and signature; coincident activities. 1301.14 Filing of application; acceptance for filing; defective applications. 1301.15 Additional information. 1301.16 Amendments to and withdrawal of applications. 1301.17 Special procedures for certain appli cations. 1301.18 Research protocols. 1301.19 Special requirements for online pharmacies. EXCEPTIONS TO REGISTRATION AND FEES 1301.21 Exception from fees. 1301.22 Exemption of agents and employees; affiliated practitioners. 1301.23 Exemption of certain military and other personnel. 1301.24 Exemption of law enforcement offi cials. 1301.25 Registration regarding ocean ves sels, aircraft, and other entities. 1301.26 Exemptions from import or export requirements for personal medical use. 1301.27 Separate registration by retail phar macies for installation and operation of automated dispensing systems at long term care facilities. 1301.28 Exemption from separate registra tion for practitioners dispensing or pre scribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. 1301.29 [Reserved] ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION 1301.31 Administrative review generally. 1301.32 Action on applications for research in Schedule I substances. 1301.33 Application for bulk manufacture of Schedule I and II substances. 1301.34 Application for importation of Schedule I and II substances. 1301.35 Certificate of registration; denial of registration. 1301.36 Suspension or revocation of registra tion; suspension of registration pending final order; extension of registration pending final order. 1301.37 Order to show cause. HEARINGS 1301.41 Hearings generally. 1301.42 Purpose of hearing. 1301.43 Request for hearing or appearance; waiver. 1301.44 Burden of proof. 1301.45 Time and place of hearing. 1301.46 Final order. MODIFICATION, TRANSFER, AND TERMINATION OF REGISTRATION 1301.51 Modification in registration. 1301.52 Termination of registration; transfer of registration; distribution upon dis continuance of business. SECURITY REQUIREMENTS 1301.71 Security requirements generally. 1301.72 Physical security controls for non practitioners; narcotic treatment pro grams and compounders for narcotic treatment programs; storage areas. 1301.73 Physical security controls for non practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas. 1301.74 Other security controls for non practitioners; narcotic treatment pro grams and compounders for narcotic treatment programs. 1301.75 Physical security controls for prac titioners. 1301.76 Other security controls for practi tioners. 1301.77 Security controls for freight for warding facilities. EMPLOYEE SCREENING—NON-PRACTITIONERS 1301.90 Employee screening procedures. 1301.91 Employee responsibility to report drug diversion. 1301.92 Illicit activities by employees. 1301.93 Sources of information for employee checks. AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958, 965. SOURCE: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00032 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 23 Drug Enforcement Administration, Justice § 1301.12 GENERAL INFORMATION § 1301.01 Scope of this part 1301. Procedures governing the registra tion of manufacturers, distributors, dispensers, importers, and exporters of controlled substances pursuant to sec tions 301–304 and 1007–1008 of the Act (21 U.S.C. 821–824 and 957–958) are set forth generally by those sections and specifi cally by the sections of this part. [62 FR 13945, Mar. 24, 1997] § 1301.02 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 13945, Mar. 24, 1997] § 1301.03 Information; special instruc tions. Information 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. [75 FR 10676, Mar. 9, 2010] REGISTRATION § 1301.11 Persons required to register; requirement of modification of reg istration authorizing activity as an online pharmacy. (a) Every person who manufactures, distributes, dispenses, imports, or ex ports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of any controlled sub stance shall obtain a registration un less exempted by law or pursuant to §§ 1301.22 through 1301.26. Except as pro vided in paragraph (b) of this section, only persons actually engaged in such activities are required to obtain a reg istration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent cor poration of a corporation manufac turing controlled substances is not re quired to obtain a registration.) (b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C. 823(f) and 841(h)), it is unlawful for any person who falls within the definition of ‘‘on line pharmacy’’ (as set forth in section 102(52) of the Act (21 U.S.C. 802(52)) and § 1300.04(h) of this chapter) to deliver, distribute, or dispense a controlled sub stance by means of the Internet if such person is not validly registered with a modification of such registration au thorizing such activity (unless such person is exempt from such modified registration requirement under the Act or this chapter). The Act further pro vides that the Administrator may only issue such modification of registration to a person who is registered as a phar macy under section 303(f) of the Act (21 U.S.C. 823(f)). Accordingly, any phar macy registered pursuant to § 1301.13 of this part that falls within the defini tion of an online pharmacy and pro poses to dispense controlled substances by means of the Internet must obtain a modification of its registration author izing such activity following the sub mission of an application in accordance with § 1301.19 of this part. This require ment does not apply to a registered pharmacy that does not fall within the definition of an online pharmacy set forth in § 1300.04(h). Under the Act, per sons other than registered pharmacies are not eligible to obtain such a modi fication of registration but remain lia ble under section 401(h) of the Act (21 U.S.C. 841(h)) if they deliver, dis tribute, or dispense a controlled sub stance while acting as an online phar macy without being validly registered with a modification authorizing such activity. [74 FR 15621, Apr. 6, 2009] § 1301.12 Separate registrations for separate locations. (a) A separate registration is re quired for each principal place of busi ness or professional practice at one general physical location where con trolled substances are manufactured, distributed, imported, exported, or dis pensed by a person. (b) The following locations shall be deemed not to be places where con trolled substances are manufactured, distributed, or dispensed: VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00033 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 24 21 CFR Ch. II (4–1–16 Edition) § 1301.13 (1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such sub stances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of subsection 302(c)(2) or sub section 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 957(b)(1)(B)); (2) An office used by agents of a reg istrant where sales of controlled sub stances are solicited, made, or super vised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a dis tribution point for filling sales orders; and (3) An office used by a practitioner (who is registered at another location in the same State or jurisdiction of the United States) where controlled sub stances are prescribed but neither ad ministered nor otherwise dispensed as a regular part of the professional prac tice of the practitioner at such office, and where no supplies of controlled substances are maintained. (4) A freight forwarding facility, as defined in § 1300.01 of this part, provided that the distributing registrant oper ating the facility has submitted writ ten notice of intent to operate the fa cility by registered mail, return re ceipt requested (or other suitable means of documented delivery) and such notice has been approved. The no tice shall be submitted to the Special Agent in Charge of the Administra tion’s offices in both the area in which the facility is located and each area in which the distributing registrant main tains a registered location that will transfer controlled substances through the facility. The notice shall detail the registered locations that will utilize the facility, the location of the facil ity, the hours of operation, the indi vidual(s) responsible for the controlled substances, the security and record keeping procedures that will be em ployed, and whether controlled sub stances returns will be processed through the facility. The notice must also detail what state licensing re quirements apply to the facility and the registrant’s actions to comply with any such requirements. The Special Agent in Charge of the DEA Office in the area where the freight forwarding facility will be operated will provide written notice of approval or dis approval to the person within thirty days after confirmed receipt of the no tice. Registrants that are currently op erating freight forwarding facilities under a memorandum of understanding with the Administration must provide notice as required by this section no later than September 18, 2000 and re ceive written approval from the Spe cial Agent in Charge of the DEA Office in the area in which the freight for warding facility is operated in order to continue operation of the facility. [62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000; 71 FR 69480, Dec. 1, 2006] § 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities. (a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the appli cation for registration is granted and a Certificate of Registration is issued by the Administrator to such person. (b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration, except that a bulk manufacturer of Schedule I or II con trolled substances or an importer of Schedule I or II controlled substances may apply to be reregistered no more than 120 days before the expiration date of their registration. (c) At the time a manufacturer, dis tributor, reverse distributor, re searcher, analytical lab, importer, ex porter or narcotic treatment program is first registered, that business activ ity shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration date of the registrations of all reg istrants within any group will be the last date of the month designated for that group. In assigning any of these VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00034 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 25 Drug Enforcement Administration, Justice § 1301.13 business activities to a group, the Ad ministration may select a group the expiration date of which is less than one year from the date such business activity was registered. If the business activity is assigned to a group which has an expiration date less than three months from the date of which the business activity is registered, the reg istration shall not expire until one year from that expiration date; in all other cases, the registration shall ex pire on the expiration date following the date on which the business activity is registered. (d) At the time a retail pharmacy, hospital/clinic, practitioner or teach ing institution is first registered, that business activity shall be assigned to one of twelve groups, which shall cor respond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last day of the month designated for that group. In assigning any of the above business activities to a group, the Administration may select a group the expiration date of which is not less than 28 months nor more than 39 months from the date such business ac tivity was registered. After the initial registration period, the registration shall expire 36 months from the initial expiration date. (e) Any person who is required to be registered and who is not so registered, shall make application for registration for one of the following groups of con trolled substances activities, which are deemed to be independent of each other. Application for each registration shall be made on the indicated form, and shall be accompanied by the indi cated fee. Fee payments shall be made in the form of a personal, certified, or cashier’s check or money order made payable to the ‘‘Drug Enforcement Ad ministration’’. The application fees are not refundable. Any person, when reg istered to engage in the activities de scribed in each subparagraph in this paragraph, shall be authorized to en gage in the coincident activities de scribed without obtaining a registra tion to engage in such coincident ac tivities, provided that, unless specifi cally exempted, he/she complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities. Any per son who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph under coincident ac tivities. A single registration to engage in any group of independent activities listed below may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person reg istered to conduct research with con trolled substances listed in Schedule I may conduct research with any sub stances listed in Schedule I for which he/she has filed and had approved a re search protocol. (1) Business activity Controlled sub-stances DEA Application forms Application fee ($) Registration period (years) Coincident activities allowed (i) Manufacturing Schedules I–V ... New—225 Re newal—225a. 3,047 1 Schedules I–V: May distribute that sub stance or class for which registration was issued; may not distribute any substance or class for which not reg istered. Schedules II–V: May conduct chemical analysis and preclinical research (in cluding quality control analysis) with substances listed in those schedules for which authorization as a mfr. was issued. (ii) Distributing .... Schedules I–V ... New—225 Re newal—225a. 1,523 1 May acquire Schedules II–V controlled substances from collectors for the purposes of destruction. (iii) Reverse dis tributing. Schedules I–V ... New–225 Re newal–225a. 1,523 1 VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00035 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 26 21 CFR Ch. II (4–1–16 Edition) § 1301.13 Business activity Controlled sub-stances DEA Application forms Application fee ($) Registration period (years) Coincident activities allowed (iv) Dispensing or instructing (in cludes Practi tioner, Hospital/ Clinic, Retail Pharmacy, Central fill phar macy, Teaching Institution). Schedules II–V .. New–224 Re newal–224a. 731 3 May conduct research and instructional activities with those substances for which registration was granted, ex cept that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleagi nous solution or solid dosage form containing a narcotic controlled sub stance in Schedule II–V in a propor tion not exceeding 20% of the com plete solution, compound or mixture. A retail pharmacy may perform cen tral fill pharmacy activities. (v) Research ....... Schedule I ......... New–225 Re newal–225a. 244 1 A researcher may manufacture or im port the basic class of substance or substances for which registration was issued, provided that such man ufacture or import is set forth in the protocol required in § 1301.18 and to distribute such class to persons reg istered or authorized to conduct re search with such class of substance or registered or authorized to con duct chemical analysis with con trolled substances. (vi) Research ...... Schedules II–V .. New–225 Re newal–225a. 244 1 May conduct chemical analysis with controlled substances in those schedules for which registration was issued; manufacture such sub stances if and to the extent that such manufacture is set forth in a state ment filed with the application for registration or reregistration and pro vided that the manufacture is not for the purposes of dosage form devel opment; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical anal ysis, instructional activities or re search with such substances, and to persons exempted from registration pursuant to § 1301.24; and conduct instructional activities with controlled substances. (vii) Narcotic Treatment Pro gram (including compounder). Narcotic Drugs in Schedules II–V. New–363 Re newal–363a. 244 1 (viii) Importing ..... Schedules I–V ... New–225 Re newal–225a. 1,523 1 May distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered. (ix) Exporting ...... Schedules I–V ... New–225 Re newal–225a. 1,523 1 VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00036 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 27 Drug Enforcement Administration, Justice § 1301.13 Business activity Controlled sub-stances DEA Application forms Application fee ($) Registration period (years) Coincident activities allowed (x) Chemical Analysis. Schedules I–V ... New–225 Re newal–225a. 244 