HaCKeRz Kr0nlcKLeZ 1/HaCKeRz Kr0nlcKLeZ.iso/drugs/60.fr.17636

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<ARTICLE>
Date="04/07/95"
Citation="60 FR 17636"
Group="legal"
Type="RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
Subject="Contents of Records and Reports"
<HEADER>
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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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 [phone].

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


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The Contents entry for this article reads as follows:

Prescription drug products; reporting and recordkeeping requirements, 17636
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