[Federal Register Volume 60, Number 67 (Friday, April 7, 1995)]
[Rules and Regulations]
[Pages 17636-17637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8592]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[DEA No. 122F]
RIN 1117-AA25
Contents of Records and Reports
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: The interim rule published 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) is
adopted without change. Specifically, the amendment clarifies that for
prescription drug products, prescription and hospital records shall be
adequate to satisfy recordkeeping requirements. In addition, this final
rule clarifies that for the distribution of these products to
hospitals, pharmacies and other entities, normal business records shall
be considered adequate if they meet the requirements of 21 CFR 1310.06
(a) and (b).
EFFECTIVE DATE: April 7, 1995.
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 October 11, 1994, the Acting
Administrator of the DEA published an interim rule (59 FR 51364) which
clarified 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, this interim rule clarified
that for prescription drug products, prescription and hospital records
kept in the normal course of medical treatment are adequate to meet the
recordkeeping requirements for each record required under 21 CFR
1310.03. However, the interim notice stated that reports as specified
in 21 CFR 1310.05 and notification requirements as set forth in 21 CFR
1313 must still be satisfied for these products. Interested parties had
until November 10, 1994 to submit comments and objections.
In response to the October 11, 1994 interim rule, one comment was
submitted by Abbott Laboratories. In this comment Abbott requested that
records for the distribution of prescription ephedrine injectable
products, which are kept in the normal course of business, be
considered adequate to satisfy the recordkeeping requirements, just as
prescription and hospital records kept in the normal course of medical
treatment shall be considered adequate. Abbott further stated that
normal business records contain (1) the name and address of both
parties to the transaction; (2) the date of the regulated transaction;
(3) the name and quantity of the prescription drug product; (4) the
method of transfer; and (5) an Abbott customer identification number.
Upon review of Abbott's comment, DEA has determined that no further
amendment to the regulations are required. Existing provisions of 21
CFR 1310.06 (which detail the sufficiency of records kept in the normal
course of business) are broad enough to enable businesses to meet the
requirements pertaining to injectable ephedrine products without any
new burden. Therefore, the interim rule (59 FR [[Page 17637]] 51364) is
herein finalized without change.
The contents of records required for regulated transactions are
stated in 21 CFR 1310.06. Specifically, 21 CFR 1310.06(a)(5) provides
that each record shall include the type of identification used by the
purchaser and any unique number on that identification. It is the
responsibility of the regulated person who engages in a regulated
transaction to identify the other party to the transaction and verify
the existence and apparent validity of a business entity ordering a
listed chemical in compliance with 21 CFR 1310.07. If the assignment of
a company customer identification number is based upon meeting all
requirements as specified in 21 CFR 1310.07, and this customer
identification number can be cross-referenced with the type of
identification used to verify the existence and apparent validity of
the purchaser and any unique number on that identification, then a
customer identification number will be deemed adequate to meet the
requirements of 21 CFR 1310.06(a)(5).
Further, 21 CFR 1310.06(b) states that normal business records
shall be considered adequate if they contain the information listed in
21 CFR 1310.06(a) and are readily retrievable from other business
records of the regulated person. Thus, if these records are readily
retrievable and meet all the requirements of 21 CFR 1310.06(a) then
these records shall be deemed adequate. However, it is the
responsibility of each regulated person to ensure that all requirements
of 21 CFR 1310.06 are adequately met if relying on normal business
records to satisfy the recordkeeping requirements of 21 CFR 1310.03.
The products in question are prescription products which are
already subject to strict Federal and state controls. This final rule
modifies 21 CFR 1310.06(b) 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 recordkeeping requirements.
This rule has been drafted and reviewed in accordance with
Executive Order 12866, Section 1(b), Principles of Regulation. The
Deputy Administrator has determined that this rule is not a significant
regulatory action under Executive Order 12866 Section 3(f), Regulatory
Planning and Review. This action allows relief from regulatory
requirements by permitting the use of normal business records for these
prescription products rather than requiring the creation of separate
records of transactions. Accordingly, this rule has not been reviewed
by the Office of Management and Budget.
The Deputy Administrator in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by
approving it certifies that this regulation will not have a significant
economic impact on a substantial number of small entities.
This action has been analyzed in accordance with the principles and
criteria in Executive Order 12612, and it has been determined that the
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.
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
Accordingly, the interim rule amending 21 CFR part 1310 which was
published at 59 FR 51364 on October 11, 1994, is adopted as a final
rule without change.
Dated: March 20, 1995.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 95-8592 Filed 4-6-95; 8:45 am]
BILLING CODE 4410-09-M
