 |
Code of Federal Regulations (Last Updated: November 8, 2024) |
 |
Title 21 - Food and Drugs |
|
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
|
SubChapter D - Drugs for Human Use |
|
|
Part 431 - CERTIFICATION OF ANTIBIOTIC DRUGS |
| Subpart A - General Provisions |
| § 431.1 - Requests for certification, check tests and assays, and working standards; information and samples required. |
| § 431.5 - Samples for sterility testing. |
| § 431.10 - Certification. |
| § 431.11 - Conditions on the effectiveness of certificates. |
| § 431.12 - Certification of antibiotic drugs after shipment in bulk containers. |
| § 431.17 - Request to provide for certification of an antibiotic drug. |
| § 431.20 - Disposition of outdated drugs. |
| Subpart B - Administrative Procedures |
| § 431.50 - Forms for certification or exemption of antibiotic drugs. |
| § 431.51 - Suspension of certification service. |
| § 431.52 - Hearings. |
| § 431.53 - Fees. |
| Subpart C - Records and Reports |
| § 431.61 - Records of distribution. |
| § 431.62 - Records retention. |
| Subpart D - Confidentiality of Information |
| § 431.70 - Confidentiality of data and information in an investigational new drug notice for an antibiotic drug. |