[Title 21 CFR 1301]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS92002-04-012002-04-01falseREGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1301PART 1301FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES--Table of Contents
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.
1301.12 Separate registrations for separate locations.
1301.13 Application for registration; time for application; expiration
date; registration for independent activities; application
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 applications.
1301.18 Research protocols.
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 officials.
1301.25 Registration regarding ocean vessels, aircraft, and other
entities.
1301.26 Exemptions from import or export requirements for personal
medical use.
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 registration; 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 discontinuance of business.
Security Requirements
1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic
treatment programs and compounders for narcotic treatment
programs; storage areas.
1301.73 Physical security controls for nonpractitioners; compounders for
narcotic treatment programs; manufacturing and compounding
areas.
1301.74 Other security controls for nonpractitioners; narcotic treatment
programs and compounders for narcotic treatment programs.
1301.75 Physical security controls for practitioners.
1301.76 Other security controls for practitioners.
1301.77 Security controls for freight forwarding 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, 871(b), 875, 877.
[[Page 14]]
Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
General Information
Sec. 1301.01 Scope of this part 1301.
Procedures governing the registration of manufacturers,
distributors, dispensers, importers, and exporters of controlled
substances pursuant to sections 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 specifically by the sections of this part.
[62 FR 13945, Mar. 24, 1997]
Sec. 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]
Sec. 1301.03 Information; special instructions.
Information regarding procedures under these rules and instructions
supplementing these rules will be furnished upon request by writing to
the Registration Unit, Drug Enforcement Administration, Department of
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 23, 1973,
and amended at 51 FR 5319, Feb. 13, 1986]
Registration
Sec. 1301.11 Persons required to register.
(a) Every person who manufactures, distributes, dispenses, imports,
or exports any controlled substance or who proposes to engage in the
manufacture, distribution, dispensing, importation or exportation of any
controlled substance shall obtain a registration unless exempted by law
or pursuant to Secs. 1301.22-1301.26. Only persons actually engaged in
such activities are required to obtain a registration; related or
affiliated persons who are not engaged in such activities are not
required to be registered. (For example, a stockholder or parent
corporation of a corporation manufacturing controlled substances is not
required to obtain a registration.)
(b) [Reserved]
[62 FR 13945, Mar. 24, 1997]
Sec. 1301.12 Separate registrations for separate locations.
(a) A separate registration is required for each principal place of
business or professional practice at one general physical location where
controlled substances are manufactured, distributed, imported, exported,
or dispensed by a person.
(b) The following locations shall be deemed not to be places where
controlled substances are manufactured, distributed, or dispensed:
(1) A warehouse where controlled substances are stored by or on
behalf of a registered person, unless such substances 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
subsection 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 registrant where sales of
controlled substances are solicited, made, or supervised but which
neither contains such substances (other than substances for display
purposes or lawful distribution as samples only) nor serves as a
distribution point for filling sales orders; and
(3) An office used by a practitioner (who is registered at another
location) where controlled substances are prescribed but neither
administered nor otherwise dispensed as a regular part of the
professional practice of the practitioner at such office, and where no
supplies of controlled substances are maintained.
(4) A freight forwarding facility, as defined in Sec. 1300.01 of
this part, provided that the distributing registrant operating the
facility has submitted written notice of intent to operate the facility
by registered mail, return receipt requested (or other suitable means of
documented delivery) and such notice has been approved. The notice shall
be submitted to the Special Agent in Charge of the Administration's
offices in both the area in which the facility is located and each area
in
[[Page 15]]
which the distributing registrant maintains 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 facility, the hours of operation, the individual(s)
responsible for the controlled substances, the security and
recordkeeping procedures that will be employed, and whether controlled
substances returns will be processed through the facility. The notice
must also detail what state licensing requirements 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 disapproval to the person within thirty days after confirmed
receipt of the notice. Registrants that are currently operating 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 receive written approval from the Special
Agent in Charge of the DEA Office in the area in which the freight
forwarding 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]
Sec. 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 application 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 controlled
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, distributor, researcher, analytical
lab, importer, exporter or narcotic treatment program is first
registered, that business activity 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 registrants within any group will be
the last date 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 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
registration shall not expire until one year from that expiration date;
in all other cases, the registration shall expire 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
teaching institution is first registered, that business activity 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
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 activity 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 controlled 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 indicated
fee. Fee payments shall be made
[[Page 16]]
in the form of a personal, certified, or cashier's check or money order
made payable to the ``Drug Enforcement Administration''. The application
fees are not refundable. Any person, when registered to engage in the
activities described in each subparagraph in this paragraph, shall be
authorized to engage in the coincident activities described without
obtaining a registration to engage in such coincident activities,
provided that, unless specifically exempted, he/she complies with all
requirements and duties prescribed by law for persons registered to
engage in such coincident activities. Any person 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 activities. 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 registered to conduct research
with controlled substances listed in Schedule I may conduct research
with any substances listed in Schedule I for which he/she has filed and
had approved a research protocol.
(1)
----------------------------------------------------------------------------------------------------------------
Application Registration
Business activity Controlled DEA application fee period Coincident
substances forms (dollars) (years) activities allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing Schedules I through New--225 875 1 Schedules I through
V Renewal--225a 875 V: May distribute
that substance or
class for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
Schedules II
through V: May
conduct chemical
analysis and
preclinical
research (including
quality control
analysis) with
substances listed
in those schedules
for which
authorization as a
manufacturer was
issued.
(ii) Distributing Schedules I through New--225 438 1 ....................
V Renewal--225a 438
(iii) Dispensing or Schedules II through New--224 210 3 May conduct research
Instructing (Includes V Renewal--224a 210 and instructional
Practitioner Hospital/ activities with
Clinic, Retail those substances
Pharmacy, Teaching for which
Institution) registration was
granted, except
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
oleaginous solution
or solid dosage
form containing a
narcotic controlled
substance in
Schedule II through
V in a proportion
not exceeding 20
percent of the
complete solution,
compound, or
mixture.
(iv) Research Schedule I New--225 70 1 A researcher may
Renewal--225a 70 manufacture or
import the basic
class of substance
or substances for
which registration
was issued,
provided that such
manufacture or
import is set forth
in the protocol
required in Section
1301.18 and to
distribute such
class to persons
registered or
authorized to
conduct research
with such class of
substance or
registered or
authorized to
conduct chemical
analysis with
controlled
substances.
