StacksVerified U.S. regulatory reference

21 CFR §200.51

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)All aqueous-based drug products for oral inhalation must be manufactured to be sterile.
  2. (b)Manufacturers must also comply with the requirements in § 211.113(b) of this chapter.