LAC 51:VI.1523 – Product Containers and Their Components [formerly paragraph 6:203]

A. Specifications, test methods, cleaning procedures and when indicated, sterilization procedures shall be used to assure that containers, closures and other component parts of drug packages are suitable for their intended use. Containers for parenteral drugs, drug products or drug components shall be cleansed with water which has been filtered through a non-fiber releasing filter. Product containers and their components shall not be reactive, additive or absorptive so as to alter the safety, strength, identity, quality or purity of the drug or its components beyond the official or established requirements, and shall provide protection against external factors that can cause the deterioration or contamination of the drug.

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

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1254 (June 2002).