Date="10/11/94" Citation="59 FR 51364" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Contents of Records and Reports"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 Contents of Records and Reports AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Interim rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 Contents of Records and Reports AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Interim rule. + ------------------------------------------------------------ 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 ------------------------------------------------------ The Contents entry for this article reads as follows: Prescription drug products; reporting and recordkeeping requirements, 51364