b.Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substance for which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration.
5.Transactions Reported. Acquisition/distribution transaction reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, or supply by the federal government) and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, theft, destruction or seizure by government agencies). Manufacturing reports shall provide data on material manufactured, manufacture from other material, use in manufacturing other material and use in producing dosage forms.
6.Exceptions. A registered institutional practitioner who repackages or relabels exclusively for distribution or who distributes exclusively to (for dispensing by) agents, employees, or affiliated institutional practitioners of the licensee may be exempted from filing reports under this section by applying to the ARCOS Unit of the DEA.
D.Reports of Theft or Loss. The licensee shall notify the New Orleans Field Division Office of the DEA, or its successor, and the board, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of such theft or loss. The supplier is responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to Subsection E of this Section, within one business day of discovery of such theft or loss. The licensee shall also complete, and submit to the New Orleans Field Division Office of the DEA, or its successor, and the board, DEA Form 106, or its electronic equivalent, regarding the theft or loss. Thefts and significant losses shall be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them. When determining whether a loss is significant, a licensee should consider, among others, the following factors:
1.the actual quantity of controlled substances lost in relation to the type of business;
2.the specific controlled substances lost;
3.whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
4.a pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses, and, if known;
5.whether the specific controlled substances are likely candidates for diversion; and
6.local trends and other indicators of the diversion potential of the missing controlled substance.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2145 (October 2008).
Subchapter F.Production, Distribution, and Utilization
A.A licensee located in Louisiana engaged in the manufacture of controlled dangerous substances within Schedules I, II, III, IV, or V shall prepare a complete and accurate record of the date of manufacture, the theoretical and actual yields, the quantity used for quality control, the identity of batch numbers or other appropriate identification, and the quantity of any product reworked for any reason for each manufactured batch of controlled dangerous substances or each manufactured batch of drugs in which a controlled dangerous substance was used as a raw material.
B.The licensee shall maintain manufacturing records in such a manner that the identity of a batch of controlled dangerous substances finished product can be matched to the identity of the controlled dangerous substance raw material used to make that product.
C.The licensee shall maintain any other such records as are necessary to account for all controlled dangerous substances used in the manufacturing process.
D.A building where manufacturing takes place shall be maintained in a clean and orderly manner and shall be of a suitable size, construction, and location to facilitate cleaning, maintenance, processing, and packing, labeling, or storing of legend drugs pursuant to federal and state requirements.
E.All manufacturers shall employ security precautions by ensuring controlled access to premises to avoid drug diversion, including adequate legend drug storage, alarm system security, and adequate lighting and protection of the premises.
F.Finished products, warehouse control, and distribution procedures shall include a system by which the distribution of each lot of drug can be readily determined to facilitate its recall if necessary. Records within the system shall contain the name and address of the consignee, date and quantity shipped, and the lot or control number of the drug. Records shall be retained a minimum of two years after the distribution of the drug has been completed, or for one year after the expiration date of the drug, whichever is longer.
G.To assure the quality of the finished product, warehouse control shall include a system whereby the oldest approved stock is distributed first.
AUTHORITY NOTE:Promulgated in accordance with R.S.40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2147 (October 2008).
A.A distributor licensee handling controlled substances in Schedules I or II shall maintain complete and accurate records of the original copies of all order forms received and filled for orders of controlled substances within these schedules. This file shall be kept separate from the licensee's other business and professional records and shall be kept in
Louisiana Register Vol. 34, No. 10 October 20, 2008