1 May manufacture and import controlled substances for analytical or instruc tional activities; may distribute such substances to persons registered or authorized to conduct chemical anal ysis, instructional activities, or re search with such substances and to persons exempted from registration pursuant to § 1301.24; may export such substances to persons in other countries performing chemical anal ysis or enforcing laws related to con trolled substances or drugs in those countries; and may conduct instruc tional activities with controlled sub stances. (2) DEA Forms 224, 225, and 363 may be obtained at any area office of the Administration or 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. (3) Registrants will receive renewal notifications approximately 60 days prior to the registration expiration date. DEA Forms 224a, 225a, and 363a may be mailed, as applicable, to reg istrants; if any registered person does not receive such notification within 45 days before the registration expiration date, the registrant must promptly give notice of such fact and may re quest such forms by writing to the Registration Section, Drug Enforce ment Administration. (f) Each application for registration to handle any basic class of controlled substance listed in Schedule I (except to conduct chemical analysis with such classes), and each application for reg istration to manufacture a basic class of controlled substance listed in Sched ule II shall include the Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each basic class to be covered by such registration. (g) Each application for registration to import or export controlled sub stances shall include the Administra tion Controlled Substances Code Num ber, as set forth in part 1308 of this chapter, for each controlled substance whose importation or exportation is to be authorized by such registration. Registration as an importer or ex porter shall not entitle a registrant to import or export any controlled sub stance not specified in such registra tion. (h) Each application for registration to conduct research with any basic class of controlled substance listed in Schedule II shall include the Adminis tration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each such basic class to be manufactured or imported as a coinci dent activity of that registration. A statement listing the quantity of each such basic class of controlled substance to be imported or manufactured during the registration period for which appli cation is being made shall be included with each such application. For pur poses of this paragraph only, manufac turing is defined as the production of a controlled substance by synthesis, ex traction or by agricultural/horti cultural means. (i) Each application shall include all information called for in the form, un less the item is not applicable, in which case this fact shall be indicated. (j) Each application, attachment, or other document filed as part of an ap plication, shall be signed by the appli cant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corpora tion, corporate division, association, trust or other entity. An applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the ap plicant by filing with the Registration VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00037 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 28 21 CFR Ch. II (4–1–16 Edition) § 1301.14 Unit of the Administration a power of attorney for each such individual. The power of attorney shall be signed by a person who is authorized to sign appli cations under this paragraph and shall contain the signature of the individual being authorized to sign applications. The power of attorney shall be valid until revoked by the applicant. [62 FR 13946, Mar. 24, 1997, as amended at 68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 68 FR 58598, Oct. 10, 2003; 71 FR 51112, Aug. 29, 2006; 74 FR 15622, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 77 FR 15248, Mar. 15, 2012; 79 FR 53560, Sept. 9, 2014] § 1301.14 Filing of application; accept ance for filing; defective applica tions. (a) All applications for registration shall be submitted for filing to the Registration Unit, Drug Enforcement Administration. The appropriate reg istration fee and any required attach ments must accompany the applica tion. See the Table of DEA Mailing Ad dresses in § 1321.01 of this chapter for the current mailing address. (b) Any person required to obtain more than one registration may submit all applications in one package. Each application must be complete and should not refer to any accompanying application for required information. (c) Applications submitted for filing are dated upon receipt. If found to be complete, the application will be ac cepted for filing. Applications failing to comply with the requirements of this part will not generally be accepted for filing. In the case of minor defects as to completeness, the Administrator may accept the application for filing with a request to the applicant for ad ditional information. A defective appli cation will be returned to the applicant within 10 days following its receipt with a statement of the reason for not accepting the application for filing. A defective application may be corrected and resubmitted for filing at any time; the Administrator shall accept for fil ing any application upon resubmission by the applicant, whether complete or not. (d) Accepting an application for fil ing does not preclude any subsequent request for additional information pur suant to § 1301.15 and has no bearing on whether the application will be grant ed. [62 FR 13948, Mar. 24, 1997, as amended at 75 FR 10676, Mar. 9, 2010] § 1301.15 Additional information. The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he/she deems nec essary to determine whether the appli cation should be granted. The failure of the applicant to provide such docu ments or statements within a reason able time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consider ation by the Administrator in granting or denying the application. [62 FR 13948, Mar. 24, 1997] § 1301.16 Amendments to and with drawal of applications. (a) An application may be amended or withdrawn without permission of the Administrator at any time before the date on which the applicant re ceives an order to show cause pursuant to § 1301.37. An application may be amended or withdrawn with permission of the Administrator at any time where good cause is shown by the ap plicant or where the amendment or withdrawal is in the public interest. (b) After an application has been ac cepted for filing, the request by the ap plicant that it be returned or the fail ure of the applicant to respond to offi cial correspondence regarding the ap plication, when sent by registered or certified mail, return receipt re quested, shall be deemed to be a with drawal of the application. [62 FR 13949, Mar. 24, 1997] § 1301.17 Special procedures for cer tain applications. (a) If, at the time of application for registration of a new pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant may include with his/her application an affidavit as to the existence of the State license in the following form: VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00038 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 29 Drug Enforcement Administration, Justice § 1301.17 Affidavit for New Pharmacy I, llllllllll, the llllllllll (Title of officer, official, partner, or other position) of llllllllll (Corporation, partner ship, or sole proprietor), doing business as llllllllll (Store name) at llllllllll (Number and Street), llllllllll (City) llllll (State) llllll (Zip code), hereby certify that said store was issued a pharmacy permit No. llll by the llllllll (Board of Pharmacy or Licensing Agency) of the State of llllll on llllll (Date). This statement is submitted in order to ob tain a Drug Enforcement Administration registration number. I understand that if any information is false, the Administration may immediately suspend the registration for this store and commence proceedings to revoke under 21 U.S.C. 824(a) because of the danger to public health and safety. I further understand that any false information con tained in this affidavit may subject me per sonally and the above-named corporation/ partnership/business to prosecution under 21 U.S.C. 843, the penalties for conviction of which include imprisonment for up to 4 years, a fine of not more than $30,000 or both. llllllllllllllllllllllll Signature (Person who signs Application for Registration) State of lllllllllllllllllll County of llllllllllllllllll Subscribed to and sworn before me this lllllll day of lllllll, 19ll. llllllllllllllllllllllll Notary Public (b) Whenever the ownership of a pharmacy is being transferred from one person to another, if the transferee owns at least one other pharmacy li censed in the same State as the one the ownership of which is being trans ferred, the transferee may apply for registration prior to the date of trans fer. The Administrator may register the applicant and authorize him to ob tain controlled substances at the time of transfer. Such registration shall not authorize the transferee to dispense controlled substances until the phar macy has been issued a valid State li cense. The transferee shall include with his/her application the following affidavit: Affidavit for Transfer of Pharmacy I, llllllllll, the llllllllll (Title of officer, official, partner or other position) of llllllllll (Corporation, partner ship, or sole proprietor), doing business as llllllllll (Store name) hereby cer tify: (1) That said company was issued a phar macy permit No.llllllby the llllllllll (Board of Pharmacy of Licensing Agency) of the State of llllll and a DEA Registration Number llllllllll for a pharmacy located at llllllllll (Number and Street) llllll (City) llllll (State) llllll (Zip Code); and (2) That said company is acquiring the pharmacy business of llllllllll (Name of Seller) doing business asllllllllllwith DEA Registration Number llllll on or about llllll (Date of Transfer) and that said company has applied (or will apply on llllll (Date) for a pharmacy permit from the board of pharmacy (or licensing agency) of the State of llllll to do business as llllllllll (Store name) at llllllllll (Number and Street) llllllllll (City) llllll (State) llllll (Zip Code). This statement is submitted in order to obtain a Drug Enforcement Admin istration registration number. I understand that if a DEA registration number is issued, the pharmacy may acquire controlled substances but may not dispense them until a pharmacy permit or license is issued by the State board of pharmacy or li censing agency. I understand that if any information is false, the Administration may immediately suspend the registration for this store and commence proceedings to revoke under 21 U.S.C. 824(a) because of the danger to public health and safety. I further understand that any false information contained in this affi davit may subject me personally to prosecu tion under 21 U.S.C. 843, the penalties for conviction of which include imprisonment for up to 4 years, a fine of not more than $30,000 or both. llllllllllllllllllllllll Signature (Person who signs Application for Registration) State of lllllllllllllllllll County of llllllllllllllllll Subscribed to and sworn before me this llllllll day of lllllllll, 19ll. llllllllllllllllllllllll Notary Public (c) If at the time of application for a separate registration at a long term care facility, the retail pharmacy has been issued a license, permit, or other form of authorization from the appro priate State agency to install and oper ate an automated dispensing system VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00039 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 30 21 CFR Ch. II (4–1–16 Edition) § 1301.18 for the dispensing of controlled sub stances at the long term care facility, the applicant must include with his/her application for registration (DEA Form 224) an affidavit as to the existence of the State authorization. Exact lan guage for this affidavit may be found at the DEA Diversion Control Program Web site. The affidavit must include the following information: (1) The name and title of the cor porate officer or official signing the af fidavit; (2) The name of the corporation, partnership or sole proprietorship oper ating the retail pharmacy; (3) The name and complete address (including city, state, and Zip code) of the retail pharmacy; (4) The name and complete address (including city, state, and Zip code) of the long term care facility at which DEA registration is sought; (5) Certification that the named re tail pharmacy has been authorized by the state Board of Pharmacy or licens ing agency to install and operate an automated dispensing system for the dispensing of controlled substances at the named long term care facility (in cluding the license or permit number, if applicable); (6) The date on which the authoriza tion was issued; (7) Statements attesting to the fol lowing: (i) The affidavit is submitted to ob tain a Drug Enforcement Administra tion registration number; (ii) If any material information is false, the Administrator may com mence proceedings to deny the applica tion under section 304 of the Act (21 U.S.C. 824(a)); (iii) Any false or fraudulent material information contained in this affidavit may subject the person signing this af fidavit and the above-named corpora tion/partnership/business to prosecu tion under section 403 of the Act (21 U.S.C. 843); (8) Signature of the person author ized to sign the Application for Reg istration for the named retail phar macy; (9) Notarization of the affidavit. (d) The Administrator shall follow the normal procedures for approving an application to verify the statements in the affidavit. If the statements prove to be false, the Administrator may re voke the registration on the basis of section 304(a)(1) of the Act (21 U.S.C. 824(a)(1)) and suspend the registration immediately by pending revocation on the basis of section 304(d) of the Act (21 U.S.C. 824(d)). At the same time, the Administrator may seize and place under seal all controlled substances possessed by the applicant under sec tion 304(f) of the Act (21 U.S.C. 824(f)). Intentional misuse of the affidavit pro cedure may subject the applicant to prosecution for fraud under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining controlled substances through registration by fraudulent means may subject the applicant to prosecution under section 403(a)(3) of the Act (21 U.S.C. 843(a)(3)). The pen alties for conviction of either offense include imprisonment for up to 4 years, a fine not exceeding $30,000 or both. [62 FR 13949, Mar. 24, 1997, as amended at 70 FR 25465, May 13, 2005] § 1301.18 Research protocols. (a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form and contain the following infor mation where applicable: (1) Investigator: (i) Name, address, and DEA registra tion number; if any. (ii) Institutional affiliation. (iii) Qualifications, including a cur riculum vitae and an appropriate bibli ography (list of publications). (2) Research project: (i) Title of project. (ii) Statement of the purpose. (iii) Name of the controlled sub stances or substances involved and the amount of each needed. (iv) Description of the research to be conducted, including the number and species of research subjects, the dosage to be administered, the route and method of administration, and the du ration of the project. (v) Location where the research will be conducted. (vi) Statement of the security provi sions for storing the controlled sub stances (in accordance with § 1301.75) and for dispensing the controlled sub stances in order to prevent diversion. VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00040 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 31 Drug Enforcement Administration, Justice § 1301.19 (vii) If the investigator desires to manufacture or import any controlled substance listed in paragraph (a)(2)(iii) of this section, a statement of the quantity to be manufactured or im ported and the sources of the chemicals to be used or the substance to be im ported. (3) Authority: (i) Institutional approval. (ii) Approval of a Human Research Committee for human studies. (iii) Indication of an approved active Notice of Claimed Investigational Ex emption for a New Drug (number). (iv) Indication of an approved funded grant (number), if any. (b) In the case of a clinical investiga tion with controlled substances listed in Schedule