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:10/2/2017)... 2017 Diplomat Pharmacy, Inc. (NYSE: ... Consulting, LLC , and named its founder as Diplomat,s ... Tennessee , will operate under Diplomat ... service offerings for health care partners to include IT ... "In an interoperable world, technology delivers comprehensive ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
(Date:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation ... and home sensors for real-time monitoring of patients with ... nonprofit organization focused on disruptive health solutions for rare ... system to record and integrate behavioral, cognitive, physiological and ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to ... unique items from across the nation, this holiday-themed event will raise funds and awareness ... VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/13/2017)... ... , ... “The Journey: From the Mountains to the Mission Field”: the story ... the Philippines. “The Journey: From the Mountains to the Mission Field” is the creation ... has taught all ages and currently teaches a class of ladies at her church, ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... now treating sleep apnea using cutting-edge Oventus O2Vent technology. As many ... sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer significant ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... introduction of an innovative new design of the shoulder pad. The shoulder pad ... comfort while controlling your pain while using cold therapy. By utilizing ice and water ...
Breaking Medicine News(10 mins):