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21 C.F.R. § 200.51   Aqueous-based drug products for oral inhalation.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 200—GENERAL
Subpart C—Requirements for Specific Classes of Drugs

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§ 200.51   Aqueous-based drug products for oral inhalation.

(a) All aqueous-based drug products for oral inhalation must be manufactured to be sterile.

(b) Manufacturers must also comply with the requirements in §211.113(b) of this chapter.

[65 FR 34089, May 26, 2000]

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