I, the applicant shall sub mit three copies of a Notice of Claimed Investigational Exemption for a New Drug (IND) together with a statement of the security provisions (as pro scribed in paragraph (a)(2)(vi) of this section for a research protocol) to, and have such submission approved by, the Food and Drug Administration as re quired in 21 U.S.C. 355(i) and § 130.3 of this title. Submission of this Notice and statement to the Food and Drug Administration shall be in lieu of a re search protocol to the Administration as required in paragraph (a) of this sec tion. The applicant, when applying for registration with the Administration, shall indicate that such notice has been submitted to the Food and Drug Administration by submitting to the Administration with his/her DEA Form 225 three copies of the following certifi cate: I hereby certify that on llllllllll (Date), pursuant to 21 U.S.C. 355(i) and 21 CFR 130.3, I, llllllllll (Name and Address of IND Sponsor) submitted a Notice of Claimed Investigational Exemption for a New Drug (IND) to the Food and Drug Ad ministration for: llllllllllllllllllllllll (Name of Investigational Drug). llllllllllllllllllllllll (Date) llllllllllllllllllllllll (Signature of Applicant). (c) In the event that the registrant desires to increase the quantity of a controlled substance used for an ap proved research project, he/she shall submit a request to the Registration Unit, Drug Enforcement Administra tion, by registered mail, return receipt requested. See the Table of DEA Mail ing Addresses in § 1321.01 of this chapter for the current mailing address. The re quest shall contain the following infor mation: DEA registration number; name of the controlled substance or substances and the quantity of each authorized in the approved protocol; and the additional quantity of each de sired. Upon return of the receipt, the registrant shall be authorized to pur chase the additional quantity of the controlled substance or substances specified in the request. The Adminis tration shall review the letter and for ward it to the Food and Drug Adminis tration together with the Administra tion comments. The Food and Drug Ad ministration shall approve or deny the request as an amendment to the pro tocol and so notify the registrant. Ap proval of the letter by the Food and Drug Administration shall authorize the registrant to use the additional quantity of the controlled substance in the research project. (d) In the event the registrant desires to conduct research beyond the vari ations provided in the registrant’s ap proved protocol (excluding any in crease in the quantity of the controlled substance requested for his/her re search project as outlined in paragraph (c) of this section), he/she shall submit three copies of a supplemental protocol in accordance with paragraph (a) of this section describing the new re search and omitting information in the supplemental protocol which has been stated in the original protocol. Supple mental protocols shall be processed and approved or denied in the same manner as original research protocols. [62 FR 13949, Mar. 24, 1997, as amended at 75 FR 10676, Mar. 9, 2010] § 1301.19 Special requirements for on line pharmacies. (a) A pharmacy that has been issued a registration under § 1301.13 may re quest that the Administrator modify its registration to authorize the phar macy to dispense controlled substances by means of the Internet as an online pharmacy. The Administrator may deny an application for a modification VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00041 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 32 21 CFR Ch. II (4–1–16 Edition) § 1301.21 of registration if the Administrator de termines that the issuance of a modi fication would be inconsistent with the public interest. In determining the public interest, the Administrator will consider the factors listed in section 303(f) of the Act (21 U.S.C. 823(f)). (b) Each online pharmacy shall com ply with the requirements of State law concerning licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses, or offers to deliver, dis tribute, or dispense controlled sub stances by means of the Internet. (c) Application for a modified reg istration authorizing the dispensing of controlled substances by means of the Internet will be made by an online ap plication process as specified in § 1301.13 of this part. Subsequent online phar macy registration renewals will be ac complished by an online process. (d) A pharmacy that seeks to dis continue its modification of registra tion authorizing it to dispense con trolled substances by means of the Internet as an online pharmacy (but continue its business activity as a non online pharmacy) shall so notify the Administrator by requesting to modify its registration to reflect the appro priate business activity. Once the reg istration has been so changed, the pharmacy may no longer dispense con trolled substances by means of the Internet. A pharmacy that has so changed its registration status back to that of a non-online pharmacy remains responsible for submitting reports in accordance with § 1304.55 of this chapter with respect to any controlled sub stances that it dispensed while it was registered with a modification author izing it to operate as an online phar macy. (e) Registrants applying for modified registrations under this section must comply with notification and reporting requirements set forth in §§ 1304.40, 1304.45, 1304.50, and 1304.55 of this chap ter. (f) No person (including a registrant) required to obtain a modification of a registration under §§ 1301.11(b) and 1301.13 of this part authorizing it to op erate as an online pharmacy may en gage in any activity for which such modification of registration is required until the application for such modified registration is granted and an active Certificate of Registration indicating the modification of the registration has been issued by the Administrator to such person. [74 FR 15622, Apr. 6, 2009] EXCEPTIONS TO REGISTRATION AND FEES § 1301.21 Exemption from fees. (a) The Administrator shall exempt from payment of an application fee for registration or reregistration: (1) Any hospital or other institution which is operated by an agency of the United States (including the U.S. Army, Navy, Marine Corps., Air Force, and Coast Guard), of any State, or any political subdivision or agency thereof. (2) Any individual practitioner who is required to obtain an individual reg istration in order to carry out his or her duties as an official of an agency of the United States (including the U.S. Army, Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any political subdivision or agency thereof. (b) In order to claim exemption from payment of a registration or rereg istration application fee, the registrant shall have completed the certification on the appropriate application form, wherein the registrant’s superior (if the registrant is an individual) or offi cer (if the registrant is an agency) cer tifies to the status and address of the registrant and to the authority of the registrant to acquire, possess, or han dle controlled substances. (c) Exemption from payment of a reg istration or reregistration application fee does not relieve the registrant of any other requirements or duties pre scribed by law. [62 FR 13950, Mar. 24, 1997] § 1301.22 Exemption of agents and em ployees; affiliated practitioners. (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 such agent or employee is acting in the usual course of his/her business or em ployment. VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00042 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 33 Drug Enforcement Administration, Justice § 1301.24 (b) An individual practitioner who is an agent or employee of another prac titioner (other than a mid-level practi tioner) registered to dispense con trolled substances may, when acting in the normal course of business or em ployment, administer or dispense (other than by issuance of prescription) controlled substances if and to the ex tent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself. (c) An individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or em ployment, administer, dispense, or pre scribe controlled substances under the registration of the hospital or other in stitution which is registered in lieu of being registered him/herself, provided that: (1) Such dispensing, administering or prescribing is done in the usual course of his/her professional practice; (2) Such individual practitioner is au thorized or permitted to do so by the jurisdiction in which he/she is prac ticing; (3) The hospital or other institution by whom he/she is employed has verified that the individual practi tioner is so permitted to dispense, ad minister, or prescribe drugs within the jurisdiction; (4) Such individual practitioner is acting only within the scope of his/her employment in the hospital or institu tion; (5) The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practi tioner so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suf fix to the institution’s DEA registra tion number, preceded by a hyphen (e.g., APO123456–10 or APO123456–A12); and (6) A current list of internal codes and the corresponding individual prac titioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the author ity of the prescribing individual practi tioner. [62 FR 13950, Mar. 24, 1997] § 1301.23 Exemption of certain mili tary and other personnel. (a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his/her offi cial duties. Such officials shall follow procedures set forth in part 1306 of this chapter regarding prescriptions, but shall state the branch of service or agency (e.g., ‘‘U.S. Army’’ or ‘‘Public Health Service’’) and the service iden tification number of the issuing official in lieu of the registration number re quired on prescription forms. The serv ice identification number for a Public Health Service employee is his/her So cial Security identification number. (b) The requirement of registration is waived for any official or agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or Public Health Service who or which is authorized to import or export controlled substances in the course of his/her official duties. (c) If any official exempted by this section also engages as a private indi vidual in any activity or group of ac tivities for which registration is re quired, such official shall obtain a reg istration for such private activities. [62 FR 13951, Mar. 24, 1997] § 1301.24 Exemption of law enforce ment officials. (a) The requirement of registration is waived for the following persons in the circumstances described in this sec tion: (1) Any officer or employee of the Ad ministration, any officer of the U.S. Customs Service, any officer or em ployee of the United States Food and Drug Administration, and any other Federal officer who is lawfully engaged in the enforcement of any Federal law relating to controlled substances, VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00043 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 34 21 CFR Ch. II (4–1–16 Edition) § 1301.25 drugs or customs, and is duly author ized to possess or to import or export controlled substances in the course of his/her official duties; and (2) Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his/her offi cial duties. (b) Any official exempted by this sec tion may, when acting in the course of his/her official duties, procure any con trolled substance in the course of an inspection, in accordance with § 1316.03(d) of this chapter, or in the course of any criminal investigation involving the person from whom the substance was procured, and may pos sess any controlled substance and dis tribute any such substance to any other official who is also exempted by this section and acting in the course of his/her official duties. (c) In order to enable law enforce ment agency laboratories, including laboratories of the Administration, to obtain and transfer controlled sub stances for use as standards in chem ical analysis, such laboratories shall obtain annually a registration to con duct chemical analysis. Such labora tories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described in section 515(d) of the Act (21 U.S.C. 885(d)). For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by of ficials exempted by this section. (d) In addition to the activities au thorized under a registration to con duct chemical analysis pursuant to § 1301.13(e)(1)(ix), laboratories of the Administration shall be authorized to manufacture or import controlled sub stances for any lawful purpose, to dis tribute or export such substances to any person, and to import and export such substances in emergencies with out regard to the requirements of part 1312 of this chapter if a report con cerning the importation or exportation is made to the Drug Operations Section of the Administration within 30 days of such importation or exportation. [62 FR 13951, Mar. 24, 1997] § 1301.25 Registration regarding ocean vessels, aircraft, and other entities. (a) If acquired by and dispensed under the general supervision of a medical of ficer described in paragraph (b) of this section, or the master or first officer of the vessel under the circumstances de scribed in paragraph (d) of this section, controlled substances may be held for stocking, be maintained in, and dis pensed from medicine chests, first aid packets, or dispensaries: (1) On board any vessel engaged in international trade or in trade between ports of the United States and any merchant vessel belonging to the U.S. Government; (2) On board any aircraft operated by an air carrier under a certificate of per mit issued pursuant to the Federal Aviation Act of 1958 (49 U.S.C. 1301); and (3) In any other entity of fixed or transient location approved by the Ad ministrator as appropriate for applica tion of this section (e.g., emergency kits at field sites of an industrial firm). (b) A medical officer shall be: (1) Licensed in a state as a physician; (2) Employed by the owner or oper ator of the vessel, aircraft or other en tity; and (3) Registered under the Act at either of the following locations: (i) The principal office of the owner or operator of the vessel, aircraft or other entity or (ii) At any other location provided that the name, address, registration number and expiration date as they ap pear on his/her Certificate of Registra tion (DEA Form 223) for this location are maintained for inspection at said principal office in a readily retrievable manner. (c) A registered medical officer may serve as medical officer for more than one vessel, aircraft, or other entity under a single registration, unless he/ she serves as medical officer for more than one owner or operator, in which case he/she shall either maintain a sep arate registration at the location of the principal office of each such owner VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00044 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 35 Drug Enforcement Administration, Justice § 1301.25 or operator or utilize one or more reg istrations pursuant to paragraph (b)(3)(ii) of this section. (d) If no medical officer is employed by the owner or operator of a vessel, or in the event such medical officer is not accessible and the acquisition of con trolled substances is required, the mas ter or first officer of the vessel, who shall not be registered under the Act, may purchase controlled substances from a registered manufacturer or dis tributor, or from an authorized phar macy as described in paragraph (f) of this section, by following the procedure outlined below: (1) The master or first officer of the vessel must personally appear at the vendor’s place of business, present proper identification (e.g., Seaman’s photographic identification card) and a written requisition for the controlled substances. (2) The written requisition must be on the vessel’s official stationery or purchase order form and must include the name and address of the vendor, the name of the controlled substance, description of the controlled substance (dosage form, strength and number or volume per container) number of con tainers ordered, the name of the vessel, the vessel’s official number and coun try of registry, the owner or operator of the vessel, the port at which the ves sel is located, signature of the vessel’s officer who is ordering the controlled substances and the date of the requisi tion. (3) The vendor may, after verifying the identification of the vessel’s officer requisitioning the controlled sub stances, deliver the control substances to that officer. The transaction shall be documented, in triplicate, on a record of sale in a format similar to that outlined in paragraph (d)(4) of this section. The vessel’s requisition shall be attached to copy 1 of the record of sale and filed with the controlled sub stances records of the vendor, copy 2 of the record of sale shall be furnished to the officer of the vessel and retained aboard the vessel, copy 3 of the record of sale shall be forwarded to the near est DEA Division Office within 15 days after the end of the month in which the sale is made. (4) The vendor’s record of sale should be similar to, and must include all the information contained in, the below listed format. SALE OF CONTROLLED SUBSTANCES TO VESSELS (Name of registrant) llllllllllll (Address of registrant) lllllllllll (DEA registration number) lllllllll Line No. Number of pack-ages ordered Size of packages Name of product Packages distrib uted Date distributed 1 ...................................... .............................. .............................. ............................ .............................. ............................ 2 ...................................... .............................. .............................. ............................ .............................. ............................ 3 ...................................... .............................. .............................. ............................ .............................. ............................ FOOTNOTE: Line numbers may be continued according to needs of the vendor. Number of lines completed lllllllll Name of vessel lllllllllllllll Vessel’s official number lllllllllll Vessel’s country of registry lllllllll Owner or operator of the vessel lllllll Name and title of vessel’s officer who pre sented the requisition llll Signature of vessel’s officer who presented the requisition llll (e) Any medical officer described in paragraph (b) of this section shall, in addition to complying with all require ments and duties prescribed for reg istrants generally, prepare an annual report as of the date on which his/her registration expires, which shall give in detail an accounting for each vessel, aircraft, or other entity, and a sum mary accounting for all vessels, air craft, or other entities under his/her supervision for all controlled sub stances purchased, dispensed or dis posed of during the year. The medical officer shall maintain this report with other records required to be kept under the Act and, upon request, deliver a copy of the report to the Administra tion. The medical officer need not be present when controlled substances are dispensed, if the person who actually dispensed the controlled substances is responsible to the medical officer to justify his/her actions. VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00045 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 36 21 CFR Ch. II (4–1–16 Edition) § 1301.26 (f) Any registered pharmacy that wishes to distribute controlled sub stances pursuant to this section shall be authorized to do so, provided: (1) The registered pharmacy notifies the nearest Division Office of the Ad ministration of its intention to so dis tribute controlled substances prior to the initiation of such activity. This no tification shall be by registered mail and shall contain the name, address, and registration number of the phar macy as well as the date upon which such activity will commence; and (2) Such activity is authorized by state law; and (3) The total number of dosage units of all controlled substances distributed by the pharmacy during any calendar year in which the pharmacy is reg istered to dispense does not exceed the limitations imposed upon such dis tribution by § 1307.11(a)(4) and (b) of this chapter. (g) Owners or operators of vessels, aircraft, or other entities described in this section shall not be deemed to pos sess or dispense any controlled sub stance acquired, stored and dispensed in accordance with this section. Addi tionally, owners or operators of ves sels, aircraft, or other entities de scribed in this section or in Article 32 of the Single Convention on Narcotic Drugs, 1961, or in Article 14 of the Con vention on Psychotropic Substances, 1971, shall not be deemed to import or export any controlled substances pur chased and stored in accordance with that section or applicable article. (h) The Master of a vessel shall pre pare a report for each calendar year which shall give in detail an account ing for all controlled substances pur chased, dispensed, or disposed of during the year. The Master shall file this re port with the medical officer employed by the owner or operator of his/her ves sel, if any, or, if not, he/she shall main tain this report with other records re quired to be kept under the Act and, upon request, deliver a copy of the re port to the Administration. (i) Controlled substances acquired and possessed in accordance with this section shall be distributed only to per sons under the general supervision of the medical officer employed by the owner or operator of the vessel, air craft, or other entity, except in accord ance with part 1317 of this chapter. [62 FR 13951, Mar. 24, 1997, as amended at 79 FR 53561, Sept. 9, 2014] § 1301.26 Exemptions from import or export requirements for personal medical use. Any individual who has in his/her possession a controlled substance listed in schedules II, III, IV, or V, which he/ she has lawfully obtained for his/her personal medical use, or for adminis tration to an animal accompanying him/her, may enter or depart the United States with such substance not withstanding sections 1002–1005 of the Act (21 U.S.C. 952–955), provided the fol lowing conditions are met: (a) The controlled substance is in the original container in which it was dis pensed to the individual; and (b) The individual makes a declara tion to an appropriate official of the Bureau of Customs and Border Protec tion stating: (1) That the controlled substance is possessed for his/her personal use, or for an animal accompanying him/her; and (2) The trade or chemical name and the symbol designating the schedule of the controlled substance if it appears on the container label, or, if such name does not appear on the label, the name and address of the pharmacy or practi tioner who dispensed the substance and the prescription number. (c) In addition to (and not in lieu of) the foregoing requirements of this sec tion, a United States resident may im port into the United States no more than 50 dosage units combined of all such controlled substances in the indi vidual’s possession that were obtained abroad for personal medical use. (For purposes of this section, a United States resident is a person whose resi dence (i.e., place of general abode— meaning one’s principal, actual dwell ing place in fact, without regard to in tent) is in the United States.) This 50 dosage unit limitation does not apply to controlled substances lawfully ob tained in the United States pursuant to a prescription issued by a DEA reg istrant. [69 FR 55347, Sept. 14, 2004] VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00046 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 37 Drug Enforcement Administration, Justice § 1301.28 § 1301.27 Separate registration by re tail pharmacies for installation and operation of automated dispensing systems at long term care facilities. (a) A retail pharmacy may install and operate automated dispensing sys tems, as defined in § 1300.01 of this chapter, at long term care facilities, under the requirements of § 1301.17. No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long term care facility. (b) Retail pharmacies installing and operating automated dispensing sys tems at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated dispensing sys tems are located. If more than one reg istered retail pharmacy operates auto mated dispensing systems at the same long term care facility, each retail pharmacy must maintain a registra tion at the long term care facility. (c) A registered retail pharmacy ap plying for a separate registration to operate an automated dispensing sys tem for the dispensing of controlled substances at a long term care facility is exempt from application fees for any such additional registrations. [70 FR 25465, May 13, 2005] § 1301.28 Exemption from separate registration for practitioners dis pensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Ad ministration specifically for use in maintenance or detoxification treatment. (a) An individual practitioner may dispense or prescribe Schedule III, IV, or V narcotic controlled drugs or com binations of narcotic controlled drugs which have been approved by the Food and Drug Administration (FDA) spe cifically for use in maintenance or de toxification treatment without obtain ing the separate registration required by § 1301.13(e) if all of the following con ditions are met: (1) The individual practitioner meets the conditions specified in paragraph (b) of this section. (2) The narcotic drugs or combina tion of narcotic drugs meet the condi tions specified in paragraph (c) of this section. (3) The individual practitioner is in compliance with either paragraph (d) or paragraph (e) of this section. (b)(1) The individual practitioner must submit notification to the Sec retary of Health and Human Services stating the individual practitioner’s in tent to dispense or prescribe narcotic drugs under paragraph (a) of this sec tion. The notice must contain all of the following certifications: (i) The individual practitioner is reg istered under § 1301.13 as an individual practitioner and is a ‘‘qualifying physi cian’’ as defined in section 303(g)(2)(G) of the Act (21 U.S.C. 823(g)(2)(G)). (ii) The individual practitioner has the capacity to refer the patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs for appropriate coun seling and other appropriate ancillary services. (iii) The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs under this section will not exceed 30 at any one time un less, not sooner than 1 year after the date on which the practitioner sub mitted the initial notification to the Secretary of Health and Human Serv ices, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second noti fication under this subparagraph shall contain the certifications required by subparagraphs (i) and (ii) of this para graph. The Secretary of Health and Human Services may promulgate regu lations to change the total number of patients. (2) If an individual practitioner wish es to prescribe or dispense narcotic drugs pursuant to paragraph (e) of this section, the individual practitioner must provide the Secretary of Health and Human Services the following: (i) Notification as required under paragraph (b)(1) of this section in writ ing, stating the individual practi tioner’s name and DEA registration number issued under § 1301.13. (ii) If the individual practitioner is a member of a group practice, the names of the other individual practitioners in VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00047 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 38 21 CFR Ch. II (4–1–16 Edition) § 1301.28 the group and the DEA registration numbers issued to the other individual practitioners under § 1301.13. (c) The narcotic drugs or combina tion of narcotic drugs to be dispensed or prescribed under this section must meet all of the following conditions: (1) The drugs or combination of drugs have been approved for use in ‘‘main tenance treatment’’ or ‘‘detoxification treatment’’ under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act. (2) The drugs or combination of drugs have not been the subject of an adverse determination by the Secretary of Health and Human Services, after con sultation with the Attorney General, that the use of the drugs or combina tion of drugs requires additional stand ards respecting the qualifications of practitioners or the quantities of the drugs that may be provided for unsu pervised use. (d)(1) After receiving the notification submitted under paragraph (b) of this section, the Secretary of Health and Human Services will forward a copy of the notification to the Administrator. The Secretary of Health and Human Services will have 45 days from the date of receipt of the notification to make a determination of whether the individual practitioner involved meets all requirements for a waiver under section 303(g)(2)(B) of the Act (21 U.S.C. 823(g)(2)(B)). Health and Human Serv ices will notify DEA of its determina tion regarding the individual practi tioner. If the individual practitioner has the appropriate registration under § 1301.13, then the Administrator will issue the practitioner an identification number as soon as one of the following conditions occurs: (i) The Administrator receives a posi tive determination from the Secretary of Health and Human Services before the conclusion of the 45-day review pe riod, or (ii) The 45-day review period has con cluded and no determination by the Secretary of Health and Human Serv ices has been made. (2) If the Secretary denies certifi cation to an individual practitioner or withdraws such certification once it is issued, then DEA will not issue the in dividual practitioner an identification number, or will withdraw the identi fication number if one has been issued. (3) The individual practitioner must include the identification number on all records when dispensing and on all prescriptions when prescribing narcotic drugs under this section. (e) An individual practitioner may begin to prescribe or dispense narcotic drugs to a specific individual patient under this section before receiving an identification number from the Admin istrator if the following conditions are met: (1) The individual practitioner has submitted a written notification under paragraph (b) of this section in good faith to the Secretary of Health and Human Services. (2) The individual practitioner rea sonably believes that the conditions specified in paragraphs (b) and (c) of this section have been met. (3) The individual practitioner rea sonably believes that the treatment of an individual patient would be facili tated if narcotic drugs are prescribed or dispensed under this section before the sooner of: (i) Receipt of an identification num ber from the Administrator, or (ii) Expiration of the 45-day period. (4) The individual practitioner has notified both the Secretary of Health and Human Services and the Adminis trator of his or her intent to begin pre scribing or dispensing the narcotic drugs before expiration of the 45-day period. (5) The Secretary has not notified the registrant that he/she is not qualified under paragraph (d) of this section. (6) The individual practitioner has the appropriate registration under § 1301.13. (f) If an individual practitioner dis penses or prescribes Schedule III, IV, or V narcotic drugs approved by the Food and Drug Administration specifically for maintenance or detoxification treatment in violation of any of the conditions specified in paragraphs (b), (c) or (e) of this section, the Adminis trator may revoke the individual prac titioner’s registration in accordance with § 1301.36. [70 FR 36342, June 23, 2005, as amended at 73 FR 29688, May 22, 2008] VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00048 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 39 Drug Enforcement Administration, Justice § 1301.33 § 1301.29 [Reserved] ACTION ON APPLICATION FOR REGISTRA TION: REVOCATION OR SUSPENSION OF REGISTRATION § 1301.31 Administrative review gen erally. The Administrator may inspect, or cause to be inspected, the establish ment of an applicant or registrant, pur suant to subpart A of part 1316 of this chapter. The Administrator shall re view the application for registration and other information gathered by the Administrator regarding an applicant in order to determine whether the ap plicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 U.S.C. 958) of the Act have been met by the appli cant. [62 FR 13953, Mar. 24, 1997] § 1301.32 Action on applications for re search in Schedule I substances. (a) In the case of an application for registration to conduct research with controlled substances listed in Sched ule I, the Administrator shall process the application and protocol and for ward a copy of each to the Secretary of Health and Human Services (Secretary) within 7 days after receipt. The Sec retary shall determine the qualifica tions and competency