federal_register: 03-19289
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 03-19289 | Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma | Proposed Rule | The Food and Drug Administration (FDA) is proposing to revise the labeling and storage requirements for certain human blood and blood components, including Source Plasma, by combining, simplifying, and updating specific regulations applicable to container labeling and instruction circulars, and the shipping and storage temperatures for frozen noncellular blood components. This proposed rule would facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the "ABC Codabar" system for labeling blood and blood components. FDA is taking this action as part of its "Blood Initiative" to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the licensing and regulation of blood products. This proposed rule is intended to help ensure the continued safety of the blood supply, and to help ensure consistency in container labeling and storage temperatures. | 2003-07-30 | 2003 | 7 | https://www.federalregister.gov/documents/2003/07/30/03-19289/revisions-to-labeling-and-storage-requirements-for-blood-and-blood-components-including-source | https://www.govinfo.gov/content/pkg/FR-2003-07-30/pdf/03-19289.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to revise the labeling and storage requirements for certain human blood and blood components, including Source Plasma, by combining, simplifying, and updating specific regulations applicable to... |