[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