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:
P.O. Box 28293
Washington, DC 20005
5.Each manufacturer, distributor, 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
Louisiana Register Vol. 34, No. 10 October 20, 2008