[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
