Navigation Links
FDA Advises Manufacturers to Test Glycerin for Possible,Contamination

Glycerin Contaminated with Diethylene Glycol (DEG) Remains a Potential Health Hazard to Consumers

ROCKVILLE, Md., May 4, 2007-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 d eaths. 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 occurred 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.

For a copy of the guidance, go to http://www.fda.gov/cder/guidance/7654fnl.htm

Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


'"/>




Related medicine technology :

1. NIEHS Researchers Identify Enzyme Critical in DNA Replication
2. Velcade (bortezomib) for Injection Based Induction Therapy Delivered High Post-Transplant Complete Remission Rate, a Critical Marker for Increased Overall Survival
3. Critical Therapeutics Announces the Publication of Data for ZyfloCR (Zileuton) Extended-Release Tablets in the Journal of Asthma
4. Critical Therapeutics Announces the Publication of New Preclincial HMGB1 Data in Nature Immunology
5. Data Show SuperGens Multi-Targeted Tyrosine Kinase Inhibitor Suppresses Critical Double-Stranded DNA Repair Protein, Rad51
6. MIV Therapeutics Announces Pivotal Test Results Further Validating Company Stent Coatings Meet Critical FDA Fatigue Guidelines
7. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
8. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting Systems Success in Mouse Model Reported in Cancer Cell
9. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
10. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
11. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)...   Acsis , a leading provider of supply ... research and advisory firm IDC has named it a ... Pharmaceutical Track and Trace Software 2016 Vendor Assessment (doc ... of the capabilities and business strategies of 10 vendors ... Logo - http://photos.prnewswire.com/prnh/20160427/360791LOGO ...
(Date:4/27/2016)... 27, 2016  Hologic, Inc. (Nasdaq: ... for the fiscal second quarter ended March 26, ... $0.24 increased 41.2%, and non-GAAP diluted EPS of ... 5.8% on a reported basis, and 6.3% on ... posted another good quarter, highlighted by 14.6% growth ...
(Date:4/27/2016)... 27, 2016 Elekta today announced ... will be the focal point of seven scientific presentations ... Society for Radiotherapy & Oncology, taking place April 29 ... state-of-the-art radiotherapy system and a high-field MRI scanner with ... the patient,s anatomy in real time. The MR-linac is ...
Breaking Medicine Technology:
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... ... raising awareness for Duchenne muscular dystrophy, and funding for Duchenne research, participated in ... efficacy of the Sarepta Therapeutic’s novel Duchenne drug eteplirsen. The meeting at the ...
(Date:4/29/2016)... ... April 29, 2016 , ... Pro3rd Grunge is a package of 30 grunge-themed ... to introduce people, characters, and locations without having to set a single keyframe. Choose ... many more design components. Simply select a preset and drag it into the ...
(Date:4/29/2016)... ... April 29, 2016 , ... Orthodontics Limited, one of the ... and Dr. Middleberg, were asked by Invisalign to present an “Ask ... seminar, titled “Advancing the Biomechanics of Invisalign Clear Aligners,” Dr. Gemmi and Dr. ...
(Date:4/28/2016)... ... April 28, 2016 , ... Sanford ... this week. A group of researchers and leaders from Sanford Health were selected ... Medicine and Its Cultural Impact ” and receive the 2016 Pontifical Key Innovation ...
(Date:4/28/2016)... ... ... Head Over Heels Athletic Arts’ gymnast, Brooklyn Varize, has qualified to compete in ... University of Montana on April 28-May 1. Varize will compete on Saturday against the ... qualify, Varize needed to place top seven all-around in her respective age group. Varize ...
Breaking Medicine News(10 mins):