Navigation Links
American Academy of Ophthalmology Issues Statement on Provisions to Pharmaceutical Compounding Quality and Accountability Act
Date:5/29/2013

WASHINGTON, May 29, 2013 /PRNewswire-USNewswire/ -- As legislation to toughen oversight of compounding pharmaceuticals goes to the Senate floor for further debate, ophthalmologists are warning Congress of the unintended consequences of proposed provisions to the bill that require a named prescription for many uses of compounded drugs. While it is largely supportive of the higher safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) would impose on compounding pharmacies and manufacturers, the American Academy of Ophthalmology is seeking exemptions from Sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation. The Academy points out that there is no evidence to suggest that labeling a drug with a patient's name increases the safety of the repackaging process.

(Logo: http://photos.prnewswire.com/prnh/20130405/MM89329LOGO)

"Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients," said David W. Parke II , M.D., CEO of the American Academy of Ophthalmology. "The American Academy of Ophthalmology shares the concerns of Congress regarding the need to ensure that these products are compounded in the most sterile and safest manner possible in order to protect public health. As part of that process, however, the Academy urges the continued availability of these sight-saving medications without requiring patient-specific prescriptions, as time is often a critical element in preventing irreversible blindness. The Academy believes that compounding can be done in a safe and efficacious manner and support Congress in ensuring the safe availability of these medications for eye physicians and surgeons and the patients they serve."

About the American Academy of Ophthalmology
The American Academy of Ophthalmology, headquartered in San Francisco, is the world's largest association of eye physicians and surgeons — Eye M.D.s— with nearly 32,000 members worldwide.  Eye health care is provided by the three "O's" – ophthalmologists, optometrists, and opticians. It is the ophthalmologist, or Eye M.D., who has the education and training to treat it all: eye diseases, infections and injuries, and perform eye surgery. For more information, visit www.aao.org.  The Academy's EyeSmart® program educates the public about the importance of eye health and empowers them to preserve healthy vision. EyeSmart provides the most trusted and medically accurate information about eye diseases, conditions and injuries. OjosSanos™ is the Spanish-language version of the program. Visit www.geteyesmart.org or www.ojossanos.org  to learn more.


'/>"/>
SOURCE American Academy of Ophthalmology
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Douglas Harrington, MD Speaks at American Academy of Physicians Assistants 2013 Conference in Washington, DC
2. DelMar Pharmaceuticals to Present Clinical Trials Data for VAL-083 Brain Cancer Trial at the American Society of Clinical Oncology (ASCO) Annual Meeting
3. Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting
4. Annual Healthcare Cost for a Typical American Family is $22,030 According to 2013 Milliman Medical Index
5. Ambit Biosciences Announces Presentations of Data from Clinical Investigations of Quizartinib at the Annual Meeting of the American Society of Clinical Oncology
6. Specific Technologies Bloodstream Infection Identification Solutions Discussed at the American Society for Microbiology Conference by Award Lecturer Christine Ginocchio
7. Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting
8. Boehringer Ingelheim to Present 17 Abstracts at the Annual American Thoracic Society International Conference
9. Asmacure to Present Four Posters on Novel Pulmonary Development Compound ASM-024 at American Thoracic Society 2013 International Conference
10. AbbVie to Present Data on Investigational Anti-Cancer Compounds at American Society of Clinical Oncology Annual Meeting
11. Amgen Highlights Data To Be Presented At American Society of Clinical Oncology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released ... failing their residents by lacking a comprehensive, proven plan to eliminate ... a definitive ranking of how states are tackling the worst drug ... only four states – Kentucky , ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their ... Eyeglasses . , Millions of individuals in the United States and Canada wear eyeglasses. ... way to both correct vision and make a fashion statement. Even celebrities use glasses ...
(Date:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
Breaking Medicine News(10 mins):