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"

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.

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. + ------------------------------------------------------------ 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 ------------------------------------------------------ The Contents entry for this article reads as follows: Prescription drug products; reporting and recordkeeping requirements, 17636