of the applicant, as well as the merits of the protocol (and shall notify the Administrator of his/her determination) within 21 days after receipt of the application and complete protocol, except that in the case of a clinical investigation, the Secretary shall have 30 days to make such determination and notify the Ad ministrator. The Secretary, in deter mining the merits of the protocol, shall consult with the Administrator as to effective procedures to safeguard ade quately against diversion of such con trolled substances from legitimate medical or scientific use. (b) An applicant whose protocol is de fective shall be notified by the Sec retary within 21 days after receipt of such protocol from the Administrator (or in the case of a clinical investiga tion within 30 days), and he/she shall be requested to correct the existing de fects before consideration shall be given to his/her submission. (c) If the Secretary determines the applicant qualified and competent and the research protocol meritorious, he/ she shall notify the Administrator in writing of such determination. The Ad ministrator shall issue a certificate of registration within 10 days after re ceipt of this notice, unless he/she deter mines that the certificate of registra tion should be denied on a ground spec ified in section 304(a) of the Act (21 U.S.C. 824(a)). In the case of a supple mental protocol, a replacement certifi cate of registration shall be issued by the Administrator. (d) If the Secretary determines that the protocol is not meritorious and/or the applicant is not qualified or com petent, he/she shall notify the Adminis trator in writing setting forth the rea sons for such determination. If the Ad ministrator determines that grounds exist for the denial of the application, he/she shall within 10 days issue an order to show cause pursuant to § 1301.37 and, if requested by the appli cant, hold a hearing on the application pursuant to § 1301.41. If the grounds for denial of the application include a de termination by the Secretary, the Sec retary or his duly authorized agent shall furnish testimony and documents pertaining to his determination at such hearing. (e) Supplemental protocols will be processed in the same manner as origi nal research protocols. If the proc essing of an application or research protocol is delayed beyond the time limits imposed by this section, the ap plicant shall be so notified in writing. [62 FR 13953, Mar. 24, 1997] § 1301.33 Application for bulk manu facture of Schedule I and II sub stances. (a) In the case of an application for registration or reregistration to manu facture in bulk a basic class of con trolled substance listed in Schedule I or II, the Administrator shall, upon the filing of such application, publish in the FEDERAL REGISTER a notice naming the applicant and stating that such ap plicant has applied to be registered as a bulk manufacturer of a basic class of narcotic or nonnarcotic controlled sub stance, which class shall be identified. A copy of said notice shall be mailed VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00049 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 40 21 CFR Ch. II (4–1–16 Edition) § 1301.34 simultaneously to each person reg istered as a bulk manufacturer of that basic class and to any other applicant therefor. Any such person may, within 60 days from the date of publication of the notice in the FEDERAL REGISTER, file with the Administrator written comments on or objections to the issuance of the proposed registration. (b) In order to provide adequate com petition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply. (c) This section shall not apply to the manufacture of basic classes of con trolled substances listed in Schedules I or II as an incident to research or chemical analysis as authorized in § 1301.13(e)(1). [62 FR 13953, Mar. 24, 1997] § 1301.34 Application for importation of Schedule I and II substances. (a) In the case of an application for registration or reregistration to import a controlled substance listed in Sched ule I or II, under the authority of sec tion 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator shall, upon the filing of such application, publish in the FEDERAL REGISTER a no tice naming the applicant and stating that such applicant has applied to be registered as an importer of a Schedule I or II controlled substance, which sub stance shall be identified. A copy of said notice shall be mailed simulta neously to each person registered as a bulk manufacturer of that controlled substance and to any other applicant therefor. Any such person may, within 30 days from the date of publication of the notice in the FEDERAL REGISTER, file written comments on or objections to the issuance of the proposed reg istration, and may, at the same time, file a written request for a hearing on the application pursuant to § 1301.43. If a hearing is requested, the Adminis trator shall hold a hearing on the ap plication in accordance with § 1301.41. Notice of the hearing shall be published in the FEDERAL REGISTER, and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Any such person may participate in the hearing by filing a notice of appearance in ac cordance with § 1301.43 of this chapter. Notice of the hearing shall contain a summary of all comments and objec tions filed regarding the application and shall state the time and place for the hearing, which shall not be less than 30 days after the date of publica tion of such notice in the FEDERAL REGISTER. A hearing pursuant to this section may be consolidated with a hearing held pursuant to § 1301.35 or § 1301.36 of this part. (b) The Administrator shall register an applicant to import a controlled substance listed in Schedule I or II if he/she determines that such registra tion is consistent with the public inter est and with U.S. obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered: (1) Maintenance of effective controls against diversion of particular con trolled substances and any controlled substance in Schedule I or II com pounded therefrom into other than le gitimate medical, scientific research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and in dustrial purposes; (2) Compliance with applicable State and local law; (3) Promotion of technical advances in the art of manufacturing these sub stances and the development of new substances; (4) Prior conviction record of appli cant under Federal and State laws re lating to the manufacture, distribu tion, or dispensing of such substances; (5) Past experience in the manufac ture of controlled substances, and the existence in the establishment of effec tive control against diversion; (6) That the applicant will be per mitted to import only: (i) Such amounts of crude opium, poppy straw, concentrate of poppy VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00050 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 41 Drug Enforcement Administration, Justice § 1301.35 straw, and coca leaves as the Adminis trator finds to be necessary to provide for medical, scientific, or other legiti mate purposes; or (ii) Such amounts of any controlled substances listed in Schedule I or II as the Administrator shall find to be nec essary to provide for the medical, sci entific, or other legitimate needs of the United States during an emergency in which domestic supplies of such sub stances are found by the Administrator to be inadequate; or (iii) Such amounts of any controlled substance listed in Schedule I or II as the Administrator shall find to be nec essary to provide for the medical, sci entific, or other legitimate needs of the United States in any case in which the Administrator finds that competition among domestic manufacturers of the controlled substance is inadequate and will not be rendered adequate by the registration of additional manufactur ers under section 303 of the Act (21 U.S.C. 823); or (iv) Such limited quantities of any controlled substance listed in Schedule I or II as the Administrator shall find to be necessary for scientific, analyt ical or research uses; and (7) Such other factors as may be rel evant to and consistent with the public health and safety. (c) In determining whether the appli cant can and will maintain effective controls against diversion within the meaning of paragraph (b) of this sec tion, the Administrator shall consider among other factors: (1) Compliance with the security re quirements set forth in §§ 1301.71– 1301.76; and (2) Employment of security proce dures to guard against in-transit losses within and without the jurisdiction of the United States. (d) In determining whether competi tion among the domestic manufactur ers of a controlled substance is ade quate within the meaning of para graphs (b)(1) and (b)(6)(iii) of this sec tion, as well as section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Ad ministrator shall consider: (1) The extent of price rigidity in the light of changes in: (i) raw materials and other costs and (ii) conditions of supply and demand; (2) The extent of service and quality competition among the domestic man ufacturers for shares of the domestic market including: (i) Shifts in market shares and (ii) Shifts in individual customers among domestic manufacturers; (3) The existence of substantial dif ferentials between domestic prices and the higher of prices generally pre vailing in foreign markets or the prices at which the applicant for registration to import is committed to undertake to provide such products in the domes tic market in conformity with the Act. In determining the existence of sub stantial differentials hereunder, appro priate consideration should be given to any additional costs imposed on domes tic manufacturers by the requirements of the Act and such other cost-related and other factors as the Administrator may deem relevant. In no event shall an importer’s offering prices in the United States be considered if they are lower than those prevailing in the for eign market or markets from which the importer is obtaining his/her sup ply; (4) The existence of competitive re straints imposed upon domestic manu facturers by governmental regulations; and (5) Such other factors as may be rel evant to the determinations required under this paragraph. (e) In considering the scope of the do mestic market, consideration shall be given to substitute products which are reasonably interchangeable in terms of price, quality and use. (f) The fact that the number of exist ing manufacturers is small shall not demonstrate, in and of itself, that ade quate competition among them does not exist. [62 FR 13953, Mar. 24, 1997] § 1301.35 Certificate of registration; denial of registration. (a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if the issuance of registration or reregistration is re quired under the applicable provisions of sections 303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00051 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 42 21 CFR Ch. II (4–1–16 Edition) § 1301.36 the issuance of registration or rereg istration is not required, the Adminis trator shall deny the application. Be fore denying any application, the Ad ministrator shall issue an order to show cause pursuant to § 1301.37 and, if requested by the applicant, shall hold a hearing on the application pursuant to § 1301.41. (b) If in response to a show cause order a hearing is requested by an ap plicant for registration or reregistra tion to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, notice that a hearing has been requested shall be published in the FEDERAL REGISTER and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Any person entitled to file comments or objections to the issuance of the proposed reg istration pursuant to § 1301.33(a) may participate in the hearing by filing no tice of appearance in accordance with § 1301.43. Such persons shall have 30 days to file a notice of appearance after the date of publication of the notice of a request for a hearing in the FEDERAL REGISTER. (c) The Certificate of Registration (DEA Form 223) shall contain the name, address, and registration num ber of the registrant, the activity au thorized by the registration, the sched ules and/or Administration Controlled Substances Code Number (as set forth in part 1308 of this chapter) of the con trolled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expira tion date of the registration. The reg istrant shall maintain the certificate of registration at the registered loca tion in a readily retrievable manner and shall permit inspection of the cer tificate by any official, agent or em ployee of the Administration or of any Federal, State, or local agency engaged in enforcement of laws relating to con trolled substances. [62 FR 13954, Mar. 24, 1997] § 1301.36 Suspension or revocation of registration; suspension of registra tion pending final order; extension of registration pending final order. (a) For any registration issued under section 303 of the Act (21 U.S.C. 823), the Administrator may: (1) Suspend the registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time. (2) Revoke the registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)). (b) For any registration issued under section 1008 of the Act (21 U.S.C. 958), the Administrator may: (1) Suspend the registration pursuant to section 1008(d) of the Act (21 U.S.C. 958(d)) for any period of time. (2) Revoke the registration pursuant to section 1008(d) of the Act (21 U.S.C. 958(d)) if he/she determines that such registration is inconsistent with the public interest as defined in section 1008 or with the United States obliga tions under international treaties, con ventions, or protocols in effect on Oc tober 12, 1984. (c) The Administrator may limit the revocation or suspension of a registra tion to the particular controlled sub stance, or substances, with respect to which grounds for revocation or sus pension exist. (d) Before revoking or suspending any registration, the Administrator shall issue an order to show cause pur suant to § 1301.37 and, if requested by the registrant, shall hold a hearing pursuant to § 1301.41. (e) The Administrator may suspend any registration simultaneously with or at any time subsequent to the serv ice upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where he/she finds that there is an imminent danger to the public health or safety. If the Administrator so suspends, he/she shall serve with the order to show cause pursuant to § 1301.37 an order of immediate suspen sion which shall contain a statement of his findings regarding the danger to public health or safety. (f) Upon service of the order of the Administrator suspending or revoking registration, the registrant shall im mediately deliver his/her Certificate of VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00052 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 43 Drug Enforcement Administration, Justice § 1301.37 Registration, any order forms, and any import or export permits in his/her pos session to the nearest office of the Ad ministration. The suspension or rev ocation of a registration shall suspend or revoke any individual manufac turing or procurement quota fixed for the registrant pursuant to part 1303 of this chapter and any import or export permits issued to the registrant pursu ant to part 1312 of this chapter. Also, upon service of the order of the Admin istrator revoking or suspending reg istration, the registrant shall, as in structed by the Administrator: (1) Deliver all controlled substances in his/her possession to the nearest of fice of the Administration or to au thorized agents of the Administration; or (2) Place all controlled substances in his/her possession under seal as de scribed in sections 304(f) or 1008(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)). (g) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certifi cate of Registration for all substances not affected by such revocation or sus pension; no fee shall be required to be paid for the new Certificate of Reg istration. The registrant shall deliver the old Certificate of Registration and, if appropriate, any order forms in his/ her possession to the nearest office of the Administration. The suspension or revocation of a registration, when lim ited to a particular basic class or class es of controlled substances, shall sus pend or revoke any individual manu facturing or procurement quota fixed for the registrant for such class or classes pursuant to part 1303 of this chapter and any import or export per mits issued to the registrant for such class