[[Page 17]]
(v) Research Schedules II through New--225 70 1 May conduct chemical
V Renewal--225a 70 analysis with
controlled
substances in those
schedules for which
registration was
issued; manufacture
such substances if
and to the extent
that such
manufacture is set
forth in a
statement filed
with the
application for
registration or
reregistration and
provided that the
manufacture is not
for the purposes of
dosage form
development; import
such substances for
research purposes;
distribute such
substances to
persons registered
or authorized to
conduct chemical
analysis,
instructional
activities, or
research with such
substances, and to
persons exempted
from registration
pursuant to Section
1301.24; and
conduct
instructional
activities with
controlled
substances.
(vi) Narcotic Treatment Narcotic Drugs in New--363 70 1 ....................
Program (including Schedules II Renewal--363a 70
compounder) through V
(vii) Importing Schedules I through New--225 438 1 May distribute that
V Renewal--225a 438 substance or class
for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
(viii) Exporting Schedules I through New--225 438 1 ....................
V Renewal--225a 438
(ix) Chemical Analysis Schedules I through New--225 70 1 May manufacture and
V Renewal--225a 70 import controlled
substances for
analytical or
instructional
activities; may
distribute such
substances to
persons registered
or authorized to
conduct chemical
analysis,
instructional
activities, or
research with such
substances and to
persons exempted
from registration
pursuant to Section
1301.24; may export
such substances to
persons in other
countries
performing chemical
analysis or
enforcing laws
relating to
controlled
substances or drugs
in those countries;
and may conduct
instructional
activities with
controlled
substances.
----------------------------------------------------------------------------------------------------------------
(2) DEA Forms 224, 225, and 363 may be obtained at any area office
of the Administration or by writing to the Registration Unit, Drug
Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005.
(3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable, to
each registered person approximately 60 days before the expiration date
of his/her registration; if any registered person does not receive such
forms within 45 days before the expiration date of his/her registration,
he/she must promptly give notice of such fact and request such forms by
writing to the Registration Unit of the Administration at the foregoing
address.
(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 registration to
manufacture a basic class of controlled substance listed in Schedule II
shall include the Administration Controlled Substances Code Number, as
set forth in part 1308 of this chapter,
[[Page 18]]
for each basic class to be covered by such registration.
(g) Each application for registration to import or export controlled
substances shall include the Administration Controlled Substances Code
Number, 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 exporter shall not entitle
a registrant to import or export any controlled substance not specified
in such registration.
(h) Each application for registration to conduct research with any
basic class of controlled substance listed in Schedule II shall include
the Administration 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 coincident 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
application is being made shall be included with each such application.
For purposes of this paragraph only, manufacturing is defined as the
production of a controlled substance by synthesis, extraction or by
agricultural/horticultural means.
(i) Each application shall include all information called for in the
form, unless 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 application, shall be signed by the applicant, if an individual; by a
partner of the applicant, if a partnership; or by an officer of the
applicant, if a corporation, 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
applicant by filing with the Registration 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 applications 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]
Sec. 1301.14 Filing of application; acceptance for filing; defective applications.
(a) All applications for registration shall be submitted for filing
to the Registration Unit, Drug Enforcement Administration, Department of
Justice, Post Office Box 28083, Central Station, Washington, DC 20005.
The appropriate registration fee and any required attachments must
accompany the application.
(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 accepted 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 additional information. A defective
application 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
filing any application upon resubmission by the applicant, whether
complete or not.
(d) Accepting an application for filing does not preclude any
subsequent request for additional information pursuant to Sec. 1301.15
and has no bearing on whether the application will be granted.
[62 FR 13948, Mar. 24, 1997]
Sec. 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 necessary to determine whether the application should be granted.
The failure of
[[Page 19]]
the applicant to provide such documents or statements within a
reasonable 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 consideration by the Administrator in granting or denying the
application.
[62 FR 13948, Mar. 24, 1997]
Sec. 1301.16 Amendments to and withdrawal 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
receives an order to show cause pursuant to Sec. 1301.37. An application
may be amended or withdrawn with permission of the Administrator at any
time where good cause is shown by the applicant or where the amendment
or withdrawal is in the public interest.
(b) After an application has been accepted for filing, the request
by the applicant that it be returned or the failure of the applicant to
respond to official correspondence regarding the application, when sent
by registered or certified mail, return receipt requested, shall be
deemed to be a withdrawal of the application.
[62 FR 13949, Mar. 24, 1997]
Sec. 1301.17 Special procedures for certain 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:
Affidavit for New Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner, or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) at -------------------- (Number and Street),
-------------------- (City) ------------ (State) ------------ (Zip
code), hereby certify that said store was issued a pharmacy permit No.
-------- by the ---------------- (Board of Pharmacy or Licensing Agency)
of the State of ------------ on ------------ (Date).
This statement is submitted in order to obtain 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 contained in this affidavit may subject me
personally 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.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this -------- day of --------,
19------.
________________________________________________________________________
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 licensed in the same State as the one the ownership of which is
being transferred, the transferee may apply for registration prior to
the date of transfer. The Administrator may register the applicant and
authorize him to obtain controlled substances at the time of transfer.
Such registration shall not authorize the transferee to dispense
controlled substances until the pharmacy has been issued a valid State
license. The transferee shall include with his/her application the
following affidavit:
Affidavit for Transfer of Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) hereby certify:
(1) That said company was issued a pharmacy permit No.------------by
the -------------------- (Board of Pharmacy of Licensing Agency) of the
State of ------------ and a DEA Registration Number --------------------
for a pharmacy located at -------------------- (Number and Street) ----
-------- (City) ------------ (State) ------------ (Zip Code); and
(2) That said company is acquiring the pharmacy business of --------
------------ (Name of Seller) doing business
[[Page 20]]
as--------------------with DEA Registration Number ------------ on or
about ------------ (Date of Transfer) and that said company has applied
(or will apply on ------------ (Date) for a pharmacy permit from the
board of pharmacy (or licensing agency) of the State of ------------ to
do business as -------------------- (Store name) at --------------------
(Number and Street) -------------------- (City) ------------ (State) --
---------- (Zip Code).
This statement is submitted in order to obtain a Drug Enforcement
Administration 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 licensing 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 affidavit may subject me personally 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.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this----day of------------, 19--
--.
________________________________________________________________________
Notary Public
(c) 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 revoke 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 section 304(f) of
the Act (21 U.S.C. 824(f)). Intentional misuse of the affidavit
procedure 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 penalties 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]
Sec. 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
information where applicable:
(1) Investigator:
(i) Name, address, and DEA registration number; if any.
(ii) Institutional affiliation.
(iii) Qualifications, including a curriculum vitae and an
appropriate bibliography (list of publications).
(2) Research project:
(i) Title of project.
(ii) Statement of the purpose.
(iii) Name of the controlled substances 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 duration of the project.
(v) Location where the research will be conducted.
(vi) Statement of the security provisions for storing the controlled
substances (in accordance with Sec. 1301.75) and for dispensing the
controlled substances in order to prevent diversion.
(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 imported and the sources
of the chemicals to be used or the substance to be imported.
(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 Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(b) In the case of a clinical investigation with controlled
substances listed
[[Page 21]]
in Schedule I, the applicant shall submit three copies of a Notice of
Claimed Investigational Exemption for a New Drug (IND) together with a
statement of the security provisions (as proscribed 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 required in
21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission of this Notice
and statement to the Food and Drug Administration shall be in lieu of a
research protocol to the Administration as required in paragraph (a) of
this section. 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 certificate:
I hereby certify that on -------------------- (Date), pursuant to 21
U.S.C. 355(i) and 21 CFR 130.3, I, -------------------- (Name and
Address of IND Sponsor) submitted a Notice of Claimed Investigational
Exemption for a New Drug (IND) to the Food and Drug Administration for:
________________________________________________________________________
(Name of Investigational Drug).
________________________________________________________________________
(Date)
________________________________________________________________________
(Signature of Applicant).
(c) In the event that the registrant desires to increase the
quantity of a controlled substance used for an approved research
project, he/she shall submit a request to the Registration Unit, Drug
Enforcement Administration, Post Office Box 28083, Central Station,
Washington, DC 20005, by registered mail, return receipt requested. The
request shall contain the following information: 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 desired. Upon return of the receipt, the registrant shall be
authorized to purchase the additional quantity of the controlled
substance or substances specified in the request. The Administration
shall review the letter and forward it to the Food and Drug
Administration together with the Administration comments. The Food and
Drug Administration shall approve or deny the request as an amendment to
the protocol and so notify the registrant. Approval 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 variations provided in the registrant's approved protocol (excluding
any increase in the quantity of the controlled substance requested for
his/her research 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
research and omitting information in the supplemental protocol which has
been stated in the original protocol. Supplemental protocols shall be
processed and approved or denied in the same manner as original research
protocols.
[62 FR 13949, Mar. 24, 1997]
Exceptions to Registration and Fees
Sec. 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 registration 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
reregistration 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 officer
(if the registrant is an agency) certifies to the status and address of
the registrant and to the authority of the
[[Page 22]]
registrant to acquire, possess, or handle controlled substances.
(c) Exemption from payment of a registration or reregistration
application fee does not relieve the registrant of any other
requirements or duties prescribed by law.
[62 FR 13950, Mar. 24, 1997]
Sec. 1301.22 Exemption of agents and employees; 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 employment.
(b) An individual practitioner who is an agent or employee of
another practitioner (other than a mid-level practitioner) registered to
dispense controlled substances may, when acting in the normal course of
business or employment, administer or dispense (other than by issuance
of prescription) controlled substances if and to the extent 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 employment, administer, dispense, or prescribe controlled
substances under the registration of the hospital or other institution
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 authorized or permitted to do so
by the jurisdiction in which he/she is practicing;
(3) The hospital or other institution by whom he/she is employed has
verified that the individual practitioner is so permitted to dispense,
administer, or prescribe drugs within the jurisdiction;
(4) Such individual practitioner is acting only within the scope of
his/her employment in the hospital or institution;
(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 practitioner so authorized. The code number shall consist of
numbers, letters, or a combination thereof and shall be a suffix to the
institution's DEA registration number, preceded by a hyphen (e.g.,
APO123456-10 or APO123456-A12); and
(6) A current list of internal codes and the corresponding
individual practitioners 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
authority of the prescribing individual practitioner.
[62 FR 13950, Mar. 24, 1997]
Sec. 1301.23 Exemption of certain military 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 official 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
identification number of the issuing official in lieu of the
registration number required on prescription forms. The service
identification number for a Public Health Service employee is his/her
Social 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.
[[Page 23]]
(c) If any official exempted by this section also engages as a
private individual in any activity or group of activities for which
registration is required, such official shall obtain a registration for
such private activities.
[62 FR 13951, Mar. 24, 1997]
Sec. 1301.24 Exemption of law enforcement officials.
(a) The requirement of registration is waived for the following
persons in the circumstances described in this section:
(1) Any officer or employee of the Administration, any officer of
the U.S. Customs Service, any officer or employee 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, drugs or customs, and is duly authorized 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
official duties.
(b) Any official exempted by this section may, when acting in the
course of his/her official duties, procure any controlled substance in
the course of an inspection, in accordance with Sec. 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 possess any
controlled substance and distribute 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 enforcement agency laboratories,
including laboratories of the Administration, to obtain and transfer
controlled substances for use as standards in chemical analysis, such
laboratories shall obtain annually a registration to conduct chemical
analysis. Such laboratories 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 officials exempted
by this section.
(d) In addition to the activities authorized under a registration to
conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix),
laboratories of the Administration shall be authorized to manufacture or
import controlled substances for any lawful purpose, to distribute or
export such substances to any person, and to import and export such
substances in emergencies without regard to the requirements of part
1312 of this chapter if a report concerning 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]
Sec. 1301.25 Registration regarding ocean vessels, aircraft, and other entities.
(a) If acquired by and dispensed under the general supervision of a
medical officer described in paragraph (b) of this section, or the
master or first officer of the vessel under the circumstances described
in paragraph (d) of this section, controlled substances may be held for
stocking, be maintained in, and dispensed 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 permit 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 Administrator as appropriate for application 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 operator of the vessel, aircraft or
other entity; and
[[Page 24]]
(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 appear on his/her
Certificate of Registration (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 separate
registration at the location of the principal office of each such owner
or operator or utilize one or more registrations 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 controlled substances is required, the master or first
officer of the vessel, who shall not be registered under the Act, may
purchase controlled substances from a registered manufacturer or
distributor, or from an authorized pharmacy 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 containers ordered, the name of the vessel, the
vessel's official number and country of registry, the owner or operator
of the vessel, the port at which the vessel is located, signature of the
vessel's officer who is ordering the controlled substances and the date
of the requisition.
