Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter E - Recordkeeping Requirements › Section LIII-2731 - General Information

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Persons Required to Keep Records and File Reports
1. Each licensee shall maintain the records
				  and inventories and shall file the reports required by this Chapter, except as
				  exempted by this Section. Any licensee who is authorized to conduct other
				  activities without being registered to conduct those activities by federal law
				  shall maintain the records and inventories and shall file the reports required
				  by this Section for persons registered to conduct such activities. This 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 does it require that separate records are required for each
				  activity. Thus, when a researcher manufactures a controlled item, he shall keep
				  a record of the quantity manufactured; when he distributes a quantity of the
				  item, he shall use and keep invoices or order forms to document the transfer;
				  when he imports a substance, he keeps as part of his records the documentation
				  required of an importer; and when substances are used in chemical analysis, he
				  need not keep a record of this because such a record would not be required of
				  him 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 controlled items in one place, and every two years take
				  inventory of all items on hand, regardless of whether the substances were
				  manufactured by him, imported by him, or purchased domestically by him, of
				  whether the substances will be administered to subjects, distributed to other
				  researchers, or destroyed during chemical analysis.
2. An individual practitioner is required to
				  keep records of controlled substances in Schedules II, III, IV, and V which are
				  dispensed, other than by prescribing or administering in the lawful course of
				  professional practice.
3. An
				  individual practitioner is not required to keep records of controlled
				  substances in Schedules II, III, IV, and V which are prescribed in the lawful
				  course of professional practice, unless such substances are prescribed in the
				  course of maintenance or detoxification treatment of an individual.
4. An individual practitioner is not required
				  to keep records of controlled substances listed in Schedules II, III, IV and V
				  which are administered in the lawful course of professional practice unless the
				  practitioner regularly engages in the dispensing or administering of controlled
				  substances and charges patients, either separately or together with charges for
				  other professional services, for substances so dispensed or administered.
				  Records are required to be kept for controlled substances administered in the
				  course of maintenance or detoxification treatment of an individual.
5. Each registered mid-level practitioner
				  shall maintain in a readily retrievable manner those documents required by the
				  state in which he practices which describe the conditions and extent of his
				  authorization to dispense or distribute controlled substances and shall make
				  such documents available for inspection and copying by authorized agents of the
				  board. Examples of such documentation include protocols, practice guidelines or
				  practice agreements.
6. Licensees
				  using any controlled substances while conducting preclinical research, in
				  teaching at a registered establishment which maintains records with respect to
				  such substances or conducting research in conformity with an exemption granted
				  under Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21
				  U.S.C. 355(i) or
				  360
				  b(j)) at a registered establishment which maintains records in accordance with
				  either of those sections, are not required to keep records if he notifies the
				  DEA and the board of the name, address, and registration number of the
				  establishment maintaining such records. This notification shall be given at the
				  time the person applies for a CDS license or his renewal and shall be made in
				  the form of an attachment to the application, which shall be filed with the
				  application.
7. A distributing
				  licensee who utilizes a freight forwarding facility shall maintain records to
				  reflect transfer of controlled substances through the facility. These records
				  shall contain the date, time of transfer, number of cartons, crates, drums or
				  other packages in which commercial containers of controlled substances are
				  shipped and authorized signatures for each transfer. A distributing licensee
				  may, as part of the initial request to operate a freight forwarding facility,
				  request permission to store records at a central location. Approval of the
				  request to maintain central records would be implicit in the approval of the
				  request to operate the facility. Otherwise, a request to maintain records at a
				  central location shall be submitted in accordance with this Section. These
				  records shall be maintained for a period of two years.
8. With respect to any and all records
				  required by this Chapter which are maintained in a language other than English,
				  the person responsible for maintaining such records shall provide a document
				  accurately translating such records to English within 72 hours of such request
				  by the board or an agent of the board.