Title 21--Food and Drugs


CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 431--CERTIFICATION OF ANTIBIOTIC DRUGS


TEXT PDF431.1 Requests for certification, check tests and assays, and working standards; information and samples required.
TEXT PDF431.5 Samples for sterility testing.
TEXT PDF431.10 Certification.
TEXT PDF431.11 Conditions on the effectiveness of certificates.
TEXT PDF431.12 Certification of antibiotic drugs after shipment in bulk containers.
TEXT PDF431.17 Request to provide for certification of an antibiotic drug.
TEXT PDF431.20 Disposition of outdated drugs.
TEXT PDF431.50 Forms for certification or exemption of antibiotic drugs.
TEXT PDF431.51 Suspension of certification service.
TEXT PDF431.52 Hearings.
TEXT PDF431.53 Fees.
TEXT PDF431.61 Records of distribution.
TEXT PDF431.62 Records retention.
TEXT PDF431.70 Confidentiality of data and information in an investigational new drug notice for an antibiotic drug.





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