Rules - 1999
[Federal Register: July 27, 1999 (Volume 64, Number 143)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA NUMBER 168-F]
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.
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.
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).