[Federal Register Volume 60, Number 163 (Wednesday, August 23, 1995)]
[Proposed Rules]
[Pages 43732-43735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20890]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1303, 1304 and 1305
[DEA-108P]
RIN 1117-AA19
Definition and Registration of Disposers
agency: Drug Enforcement Administration (DEA), Justice.
action: Notice of proposed rulemaking.
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summary: The DEA proposes to amend its regulations to define the term
Disposer and establish a new category of manufacturer registration. DEA
is also proposing to amend the regulations to exempt disposers from the
quota requirements; to delineate the records and reports required of
disposers; and to set out order form procedures for disposers. DEA is
proposing these amendments in response to industry requests. The
proposed amendments establish the regulatory guidelines under which
disposers may handle controlled substances.
dates: Comments and objections must be submitted by October 23, 1995.
addresses: Comments and objections should be submitted in quintuplicate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, Washington, DC 20537 Attention:
Federal Register Representative/CCR.
for further information contact: Mr. G. Thomas Gitchel, Chief, Liaison
and Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Telephone (202) 307-7297.
supplementary information: In years past, most pharmaceutical
manufacturers and wholesalers, as a service to their customers,
accepted returns of outdated/damaged controlled substances. Also,
agencies such as DEA and state Boards of Pharmacy accepted surrendered
drugs or witnessed their destruction by registrants.
Over the past several years, environmental concerns and regulations
have eliminated many of the disposal options which had been available.
As a result, drug manufacturers and government agencies alike are
increasingly reluctant to be involved in the disposal process.
Pursuant to 21 CFR 1307.21, registrants may request permission to
conduct disposal on their own without the benefit of DEA or State
witness. In many cases, blanket permission is granted to manufacturers
and distributors who have an ongoing need to dispose of unwanted
substances. Their disposal must first have DEA authorization in
writing, with a set schedule established. Other firms are granted
disposal authority on a case by case basis.
In instances where DEA grants registrants authority to dispose of
controlled substances, it is permissible for that registrant to utilize
the services of an Environmental Protection Agency approved incinerator
located in the area of the registrant's choice. The only caveat
pursuant to DEA policy is that the registrant provide two designated
responsible individuals to accompany the drugs to the disposal site and
actually witness the destruction. The proposes registration of
``disposers'' will not alter the permissibility of this practice.
Traditionally, DEA has been opposed to granting DEA registrations
to firms solely or primarily engaged in the disposal of controlled
substances since they are not an essential link in the closed
distribution system which the Controlled Substances Act established to
control the flow of drugs from the manufacturer to the ultimate user.
However, due to the changes in distribution patterns from local to a
more national distribution, the time and resources expended by DEA in
handling surrendered drugs, and the time expended by manufacturers, a
disposer registration is becoming an essential link.
Title 21, CFR 1302.02(d) defines manufacture in part as ``the
producing, preparation, propagation, compounding, or processing of a
drug or substance. . .''. The section further defines a manufacturer as
``a person who manufactuers a drug or other substance . . . '' By its
nature, a disposer processes a drug or other substance. Therefore, a
disposer falls within the definition of manufacturer. However, due to
the limited nature of the activity conducted by a disposer, a separate
designation is necessary. Therefore, disposers will be registered as a
subcategory of manufacturer.
The basic requirements for registration as a disposer will be
similar to those currently imposed on all registrants at the
manufacturer/distributor level. They include, but are not necessarily
limited to: Security; all applicants must install at the registered
premises physical security controls which meet the existing standards
of 21 CFR 1301.71 and 1301.72. Recordkeeping; in accordance with 21 CFR
1304, periodic inventories and records of all controlled substances
received, destroyed or distributed back to the original, registered
manufacturers must be maintained. Due to the unique nature of this
registration activity, the applicant must, consistent with 21 U.S.C.
823(a)(5), adequately describe the receipt and accountability methods
and records to be employed to ensure the establishment of effective
controls against diversion. Order Forms must be completed for all
Schedule I and III items received and transferred ARCOS reports will be
required. In addition to the DEA requirements, disposer applicants must
obtain the appropriate state and federal approvals for controlled
substance and disposal activities.
In conjunction with the proposed amendments outlined above,
proposed
[[Page 43733]]
amendments are being made to a number of sections which currently are
gender specific to make them gender appropriate.
The Deputy Assistant Administrator, Office of Diversion Control,
hereby certifies that this purposed rule, initiated in the public
interest is required to address disposers of controlled substances
which are not covered by the existing regulations. This regulation will
not have a significant economic impact on a substantial number of small
entities; therefore no regulatory flexibility analysis is required in
accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et. seq.
The Deputy Assistant Administrator, Office of Diversion Control has
determined that this rule is not a significant regulatory action under
Executive Order 12866, Section 3(f) Regulatory Planning and Review, and
therefore has not been reviewed by the Office of Management and Budget.
