HaCKeRz KrOnIcKLeZ 3/HaCKeRz_KrOnIcKLeZ.iso/drugs/60.fr.43732

Text File | 1996-05-06 | 21KB | 484 lines

<ARTICLE>
Date="08/23/95"
Citation="60 FR 43732"
Group="legal"
Type="PROPOSED RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
Subject="Definition and Registration of Disposers"
<HEADER>
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.
</HEADER>
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
[phone].

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accepted returns of outdated/damaged controlled substances.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


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The Contents entry for this article reads as follows:

Disposers; definition and registration, 43732
</ARTICLE>

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