(3) The vendor may, after verifying the identification of the
vessel's officer requisitioning the controlled substances, 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
substances 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 nearest 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)____________________________________________________
(Address of registrant)_________________________________________________
(DEA registration number)_______________________________________________
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Packages
Line No. packages ordered Size of packages Name of product distributed Date distributed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.......................................................... ................. ................. ................ ................. ................
2.......................................................... ................. ................. ................ ................. ................
3.......................................................... ................. ................. ................ ................. ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnote: Line numbers may be continued according to needs of the vendor.
Number of lines completed_______________________________________________
Name of vessel__________________________________________________________
Vessel's official number________________________________________________
Vessel's country of registry____________________________________________
Owner or operator of the vessel_________________________________________
Name and title of vessel's officer who presented the requisition ------
--
Signature of vessel's officer who presented the requisition --------
[[Page 25]]
(e) Any medical officer described in paragraph (b) of this section
shall, in addition to complying with all requirements and duties
prescribed for registrants 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 summary
accounting for all vessels, aircraft, or other entities under his/her
supervision for all controlled substances purchased, dispensed or
disposed 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 Administration. 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.
(f) Any registered pharmacy that wishes to distribute controlled
substances pursuant to this section shall be authorized to do so,
provided:
(1) The registered pharmacy notifies the nearest Division Office of
the Administration of its intention to so distribute controlled
substances prior to the initiation of such activity. This notification
shall be by registered mail and shall contain the name, address, and
registration number of the pharmacy 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 registered to dispense does not exceed the limitations
imposed upon such distribution by Sec. 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 possess or dispense any
controlled substance acquired, stored and dispensed in accordance with
this section. Additionally, owners or operators of vessels, aircraft, or
other entities described in this section or in Article 32 of the Single
Convention on Narcotic Drugs, 1961, or in Article 14 of the Convention
on Psychotropic Substances, 1971, shall not be deemed to import or
export any controlled substances purchased and stored in accordance with
that section or applicable article.
(h) The Master of a vessel shall prepare a report for each calendar
year which shall give in detail an accounting for all controlled
substances purchased, dispensed, or disposed of during the year. The
Master shall file this report with the medical officer employed by the
owner or operator of his/her vessel, if any, or, if not, he/she 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
Administration.
(i) Controlled substances acquired and possessed in accordance with
this section shall not be distributed to persons not under the general
supervision of the medical officer employed by the owner or operator of
the vessel, aircraft, or other entity, except in accordance with
Sec. 1307.21 of this chapter.
[62 FR 13951, Mar. 24, 1997]
Sec. 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 administration to an
animal accompanying him/her, may enter or depart the United States with
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C.
952-955), providing the following conditions are met:
(a) The controlled substance is in the original container in which
it was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate official of
the U.S. Customs Service 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
[[Page 26]]
and address of the pharmacy or practitioner who dispensed the substance
and the prescription number, if any; and
(c) The importation of the controlled substance for personal medical
use is authorized or permitted under other Federal laws and state law.
[62 FR 13952, Mar. 24, 1997]
Action on Application for Registration: Revocation or Suspension of
Registration
Sec. 1301.31 Administrative review generally.
The Administrator may inspect, or cause to be inspected, the
establishment of an applicant or registrant, pursuant to subpart A of
part 1316 of this chapter. The Administrator shall review the
application for registration and other information gathered by the
Administrator regarding an applicant in order to determine whether the
applicable 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 applicant.
[62 FR 13953, Mar. 24, 1997]
Sec. 1301.32 Action on applications for research in Schedule I substances.
(a) In the case of an application for registration to conduct
research with controlled substances listed in Schedule I, the
Administrator shall process the application and protocol and forward a
copy of each to the Secretary of Health and Human Services (Secretary)
within 7 days after receipt. The Secretary shall determine the
qualifications 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 Administrator. The Secretary, in determining the merits of the
protocol, shall consult with the Administrator as to effective
procedures to safeguard adequately against diversion of such controlled
substances from legitimate medical or scientific use.
(b) An applicant whose protocol is defective shall be notified by
the Secretary within 21 days after receipt of such protocol from the
Administrator (or in the case of a clinical investigation within 30
days), and he/she shall be requested to correct the existing defects
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 Administrator shall
issue a certificate of registration within 10 days after receipt of this
notice, unless he/she determines that the certificate of registration
should be denied on a ground specified in section 304(a) of the Act (21
U.S.C. 824(a)). In the case of a supplemental protocol, a replacement
certificate 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 competent, he/she shall notify
the Administrator in writing setting forth the reasons for such
determination. If the Administrator determines that grounds exist for
the denial of the application, he/she shall within 10 days issue an
order to show cause pursuant to Sec. 1301.37 and, if requested by the
applicant, hold a hearing on the application pursuant to Sec. 1301.41.
If the grounds for denial of the application include a determination by
the Secretary, the Secretary 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
original research protocols. If the processing of an application or
research protocol is delayed beyond the time limits imposed by this
section, the applicant shall be so notified in writing.
[62 FR 13953, Mar. 24, 1997]
Sec. 1301.33 Application for bulk manufacture of Schedule I and II substances.
(a) In the case of an application for registration or reregistration
to manufacture in bulk a basic class of controlled substance listed in
Schedule I or II, the Administrator shall, upon the filing of such
application, publish in
[[Page 27]]
the Federal Register a notice naming the applicant and stating that such
applicant has applied to be registered as a bulk manufacturer of a basic
class of narcotic or nonnarcotic controlled substance, which class shall
be identified. A copy of said notice shall be mailed simultaneously to
each person registered 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 competition, 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 controlled substances listed in Schedules I or II as an incident to
research or chemical analysis as authorized in Sec. 1301.13(e)(1).
[62 FR 13953, Mar. 24, 1997]
Sec. 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 Schedule I or II, under the
authority of section 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 notice 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 substance shall be identified. A copy of
said notice shall be mailed simultaneously 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 registration, and may,
at the same time, file a written request for a hearing on the
application pursuant to Sec. 1301.43. If a hearing is requested, the
Administrator shall hold a hearing on the application in accordance with
Sec. 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
accordance with Sec. 1301.43 of this chapter. Notice of the hearing
shall contain a summary of all comments and objections 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 publication of
such notice in the Federal Register. A hearing pursuant to this section
may be consolidated with a hearing held pursuant to Sec. 1301.35 or
Sec. 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 registration is consistent with the public interest 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 controlled substances and any controlled substance in
Schedule I or II compounded therefrom into other than legitimate
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 industrial purposes;
(2) Compliance with applicable State and local law;
(3) Promotion of technical advances in the art of manufacturing
these substances and the development of new substances;
(4) Prior conviction record of applicant under Federal and State
laws relating to the manufacture, distribution, or dispensing of such
substances;
[[Page 28]]
(5) Past experience in the manufacture of controlled substances, and
the existence in the establishment of effective control against
diversion;
(6) That the applicant will be permitted to import only:
(i) Such amounts of crude opium, poppy straw, concentrate of poppy
straw, and coca leaves as the Administrator finds to be necessary to
provide for medical, scientific, or other legitimate purposes; or
(ii) Such amounts of any controlled substances listed in Schedule I
or II as the Administrator shall find to be necessary to provide for the
medical, scientific, or other legitimate needs of the United States
during an emergency in which domestic supplies of such substances 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 necessary to provide for the
medical, scientific, 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
manufacturers 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, analytical or research uses; and
(7) Such other factors as may be relevant to and consistent with the
public health and safety.
(c) In determining whether the applicant can and will maintain
effective controls against diversion within the meaning of paragraph (b)
of this section, the Administrator shall consider among other factors:
(1) Compliance with the security requirements set forth in
Secs. 1301.71-1301.76; and
(2) Employment of security procedures to guard against in-transit
losses within and without the jurisdiction of the United States.
(d) In determining whether competition among the domestic
manufacturers of a controlled substance is adequate within the meaning
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator
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
manufacturers 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 differentials between domestic
prices and the higher of prices generally prevailing in foreign markets
or the prices at which the applicant for registration to import is
committed to undertake to provide such products in the domestic market
in conformity with the Act. In determining the existence of substantial
differentials hereunder, appropriate consideration should be given to
any additional costs imposed on domestic 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 foreign market or markets from which the
importer is obtaining his/her supply;
(4) The existence of competitive restraints imposed upon domestic
manufacturers by governmental regulations; and
(5) Such other factors as may be relevant to the determinations
required under this paragraph.
(e) In considering the scope of the domestic 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 existing manufacturers is small
shall not demonstrate, in and of itself, that adequate competition among
them does not exist.
[62 FR 13953, Mar. 24, 1997]
[[Page 29]]
Sec. 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 required under the applicable provisions of sections
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the
issuance of registration or reregistration is not required, the
Administrator shall deny the application. Before denying any
application, the Administrator shall issue an order to show cause
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold
a hearing on the application pursuant to Sec. 1301.41.
(b) If in response to a show cause order a hearing is requested by
an applicant for registration or reregistration 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
registration pursuant to Sec. 1301.33(a) may participate in the hearing
by filing notice of appearance in accordance with Sec. 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 number of the registrant, the activity
authorized by the registration, the schedules and/or Administration
Controlled Substances Code Number (as set forth in part 1308 of this
chapter) of the controlled substances which the registrant is authorized
to handle, the amount of fee paid (or exemption), and the expiration
date of the registration. The registrant shall maintain the certificate
of registration at the registered location in a readily retrievable
manner and shall permit inspection of the certificate by any official,
agent or employee of the Administration or of any Federal, State, or
local agency engaged in enforcement of laws relating to controlled
substances.
[62 FR 13954, Mar. 24, 1997]
Sec. 1301.36 Suspension or revocation of registration; suspension of
registration 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 obligations under international treaties, conventions,
or protocols in effect on October 12, 1984.
(c) The Administrator may limit the revocation or suspension of a
registration to the particular controlled substance, or substances, with
respect to which grounds for revocation or suspension exist.
(d) Before revoking or suspending any registration, the
Administrator shall issue an order to show cause pursuant to
Sec. 1301.37 and, if requested by the registrant, shall hold a hearing
pursuant to Sec. 1301.41.
(e) The Administrator may suspend any registration simultaneously
with or at any time subsequent to the service 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 Sec. 1301.37
an order of immediate suspension which shall contain a statement of his
findings regarding the danger to public health or safety.
[[Page 30]]
(f) Upon service of the order of the Administrator suspending or
revoking registration, the registrant shall immediately deliver his/her
Certificate of Registration, any order forms, and any import or export
permits in his/her possession to the nearest office of the
Administration. The suspension or revocation of a registration shall
suspend or revoke any individual manufacturing or procurement quota
fixed for the registrant pursuant to part 1303 of this chapter and any
import or export permits issued to the registrant 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 Administrator:
(1) Deliver all controlled substances in his/her possession to the
nearest office of the Administration or to authorized agents of the
Administration; or
(2) Place all controlled substances in his/her possession under seal
as described 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 Certificate of Registration for all substances not affected
by such revocation or suspension; no fee shall be required to be paid
for the new Certificate of Registration. 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 limited to a particular
basic class or classes of controlled substances, shall suspend or revoke
any individual manufacturing or procurement quota fixed for the
registrant for such class or classes pursuant to part 1303 of this
chapter and any import or export permits 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 Administrator:
(1) Deliver to the nearest office of the Administration or to
authorized agents of the Administration all of the particular controlled
substance or substances affected by the revocation or suspension which
are in his/her possession; 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 proceedings upon the revocation or suspension, including any
judicial review thereof, unless sooner withdrawn by the Administrator or
dissolved by a court of competent jurisdiction. Any registrant whose
registration is suspended under paragraph (e) of this section may
request a hearing on the revocation or suspension of his/her
registration at a time earlier than specified in the order to show cause
pursuant to Sec. 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 applied 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 expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the Administrator so issues
his/her order. The Administrator may extend any other existing
registration under the circumstances contemplated in this section even
though the registrant failed to apply for reregistration at least 45
days before expiration of the existing registration, with or without
request by the registrant, if the Administrator finds that such
extension is not inconsistent with the public health and safety.
[62 FR 13955, Mar. 24, 1997]
Sec. 1301.37 Order to show cause.
(a) If, upon examination of the application for registration from
any applicant and other information gathered by the Administration
regarding the applicant, the Administrator is unable to make the
determinations required
[[Page 31]]
by the applicable provisions of section 303 and/or section 1008 of the
Act (21 U.S.C. 823 and 958) to register the applicant, the Administrator
shall serve 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 registrant, 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 registrant 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 appear 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 contain a
statement of the legal basis for such hearing and for the denial,
revocation, 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 Sec. 1301.43. If a hearing is requested, the
Administrator shall hold a hearing at the time and place stated in the
order, pursuant to Sec. 1301.41.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.
[62 FR 13955, Mar. 24, 1997]
Hearings
Sec. 1301.41 Hearings generally.
(a) In any case where the Administrator shall hold a hearing on any
registration or application therefor, the procedures for such hearing
shall be governed generally by the adjudication procedures set forth in
the Administrative 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
Secs. 1301.42-1301.46 of this part, and by the procedures for
administrative hearings under the Act set forth in Secs. 1316.41-1316.67
of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or any
other law of the United States.
[62 FR 13956, Mar. 24, 1997]
Sec. 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
registration to import or to manufacture in bulk a basic class of
controlled substance listed in Schedule I or II. Extensive argument
should not be offered into evidence but rather presented in opening or
closing statements of counsel or in memoranda or proposed findings of
fact and conclusions of law.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.43 Request for hearing or appearance; waiver.
(a) Any person entitled to a hearing pursuant to Sec. 1301.32 or
Secs. 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
publication of notice of the application for registration in the Federal
Register in the case of Sec. 1301.34), file with the Administrator a
written request for a hearing in the form prescribed in Sec. 1316.47 of
this chapter.
(b) Any person entitled to participate in a hearing pursuant to
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30
days of the date of publication of notice of the request for a hearing
in the Federal Register, file with the Administrator a written notice of
intent to participate in such hearing in the form prescribed in
Sec. 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 Sec. 1301.32 or Secs. 1301.34-1301.36 may, within the period
permitted for filing a request for a hearing or a notice of appearance,
file with the Administrator a
[[Page 32]]
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 of fact and law involved in such hearing. 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 Sec. 1301.32 or Secs. 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 participate in the
hearing, unless such person shows good cause for such failure.
(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
Sec. 1301.46 without a hearing.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.44 Burden of proof.
(a) At any hearing on an application to manufacture any controlled
substance listed in Schedule I or II, the applicant shall have the
burden of proving that the requirements for such registration 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 Sec. 1301.35(b) shall
have the burden of proving any propositions 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 program or as a compounder,
the applicant shall have the burden of proving that the requirements for
each registration 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
registered to import or export any controlled substance listed in
Schedule I or II, the applicant shall have the burden of proving that
the requirements for such registration pursuant to sections 1008(a) and
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other
person participating in the hearing pursuant to Sec. 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 denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 or section 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 Administration 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
satisfied.
[62 FR 13956, Mar. 24, 1997]
Sec. 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 published in the Federal
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter
it may be moved to a different place and may be continued from day to
day or recessed to a later day without notice other than announcement
thereof by the presiding officer at the hearing.
[62 FR 13956, Mar. 24, 1997]
Sec. 1301.46 Final order.
As soon as practicable after the presiding officer has certified the
record to the Administrator, the Administrator shall issue his/her order
on the granting, denial, revocation, or suspension of registration. In
the event that an application for registration to import 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 suspended, 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
[[Page 33]]
shall serve one copy of his/her order upon each party in the hearing.
[62 FR 13956, Mar. 24, 1997]
Modification, Transfer and Termination of Registration
Sec. 1301.51 Modification in registration.
Any registrant may apply to modify his/her registration to authorize
the handling of additional controlled substances or to change his/her
name or address, by submitting a letter of request to the Registration
Unit, Drug Enforcement Administration, Department of Justice, Post
Office Box 28083, Central Station, Washington, DC 20005. The letter
shall contain the registrant's name, address, and registration number as
printed on the certificate of registration, and the substances and/or
schedules to be added to his/her registration or the new name or address
and shall be signed in accordance with Sec. 1301.13(j). If the
registrant is seeking to handle additional controlled substances listed
in Schedule I for the purpose of research or instructional activities,
he/she shall attach three copies of a research protocol describing each
research project involving the additional substances, or two copies of a
statement describing the nature, extent, and duration of such
instructional activities, as appropriate. No fee shall be required to be
paid for the modification. The request for modification shall be handled
in the same manner as an application for registration. If the
modification in registration is approved, 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.
[62 FR 13956, Mar. 24, 1997]
Sec. 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 shall terminate if and when such person dies,
ceases legal existence, or discontinues business or professional
practice. Any registrant who ceases legal existence or discontinues
business or professional practice shall notify the Administrator
promptly of such fact.
(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 person seeking authority to transfer a registration
shall submit a written request, providing full details regarding the
proposed transfer of registration, to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537.
(c) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substances (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 possession, to the Registration Unit, Drug
Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005. Any controlled substances
in his/her possession may be disposed of in accordance with Sec. 1307.21
of this chapter.
(d) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substance (by transferring such
business activities 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 instances), the following information:
(1) The name, address, registration number, and authorized business
activity of the registrant discontinuing the business (registrant-
transferor);
(2) The name, address, registration number, and authorized business
activity of the person acquiring the business (registrant-transferee);
(3) Whether the business activities will be continued at the
location registered by the person discontinuing business, or moved to
another location (if the latter, the address of the new location should
be listed);
[[Page 34]]
(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 indicated); 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) controlled
substances in his/her possession to the registrant-transferee in
accordance with the following:
(1) On the date of transfer of the controlled substances, a complete
inventory of all controlled substances being transferred shall be taken
in accordance with Sec. 1304.11 of this chapter. This inventory shall
serve as the final inventory of the registrant-transferor and the
initial inventory of the registrant-transferee, and a copy of the
inventory shall be included in the records of each person. It shall not
be necessary to file a copy of the inventory with the Administration
unless requested 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 controlled substances, all
records required to be kept by the registrant-transferor with reference
to the controlled substances being transferred, under part 1304 of this
chapter, shall be transferred to the registrant-transferee.
Responsibility 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 required; no
additional report will be required from him, if no further transactions
involving controlled substances are consummated by him. The initial
report of the registrant-transferee shall account for transactions
beginning 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.
[62 FR 13957, Mar. 24, 1997]
Security Requirements
Sec. 1301.71 Security requirements generally.
