Navigation Links
FDA Advises Manufacturers to Test Glycerin for Possible Contamination

The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.

At the present time, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.

DEG poisoning is an important public safety issue and FDA is exploring how supplies of glycerin become contaminated. In addition, FDA is working with a variety of manufacturing and pharmacist organizations to raise awareness of this risk and to put into place controls to ensure that this problem does not happen in the U.S. or elsewhere.

The most recent incident occurred in Panama in September 2006 and involved DEG-contaminated glycerin used in cough syrup, which resulted in dozens of hospitalizations for serious injury and more than 40 deaths. In late 1995 and early 1996, at least 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup. Between 1990 and 1998, similar incidents of DEG poisoning reportedly oc curred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths. In 1937, more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections. This incident led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation's primary statute on the regulation of drugs.

FDA reminds pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP). The guidance provides recommendations for complying with CGMP and is intended to help manufacturers, compounders, repackers, and suppliers avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.


'"/>




Related medicine news :

1. Plan for Death, Health Center Advises People
2. Health Watchdog Advises a Rethink on NHS Cancer Services
3. Sleep Apnea: Take It to Heart, Loyola Advises
4. Yogi Ram Dev Advises Youth to Exercise Self-control
5. Doctor Advises Caution Over Flu Drug
6. Clampdown On Fake Drugs Manufacturers In India – New Bill Enacte
7. Drugs Manufacturers Capitalizing On The Surge In Demand For Bone Health Care
8. German Manufacturers Find a Solution for DVT
9. Manufacturers of Infant Formula Milk Asked to Do Away With Exaggerated Nutritional Claims
10. Study Finds Glycerin to Be a Good Source for Cattle Feed
11. Life Saving Cancer Drugs – From Chicken! Possible Says Dolly’ Creatos
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/24/2016)... ... May 24, 2016 , ... ... managed services today announced a strategic partnership with Five9 (Nasdaq: FIVN), a ... Altura, one of Avaya’s largest Platinum Business Partners, is a leading provider ...
(Date:5/24/2016)... ... ... Brunswick, New Jersey: This year marks Children’s Specialized Hospital ’s 125th anniversary of ... the hospital has themed the milestone “Hats Off” and kicked off the yearlong celebration ... May 21, at Johnson Park in Piscataway, New Jersey. , “Hats Off” ...
(Date:5/24/2016)... ... 24, 2016 , ... Loma Linda University Health (LLUH) has officially broken ground ... Hospital. Over 3,000 people looked on as the shovels hit the dirt at the ... , During the program, Richard H. Hart, MD, DrPH, president, LLUH, recapped the ...
(Date:5/24/2016)... ... May 24, 2016 , ... A newly released report reveals that improving ... to trusted resources, both in face-to-face interactions and online. In “Heard, Not Judged – ... that the creative use of mobile digital devices can be an effective tool to ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... Jonathan (Jon) Otterstatter to its board of directors. Otterstatter is co-founder, president ... the development of technological innovations that lead to broad-based healthcare solutions. , “Jon ...
Breaking Medicine News(10 mins):
(Date:5/20/2016)... PUNE, India , May 20, 2016 /PRNewswire/ ... Professional Survey Report 2016 to Medical Devices of ... professional and in-depth survey on the current state ... basic overview of the industry like definitions, classifications, ... gives information about manufacturing process like Raw Material ...
(Date:5/20/2016)... ReportsnReports.com adds "Plaque Psoriasis ... research report with comprehensive information on the therapeutic ... comparative analysis at various stages, therapeutics assessment by ... administration (RoA) and molecule type, along with latest ... also reviews key players involved in the therapeutic ...
(Date:5/19/2016)... , May 19, 2016 According to a ... 2016-2017, G7 Countries, (U.S., Germany , ... Spain , and Japan )", published by ... 2021, at a CAGR of 13.9% from 2016 to 2021. ... Browse 14 market data Tables spread through 26 Pages and in-depth ...
Breaking Medicine Technology: