Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, April 24, 2014
Pharmakon Pharmaceuticals, Noblesville, IN has Received Two 483 from the FDA after Registering As an Outsourcing Facility--Registered on 1/23/14 FDA 483s issued on 3/13/14 and 4/8/14
Charles Leiter, President and CEO of Leiter’s Compounding, to be featured speaker at ASCRS Symposium and Congress; Leiter touts compounding more than 1 million sterile preparations in the last 25 years
Boston, MA (PRWEB) April 24, 2014
President and CEO of Leiter’s Compounding, Charles Leiter, is set to present on Compounding Quality Assurance at the annual ASCRS Symposium and Congress in Boston on April 25, 2014. The conference is an annual convention for top Cataract and Refractive surgeons from across the country.Charles was asked to give his widely acclaimed presentation on “Quality Assurance programs in Compounding Pharmacies” and how Leiter’s exemplifies the gold standard in the industry. He will discuss Outsourcing Facilities and the Food and Drug Administration’s role in compounding.
Leiter said, “The number one rule for doctors when ordering a compounded medication is to verify that the pharmacy is PCAB accredited. If the compounding facility is registered as an Outsourcing Facility, it should be verified that the facility is operating at cGMP. Prescribing Physicians cannot continue to rely on the lowest cost provider in the industry.”
Leiter concluded, “Compounded medications provide a unique role in improving therapeutic outcomes. When compounding is done right, it is safe and effective.”
About Leiter's Compounding
Leiter’s Compounding is a compounding facility located in San Jose, California and is an FDA registered Outsourcing Facility. Leiter’s Compounding is the industry leader in sterile and non-sterile Ophthalmic compounds and compounds over 11,000 custom prescription medications. It is currently operated by President and CEO Charles Leiter, Pharm. D. Leiter’s Compounding Pharmacy has compounded more than 1 million sterile doses in the last 25 years.
Visit Leiter’s Compounding Pharmacy online at http://www.leiterrx.com
About ASCRS
The American Society of Cataract and Refractive Surgery is an international, educational society with more than 9,000 members. Its mission is to advance the art and science of ophthalmic surgery and the knowledge and skills of ophthalmic surgeons by providing clinical and practice management education and by working with patients, government, and the medical community to promote the delivery and advancement of high-quality eye care.
Learn more about ASCRS on their website at http://www.ascrs.org
quoted from here
American Bar Association Health Law Section Seminar on Anti-Kickback Law Basics
Wednesday, April 23, 2014
Prescription Drug Abuse Workgroup Formed in Senate Health Committee
Topics: Federal regulations and Prescription drug abuse
With more than 16,000 lives lost each year due to opioid-related overdoses, the Senate Committee on Health Education Labor and Pensions (HELP) is establishing a working group to address the national prescription drug abuse epidemic. The bipartisan HELP Committee Prescription Drug Working Group will meet to discuss the challenges of prescription drug abuse, and what actions federal, state, and local governments, law enforcement, private organizations, and health care providers are taking to address the issue. The working group will also consider potential solutions, indicates a press release from the Senate HELP Committee.quoted from here
The PAWS Pet Company’s (PraXsyn) 10K was filed this afternoon.
PALO ALTO, CA, April 23, 2014 -- The PAWS Pet Company, Inc. (OTCQB: PAWS), announces that its 10K filing was submitted to the SEC this afternoon. “We would like to thank our auditors and our financial team that worked around the clock to get it done,” said Dan Wiesel, CEO of The PAWS Pet Company. “With the 10K complete, we are looking forward to filing the 10Q which will incorporate the results of our new merger partner Mesa Pharmacy”.
Our goal at the new PraXsyn to is provide medical practitioners with products and services to help them help their patients. Our Mesa Pharmacy division currently provides doctors with an alternative to oral pain medications. Mesa focuses on providing custom compounded non-narcotic, transdermal topical pain medications that are marketed to industrial health physicians and clinics. Mesa has developed a series of topical ointments, in different strengths, that provide the pain relief doctors seek.
About PraXsyn, Inc.
PraXsyn, Inc. is dedicated to providing medical practitioners with medications and services for their patients. We currently formulate transdermal creams and ointments in our compounding pharmacy, Mesa Pharmacy. These are geared to patients suffering from long-term pain associated with work place related injuries. In the near future, we will be instituting our Point of Care/In-Office Dispensing Program, and our In-Office Toxicology Testing. As the medical industry changes, PraXsyn will be there to provide different delivery systems.
For additional information go to www.praxsyn.com?
Company Contact: ir@praxsyn.com
Forward-Looking Statements
Certain statements made in this press release are forward-looking in nature (within the meaning of the Private Securities Litigation Reform Act of 1995) and, accordingly, are subject to risks and uncertainties. The actual results may differ materially from those described or contemplated and consequently, you should not rely on these forward-looking statements as predictions of future events. Certain of these risks and uncertainties are discussed in the reports we filed with the SEC.
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