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and double blind studies.

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

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2138 (October 2008).

§2725.Location and Size of Symbol on Label and Labeling

A.The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf. The symbol on all other labeling shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.

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

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2139 (October 2008).

§2727.Sealing of Controlled Substances

A.On each bottle, multiple dose vial, or other commercial container of any controlled substance, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper or such container a seal to disclose upon inspection any tampering or opening of the container.

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

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2139 (October 2008).

§2729.Labeling and Packaging Requirements for Imported and Exported Controlled Substances

A.The symbol requirements of this Section apply to every commercial container containing, and to all labeling of, controlled substances imported into the jurisdiction of and/or the customs territory of Louisiana.

B.The symbol requirements of this Section do not apply to any commercial containers containing, or any labeling of, a controlled substance intended for export from Louisiana.

C.The sealing requirements of this Section apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or any narcotic controlled substance listed in schedule III or IV, imported into, exported from, or intended for export from, Louisiana.

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

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2139 (October 2008)

Subchapter E.Recordkeeping Requirements

§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) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i) or 360b(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

Louisiana Register   Vol. 34, No. 10   October 20, 2008

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