(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 registrant has provided
effective controls against diversion, the Administrator shall use the
security requirements set forth in Secs. 1301.72-1301.76 as standards
for the physical security controls and operating procedures necessary to
prevent diversion. Materials and construction which will provide a
structural equivalent to the physical security controls set forth in
Secs. 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
Secs. 1301.72-1301.76 may be deemed sufficient by the Administrator
after evaluation of the overall security system and needs of the
applicant or registrant. In evaluating the overall security system of a
registrant or applicant, the Administrator may consider any of the
following 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, preparing dosage forms, packaging, labeling, cooperative
buying, etc.);
(2) The type and form of controlled substances handled (e.g., bulk
liquids or dosage units, usable powders or nonusable powders);
(3) The quantity of controlled substances 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
[[Page 35]]
characteristics of the building or buildings;
(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 systems 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 perimeter fencing, if any;
(11) The adequacy of supervision over employees having access to
manufacturing and storage areas;
(12) The procedures for handling business guests, visitors,
maintenance personnel, and nonemployee service personnel;
(13) The availability of local police protection or of the
registrant's or applicant's security personnel, and;
(14) The adequacy of the registrant's or applicant's system for
monitoring the receipt, manufacture, distribution, and disposition of
controlled substances in its operations.
(c) When physical security controls become inadequate as a result of
a controlled substance being transferred to a different schedule, or as
a result of a noncontrolled substance being listed on any schedule, or
as a result of a significant increase in the quantity of controlled
substances in the possession of the registrant during normal business
operations, the physical security controls shall be expanded and
extended accordingly. A registrant may adjust physical security controls
within the requirements set forth in Secs. 1301.72-1301.76 when the need
for such controls decreases as a result of a controlled substance being
transferred to a different schedule, or a result of a controlled
substance being removed from control, or as a result of a significant
decrease in the quantity of controlled substances in the possession of
the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a
proposed security system substantially complies with, or is the
structural equivalent of, the requirements set forth in Secs. 1301.72-
1301.76 may submit any plans, blueprints, sketches or other materials
regarding the proposed security system either to the Special Agent in
Charge in the region in which the system will be used, or to the
Diversion Operations Section, Drug Enforcement Administration,
Department of Justice, Washington, DC 20537.
(e) Physical security controls of locations registered under the
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on
April 30, 1971, shall be deemed to comply substantially with the
standards set forth in Secs. 1301.72, 1301.73 and 1301.75. Any new
facilities or work or storage areas constructed or utilized for
controlled substances, 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 Secs. 1301.72, 1301.73 and 1301.75, notwithstanding that such
facilities or work or storage areas have physical security controls
similar to those previously approved by the Administration.
[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22,
1982; 51 FR 5319, Feb. 13, 1986]
Sec. 1301.72 Physical security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs;
storage areas.
(a) Schedules I and II. Raw material, bulk materials awaiting
further processing, and finished products which are controlled
substances listed in Schedule I or II (except GHB that is manufactured
or distributed in accordance with an exemption under section 505(i) of
the FFDCA which shall be subject to the requirements of paragraph (b) of
this section) 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
[[Page 36]]
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 removed; and
(iii) Which safe or steel cabinet, if necessary, depending upon the
quantities and type of controlled substances stored, is equipped with an
alarm system which, upon attempted unauthorized entry, shall transmit a
signal directly to a central protection company 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 construction with a steel door,
combination or key lock, and an alarm system; or
(3) A vault constructed after September 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
reinforced 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 manipulation, and 20 man-hours against radiological
techniques;
(iii) Which vault, if operations require it to remain open for
frequent access, 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 control station operated
by the registrant, or such other protection as the Administrator may
approve, and, if necessary, 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 following: 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 material, 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 accordance with an exemption under
section 505(i) of the FFDCA, shall be stored in the following secure
storage areas:
(1) A safe or steel cabinet as described in paragraph (a)(1) of this
section;
(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 substances 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 substantial 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 otherwise
constructed to inhibit removal. Locking devices for such doors shall be
[[Page 37]]
either of the multiple-position combination or key lock type and:
(a) In the case of key locks, shall require 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 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
alternative, 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 constructed of No. 10 gauge steel
fabric on a metal door frame in a metal door flange, and in all other
respects conforms 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 registrant, or to such
other source of protection as the Administrator may approve;
(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
acknowledgment has been made by the Special Agent in Charge of DEA for
the area in which such building or enclosure is situated;
(7) Such other secure storage areas as may be approved by the
Administrator after considering the factors listed in Sec. 1301.71(b),
(1) through (14);
(8)(i) Schedule III through V controlled substances may be stored
with Schedules I and II controlled substances under security measures
provided by 21 CFR 1301.72(a);
(ii) Non-controlled drugs, substances and other materials may be
stored with Schedule III through V controlled substances in any of the
secure storage areas required by 21 CFR 1301.72(b), provided that
permission for such storage of non-controlled items is obtained in
advance, in writing, from the Special Agent in Charge of DEA for the
area in which such storage area is situated. 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
substances.
(c) Multiple storage areas. Where several types or classes of
controlled substances 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
section.
(d) Accessibility to storage areas. The controlled substances
storage areas shall be accessible only to an absolute minimum number of
specifically authorized employees. When it is necessary for employee
maintenance personnel, nonemployee maintenance personnel, business
guests, or visitors to be present in or pass through controlled
substances storage areas, the registrant shall provide for adequate
[[Page 38]]
observation of the area by an employee specifically authorized in
writing.
[36 FR 18730, Sept. 21, 1971, as amended at 37 FR 15919, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, l973]
Editorial Note: For Federal Register citations affecting
Sec. 1301.72, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1301.73 Physical security controls for non-practitioners;
compounders for narcotic treatment programs; manufacturing and
compounding areas.
All manufacturing activities (including processing, packaging and
labeling) involving controlled substances listed in any schedule and all
activities of compounders shall be conducted in accordance 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 terminated at the end of a workday (except where a
continuous process or other normal manufacturing operation should not be
interrupted), the processing area or tanks, vessels, bins or bulk
containers containing such substances shall be securely locked, with
adequate security for the area or building. 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 registrant.
(b) Manufacturing activities with controlled substances shall be
conducted in an area or areas of clearly defined limited access which is
under surveillance by an employee or employees designated in writing as
responsible for the area. ``Limited access'' may be provided, in the
absence of physical dividers such as walls or partitions, by traffic
control lines or restricted space designation. The employee designated
as responsible for the area may be engaged 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 controlled substances, the
manufacturing areas shall be accessible to only those employees required
for efficient operation. When it is necessary for employee maintenance
personnel, nonemployee maintenance personnel, business guests, or
visitors to be present in or pass through manufacturing areas during
production of controlled substances, 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,
l973 and amended at 39 FR 37984, Oct. 25, 1974]
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
(a) Before distributing a controlled substance to any person who the
registrant does not know to be registered to possess the controlled
substance, the registrant shall make a good faith inquiry either with
the Administration or with the appropriate State controlled 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 registrant suspicious orders of controlled substances. The
registrant shall inform the Field Division Office of the Administration
in his area of suspicious orders when discovered by the registrant.
