X hits on this document

Word document

I.EXECUTIVE ORDERS - page 172 / 359

1591 views

0 shares

0 downloads

0 comments

172 / 359

(h).the theoretical and actual yields; and
(i).such other information as is necessary to account for all controlled substances used in the manufacturing process;
vi.the quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in Clause B.1.a.v of this Section;
vii.the quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address, and registration number of each person to whom a distribution was made;
viii.the quantity exported directly by the licensee (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation;
ix.the quantity distributed or disposed of in any other manner by the licensee (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity distributed or disposed; and
x.the originals of all written certifications of available procurement quotas submitted by other persons as required by federal law relating to each order requiring the distribution of a basic class of controlled substance listed in Schedule I or II.
b.For each controlled substance in finished form:
i.the name of the substance;
ii.each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
iii.the number of containers of each such commercial finished form manufactured from bulk form by the licensee, including the information required pursuant Clause B.1.a.v of this Section;
iv.the number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired;
v.the number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;
vi.the number of units and/or commercial containers manufactured by the licensee from units in finished form received from others or imported, including:
(a).the date and batch or other identifying number of each manufacture;
(b).the operation performed (e.g., repackaging or relabeling);
(c).the number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes for such losses, if known; and
(d).such other information as is necessary to account for all controlled substances used in the manufacturing process;
vii.the number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed;
viii.the number of commercial containers exported directly by the licensee (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and
ix.the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the licensee (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.
2.Records for Distributors. Each person authorized to distribute controlled substances shall maintain records with the same information required of manufacturers pursuant to this Section.
3.Records for Dispensers and Researchers. Each person authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to this Section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser. In addition to the requirements of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription shall also comply with federal law.
4.Records for Importers and Exporters. Each person authorized to import or export controlled substances shall maintain records with the same information required of manufacturers pursuant to this Section. In addition, the quantity disposed of in any other manner by the licensee (except quantities used in manufacturing by an importer under a registration as a manufacturer), which quantities are to be recorded pursuant to this Section; and the quantity (or number of units or volume in finished form) exported, including the date, quantity (or number of units or volume), and the export permit or declaration number for each exportation, but excluding all quantities (and number of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to this Section.

C.Records for Chemical Analysts

1.Each person authorized to conduct chemical analysis with controlled substances shall maintain records with the following information for each controlled substance:
a.the name of the substance;

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

Document info
Document views1591
Page views1594
Page last viewedTue Dec 06 08:30:46 UTC 2016
Pages359
Paragraphs18243
Words293762

Comments