BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 23/09/1997

Sterility Requirements for Inhalation Solution Products

The Food and Drug Administration (FDA) is proposing to amend its regulations to require that all inhalation solutions for nebulization be sterile. Inhalation solutions for nebulization, as the term is used in this document, refers to inhalation solutions administered as a fine aqueous mist created by an atomizer or nebulizer. Currently, approximately half of these products are manufactured to be sterile. Based on reports of adverse drug experiences from contaminated nonsterile inhalation solutions for nebulization and recalls of these products, FDA is taking this action to ensure the safety and effectiveness of these solutions.

Source: Federal Register — Food and Drug AdministrationOpen original release →