Navigation Links
Three Compounders Receive Warning against Selling Inhaled Drugs

The U.S. Food and Drug Administration has warned three pharmacy compounders to stop selling unapproved inhaled drugs, on Thursday.//

The FDA sent warning letters to Reliant Pharmacy Services, RoTech Healthcare, and CCS Medical instructing these companies to halt the manufacture and distribution of several thousands of doses of compounded inhalation drugs which treat conditions like asthma and emphysema.

Steven Galson, director of the FDA's Center for Drug Evaluation and Research said, "Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk. To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible."

The FDA has said that it suspects that some of the compounders that make inhaled drug products may turn out millions of doses of the products per year which could "go well beyond traditional compounding."

The FDA said, "These compounded drugs often simply copy FDA-approved, commercially available drugs, and any differences from FDA-approved drugs do not appear to be related to patients' medical needs."

The agency noted that many drugs can be legally compounded. These are often drugs that are typically prepared for patients with special needs like allergies to an ingredient in an FDA-approved drug.

'"/>




Page: 1

Related medicine news :

1. One in Three Heart Attack Patients Have No Chest Pains
2. Nobel Prize for Medicine shared by Three scientists
3. Three Tropical Parasites Genetic Code Unravelled
4. The Future Pattern Of Weight Gain Is Laid As Early As Three Years Of Age
5. Smoking Increases The Risk Of Heart Disease By Three Times
6. Three Sisters Have One Baby and Make History
7. Three In One Ultrasound Probe For 3-D Imaging Of Heart And Tissue Destruction Developed
8. Three More Bird Flu Cases Reported By China
9. Three meals daily Keeps Keralas elderly Healthy
10. Three dimensional structure of apolipoprotein revealed
11. Delhi Witnessed 34 Meningitis Deaths In Three Months
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/23/2016)... ... ... Edward D. Buckingham, M.D . is excited announce that he has been ... out by the National Consumer Advisory Board to honor excellence in medicine. Only doctors ... award. , The National Consumer Advisory Board (NCAB) is a private organization created to ...
(Date:5/23/2016)... ... May 23, 2016 , ... The Clinical ... representatives from the Japan PMDA, US FDA, industry and academia at the ... help format data from clinical trials so that it can be shared and ...
(Date:5/23/2016)... ... May 23, 2016 , ... ComplianceOnline, the leading governance, ... host medical device summit on September 15 and 16, 2016 in San Diego, ... former FDA office bearers will be one of the largest gatherings of medical device ...
(Date:5/23/2016)... ... May 23, 2016 , ... In Pursuit of Balance (IPOB) co-founders Jasmine Hirsch ... operations at the end of 2016. , “We created IPOB to change the ... we look back on what we have achieved, we’re gratified by the response of ...
(Date:5/23/2016)... ... 2016 , ... Bio-Optronics, Inc. is delighted to announce recent ... recent and anticipated growth. , Max Elbaz was appointed as Vice President, Sales ... Max joined the Bio-Optronics team in March. His areas of expertise include international ...
Breaking Medicine News(10 mins):
(Date:5/20/2016)... , May 20, 2016 ... Therapeutic Antibody Technologies, Insulins, Growth Hormones, Recombinant Coagulation ... Biological Drugs - This New Study Reveals Selling ... Ahead ,What is the future ... the latest technological and commercial analysis. Staying ahead ...
(Date:5/19/2016)... PARIS , May 19,2016 ... Activities at Digestive Disease Week Meeting and 91 ... Society Mauna Kea Technologies (Euronext: MKEA, ... laser endomicroscopy platform, today announced that its Cellvizio ... meeting focused on gastroenterology during the month of ...
(Date:5/19/2016)... , May 19, 2016 BioLight ... an emerging global ophthalmic company focused on the discovery, ... address ophthalmic conditions, announced today that it has obtained ... ) for the manufacturing, distribution, marketing and sales ... treatment of dry eye syndrome (DES) and other ophthalmic ...
Breaking Medicine Technology: