[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Rules and Regulations]
[Pages 53959-53960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27453]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA Number 168I]
RIN 1117-AA46


Temporary Exemption From Chemical Registration for Distributors 
of Pseudoephedrine and Phenylpropanolamine Products

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim Rule with request for comments.

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SUMMARY: DEA is amending its regulations to provide a temporary 
exemption from registration for persons who distribute pseudoephedrine 
and phenylpropanolamine drug products. The Comprehensive 
Methamphetamine Control Act of 1996 (MCA) amends the Controlled 
Substances Act of 1970 (CSA) to require that, effective October 3, 
1997, persons who distribute these drug products shall be subject to 
the chemical registration requirement. To avoid interruption in the 
legitimate distribution of the drug products pending promulgation of 
final regulations and issuance of registrations, DEA is amending its 
regulations to provide certain temporary exemptions from the 
registration requirement.

DATES: October 17, 1997. Persons required to register to handle 
pseudoephedrine or phenylpropanolamine must submit an application on or 
before December 3, 1997, in order to continue their activities pending 
final action by DEA on their application. Written comments or 
objections must be submitted on or before December 16, 1997.

ADDRESSES: Comments and objections should be submitted in quintuplicate 
to the Deputy Administrator, Drug Enforcement Administration, 
Washington, DC 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, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: The Comprehensive Methamphetamine Control 
Act of 1996 (MCA) requires that, effective October 3, 1997, 
pseudoephedrine and phenylpropanolamine drug products (regulated drug 
products) will become subject to regulation as List I chemicals. Under 
this new requirement, any person who wishes to distribute, import, or 
export these products must first obtain a DEA chemical registration. 
Because full implementation of this provision and issuance of the 
registrations will not be possible prior to the October 3, 1997 
deadline, DEA is establishing temporary exemptions from the 
registration requirement for persons handling regulated drug products 
to allow for continuation of legitimate commerce in the products. In 
addition, the existing exemptions from chemical registration for 
persons registered with DEA to handle controlled substances, which is 
contained in 21 CFR 1309.25, and for distributors of prescription drug 
products, which is contained in 21 CFR 1309.28, will also apply to the 
regulated drug products.
    The first exemption applies to retail distributors of regulated 
drug products. A single transaction limit of 24 grams has been 
established by the MCA for retail distributions of regulated drug 
products. Consistent with previous proposals regarding the regulation 
of retail distributions of drug products that contain List I chemicals, 
DEA is temporarily exempting retail distributors from the registration 
requirement. Under this exemption, retail distributors will not be 
required to obtain a registration if they engage exclusively in 
distributions of regulated drug products below the 24-gram limit in a 
single transaction for legitimate medical use, either directly to walk-
in customers or in face-to-face transactions by direct sales. This 
exemption is set out in 21 CFR 1309.29(b).
    The second exemption applies to those persons who are required to 
obtain a registration. Any such person who submits an application for 
registration for activities involving regulated drug products on or 
before December 3, 1997 will be exempt from the registration 
requirement for their lawful activities with regulated drug products 
until the Administration has taken final action with respect to that 
application. This exemption is set out in 21 CFR 1310.09.
    DEA recognizes that, unlike the second exemption, which provides a 
general benefit to all affected persons, the first exemption is limited 
in its application. Therefore, while the regulatory changes in this 
notice take

[[Page 53960]]

effect upon publication, the notice is open for public comment or 
objection until December 16, 1997. Further, the exemptions are 
temporary and may be subject to change, based on the comments or 
objections received.
    The Deputy Assistant Administrator for the Office of Diversion 
Control hereby certifies that this interim rulemaking will not have a 
significant economic impact upon a substantial number of entities whose 
interests must be considered under the Regulatory Flexibility Act, 5 
U.S.C. 601 et seq. This interim rulemaking is an administrative action 
to make the regulations consistent with the law and to avoid 
interruption of legitimate commerce by granting temporary exemptions 
from registration pending promulgation, through notice and comment, of 
the regulations necessary to implement the provisions of the MCA 
pertaining to regulated drug products. Further, since this is a 
temporary action which provides affected persons with a means to comply 
with the law pending promulgation of regulations implementing the MCA, 
this action is not a significant regulatory action and therefore has 
not been reviewed by the Office of Management and Budget pursuant to 
Executive Order 12866.
    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 12612, and it has been determined that this 
interim 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 the reasons set out above, 21 CFR parts 1309 and 1310 are 
amended to read 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 1309.29 is revised to read as follows:


Sec. 1309.29  Exemption of retail distributors of regulated drug 
products.

    The requirement of registration is waived for any retail 
distributor whose activities with respect to List I chemicals are 
restricted to the distribution of below-threshold quantities of a drug 
product that contains a List I chemical that is regulated pursuant to 
Sec. 1300.02(b)(28)(1)(D) of this chapter to an individual for 
legitimate medical use.

PART 1310--[AMENDED]

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

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

    2. Section 1310.09 is amended by redesignating the existing text as 
paragraph (a) and adding a new paragraph (b) to read as follows:


Sec. 1310.09  Temporary exemption from registration.

* * * * *
    (b) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a drug 
product that contains pseudoephedrine or phenylpropanolamine that is 
regulated pursuant to Sec. 1300.02(b)(28)(1)(D) of this chapter is 
temporarily exempted from the registration requirement, provided that 
the person submits a proper application for registration on or before 
December 3, 1997. The exemption will remain in effect for each person 
who has made such application until the Administration has approved or 
denied that application. This exemption applies only to registration; 
all other chemical control requirements set forth in parts 1309, 1310, 
and 1313 of this chapter remain in full force and effect.

    Dated: October 8, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-27453 Filed 10-16-97; 8:45 am]
BILLING CODE 4410-09-M