USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products

This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, released multiple guidances

1. Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol

2. Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components

3. Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Guidance: Testing of Glycerin and Other HighRisk Drug Components for Diethylene Glycol

The purpose of this guidance is to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazards associated with glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG).

Guidance: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires

As part of this guidance, licensed establishments will also find recommendations on how to report the implementation of the acceptable AABB donor history questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).

Guidance: Recommendations for Evaluating Donor Eligibility

In this guidance, FDA provides recommendations for evaluating donor eligibility by asking individual risk-based questions. In this guidance, FDA's revised donor deferral recommendations for individuals at high risk of acquiring human immunodeficiency virus (HIV) infection are provided to blood establishments that collect blood or blood components, including Source Plasma.