SECTION 475:25-1-3. Persons required to keep records and file reports

(a)   Each registrant shall maintain the readily-retrievable records and inventories and shall file the reports required by this Chapter, except as exempted by this Section. Any registrant who is authorized to conduct other activities without being registered to conduct those activities pursuant to 475:10-1-7 shall maintain the records and inventories and shall file the reports required for persons registered to conduct such activities. This latter requirement should not be construed as requiring stocks of controlled dangerous substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control (OBN) is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled dangerous substances used in any activity. Also, the Director does not wish to require separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled dangerous substance, he/she must keep a record of the quantity manufactured; when he/she distributes a quantity of the item, he/she must use and keep invoices or order forms as required by Title 21 Code of Federal Regulations, to document the transfer. When substances are used in chemical analysis, he/she need not keep a record of this because such record would not be required of him/her under a registration to do chemical analysis. All of these records may be maintained in one consolidated record system. Similarly, the researcher may store all of his/her controlled dangerous substances in one place and every two (2) years take inventory of all items on hand, regardless of whether the substances were manufactured by him/her, purchased domestically by him/her, or whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis. This may be accomplished by keeping a log for administering similar to that kept for dispensing.

(b)   A registered individual practitioner is required to keep readily-retrievable records with respect to all controlled dangerous substances listed in Schedules II through V which he/she prescribes, administers, or dispenses in the lawful course of his/her professional practice. Practitioners shall keep a suitable book, file, or record in which information pertaining to controlled dangerous substances dispensed by the practitioner shall be preserved for a period of at least two (2) years and be available to designated law enforcement officers for their inspection and copying. These records will be maintained separate and apart from all other records.

(c)   A registered individual practitioner is required to maintain patient records for any individual receiving controlled dangerous substances whether by prescribing, administering, or dispensing. Such record will contain as a minimum the patient's full legal name, date of birth, residence address, last physician seen and when, chief complaint, and notations of date, amount, and type of controlled dangerous substance for each occasion the patient receives a controlled dangerous substance, and diagnostic and medical procedure reports. Such records should contain additional identifying information when possible, including, but not limited to, social security number or driver's license number, telephone number, next-of-kin, and general physical description of the patient. This includes authorization of refills and the number of refills authorized on the original prescription.

(d)   A registered person using any controlled dangerous substance in preclinical research or in teaching at a registered establishment which maintains records with respect to such substances is not required to keep records, unless so ordered by the Director for cause, if he/she notifies the OBN of the name, address, and registration number of the establishment maintaining such records.

[Source: Amended at 12 Ok Reg 2843, eff 7-15-95; Amended at 24 Ok Reg 2739, eff 8-11-07; Amended at 36 Ok Reg 990, eff 7-25-19]