[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Proposed Rules]
[Pages 49527-49529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23774]
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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 Secs. 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 Secs. 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 Secs. 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 Secs. 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