Oklahoma Administrative Code › Title 475 - Oklahoma State Bureau of Narcotics and Dangerous Drugs Control › Chapter 25 - Records and Reports of Registrants › Section 475:25-1-3 - Persons required to keep records and file reports

Current through Vol. 41, No. 20, July 1, 2024
(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.
Amended at 12 Ok Reg 2843,
						eff 7-15-95; Amended at 24 Ok Reg 2739, eff
						8-11-07