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

[Federal Register Volume 64, Number 143 (Tuesday, July 27, 1999)]
[Rules and Regulations]
[Pages 40516-40517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19047]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309 and 1310

[DEA NUMBER 168-F]
RIN 1117-AA46


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

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the 
Interim Final Rule, which included a request for comment, published in 
the Federal Register on October 17, 1997 (62 FR 53959). The interim 
rule amended the regulations to provide a temporary exemption from the 
registration requirement for persons who distribute pseudoephedrine and 
phenylpropanolamine drug products. No comments to the Interim Final 
Rule were received. This Final Rule makes those exemptions permanent.

FOR FURTHER INFORMATION CONTACT: Patricia Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Washington, DC 20537, 
telephone (202) 307-7297.

EFFECTIVE DATES: July 27, 1999.

SUPPLEMENTARY INFORMATION: On October 17, 1997, the Drug Enforcement 
Administration (DEA) published an Interim Final rule with request for 
comment which provided temporary exemption from the registration 
requirement for persons who distribute pseudoephedrine and 
phenylpropanolamine drug products (62 FR 53959).
    Two specific exemptions were established in this interim 
rulemaking. The first exemption dealt with retail distributors of 
regulated drug products.

[[Page 40517]]

DEA amended 21 CFR 1309.29 to exempt retail distributors of 
pseudoephedrine and phenylpropanolamine related drug products from the 
registration requirement, so long as they engaged 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. The 
second exemption dealt with persons who are required to obtain a 
registration. The interim rule amended 21 CFR 1310.09 to provide that 
any person who submitted an application for registration for activities 
involving pseudoephedrine and phenylpropanolamine regulated drug 
products on or before December 3, 1997, was exempted from the 
registration requirement for their lawful activities with regulated 
drug products until the Administration takes final action with respect 
to that application.
    No comments were received regarding this interim rulemaking. 
Therefore, the interim rule is adopted without change.
    The Deputy Assistant Administrator for the Office of Diversion 
Control hereby certifies that this final rulemaking will not have a 
significant economic impact upon a substantial number of small business 
entities whose interest must be considered under the Regulatory 
Flexibility Act, 5 U.S.C. 601 et seq. This final 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.
    The Deputy Assistant Administrator further certifies that this 
final rulemaking has been drafted in accordance with the principles in 
Executive Order 12866 Section 1-B. DEA has determined that this is not 
a significant rulemaking action.
    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 12612, and it has been determined that this 
rule does not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.
    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.
    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. this rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.
    The interim rule amending 21 CFR parts 1309 and 1310 which was 
published on October 17, 1997 at 62 FR 53959 is adopted as a final 
rule.

    Dated: June 23, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 99-19047 Filed 7-26-99; 8:45 am]
BILLING CODE 4410-09-M