HaCKeRz Kr0nlcKLeZ 1/HaCKeRz Kr0nlcKLeZ.iso/drugs/60.fr.49527

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<ARTICLE>
Date="09/26/95"
Citation="60 FR 49527"
Group="legal"
Type="PROPOSED RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
Subject="Waiver of Requirements for the Distribution of Prescription Drug Products That Contain List I Chemicals"
<HEADER>
DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA-133P]

RIN 1117-AA29

Waiver of Requirements for the Distribution of Prescription
Drug Products That Contain List I Chemicals

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.
</HEADER>
DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA-133P]

RIN 1117-AA29

Waiver of Requirements for the Distribution of Prescription
Drug Products That Contain List I Chemicals

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.
+
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SUMMARY: DEA is proposing to amend its regulations to waive
the registration requirement for persons who distribute prescription
drug products that are subject to regulation as List I chemicals
and to allow that the records required to be maintained pursuant
to the Federal Food and Drug Administration (FDA) guidelines
for prescription drug products shall be deemed adequate for
satisfying DEA's recordkeeping requirements with respect to
distribution. In response to requests from industry, DEA has
conducted a review and determined that such prescription drug
products are already subject to extensive regulatory controls
regarding their distribution and are not presently identified
as a significant source for diversion of List I chemicals to
the illicit manufacture of controlled substances. This proposed
action will relieve a large population of distributors and manufacturers
of regulated prescription drug products containing List I chemicals
from the burden of compliance with regulations in circumstances
where compliance would be unnecessary for enforcement of the
law.

DATES: Comments or objections must be received on or before
November 27, 1995.

ADDRESSES: Comments and objections should be submitted in quintuplicate
to the Deputy Administrator, Drug Enforcement Administration,
Washington, D.C. 20537, Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison
and Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, D.C. 20537, Telephone (202) 307-
7297.

SUPPLEMENTARY INFORMATION: The Domestic Chemical Diversion Control
Act of 1993 (PL 103-200) (DCDCA) amended Section 802(39) of
the Controlled Substances act (21 U.S.C. 801 et seq.) (CSA)
to remove drug products that contain either ephedrine as the
sole medicinal ingredient or ephedrine in combination with therapeutically
insignificant amounts of another medicinal ingredient (hereinafter
regulated ephedrine drug products) from the exemption granted
to drug products that contain a List I chemical that may be
marketed or distributed under the Federal Food, Drug and Cosmetic
Act (FDCA). As a result of this and the removal of the ephedrine
threshold, all distributions, importations and exportations
of regulated ephedrine drug products became subject to the chemical
registration, recordkeeping and reporting requirements of the
CSA. The intent of these actions was to establish a system of
controls to prevent the diversion of regulated ephedrine drug
products for the illicit manufacture of controlled substances.

   DEA has received a number of comments from pharmaceutical
companies expressing concerns regarding the application of the
new controls to the distribution of prescription drug products
that are subject to regulation. Primary among the concerns are:
(1) The burdens associated with compliance with the registration
and recordkeeping requirements, including the financial burden
associated with converting existing systems to satisfy the new
requirements; (2) existing Federal and state controls severely
restrict the manufacture, distribution or dispensing of the