Suspicious orders include orders of unusual size, orders deviating
substantially from a normal pattern, and orders of unusual frequency.
(c) The registrant shall notify the Field Division Office of the
Administration in his area of any theft or significant loss of any
controlled substances upon discovery of such theft or loss. The supplier
shall be responsible for reporting in-transit losses of controlled
substances by the common or contract carrier selected pursuant to
Sec. 1301.74(e), upon discovery of such theft or loss. The registrant
shall also complete DEA Form 106 regarding such theft or loss. Thefts
must be reported whether or not the controlled substances are
subsequently recovered
[[Page 39]]
and/or the responsible parties are identified and action taken against
them.
(d) The registrant shall not distribute any controlled substance
listed in Schedules II through V as a complimentary sample to any
potential or current customer (1) without the prior written request of
the customer, (2) to be used only for satisfying the legitimate 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 requirements 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 paragraph, the term
``customer'' includes a person to whom a complimentary sample of a
substance is given in order to encourage the prescribing or recommending
of the substance by the person.
(e) When shipping controlled substances, 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 public warehouse, a registrant is responsible for
selecting a warehouseman which will provide adequate security to guard
against storage losses; wherever possible, the registrant shall store
controlled substances in a public warehouse which complies with the
requirements set forth in Sec. 1301.72. In addition, the registrant
shall employ precautions (e.g., assuring that shipping containers do not
indicate that contents are controlled substances) to guard against
storage or in-transit losses.
(f) When distributing controlled substances through agents (e.g.,
detailmen), a registrant is responsible for providing and requiring
adequate security to guard against theft and diversion 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 substances(s) by
contacting the Drug Enforcement Administration.
(h) The acceptance of delivery of narcotic substances by a narcotic
treatment 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 administered at a narcotic treatment
program will be dispensed or administered directly to the patient by
either (1) the licensed practitioner, (2) a registered nurse under the
direction of the licensed practitioner, (3) a licensed practical nurse
under the direction of the licensed practitioner, or (4) a pharmacist
under the direction of the licensed practitioner.
(j) Persons enrolled in a narcotic treatment program will be
required to wait in an area physically separated from the narcotic
storage and dispensing area. This requirement will be enforced by the
program physician and employees.
(k) All narcotic treatment programs must comply with standards
established 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 unsupervised use.
(l) DEA may exercise discretion regarding the degree of security
required in narcotic treatment programs based on such factors as the
location of a program, the number of patients enrolled in a program and
the number of physicians, staff members and security guards. Similarly,
such factors will be taken into consideration when evaluating existing
security or requiring
[[Page 40]]
new security at a narcotic treatment program.
[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended at 36
FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, l973]
Editorial Note: For Federal Register citations affecting
Sec. 1301.74, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
Sec. 1301.75 Physical security controls for practitioners.
(a) Controlled substances listed in Schedule I shall be stored in a
securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV, and V
shall be stored in a securely locked, substantially constructed cabinet.
However, pharmacies and institutional practitioners may disperse such
substances throughout the stock of noncontrolled substances in such a
manner as to obstruct the theft or diversion of the controlled
substances.
(c) This section shall also apply to nonpractitioners authorized to
conduct research or chemical analysis under another registration.
(d) Carfentanil etorphine hydrochloride and diprenorphine shall be
stored in a safe or steel cabinet equivalent to a U.S. Government Class
V security 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]
Sec. 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 offense 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
surrender 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
Administration in his area of the theft or significant loss of any
controlled substances upon discovery of such loss or theft. The
registrant shall also complete DEA (or BND) Form 106 regarding such loss
or theft.
(c) Whenever the registrant distributes a controlled substance
(without being registered as a distributor, as permitted in
Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a),
(b), and (e).
[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, l973;
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957,
Mar. 24, 1997]
Sec. 1301.77 Security controls for freight forwarding facilities.
(a) All Schedule II-V controlled substances that will be temporarily
stored at the freight forwarding facility must be either:
(1) stored in a segregated area under constant observation by
designated responsible 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 individuals. 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 transferred through a freight
forwarding facility must be packed in sealed, unmarked shipping
containers.
[65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000]
[[Page 41]]
Employee Screening--Non- Practitioners
Sec. 1301.90 Employee screening procedures.
It is the position of DEA that the obtaining of certain information
by non-practitioners is vital to fairly assess the likelihood of an
employee committing 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 controlled substances are
activities that are proper subjects for inquiry. It is, therefore,
assumed that the following questions will become a part of an employer'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 committing a criminal offense? (Do not
include any traffic violations, juvenile offenses or 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, amphetamines or barbiturates, other than those prescribed 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 clearly exists. A person must
be advised that any false information or omission of information will
jeopardize his or her position with respect to employment. The
application for employment should inform a person that information
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
employment 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]
Sec. 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 program but also serves
the public interest at large. It is, therefore, the position 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
protect the confidentiality of the information and the identity of the
employee furnishing information. A failure to report information of drug
diversion will be considered in determining the feasibility of
continuing to allow an employee to work in a drug security area. The
employer shall inform all employees concerning this policy.
[40 FR 17143, Apr. 17, 1975]
Sec. 1301.92 Illicit activities by employees.
It is the position of DEA that employees who possess, sell, use or
divert controlled substances will subject themselves not only to State
or Federal prosecution for any illicit activity, but shall also
immediately become the subject of independent action regarding their
continued employment. The employer will assess the seriousness of the
employee's violation, the position of responsibility held by the
employee, past record of employment, etc., in determining whether to
suspend, transfer, terminate or take other action against the employee.
[40 FR 17143, Apr. 17, 1975]
Sec. 1301.93 Sources of information for employee checks.
DEA recommends that inquiries concerning 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 practice may require such inquiries to be made in person, rather
than by mail, and a copy of an
[[Page 42]]
authorization from the employee may be required by certain law
enforcement agencies.
DEA inquiries. Inquiries supplying identifying information should
also be furnished to DEA Field Division Offices along with written
consent from the concerned individual for a check of DEA files for
records of convictions. The Regional check will result in a national
check being made by the Field Division Office.
[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]