South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 600 - Records and Reports of Registrants › Section 61-4.600.602 - Persons Required to Keep Records and File Reports

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Each registrant shall maintain the
				records and inventories and shall file the reports required by this Part,
				except as exempted by this Section. Any registrant who is authorized to conduct
				other activities without being registered to conduct these activities, either
				pursuant to §107(b) or to §§1401 through 1404, shall maintain
				the records and inventories and shall file the reports required by this Part
				for persons registered to conduct such activities. The latter requirement
				should not be construed as requiring stocks of controlled 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 Bureau of
				Drug Control is to permit the registrant to keep one set of records which are
				adapted by the registrant to account for controlled substances used in any
				activity. The Bureau of Drug Control 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 item, he or
				she shall keep a record of the quantity manufactured; when he or she
				distributes a quantity of the item, he or she shall use and keep invoices or
				order forms to document the transfer; when he or she imports a substance, he or
				she keeps as part of his or her records the documentation required to an
				importer; and when substances are used in chemical analysis, he or she need not
				keep a record of this because such a record would not be required of him or her
				under a registration to do chemical analysis. All of those records may be
				maintained in one consolidated record system. Similarly, the researcher may
				store all of his or her controlled items in one place, and every year take
				inventory of all items in hand, regardless of whether the substances were
				manufactured by him or her, imported by him or her, or purchased domestically
				by him or her, or whether the substances will be administered to subjects,
				distributed to other researchers, or destroyed during chemical
				analysis.
(b) A registered
				individual practitioner is not required to keep specific records with respect
				to controlled substances for which he or she issues prescriptions, or orders
				for administration within an institutional practitioner setting (e.g., hospital
				"orders"), in the lawful course of his or her professional practice; provided,
				that a complete record or memorandum of such prescription or order be
				maintained upon regular patient records.
(c) A registered individual practitioner is
				required to maintain a readily retrievable record, separate from patient
				charts, of all controlled substances acquired, dispensed, administered (other
				than by the issuance of an institutional order or a prescription) distributed,
				or otherwise disposed of by the practitioner, his or her employees or agents,
				whether the controlled substance is separately charged for, included in other
				charges, or is provided at no charge. Practitioners who personally administer
				narcotic controlled substances in an emergency need only keep a simple record
				of the date, kind, quantity, and strength of the controlled substance
				administered in such emergency, and the name of the recipient. Within 72 hours
				of the emergency administration, a permanent record shall be constituted and
				included in the readily retrievable records of dispensing required herein.
				Repeated or excessive emergency administrations will require the registrant to
				notify the Bureau of Drug Control of such happenstance.
(d) A registered person using any controlled
				substance in research conducted in conformity with an exemption granted under
				§505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (
				21
				U.S.C. 355(i) ) as a
				registered establishment which maintains records in accordance with either of
				those sections is not required to keep records if he notified the Bureau of
				Drug Control of the name, address, and registration number of the establishment
				maintaining such records.
(e) A
				registered person using any controlled substance in pre-clinical research or in
				teaching at a registered establishment, which maintains records with respect to
				such substance, is not required to keep records if he notifies the Bureau of
				Drug Control of the name, address, and registration number of the establishment
				maintaining such records.
(f)
				Notice required by paragraphs (d) and (e) of this section shall be given at the
				time the person applies for registration or re-registration and shall be made
				in the form of an attachment to the application, which shall be filed with the
				application.