---- page 49528 ----

products, and; (3) the lack of any evidence that the products
are being diverted for the illicit manufacture of controlled
substances.
   In response to industry's concerns and in the interest of
limiting regulatory burdens to those necessary for the enforcement
of the law, DEA has reviewed the need for applying the chemical
registration requirement on persons who distribute regulated
prescription drug products and determined that such application
is not necessary for the enforcement of the CSA at this time.
Further, DEA has determined that distribution records required
to be maintained pursuant to the FDA guidelines set forth in
title 21, Code of Federal Regulations (21 CFR), Part 205 are
adequate for satisfying DEA's recordkeeping requirements for
distributions. This determination is based on DEA's finding
that there is presently a lack of evidence that prescription
drug products that contain List I chemicals are being diverted
for the illicit manufacture of controlled substances, the products
are already subject to an extensive system of regulatory controls,
and the DEA access to the distribution records kept under the
FDA guidelines should provide sufficient information to satisfy
the intent of the regulations.
   With respect to diversion, it has been DEA's experience that
persons seeking to divert List I chemicals for the illicit manufacture
of controlled substances have relied primarily on either non-
regulated sources or smuggled chemicals. Initially, bulk ephedrine
was the chemical of choice; following implementation of DEA's
chemical control program in 1989, over-the-counter (OTC) ephedrine
drug products which were exempt from the regulatory provisions
of the CSA became the products of choice. With implementation
of the DCDCA and regulation of the OTC ephedrine drug products,
OTC pseudoephedrine drug products became a significant source
for diversion. DEA is unaware of the diversion of prescription
drug products containing List I chemicals to clandestine drug
laboratories.
   With respect to controls, prescription drugs are already
subject to stringent requirements governing their distribution
and dispensing. A prescription drug can only be dispensed to
the public pursuant to the order of a licensed health care professional.
Further, distributors of prescription drug products are subject
to extensive licensing, security, recordkeeping and inventory
requirements. These requirements, the guidelines for which are
set forth in 21 CFR, Part 205, establish a ``closed system''
for the distribution of prescription products.
   In light of the existing controls and the lack of evidence
of diversion of regulated prescription products, application
of the registration requirement is unnecessary at this time
for the enforcement of the CSA. In addition, the information
maintained in the distribution records required under the FDA
guidelines is sufficient to satisfy DEA's needs, should an inspection
of the records be necessary. Therefore, DEA is proposing to
amend 21 CFR Part 1309 to add a new Section 1309.28, waiving
the requirement of registration for any person who distributes
a regulated prescription drug product. Further, DEA is proposing
to amend Section 1310.06 of the regulations, which currently
allows that prescription and hospital records maintained in
the course of medical practice are adequate for satisfying DEA's
requirements, to also allow that records required to be maintained
pursuant to the guidelines set forth in 21 CFR, Part 205 shall
be adequate for wholesale distributions of regulated prescription
drug products. If, however, evidence of diversion of prescription
products is seen in the future, DEA will take action to make
the products subject to the specific regulatory requirements
of the CSA.
   In addition to the proposed changes described above, Sections
1309.21 and 1309.22 are proposed to be amended to make reference
to the addition of the new waiver of the registration requirement.
   Under the CSA, the Attorney General may waive the requirement
of registration for certain manufacturers, distributors or dispensers
if it is consistent with the public interest (21 U.S.C. 822(d).
The Attorney General has delegated authority under the CSA and
all subsequent amendments to the CSA to the Administrator of
the DEA (28 CFR 0.100). The Administrator, in turn, has delegated
this authority to the Deputy Administrator pursuant to 28 CFR
0.104 (59 FR 23637 (May 6, 1994)).
   The Deputy Administrator of the Drug Enforcement Administration
hereby certifies that this proposed rulemaking will not have
a significant impact on a large number of entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C.
601 et seq. This rulemaking proposes to grant those persons
who distribute regulated prescription drug products relief from
DEA's chemical registration requirement and allow for the use
of records already maintained pursuant to FDA guidelines in
lieu of requiring that separate records be maintained. These
proposed amendments could potentially ease the regulatory burden
for 1,200 or more distributors and manufacturers of regulated
prescription drug products.
   This proposed rule has been drafted and reviewed in accordance
with Executive Order 12866. DEA has determined that this is
not a significant regulatory action under the provisions of
Executive Order 12866, section 3(f) and accordingly this rule
has not been reviewed by the Office of Management and Budget.
This rule will eliminate unnecessary regulatory requirements
for distributors of regulated prescription drug products.
   This action has been analyzed in accordance with the principles
and criteria in Executive Order 12612, and it has been determined
that the proposed rule does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.

