[Federal Register Volume 59, Number 195 (Tuesday, October 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25069]


[[Page Unknown]]

[Federal Register: October 11, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

 

Contents of Records and Reports

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim rule.

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SUMMARY: This interim rule is issued by the Deputy Administrator of the 
Drug Enforcement Administration (DEA) to clarify what records shall be 
adequate to satisfy recordkeeping requirements for Listed Chemical 
transactions under provisions of the Controlled Substances Act (CSA) as 
amended by the Chemical Diversion and Trafficking Act of 1988 (CDTA) 
and the Domestic Chemical Diversion Control Act of 1993 (DCDCA). 
Specifically, the amendment clarifies that for prescription drug 
products, prescription and hospital records shall be adequate to 
satisfy recordkeeping requirements.

EFFECTIVE DATE: November 10, 1994.

DATES: Written comments and objections must be received by November 10, 
1994.

ADDRESSES: Written comments and objections should be submitted in 
quintuplicate to the Administrator, Drug Enforcement Administration, 
Washington DC 20537, Attention: DEA Federal Register Representative/
CCR.

FOR FURTHER INFORMATION CONTACT:
Howard McClain Jr., Chief, Drug and Chemical Evaluation Section, Office 
of Diversion Control, Drug Enforcement Administration, Washington, DC 
20537, Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION: On March 17, 1994, the Acting Administrator 
of the DEA published a proposed rule in the Federal Register (59 FR 
12562) to eliminate the threshold for ephedrine under provisions of the 
Controlled Substances Act (CSA) as amended by the Chemical Diversion 
and Trafficking Act of 1988 (CDTA) and the Domestic Chemical Diversion 
Control Act of 1993 (DCDCA). This would require that recordkeeping, 
reporting and notification requirements of 21 CFR 1310 and 21 CFR 1313 
apply to all transactions involving bulk ephedrine and single entity 
ephedrine products. Interested parties had until May 2, 1994 to submit 
comments and objections.
    A comment submitted by Abbott Laboratories requested that 
prescription injectable ephedrine products continue to be exempt under 
the definition of ``regulated transaction''. Abbott further stated that 
there is no evidence of diversion of these products which are dispensed 
pursuant to a prescription.
    While the DEA agrees that it is not currently aware of the 
diversion of these single entity ephedrine injectable products, the CSA 
does not provide for the exemption of a specific form of single entity 
ephedrine product. Therefore, recordkeeping, reporting and notification 
requirements will apply to these prescription injectable products. 
However, prescription and hospital records kept in the normal course of 
medical treatment are adequate to meet the recordkeeping requirements 
of 21 CFR 1310. Therefore 21 CFR 1310.06(b) is being modified to 
reflect that for purposes of this section, prescription and hospital 
records kept in the normal course of medical treatment shall be 
adequate to meet these recordkeeping requirements for each record 
required under 21 CFR 1310.03. Reports, as specified in 21 CFR 1310.05, 
must be filed although it is anticipated that they will rarely be 
necessary. In addition, notification requirements as set forth in 21 
CFR 1313 must still be satisfied for these products.
    This action is being published as an interim rule with an effective 
date coinciding with the final rule which eliminates the threshold for 
ephedrine since this will reduce the burden on hospitals and other 
institutions which dispense ephedrine prescription products.
    The Attorney General has delegated authority under 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 hereby certifies that this interim 
rulemaking will have no significant impact upon entities whose 
interests must be considered under the Regulatory Flexibility Act, 5 
U.S.C. 601 et seq. This interim rule 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 E.O 12612, and it has been determined that the interim rule 
does not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Reporting and recordkeeping requirements.
    For reasons as set out above, 21 CFR Part 1310 is amended as 
follows:

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 1310.06 is amended by revising paragraph (b) to read as 
follows:


Sec. 1310.06  Contents 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.
* * * * *
    Dated: August 24, 1994.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 94-25069 Filed 10-7-94; 8:45 am]
BILLING CODE 4410-09-M