CFR section
21 CFR 314.81(b)(2)(ii): Other postmarketing reports
PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG · Subpart B-Applications
Key facts
| Citation | 21 CFR 314.81(b)(2)(ii) |
|---|---|
| Section | Other postmarketing reports |
| Part | PART 314-APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG |
| Subpart | Subpart B-Applications |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (ii) (a) Distribution data. Information about the quantity of the drug product distributed under the approved application, including that distributed to distributors. The information is required to include the National Drug Code (NDC) number, the total number of dosage units of each strength or potency distributed (e.g., 100,000/5 milligram tablets, 50,000/10 milliliter vials), and the quantities distributed for domestic use and the quantities distributed for foreign use. Disclosure of financial… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.