La. Admin. Code tit. 46 § LIII-2731

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2731 - General Information

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.

B. Maintenance of Records and Inventories

1. Except as otherwise provided in this Section, every inventory and other records required to be kept under this Section shall be kept by the licensee and be available, for at least two years from the date of such inventory or records, for inspection and copying by authorized employees of the board.

a. Financial and shipping records may be kept at a central location, rather than at the registered location, if the licensee has notified the board in writing of his intention to keep central records. All notifications shall include the following:

i. the nature of the records to be kept centrally;

ii. the exact location where the records will be kept;

iii. the name, address, DEA registration number and type of DEA registration of the licensee whose records are being maintained centrally;

iv. whether central records will be maintained in a manual, or computer readable, form.

b. A pharmacy which possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required by this Section for those additional registered sites at the pharmacy or other approved central location.

2. All licensees authorized to maintain a central recordkeeping system shall be subject to the following conditions.

a. The records to be maintained at the central record location shall not include executed order forms, prescriptions and/or inventories which shall be maintained at each registered location.

b. If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the licensee shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable.

c. The licensee agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the board for such records, and if the board chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the board to inspect such records at the central location upon request by such employees without a warrant of any kind.

d. In the event that a licensee fails to comply with these conditions, the board may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the licensee without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this Paragraph the licensee shall, within the time specified by the board, comply with the requirements of this Section that all records be kept at the registered location.

3. Licensees need not notify the board or obtain central recordkeeping approval in order to maintain records on an in-house computer system.

4. ARCOS participants who desire authorization to report from other than their registered locations shall obtain a separate central reporting identifier. Request for central reporting identifiers shall be submitted to:

ARCOS Unit

P.O. Box 28293

Central Station

Washington, DC 20005

5. Each manufacturer, distributor, third-party logistics provider, importer, exporter, narcotic treatment program and compounder for narcotic treatment program shall maintain inventories and records of controlled substances as follows:

a. inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the other records of the licensee; and

b. inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the licensee or in such form that the information required is readily retrievable from the ordinary business records of the licensee.

6. Each individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in this Section.

7. Each pharmacy shall maintain the inventories and records of controlled substances as follows:

a. inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate prescription file; and

b. inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for such substances shall be maintained either in a separate prescription file for controlled substances listed in Schedules III, IV, and V only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an ADP system or other electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.

C. Records of Authorized Central Fill Pharmacies and Client Pharmacies

1. Every pharmacy that utilizes the services of a central fill pharmacy shall keep a record of all central fill pharmacies, including name, address and DEA number, which are authorized to fill prescriptions on its behalf. The pharmacy shall also verify the registration for each central fill pharmacy authorized to fill prescriptions on its behalf. These records shall be made available upon request for inspection by the board.

2. Every central fill pharmacy shall keep a record of all pharmacies, including name, address and DEA number, for which it is authorized to fill prescriptions. The central fill pharmacy shall also verify the registration for all pharmacies for which it is authorized to fill prescriptions. These records shall be made available upon request for inspection by the board.

La. Admin. Code tit. 46, § LIII-2731

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2139 (October 2008), Amended by the Department of Health, Board of Pharmacy, LR 46570 (4/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.