[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