La. Admin. Code tit. 51 § VI-1501

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

Section VI-1501 - Definitions [formerly paragraph 6:191]

A. Unless otherwise specifically provided herein, the following words and terms used in this Part of the sanitary code, and all other Parts which are adopted or may be adopted, are defined for the purposes thereof as follows.

Active Ingredient-any component which is intended to furnish pharmacological activity or other direct effect in the diagnosis, care, mitigation, treatment or prevention of disease or to affect the structure of any function of the body of man or other animals. The term shall include other components which may undergo chemical change in the manufacture of the drug or be present in the finished product in a modified form intended to furnish the specified activity or effect.

Batch-a specific quantity of a drug that has uniform character and quality within specified limits, and is produced according to a single manufacturing order.

Component-any ingredient intended for use in the manufacture of drugs in dosage form, including those that may appear in the final product.

Factory-see Chapter 1, §101 of this Part.

Inactive Ingredient-any component other than an Active Ingredient present in a drug.

Lot-a batch or any portion of a batch of a drug or, in the case of a drug manufactured in a continuous process, an amount of drug product in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot and has uniform character and quality within specified limits.

Lot Numbers or Control Numbers-any distinctive combination of letters or numbers, or both from which the complete history of the manufacture, control, packaging and distribution of a batch or lot of drug can be determined.

Materials Approval Unit-any organizational element having the authority and responsibility to approve or reject components, in processing materials, packaging components and final products.

Strength-

a. the concentration of the drug substance (for example: w/w, w/v or unit dose/volume basis); and/or

b. the potency, that is the therapeutic activity of the drug substance as indicated by appropriate laboratory test or by adequately developed or clinically controlled data expressed (for example: in terms of units by reference to a standard).

La. Admin. Code tit. 51, § VI-1501

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1250 (June 2002).

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.