or classes pursuant to part 1312 of this chapter. Also, upon service of the order of the Administrator revoking or suspending registration, the registrant shall, as instructed by the Adminis trator: (1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the par ticular controlled substance or sub stances affected by the revocation or suspension which are in his/her posses sion; or (2) Place all of such substances under seal as described in sections 304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)). (h) Any suspension shall continue in effect until the conclusion of all pro ceedings upon the revocation or sus pension, including any judicial review thereof, unless sooner withdrawn by the Administrator or dissolved by a court of competent jurisdiction. Any registrant whose registration is sus pended under paragraph (e) of this sec tion may request a hearing on the rev ocation or suspension of his/her reg istration at a time earlier than speci fied in the order to show cause pursu ant to § 1301.37. This request shall be granted by the Administrator, who shall fix a date for such hearing as early as reasonably possible. (i) In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has ap plied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the Administrator has issued no order on the application on the date on which the existing registration is due to ex pire, the existing registration of the applicant shall automatically be ex tended and continue in effect until the date on which the Administrator so issues his/her order. The Administrator may extend any other existing reg istration under the circumstances con templated in this section even though the registrant failed to apply for rereg istration at least 45 days before expira tion of the existing registration, with or without request by the registrant, if the Administrator finds that such ex tension is not inconsistent with the public health and safety. [62 FR 13955, Mar. 24, 1997] § 1301.37 Order to show cause. (a) If, upon examination of the appli cation for registration from any appli cant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the appli cant, the Administrator shall serve VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00053 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 44 21 CFR Ch. II (4–1–16 Edition) § 1301.41 upon the applicant an order to show cause why the registration should not be denied. (b) If, upon information gathered by the Administration regarding any reg istrant, the Administrator determines that the registration of such registrant is subject to suspension or revocation pursuant to section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the Administrator shall serve upon the reg istrant an order to show cause why the registration should not be revoked or suspended. (c) The order to show cause shall call upon the applicant or registrant to ap pear before the Administrator at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also con tain a statement of the legal basis for such hearing and for the denial, revoca tion, or suspension of registration and a summary of the matters of fact and law asserted. (d) Upon receipt of an order to show cause, the applicant or registrant must, if he/she desires a hearing, file a request for a hearing pursuant to § 1301.43. If a hearing is requested, the Administrator shall hold a hearing at the time and place stated in the order, pursuant to § 1301.41. (e) When authorized by the Adminis trator, any agent of the Administra tion may serve the order to show cause. [62 FR 13955, Mar. 24, 1997] HEARINGS § 1301.41 Hearings generally. (a) In any case where the Adminis trator shall hold a hearing on any reg istration or application therefor, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administra tive Procedure Act (5 U.S.C. 551–559) and specifically by sections 303, 304, and 1008 of the Act (21 U.S.C. 823–824 and 958), by §§ 1301.42–1301.46 of this part, and by the procedures for admin istrative hearings under the Act set forth in §§ 1316.41–1316.67 of this chap ter. (b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other pro ceedings under the Act or any other law of the United States. [62 FR 13956, Mar. 24, 1997] § 1301.42 Purpose of hearing. If requested by a person entitled to a hearing, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for reg istration to import or to manufacture in bulk a basic class of controlled sub stance listed in Schedule I or II. Exten sive argument should not be offered into evidence but rather presented in opening or closing statements of coun sel or in memoranda or proposed find ings of fact and conclusions of law. [62 FR 13956, Mar. 24, 1997] § 1301.43 Request for hearing or ap pearance; waiver. (a) Any person entitled to a hearing pursuant to § 1301.32 or §§ 1301.34–1301.36 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause (or the date of pub lication of notice of the application for registration in the FEDERAL REGISTER in the case of § 1301.34), file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter. (b) Any person entitled to participate in a hearing pursuant to § 1301.34 or § 1301.35(b) and desiring to do so shall, within 30 days of the date of publica tion of notice of the request for a hear ing in the FEDERAL REGISTER, file with the Administrator a written notice of intent to participate in such hearing in the form prescribed in § 1316.48 of this chapter. Any person filing a request for a hearing need not also file a notice of appearance. (c) Any person entitled to a hearing or to participate in a hearing pursuant to § 1301.32 or §§ 1301.34–1301.36 may, within the period permitted for filing a request for a hearing or a notice of ap pearance, file with the Administrator a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding such person’s position on the matters VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00054 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 45 Drug Enforcement Administration, Justice § 1301.46 of fact and law involved in such hear ing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein. (d) If any person entitled to a hearing or to participate in a hearing pursuant to § 1301.32 or §§ 1301.34–1301.36 fails to file a request for a hearing or a notice of appearance, or if such person so files and fails to appear at the hearing, such person shall be deemed to have waived the opportunity for a hearing or to par ticipate in the hearing, unless such person shows good cause for such fail ure. (e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his/ her final order pursuant to § 1301.46 without a hearing. [62 FR 13956, Mar. 24, 1997] § 1301.44 Burden of proof. (a) At any hearing on an application to manufacture any controlled sub stance listed in Schedule I or II, the ap plicant shall have the burden of prov ing that the requirements for such reg istration pursuant to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other person participating in the hearing pursuant to § 1301.35(b) shall have the burden of proving any propo sitions of fact or law asserted by such person in the hearing. (b) At any hearing on the granting or denial of an applicant to be registered to conduct a narcotic treatment pro gram or as a compounder, the appli cant shall have the burden of proving that the requirements for each reg istration pursuant to section 303(g) of the Act (21 U.S.C. 823(g)) are satisfied. (c) At any hearing on the granting or denial of an application to be reg istered to import or export any con trolled substance listed in Schedule I or II, the applicant shall have the bur den of proving that the requirements for such registration pursuant to sec tions 1008(a) and (d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other person participating in the hear ing pursuant to § 1301.34 shall have the burden of proving any propositions of fact or law asserted by him/her in the hearings. (d) At any other hearing for the de nial of a registration, the Administra tion shall have the burden of proving that the requirements for such reg istration pursuant to section 303 or sec tion 1008(c) and (d) of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied. (e) At any hearing for the revocation or suspension of a registration, the Ad ministration shall have the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are satis fied. [62 FR 13956, Mar. 24, 1997] § 1301.45 Time and place of hearing. The hearing will commence at the place and time designated in the order to show cause or notice of hearing pub lished in the FEDERAL REGISTER (unless expedited pursuant to § 1301.36(h)) but thereafter it may be moved to a dif ferent place and may be continued from day to day or recessed to a later day without notice other than an nouncement thereof by the presiding officer at the hearing. [62 FR 13956, Mar. 24, 1997] § 1301.46 Final order. As soon as practicable after the pre siding officer has certified the record to the Administrator, the Adminis trator shall issue his/her order on the granting, denial, revocation, or suspen sion of registration. In the event that an application for registration to im port or to manufacture in bulk a basic class of any controlled substance listed in Schedule I or II is granted, or any application for registration is denied, or any registration is revoked or sus pended, 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. The Administrator shall serve one copy of his/her order upon each party in the hearing. [62 FR 13956, Mar. 24, 1997] VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00055 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 46 21 CFR Ch. II (4–1–16 Edition) § 1301.51 MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION § 1301.51 Modification in registration. (a) Any registrant may apply to mod ify his/her registration to authorize the handling of additional controlled sub stances or to change his/her name or address by submitting a written re quest to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Additionally, such a request may be submitted on-line at www.DEAdiversion.usdoj.gov. (1) The request shall contain: (i) The registrant’s name, address, and registration number as printed on the certificate of registration; (ii) The substances and/or schedules to be added to the registration or the new name or address; and (iii) A signature in accordance with § 1301.13(j). (2) If the registrant is seeking to han dle additional controlled substances listed in Schedule I for the purpose of research or instructional activities, the registrant shall attach three copies of a research protocol describing each re search project involving the additional substances, or two copies of a state ment describing the nature, extent, and duration of such instructional ac tivities, as appropriate. (b) Any manufacturer, distributor, reverse distributor, narcotic treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy reg istered pursuant to this part, may apply to modify its registration to be come authorized as a collector by sub mitting a written request to the Reg istration Unit, Drug Enforcement Ad ministration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing ad dress. Additionally, such request may be submitted on-line at www.DEAdiversion.usdoj.gov. (1) The request shall contain: (i) The registrant’s name, address, and registration number as printed on the certificate of registration; (ii) The method(s) of collection the registrant intends to conduct (collec tion receptacle and/or mail-back pro gram); and (iii) A signature in accordance with § 1301.13(j). (2) If a hospital/clinic with an on-site pharmacy or retail pharmacy is apply ing for a modification in registration to authorize such registrant to be a collector to maintain a collection re ceptacle at a long-term care facility in accordance with § 1317.80 of this chap ter, the request shall also include the name and physical location of each long-term care facility at which the hospital/clinic with an on-site phar macy, or the retail pharmacy, intends to operate a collection receptacle. (c) No fee shall be required for modi fication. The request for modification shall be handled in the same manner as an application for registration. If the modification of registration is ap proved, the Administrator shall issue a new certificate of registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration until expiration. [79 FR 53561, Sept. 9, 2014] § 1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business. (a) Except as provided in paragraph (b) of this section, the registration of any person, and any modifications of that registration, shall terminate, without any further action by the Ad ministration, if and when such person dies, ceases legal existence, discon tinues business or professional prac tice, or surrenders a registration. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Administrator promptly of such fact. In the case of a surrender, termination shall occur upon receipt by any employee of the Administration of a duly executed DEA form 104 or any signed writing indi cating the desire to surrender a reg istration. (b) No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the Administration may specifically designate and then only pursuant to written consent. Any per son seeking authority to transfer a reg istration shall submit a written re quest, providing full details regarding the proposed transfer of registration, VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00056 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 47 Drug Enforcement Administration, Justice § 1301.52 to the Deputy Assistant Administrator, Office of Diversion Control, Drug En forcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. (c) Any registrant desiring to dis continue business activities altogether or with respect to controlled sub stances (without transferring such business activities to another person) shall return for cancellation his/her certificate of registration, and any unexecuted order forms in his/her pos session, to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Any controlled sub stances in his/her possession may be disposed of in accordance with part 1317 of this chapter. (d) Any registrant desiring to dis continue business activities altogether or with respect to controlled substance (by transferring such business activi ties to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual in stances), the following information: (1) The name, address, registration number, and authorized business activ ity of the registrant discontinuing the business (registrant-transferor); (2) The name, address, registration number, and authorized business activ ity of the person acquiring the business (registrant-transferee); (3) Whether the business activities will be continued at the location reg istered by the person discontinuing business, or moved to another location (if the latter, the address of the new lo cation should be listed); (4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in Schedule I or II (if so, the basic class or class of the substance should be indi cated); and (5) The date on which the transfer of controlled substances will occur. (e) Unless the registrant-transferor is informed by the Special Agent in Charge, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant transferor may distribute (without being registered to distribute) con trolled substances in his/her possession to the registrant-transferee in accord ance with the following: (1) On the date of transfer of the con trolled substances, a complete inven tory of all controlled substances being transferred shall be taken in accord ance with § 1304.11 of this chapter. This inventory shall serve as the final in ventory of the registrant-transferor and the initial inventory of the reg istrant-transferee, and a copy of the in ventory shall be included in the records of each person. It shall not be nec essary to file a copy of the inventory with the Administration unless re quested by the Special Agent in Charge. Transfers of any substances listed in Schedule I or II shall require the use of order forms in accordance with part 1305 of this chapter. (2) On the date of transfer of the con trolled substances, all records required to be kept by the registrant-transferor with reference to the controlled sub stances being transferred, under part 1304 of this chapter, shall be trans ferred to the registrant-transferee. Re sponsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee. (3) In the case of registrants required to make reports