The US Requirement for Sterility in Aqueous Inhalations

In May 2000, the FDA amended its regulations requiring that all aqueous-based products for oral inhalation be manufactured sterile. The FDA rationalized that such was the danger of nonsterility to patients with cystic fibrosis, coupled with the fact that most aqueous inhalations were already being manufactured as sterile, that a rule might as well be put in place.

The contradiction inherent in this rule is that the systems for delivery of inhalation products to the patients (nebulizers) are not required to be sterile.

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