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Thursday, August 31, 2017

Opioid legislation in Connecticut highlighted on International ...

Meriden Record-Journal-13 hours ago
... aims to increase the destruction of unused medication by home health care ... By prescribing electronically, there is less potential for fraud and more data to ...

Arizona attorney general files lawsuit against Chandler opioid ...

AZFamily-16 hours ago
Attorney General Mark Brnovich today filed an Arizona Consumer Fraud ... The 

Daphne pain doctor pleads guilty to healthcare fraud, money ...

AL.com-11 hours ago
Dr. Raasan Tarabein (pictured right) and his wife, Laila Tarabein (pictured left). Laila testified in Tarabein's arraignment hearing in U.S. District Court on Monday ...

Pharmacists say Medicaid cuts could force them to close their doors

Springfield News Sun-18 hours ago
Katie Wedell Pharmacist Bob Curlis works at Sidney Hometown Pharmacy in Sidney, Aug. 29, 2017. He said he may have to stop serving Medicaid patients if ...

Janesville pharmacist sentenced for Medicare/Medicaid fraud

Madison.com-11 hours ago
A Janesville pharmacist was sentenced to two years in prison for making false reimbursement claims to Medicare and Medicaid, totaling about $740,000.

Practical Considerations for a Health System—Based 503B Sterile ...

www.pharmacypracticenews.com/Monographs-and...Compounding.../44438
14 hours ago - In today's health care marketplace, there is considerable interest in centralizingcompounded sterile preparations. Implementing a 503B outsourcing facility .

FDA Marks Down Compounder for Aseptic Shortfalls | 2017-08-31 ...

www.fdanews.com/articles/183310-fda-marks-down-compounder-for-aseptic-shortfalls
5 hours ago - A Tennessee compounding pharmacy fell short of standards for aseptic production in making sterile drugs, the FDA said. In a Form 483 issued after an ...

Question of the Day August 30, 2017 Why are so many salespeople willing to take the blame in the compounding pharmacy fraud scheme rather than pointing the finger at the pharmacy, pharmacists and others involved the scheme?


08/31/2017 07:08 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Physic Candy – Curve, a product promoted and sold for weight loss on various websites, including www.physic-candy.com, and possibly in some retail stores.
08/31/2017 07:08 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Physic Candy – Define, a product promoted and sold for weight loss on various websites, including www.physic-candy.com, and possibly in some retail stores.

New Steps To Strengthen FDA’s Inspection And Oversight Of Drug Manufacturing

New Steps To Strengthen FDA’s Inspection And Oversight Of Drug Manufacturing

The Compounding Conundrum: How Insufficient Delineation of Regulatory Responsibility Has Created a Need for State and Federal Compounding Drug Law Reform Stacy L. Worthy, Shruti R. Kulkarni, Daniel C. McClughen

The Compounding Conundrum

Food and Drug Law Journal | Volume 72 | Number 3

Upcoming Conference at FDLI

Drug Quality Security Act Conference

November 15, 2017 I Washington, DC

Human Drug Compounding Outsourcing Facility Fees FOR INDUSTRY

2017-08-23 | www.fda.gov/forindustry/userfees/humanoutsourcingfacilityuserfee/default.htm
... Human Drug Compounding Outsourcing Facility Fees. ... Q1: Are reductions in human compounding fees available to small businesses? A1: Yes. ...

The Complexities of Compounding - CDER SBIA Chronicles ... DRUGS

2017-05-24 | www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance/ucm554014.htm
... of Bulk Drug Substances That Can Be Used To Compound Drug Products ... of bulk drug substances that can be used in compounding under section ...

What's next for the FDA Relating to Compounding

"What’s Next?

FDA’s efforts have significantly impacted public health, as evidenced by corrective actions implemented by compounders and voluntary recalls of potentially contaminated or poor quality drugs. Policy documents and outreach have helped FDA clarify applicable regulatory requirements. Though progress is being made, there is still a lot of work to be done. Serious adverse events and product quality defects associated with compounded drugs continue to be reported. Follow-up inspections still show that many compounders are failing to comply with applicable requirements of the law.
FDA will continue to oversee drug compounders and will take regulatory action when appropriate to continue to protect public health. The agency is committed to building on its progress to protect patients and will continue to inspect and enforce the law against compounders, develop policy, hold advisory committee meetings, collaborate and coordinate with states, and communicate with stakeholders."

quoted from 

The Complexities of Compounding - CDER SBIA Chronicles and Audio Podcast

Recall of Veterinary Drug

Recall of Compounded Veterinary Product

VeterinaryVeterinaryView Details
cyclosporine 1%Class IILot # 20170131-03Lack of Sterility Assurance for compounded veterinary product.MedPark Pharmacy, LLC
2002 Medical Pkwy Ste 170 
Annapolis, MD 21401-3276

Recall of sterile compounded animal drugs

08/30/2017Hospira, Inc.  Vancomycin Hydrochloride for Injection  Particulate MatterHospira, Inc.

FDA observed vermin and a dead spider in a compounding pharmacy in Texas

"Vermin was observed present in areas immediately adjacent to your production area. A dead spider was observed in HEPA filter located in the ceiling of the ISO 7 clean room, approximately 10 feet from the ISO 5 laminar air flow (LAF) hood used for sterile drug processing."

See FDA 483

Wednesday, August 30, 2017

Fentanyl drives another record year of Ohio overdose deaths

ABC News-7 hours ago
Compounding the problem was the appearance of drugs like carfentanil, an opioid so powerful it's used to sedate elephants, and the lacing of drugs like cocaine ...