pursuant to part 1304 of this chapter, a report marked ‘‘Final’’ will be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is re quired; no additional report will be re quired from him, if no further trans actions involving controlled substances are consummated by him. The initial report of the registrant-transferee shall account for transactions begin ning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant and the substances transferred to him shall be reported as receipts in his/her initial report. (f) Any registrant that has been au thorized as a collector and desires to VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00057 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 48 21 CFR Ch. II (4–1–16 Edition) § 1301.71 discontinue its collection of controlled substances from ultimate users shall notify the Administration of its intent by submitting a written notification to the Registration Unit, Drug Enforce ment Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing ad dress. Additionally, such notice may be submitted on-line at www.DEAdiversion.usdoj.gov. When ceasing collection activities of an au thorized mail-back program, the reg istrant shall provide the Administra tion with the name, registered address, and registration number of the col lector that will receive the remaining mail-back packages in accordance with § 1317.70(e)(3) of this chapter. [62 FR 13957, Mar. 24, 1997, as amended at 74 FR 15623, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 76 FR 61564, Oct. 5, 2011; 79 FR 53561, Sept. 9, 2014] SECURITY REQUIREMENTS § 1301.71 Security requirements gen erally. (a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a reg istrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in §§ 1301.72–1301.76 as standards for the physical security controls and operating procedures necessary to pre vent diversion. Materials and construc tion which will provide a structural equivalent to the physical security controls set forth in §§ 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials and construction described in those sections. (b) Substantial compliance with the standards set forth in §§ 1301.72–1301.76 may be deemed sufficient by the Ad ministrator after evaluation of the overall security system and needs of the applicant or registrant. In evalu ating the overall security system of a registrant or applicant, the Adminis trator may consider any of the fol lowing factors as he may deem relevant to the need for strict compliance with security requirements: (1) The type of activity conducted (e.g., processing of bulk chemicals, pre paring dosage forms, packaging, label ing, cooperative buying, etc.); (2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or non usable powders); (3) The quantity of controlled sub stances handled; (4) The location of the premises and the relationship such location bears on security needs; (5) The type of building construction comprising the facility and the general characteristics of the building or build ings; (6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used; (7) The type of closures on vaults, safes, and secure enclosures; (8) The adequacy of key control sys tems and/or combination lock control systems; (9) The adequacy of electric detection and alarm systems, if any including use of supervised transmittal lines and standby power sources; (10) The extent of unsupervised public access to the facility, including the presence and characteristics of perim eter fencing, if any; (11) The adequacy of supervision over employees having access to manufac turing and storage areas; (12) The procedures for handling busi ness guests, visitors, maintenance per sonnel, and nonemployee service per sonnel; (13) The availability of local police protection or of the registrant’s or ap plicant’s security personnel; (14) The adequacy of the registrant’s or applicant’s system for monitoring the receipt, manufacture, distribution, and disposition of controlled sub stances in its operations; and (15) The applicability of the security requirements contained in all Federal, State, and local laws and regulations governing the management of waste. (c) When physical security controls become inadequate as a result of a con trolled substance being transferred to a different schedule, or as a result of a noncontrolled substance being listed on VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00058 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 49 Drug Enforcement Administration, Justice § 1301.72 any schedule, or as a result of a signifi cant increase in the quantity of con trolled substances in the possession of the registrant during normal business operations, the physical security con trols shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in §§ 1301.72– 1301.76 when the need for such controls decreases as a result of a controlled substance being transferred to a dif ferent schedule, or a result of a con trolled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the reg istrant during normal business oper ations. (d) Any registrant or applicant desir ing to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in §§ 1301.72– 1301.76 may submit any plans, blue prints, sketches or other materials re garding the proposed security system either to the Special Agent in Charge in the region in which the system will be used, or to the Regulatory Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. (e) Physical security controls of loca tions registered under the Harrison Narcotic Act or the Narcotics Manufac turing Act of 1960 on April 30, 1971, shall be deemed to comply substan tially with the standards set forth in §§ 1301.72, 1301.73 and 1301.75. Any new facilities or work or storage areas con structed or utilized for controlled sub stances, which facilities or work or storage areas have not been previously approved by the Administration, shall not necessarily be deemed to comply substantially with the standards set forth in §§ 1301.72, 1301.73 and 1301.75, notwithstanding that such facilities or work or storage areas have physical se curity controls similar to those pre viously approved by the Administra tion. (f) A collector shall not employ, as an agent or employee who has access to or influence over controlled substances acquired by collection, any person who has been convicted of any felony of fense relating to controlled substances or who, at any time, had an application for registration with DEA denied, had a DEA registration revoked or sus pended, or has surrendered a DEA reg istration for cause. For purposes of this subsection, ‘‘for cause’’ means in lieu of, or as a consequence of, any Federal or State administrative, civil, or crimi nal action resulting from an investiga tion of the individual’s handling of con trolled substances. [36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, July 11, 2003; 75 FR 10677, Mar. 9, 2010; 79 FR 53561, Sept. 9, 2014] § 1301.72 Physical security controls for non-practitioners; narcotic treat ment programs and compounders for narcotic treatment programs; storage areas. (a) Schedules I and II. Raw material, bulk materials awaiting further proc essing, finished products which are controlled substances listed in Sched ule I or II (except GHB that is manu factured or distributed in accordance with an exemption under section 505(i) of the Federal Food Drug and Cosmetic Act which shall be subject to the re quirements of paragraph (b) of this sec tion), and sealed mail-back packages and inner liners acquired in accordance with part 1317 of this chapter, shall be stored in one of the following secured areas: (1) Where small quantities permit, a safe or steel cabinet; (i) Which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man hours against radiological techniques; (ii) Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily re moved; and (iii) Which safe or steel cabinet, if necessary, depending upon the quan tities and type of controlled substances stored, is equipped with an alarm sys tem which, upon attempted unauthor ized entry, shall transmit a signal di rectly to a central protection company VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00059 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 50 21 CFR Ch. II (4–1–16 Edition) § 1301.72 or a local or State police agency which has a legal duty to respond, or a 24 hour control station operated by the registrant, or such other protection as the Administrator may approve. (2) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construc tion with a steel door, combination or key lock, and an alarm system; or (3) A vault constructed after Sep tember 1, 1971: (i) The walls, floors, and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1⁄2-inch steel rods tied 6 inches on center, or the structural equivalent to such rein forced walls, floors, and ceilings; (ii) The door and frame unit of which vault shall conform to the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock ma nipulation, and 20 man-hours against radiological techniques; (iii) Which vault, if operations re quire it to remain open for frequent ac cess, is equipped with a ‘‘day-gate’’ which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open; (iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or State police agency which has a legal duty to respond, or a 24-hour con trol station operated by the registrant, or such other protection as the Admin istrator may approve, and, if nec essary, holdup buttons at strategic points of entry to the perimeter area of the vault; (v) The door of which vault is equipped with contact switches; and (vi) Which vault has one of the fol lowing: Complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Administration. (b) Schedules III, IV and V. Raw mate rial, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedules III, IV, and V, and GHB when it is manufactured or distributed in ac cordance with an exemption under sec tion 505(i) of the FFDCA, shall be stored in the following secure storage areas: (1) A safe or steel cabinet as de scribed in paragraph (a)(1) of this sec tion; (2) A vault as described in paragraph (a)(2) or (3) of this section equipped with an alarm system as described in paragraph (b)(4)(v) of this section; (3) A building used for storage of Schedules III through V controlled sub stances with perimeter security which limits access during working hours and provides security after working hours and meets the following specifications: (i) Has an electronic alarm system as described in paragraph (b)(4)(v) of this section, (ii) Is equipped with self-closing, self locking doors constructed of substan tial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use and when in use is kept under direct observation of a responsible employee or agent of the registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. Regarding hinged doors, where hinges are mounted on the outside, such hinges shall be sealed, welded or other wise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position com bination or key lock type and: (a) In the case of key locks, shall re quire key control which limits access to a limited number of employees, or; (b) In the case of combination locks, the combination shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination; (4) A cage, located within a building on the premises, meeting the following specifications: (i) Having walls constructed of not less than No. 10 gauge steel fabric VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00060 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 51 Drug Enforcement Administration, Justice § 1301.73 mounted on steel posts, which posts are: (a) At least one inch in diameter; (b) Set in concrete or installed with lag bolts that are pinned or brazed; and (c) Which are placed no more than ten feet apart with horizontal one and one-half inch reinforcements every sixty inches; (ii) Having a mesh construction with openings of not more than two and one half inches across the square, (iii) Having a ceiling constructed of the same material, or in the alter native, a cage shall be erected which reaches and is securely attached to the structural ceiling of the building. A lighter gauge mesh may be used for the ceilings of large enclosed areas if walls are at least 14 feet in height, (iv) Is equipped with a door con structed of No. 10 gauge steel fabric on a metal door frame in a metal door flange, and in all other respects con forms to all the requirements of 21 CFR 1301.72(b)(3)(ii), and (v) Is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency or a local or state police agency, each having a legal duty to respond, or to a 24-hour control station operated by the reg istrant, or to such other source of pro tection as the Administrator may ap prove; (5) An enclosure of masonry or other material, approved in writing by the Administrator as providing security comparable to a cage; (6) A building or enclosure within a building which has been inspected and approved by DEA or its predecessor agency, BND, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written ac knowledgment has been made by the Special Agent in Charge of DEA for the area in which such building or enclo sure is situated; (7) Such other secure storage areas as may be approved by the Administrator after considering the factors listed in § 1301.71(b); (8)(i) Schedule III through V con trolled substances may be stored with Schedules I and II controlled sub stances under security measures pro vided by 21 CFR 1301.72(a); (ii) Non-controlled drugs, substances and other materials may be stored with Schedule III through V controlled sub stances in any of the secure storage areas required by 21 CFR 1301.72(b), provided that permission for such stor age of non-controlled items is obtained in advance, in writing, from the Spe cial Agent in Charge of DEA for the area in which such storage area is situ ated. Any such permission tendered must be upon the Special Agent in Charge’s written determination that such non-segregated storage does not diminish security effectiveness for Schedules III through V controlled sub stances. (c) Multiple storage areas. Where sev eral types or classes of controlled sub stances are handled separately by the registrant or applicant for different purposes (e.g., returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this sec tion. (d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically au thorized employees. When it is nec essary for employee maintenance per sonnel, nonemployee maintenance per sonnel, business guests, or visitors to be present in or pass through con trolled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing. [36 FR 18730, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 1301.72, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; man ufacturing and compounding areas. All manufacturing activities (includ ing processing, packaging and labeling) involving controlled substances listed in any schedule and all activities of VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00061 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 52 21 CFR Ch. II (4–1–16 Edition) § 1301.74 compounders shall be conducted in ac cordance with the following: (a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not termi nated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the proc essing area or tanks, vessels, bins or bulk containers containing such sub stances shall be securely locked, with adequate security for the area or build ing. