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
Monday, July 21, 2014
Sixth Question of the Day July 21, 2014 How many compounding pharmacies that are veterinary only are openly manufacturing and marketing illegally compounded drugs? How many compounding pharmacies that compound both human and animal drugs are openly manufacturing and makreting illegally compounded drugs?
Fifth Question of the Day July 21, 2014 Who is the contract testing lab referred to in the FDA 483 that U.S. Compounding sends their preparations to for testing? How is the contract testing lab able to return an accurate report if it is not receiving the necessary information from U.S. Compounding? Does the contracting lab indicate that it doesn't have the necessary information on its report?
read U.S. Compounding 483 report here (observation 5)
FDA Prioritizes Review of 'Abuse-Deterrent' Painkiller
Reports said the tablet, if approved, will be the first painkiller with an “abuse-deterrent formula.” Such a formula will make it harder for the drug to be crushed or liquefied so it may be snorted or injected by drug abusers.
Market Watch pointed out that the FDA only gives priority review to new drugs that propose significant and improvement to the safety and effectiveness of existing drugs.
"This is another milestone in our effort to offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology," Mark Timney, President and CEO of Purdue Pharma, was quoted saying.
Todd Baumgartner, MD, MPH, Vice President of Regulatory Affairs and chief medical officer of Purdue Pharma said that if approved by the FDA, the tablet “will be a valuable therapy for treating chronic pain.”
Read more: http://www.benzinga.com/14/07/4716634/fda-prioritizes-review-of-abuse-deterrent-painkiller#ixzz388wHoBnj
Monday, July 21, 2014 - 12:30 Reality Check: US Consumer Drug Costs Climb Ever Higher
Monday, July 21, 2014 - 12:30
Druggists and industry experts told MNI that traditional brand-name and generic drugs prices are also firming. Right alongside that, healthcare cost-sharing for prescription drugs continues to shift toward employees and others insured, by way of deductibles, co-payments, drug coverage exclusions and percentage coverage, also known as co-insurance. The moderating impact on costs in recent years from a wave of blockbuster brand-name drugs going generic, from Lipitor
to Lexapro, has faded, they said.
A pharmacy benefit management company forecasted accelerating prescription-drug cost increases in 2014 for both consumers and insurers.
continue to read here
Reality Check: US Consumer Drug Costs Climb Ever Higher
By Claudia Hirsch
--Specialty Drug Costs Biggest Driver of Drug Price Inflation --Traditional Brand-Name and Generic Drug Prices Also Rising --Consumers Face Higher Deductibles, Co-Payments and Co-Insurance Percentages
NEW YORK (MNI) - Astronomical prices of specialty drugs that treat hepatitis C, rheumatoid arthritis, cancer and other diseases are leading overall U.S. consumer prescription drug costs higher, according to pharmacists, pharmacy benefit managers and industry experts.--Specialty Drug Costs Biggest Driver of Drug Price Inflation --Traditional Brand-Name and Generic Drug Prices Also Rising --Consumers Face Higher Deductibles, Co-Payments and Co-Insurance Percentages
Druggists and industry experts told MNI that traditional brand-name and generic drugs prices are also firming. Right alongside that, healthcare cost-sharing for prescription drugs continues to shift toward employees and others insured, by way of deductibles, co-payments, drug coverage exclusions and percentage coverage, also known as co-insurance. The moderating impact on costs in recent years from a wave of blockbuster brand-name drugs going generic, from Lipitor
A pharmacy benefit management company forecasted accelerating prescription-drug cost increases in 2014 for both consumers and insurers.
continue to read here
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