Description
The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. Thisguidance documentaddresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.
Scope & Applicability
Product Classes
3specific labeling for the amount and strength of heparin
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Subject of the guidance document regarding labeling and safety testing.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2label must identify animal species such as porcine
Determines the lead FDA center for combination products
Identified Hazards
Hazards
1Safety concern addressed by labeling and testing recommendations.
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See Also (8)
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- Rheumatoid Arthritis: Developing Drug Products for Treatment (Status: Draft)
- Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (Status: Draft)
- ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (Status: Draft)
- Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (Status: Draft)
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