Cliff

Revised Guidelines for the Collection of Platelets, Pheresis

Criteria for Exemption of Lot Release

Physician Substitutes (Update)

Discontinuance of Pre-Licensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines

Control of Unsuitable Blood and Blood Components

Recommendations for Implementation of Computerization in Blood Establishments

Handling of Human Blood Source Materials

HTLV-I Antibody Testing

Extension of Dating Period For Storage of Red Blood Cells, Frozen

Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research These recommendations set forth a series of procedures by which an initially HBsAg reactive donor may be reevaluated by a blood establishment, providing that all other donor suitability requirements are met. The decision of whether an initially reactive donor is to be reevaluated is left to the blood establishment. Furthermore, a blood establishment may adopt more stringent procedures, provided they are. consistent with these recommendations. At each step in this procedure, the predominance of each test and the interpretation of results should be as specified, in the package insert for that kit.

Deferral of Donors Who Have Received Human Pituitary-Derived Growth Hormone

Reduction of the Maximum Platelet Storage Period tp 5 Days in an Approved Container

Plasma Derived from Therapeutic Plasma Exchange

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research In an April 1, 1983, Notice published in the Federal Register (Vol. 48, No. 64, page 14048), the Food and Drug Administration (FDA) advised that plasma derived from therapeutic exchange procedures is a biological product subject to the licensing provisions of the Public Health Service Act [42 USC 262 (a)] then collected and shipped for further manufacture into in vitro diagnostic products.

Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin / Roche; 13-cis-retinoic acid)

Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)