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the reg istrant. (b) Manufacturing activities with controlled substances shall be con ducted in an area or areas of clearly de fined limited access which is under sur veillance by an employee or employees designated in writing as responsible for the area. ‘‘Limited access’’ may be pro vided, in the absence of physical divid ers such as walls or partitions, by traf fic control lines or restricted space des ignation. The employee designated as responsible for the area may be en gaged in the particular manufacturing operation being conducted: Provided, That he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge. (c) During the production of con trolled substances, the manufacturing areas shall be accessible to only those employees required for efficient oper ation. When it is necessary for em ployee maintenance personnel, non employee maintenance personnel, busi ness guests, or visitors to be present in or pass through manufacturing areas during production of controlled sub stances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing. [36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 39 FR 37984, Oct. 25, 1974] § 1301.74 Other security controls for non-practitioners; narcotic treat ment programs and compounders for narcotic treatment programs. (a) Before distributing a controlled substance to any person who the reg istrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith in quiry either with the Administration or with the appropriate State con trolled substances registration agency, if any, to determine that the person is registered to possess the controlled substance. (b) The registrant shall design and operate a system to disclose to the reg istrant suspicious orders of controlled substances. The registrant shall inform the Field Division Office of the Admin istration in his area of suspicious or ders when discovered by the registrant. Suspicious orders include orders of un usual size, orders deviating substan tially from a normal pattern, and or ders of unusual frequency. (c) The registrant shall notify the Field Division Office of the Adminis tration in his area, in writing, of any theft or significant loss of any con trolled substances within one business day of discovery of the theft or loss. The supplier is responsible for report ing all in-transit losses of controlled substances by the common or contract carrier selected pursuant to paragraph (e) of this section, within one business day of discovery of such theft or loss. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subse quently recovered or the responsible parties are identified and action taken against them. When determining whether a loss is significant, a reg istrant should consider, among others, the following factors: (1) The actual quantity of controlled substances lost in relation to the type of business; (2) The specific controlled substances lost; (3) Whether the loss of the controlled substances can be associated with ac cess to those controlled substances by specific individuals, or whether the loss VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00062 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 53 Drug Enforcement Administration, Justice § 1301.74 can be attributed to unique activities that may take place involving the con trolled substances; (4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, (5) Whether the specific controlled substances are likely candidates for di version; (6) Local trends and other indicators of the diversion potential of the miss ing controlled substance. (d) The registrant shall not dis tribute any controlled substance listed in Schedules II through V as a com plimentary sample to any potential or current customer (1) without the prior written request of the customer, (2) to be used only for satisfying the legiti mate medical needs of patients of the customer, and (3) only in reasonable quantities. Such request must contain the name, address, and registration number of the customer and the name and quantity of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the require ments of part 1305 of the chapter shall be complied with for any distribution of a controlled substance listed in Schedule II. For purposes of this para graph, the term ‘‘customer’’ includes a person to whom a complimentary sam ple of a substance is given in order to encourage the prescribing or recom mending of the substance by the per son. (e) When shipping controlled sub stances, a registrant is responsible for selecting common or contract carriers which provide adequate security to guard against in-transit losses. When storing controlled substances in a pub lic warehouse, a registrant is respon sible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store con trolled substances in a public ware house which complies with the require ments set forth in § 1301.72. In addition, the registrant shall employ pre cautions (e.g., assuring that shipping containers do not indicate that con tents are controlled substances) to guard against storage or in-transit losses. (f) When distributing controlled sub stances through agents (e.g., detailmen), a registrant is responsible for providing and requiring adequate security to guard against theft and di version while the substances are being stored or handled by the agent or agents. (g) Before the initial distribution of carfentanil etorphine hydrochloride and/or diprenorphine to any person, the registrant must verify that the person is authorized to handle the sub stances(s) by contacting the Drug En forcement Administration. (h) The acceptance of delivery of nar cotic substances by a narcotic treat ment program shall be made only by a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or other authorized individual designated in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor. (i) Narcotics dispensed or adminis tered at a narcotic treatment program will be dispensed or administered di rectly to the patient by either (1) the licensed practitioner, (2) a registered nurse under the direction of the li censed practitioner, (3) a licensed prac tical nurse under the direction of the licensed practitioner, or (4) a phar macist under the direction of the li censed practitioner. (j) Persons enrolled in a narcotic treatment program will be required to wait in an area physically separated from the narcotic storage and dis pensing area. This requirement will be enforced by the program physician and employees. (k) All narcotic treatment programs must comply with standards estab lished by the Secretary of Health and Human Services (after consultation with the Administration) respecting the quantities of narcotic drugs which may be provided to persons enrolled in a narcotic treatment program for unsu pervised use. VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00063 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 54 21 CFR Ch. II (4–1–16 Edition) § 1301.75 (l) DEA may exercise discretion re garding the degree of security required in narcotic treatment programs based on such factors as the location of a pro gram, the number of patients enrolled in a program and the number of physi cians, staff members and security guards. Similarly, such factors will be taken into consideration when evalu ating existing security or requiring new security at a narcotic treatment program. (m) A reverse distributor shall not employ, as an agent or employee who has access to or influence over con trolled substances, any person who has been convicted of any felony offense re lating to controlled substances or who, at any time, had an application for reg istration with the DEA denied, had a DEA registration revoked or sus pended, or has surrendered a DEA reg istration for cause. For purposes of this subsection, ‘‘for cause’’ means in lieu of, or as a consequence of, any Federal or State administrative, civil, or crimi nal action resulting from an investiga tion of the individual’s handling of con trolled substances. [36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 1301.74, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 1301.75 Physical security controls for practitioners. (a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabi net. (b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substan tially constructed cabinet. However, pharmacies and institutional practi tioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to ob struct the theft or diversion of the con trolled substances. (c) Sealed mail-back packages and inner liners collected in accordance with part 1317 of this chapter shall only be stored at the registered location in a securely locked, substantially con structed cabinet or a securely locked room with controlled access, except as authorized by § 1317.80(d). (d) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration. (e) Carfentanil etorphine hydro chloride and diprenorphine shall be stored in a safe or steel cabinet equiva lent to a U.S. Government Class V se curity container. [39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997; 79 FR 53562, Sept. 9, 2014] § 1301.76 Other security controls for practitioners. (a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony of fense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term ‘‘for cause’’ means a sur render in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances. (b) The registrant shall notify the Field Division Office of the Adminis tration in his area, in writing, of the theft or significant loss of any con trolled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft. When determining wheth er a loss is significant, a registrant should consider, among others, the fol lowing factors: (1) The actual quantity of controlled substances lost in relation to the type of business; (2) The specific controlled substances lost; (3) Whether the loss of the controlled substances can be associated with ac cess to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the con trolled substances; VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00064 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 55 Drug Enforcement Administration, Justice § 1301.90 (4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, (5) Whether the specific controlled substances are likely candidates for di version; (6) Local trends and other indicators of the diversion potential of the miss ing controlled substance. (c) Whenever the registrant distrib utes a controlled substance (without being registered as a distributor as per mitted in §§ 1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), he/she shall comply with the requirements imposed on non-practitioners in § 1301.74(a), (b), and (e). (d) Central fill pharmacies must com ply with § 1301.74(e) when selecting pri vate, common or contract carriers to transport filled prescriptions to a re tail pharmacy for delivery to the ulti mate user. When central fill phar macies contract with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting in-transit losses upon dis covery of such loss by use of a DEA Form 106. Retail pharmacies must com ply with § 1301.74(e) when selecting pri vate, common or contract carriers to retrieve filled prescriptions from a cen tral fill pharmacy. When retail phar macies contract with private, common or contract carriers to retrieve filled prescriptions from a central fill phar macy, the retail pharmacy is respon sible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106. [36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997; 68 FR 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005; 79 FR 53562, Sept. 9, 2014] § 1301.77 Security controls for freight forwarding facilities. (a) All Schedule II–V controlled sub stances that will be temporarily stored at the freight forwarding facility must be either: (1) stored in a segregated area under constant observation by designated re sponsible individual(s); or (2) stored in a secured area that meets the requirements of Section 1301.72(b) of this Part. For purposes of this requirement, a facility that may be locked down (i.e., secured against physical entry in a manner consistent with requirements of Section 1301.72(b)(3)(ii) of this part) and has a monitored alarm system or is subject to continuous monitoring by security personnel will be deemed to meet the requirements of Section 1301.72(b)(3) of this Part. (b) Access to controlled substances must be kept to an absolute minimum number of specifically authorized indi viduals. Non-authorized individuals may not be present in or pass through controlled substances storage areas without adequate observation provided by an individual authorized in writing by the registrant. (c) Controlled substances being trans ferred through a freight forwarding fa cility must be packed in sealed, un marked shipping containers. [65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000] EMPLOYEE SCREENING—NON PRACTITIONERS § 1301.90 Employee screening proce dures. It is the position of DEA that the ob taining of certain information by non practitioners is vital to fairly assess the likelihood of an employee commit ting a drug security breach. The need to know this information is a matter of business necessity, essential to overall controlled substances security. In this regard, it is believed that conviction of crimes and unauthorized use of con trolled substances are activities that are proper subjects for inquiry. It is, therefore, assumed that the following questions will become a part of an em ployer’s comprehensive employee screening program: Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with com mitting a criminal offense? (Do not include any traffic violations, juvenile offenses or VerDate Sep<11>2014 10:48 May 12, 2016 Jkt 238078 PO 00000 Frm 00065 Fmt 8010 Sfmt 8010 Y:\SGML\238078.XXX 238078Lh o rn e o n D S K 3 0 JT 0 8 2 P R O D w ith C F R 56 21 CFR Ch. II (4–1–16 Edition) § 1301.91 military convictions, except by general court-martial.) If the answer is yes, furnish details of conviction, offense, location, date and sentence. Question. In the past three years, have you ever knowingly used any narcotics, amphet amines or barbiturates, other than those pre scribed to you by a physician? If the answer is yes, furnish details. Advice. An authorization, in writing, that allows inquiries to be made of courts and law enforcement agencies for possible pending charges or convictions must be executed by a person who is allowed to work in an area where access to controlled substances clear ly exists. A person must be advised that any false information or omission of information will jeopardize his or her position with re spect to employment. The application for employment should inform a person that in formation furnished or recovered as a result of any inquiry will not necessarily preclude employment, but will be considered as part of an overall evaluation of the person’s qualifications. The maintaining of fair em ployment practices, the protection of the person’s right of privacy, and the assurance that the results of such inquiries will be treated by the employer in confidence will be explained to the employee. [40 FR 17143, Apr. 17, 1975] § 1301.91 Employee responsibility to report drug diversion. Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security pro gram but also serves the public inter est at large. It is, therefore, the posi tion of DEA that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to pro tect the confidentiality of the informa tion and the identity of the employee furnishing information. A failure to re port information of drug diversion will be considered in determining the feasi bility of continuing to allow an em ployee to work in a drug security area. The employer shall inform all employ ees concerning this policy. [40 FR 17143, Apr. 17, 1975] § 1301.92 Illicit activities by employ ees. It is the position of DEA that em ployees who possess, sell, use or divert controlled substances will subject themselves not only to State or Fed eral prosecution for any illicit activ ity, but shall also immediately become the subject of independent action re garding their continued employment. The employer will assess the serious ness of the employee’s violation, the position of responsibility held by the employee, past record of employment, etc., in determining whether to sus pend, transfer, terminate or take other action against the employee. [40 FR 17143, Apr. 17, 1975] § 1301.93 Sources of information for employee checks. DEA recommends that inquiries con cerning employees’ criminal records be made as follows: Local inquiries. Inquiries should be made by name, date and place of birth, and other identifying information, to local courts and law enforcement agencies for records of pending charges and convictions. Local prac tice may require such inquiries to be made in person, rather than by mail, and a copy of an authorization from the employee may be re quired by certain law enforcement agencies. DEA inquiries. Inquiries supplying identi fying information should also be furnished to DEA Field Division Offices along with writ ten consent from the concerned individual for a check of DEA files for records of con victions. The Regional check will result in a national check being made by the Field Divi sion Office. [40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982] PART 1302—LABELING 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 labeling require ments. 1302.06 Sealing of controlled substances. 1302.07 Labeling and packaging require ments for imported and exported sub stances. 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