Description
FDA is issuing this policy guide to describe the circumstances in which the agency may initiate regulatory action regarding the marketing of approved new drugs and antibiotics that have been subjected to further processing or other manipulation, such as repacking, that is not covered by an approval under sections 505 or 507. (See U.S. v. Baxter Healthcare Corp., et al., CCH 38,166 Docket Nos. 89-2087/8 (7th Cir. May, 1990)).
Scope & Applicability
Product Classes
3Products requiring sterility assurance and ISO 5 environments; Products requiring sterility testing and specific environmental controls.; products requiring sterility and BUD labeling; products requiring sterility and stability testing; Products requiring sterility or container-closure integrity tests
Regulatory Action Regarding Antibiotic Drug Products
Subject of the benefit-risk assessment guidance
Stakeholders
2Entity responsible for submitting NDINs
Allowed value for reporter qualification
Identified Hazards
Hazards
1Environmental factors affecting biological products
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
- CPG Sec. 400.500 Identical or Similar Product Names (Status: Final)
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Status: Final)