This regulation will not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with Executive
Order 12612, it is determined that this rule does not have sufficient
federalism implications to warrant the preparation of a Federalsim
Assessment.
List of Subjects
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1303
Administrative practice and procedure, Drug traffic control.
21 CFR Part 1304
Drug traffic control, Reporting requirements.
21 CFR Part 1305
Drug traffic control, Reporting requirements.
For reasons set out above, 21 CFR parts 1301, 1303, 1304, and 1305
are proposed to be amended as follows:
PART 1301--[AMENDED]
1. The authority citation for Part 1301 continues to read as
follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.
2. Section 1301.02 is proposed to be amended by redesignating
paragraphs (f) through (m) as (g) through (n) and adding a new
paragraph (f) as follows:
Sec. 1301.02 Definitions.
* * * * *
(f) The term disposer means a manufacturer (as defined in
1302.02(d)) who receives controlled substances for the sole or primary
purpose of processing such substances to render them unusable.
* * * * *
3. Section 1301.22 is proposed to be amended by revising paragraphs
(b)(1) and (b)(2) and adding new paragraph (b)(7) as follows:
Sec. 1301.22 Separate registration for independent activities.
* * * * *
(b) * * *
(1) A person registered to manufacture or import any controlled
substance or basic class of controlled substance, except a person
registered to dispose of any controlled substance, shall be authorized
to distribute that substance or class, but no other substance or class
which he/she is not registered to manufacture or import; a person
registered to dispose of any controlled substance shall be authorized
to distribute such substance only to the original registered
manufacturer of the substance;
(2) A person registered to manufacture any controlled substance
listed in Schedules II through V, except a person registered to dispose
of any controlled substance, shall be authorized to conduct chemical
analysis and preclinical research (including quality control analysis)
with narcotic and non-narcotic controlled substances listed in those
schedules in which he/she is authorized to manufacture; a person
registered to dispose of any controlled substance shall be authorized
to conduct chemical analysis to ascertain that the substances received
for disposal contain controlled substances;
* * * * *
(7) A person registered in any activity is authorized as a
coincident activity to dispose of controlled substances in accordance
with Section 1307.21.
* * * * *
4. Section 1301.26 is proposed to be amended by revising paragraphs
(a)(1), (a)(2) and (b) and adding a new paragraph (a)(3) to read as
follows:
Sec. 1301.26 Exemption of law enforcement officials.
(a) * * *
(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 controlled substances in the course of his or her official
duties;
(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 posses controlled substances in the course of his or her
official duties; and
(3) Any person acting as an agent of the Administration or as an
agent of any state or local law enforcement agency to dispose of
controlled substances obtained from clandestine laboratories.
(b) Any official exempted by this section may, when acting in the
course of his or her official duties, 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 or her
official duties.
* * * * *
5. Section 1301.32 is proposed to be amended by revising paragraphs
(a)(1) and (b)(1) to read as follows:
Sec. 1301.32 Application forms; contents; signature.
(a) * * *
(1) To manufacture, distribute, or dispose of controlled
substances, he or she shall apply on DEA Form 225;
* * * * *
(b) * * *
(1) To manufacture, distribute, or dispose of controlled
substances, he or she shall apply on DEA Form 225a;
* * * * *
6. In addition to the amendments set forth above in Section
1301.32, remove the words ``he shall apply'' and add, in their place
``he or she shall apply'' in each of paragraphs (a)(2) through (a)(8)
and (b)(2) through (b)(8).
7. Section 1301.7 is proposed to be amended by revising paragraphs
(b)(13) and (b)(14) and adding a new paragraph (b)(15) to read as
follows:
Sec. 1301.71 Security requirements generally.
* * * * *
(b) * * *
(13) The availability of local police protection or of the
registrant's or applicant's security personnel;
(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; and
(15) The applicability of the security requirements contained in
all Federal, state, and local laws and regulations governing the
management of waste.
* * * * *
[[Page 43734]]
8. Section 1301.72 is proposed to be amended by revising paragraph
(b)(7) to read as follows:
Sec. 1301.72 Physical security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic treatment
programs; storage areas.
* * * * *
(b) * * *
(7) Such other secure storage areas as may be approved by the
Administrator after considering the factors listed in Section
1301.71(b), (1) through (15);
* * * * *
PART 1303--[AMENDED]
1. The authority citation for Part 1303 continues to read as
follows:
Authority: 21 U.S.C. 821, 826, 871(b).
2. Section 1303.12 is proposed to be amended by revising paragraphs
(e)(2) and (e)(3) and adding a new paragraph (e)(4) to read as follows:
Sec. 1303.12 Procurement quotas.
* * * * *
(e) * * *
(2) Any person who is registered or authorized to conduct chemical
analysis with controlled substances (for controlled substances to be
used in such analysis only);
(3) Any person who is registered to conduct research with a basic
class of controlled substance listed in Schedule I or II and who is
authorized to manufacture a quantity of such class pursuant to Section
1301.22(b) of this chapter; and
(4) Any person who is registered solely as a disposer as defined in
Section 1301.02(f) of this chapter.
* * * * *
PART 1304--[AMENDED]
1. The authority citation for Part 1304 continues to read as
follows:
Authority: 21 U.S.C. 821, 827, 871(b) 958(d) 965, unless
otherwise noted.
2. Part 1304 is proposed to be amended by adding new Section
1304.20 to read as follows:
Sec. 1304.20 Inventories of disposers.
Each person registered (by Section 1301.22(b) of this chapter) to
dispose of controlled substances shall include in his inventory the
same information required of manufacturers pursuant to Section 1304.15
(a), (c), and (d).
3. Part 1304 is proposed to be amended by adding new Section
1304.30 to read as follows:
Sec. 1304.30 Records for disposers.
Each person registered (by Section 1301.22(b) of this chapter) to
dispose of controlled substances shall maintain records with the
following information for each controlled substance:
(a) For each substance in bulk form,
(1) The name of the controlled substance;
(2) The total quantity of the controlled substance to the nearest
metric unit weight consistent with unit size;
(3) The quantity received from other persons, including the date
and quantity of each receipt and the name, address, and registration
number of the other person from whom the controlled substance was
received;
(4) The quantity distributed back to the original manufacturer of
the controlled substance including the date of and quantity of each
distribution and the name, address and registration number of the
manufacturer to whom the controlled substance was distributed;
(5) The quantity disposed of including the date and manner of
disposal, the quantity of the substance disposed, and the signatures of
two responsible employees of the registrant who witnessed the disposal.
(b) For each controlled substance in finished form,
(1) The name of the substance;
(2) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(3) The number of commercial containers of each such finished form
received from other persons, including the date of and number of
containers in each receipt and the name, address, and registration
number of the person from whom the containers were received;
(4) The number of commercial containers of each such finished form
distributed back to the original manufacturer of the substance,
including the date of and number of containers in each distribution and
the name, address, and registration number of the manufacturer to whom
the containers were distributed;
(5) The number of units or volume of finished forms and/or
commercial containers disposed of including the date and manner of
disposal, the quantity of the substance in finished form disposed, and
the signatures of two responsible employees of the registrant who
witnessed the disposal.
4. Section 1304.34 is proposed to be amended by revising paragraphs
(a) and (b) to read as follows:
Sec. 1304.34 Reports generally.
(a) All reports required by Sections 1304.35-1304.39 shall be filed
with the ARCOS Unit, P.O. Box 28293, Central Station, Washington, D.C.
20005.
(b) Reports required by Sections 1304.35-1304.39 shall be filed on
DEA Form 333, or on medial which contains the data required by DEA Form
333 and which is acceptable to the ARCOS Unit.
* * * * *
5. Part 1304 is proposed to be amended by adding a new section
1304.39 to read as follows:
Sec. 1304.39 Reports from disposers.
Each person who is registered to dispose of controlled substances
shall report as follows:
(a) Substances covered. Reports shall include data on each
controlled substance listed in Schedules I and II and on each narcotic
controlled substance listed in Schedule III (but not on any material,
compound, mixture or preparation containing a quantity of a substance
having a stimulant effect on the central nervous system, which
material, compound, mixture or preparation is listed in Schedule III or
on any narcotic controlled substance listed in Schedule V). Data shall
be presented in such a manner as to identify the particular form,
strength, and trade name, if any, of the product containing the
controlled substance for which the report is being made. For this
purpose, persons filing reports shall utilize the National Drug Code
Number assigned to the product under the National Drug Code System of
the Food and Drug Administration.
(b) Transactions reported. Reports shall provide data on each
acquisition to inventory (identifying whether it is, e.g., by purchase
or transfer, or supply by the Federal Government) and each reduction
from inventory (identifying whether it is e.g., by sale or transfer to
the manufacturer, theft, destruction, or seizure by Government
agencies). These reports shall be filed every month not later than the
15th day of the month succeeding the month for which it is submitted:
except that a registrant may be given permission to file more
frequently or less frequently (but not less than quarterly), depending
on the number of transactions being reported each time by that
registrant.
(c) Inventories reported. Reports shall provide data on the stocks
of each reported controlled substance on hand as of the close of
business on December 31 of each year. These reports shall be filed no
later than January 15 of the following year.
PART 1305--[AMENDED]
1. The authority citation for Part 1305 continues to read as
follows:
[[Page 43735]]
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
2. Section 1305.08 is proposed to be amended by revising paragraph
(b) to read as follows:
Sec. 1305.08 Persons entitled to fill order forms.
* * * * *
(b) A person who has obtained any controlled substance in Schedule
I or II by order form may return such substance, or portion thereof, to
the person from whom he/she obtained the substance, to the manufacturer
of the substance, or to a registered disposer pursuant to the order
form of the latter person;
* * * * *
Dated: August 17, 1995.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 95-20890 Filed 8-22-95; 8:45 am]
BILLING CODE 4410-09-M