List of Subjects


21 CFR Part 1309

   Administrative practice and procedure, Drug traffic control,
List I and List II chemicals, Security measures.

21 CFR Part 1310

   Drug traffic control, List I and List II chemicals, Reporting
and recordkeeping requirements.
   For reasons set out above, it is proposed that 21 CFR part
1309 be amended as follows:

PART 1309-[AMENDED]

   1. The authority citation for part 1309 continues to read
as follows:

   Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875,
877, 958.

   2. Section 1309.21 is proposed to be revised to read as follows:

sec 1309.21  Persons required to register.

   (a) Every person who distributes, imports, or exports any
List I chemical, other than those List I chemicals contained
in a product exempted under sec 1310.01(f)(1)(iv), or who proposes
to engage in the distribution, importation, or exportation of
any List I chemical, shall obtain annually a registration specific
to the List I chemicals to be handled, unless exempted by law
or pursuant to secsec 1301.24 through 1309.28. 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 distributing List I chemicals
is not required to obtain a registration.)

---- page 49529 ----

   (b) Every person who distributes or exports a List I chemical
they have manufactured, other than a List I chemical contained
in a product exempted under sec 1310.01(f)(1)(iv), or proposes
to distribute or export a List I chemical they have manufactured,
shall obtain annually a registration specific to the List I
chemicals to be handled, unless exempted by law or pursuant
to secsec 1309.24 through 1309.28.
   3. Section 1309.22 is proposed to be amended by revising
paragraph (b) to read as follows:

sec 1309.22  Separate registration for independent activities.

   (a) * * *
   (b) Every person who engages in more than one group of independent
activities shall obtain a separate registration for each group
of activities, unless otherwise exempted by the Act or secsec 1309.24
through 1309.28, except that a person registered to import any
List I chemical shall be authorized to distribute that List
I chemical after importation, but no other chemical that the
person is not registered to import.
   4. Section 1309.28 is proposed to be added to read as follows:

sec 1309.28  Exemption of distributors of regulated prescription
drug products.

   (a) The requirement of registration is waived for any person
who distributes a prescription drug product containing a List
I chemical that is regulated pursuant to sec 1310.01(f)(1)(iv).
   (b) If any person exempted by this section also engages in
the distribution, importation or exportation of a List I chemical,
other than as described in paragraph (a), the person shall obtain
a registration for such activities, as required by sec 1309.21
of this part.
   (c) The Administrator may, upon finding that continuation
of the waiver granted in paragraph (a) of this section would
not be in the public interest, suspend or revoke a person's
waiver pursuant to the procedures set forth in secsec 1309.43 through
1309.46 and 1309.51 through 1309.57 of this part.

PART 1310-[AMENDED]

   5. The authority citation for part 1310 continues to read
as follows:

   Authority: 21 U.S.C. 802, 830, 871(b).

   6. Section 1310.06 is proposed to be amended by revising
paragraph (b) to read as follows:

sec 1310.06  Content of records and reports.
*     *     *     *     *
   (b) For purposes of this section, normal business records
shall be considered adequate if they contain the information
listed in paragraph (a) of this section and are readily retrievable
from other business records of the regulated person. For prescription
drug products, prescription and hospital records kept in the
normal course of medical treatment shall be considered adequate
for satisfying the requirements of paragraph (a) with respect
to dispensing to patients, and records required to be maintained
pursuant to the Federal Food and Drug Administration guidelines
relating to the distribution of prescription drugs, as set forth
in 21 CFR part 205, shall be considered adequate for satisfying
the requirements of paragraph (a) with respect to distributions.
*     *     *     *     *
   Dated: September 11, 1995.

Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.

FR Doc. 95-23774 Filed 9-25-95; 8:45 am]
BILLING CODE 4410-09-M


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The Contents entry for this article reads as follows:

Domestic Chemical Diversion Control Act of 1993; implementation:
  List I chemicals; manufacturers, distributors, importers, and exporters-
    Registration requirement waiver, 49527
</ARTICLE>

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