The Law of Compounding Medications And Drugs

Thursday, January 5, 2017

Agenda - California State Board of Pharmacy

www.pharmacy.ca.gov/meetings/agendas/2017/17_jan_enf.pdf

15 hours ago - Enforcement and Compounding Committee Meeting. January 4, 2017. DATE: January 4, 2017. TIME: 9:00 a.m.. PLACE: DCA Headquarters, First Floor Hearing ...

meningitis-etc: Judge Blocks Subpoena For Victims' Records

meningitis-etc: Judge Blocks Subpoena For Victims' Records: By Walter F. Roche Jr. An attempt by the man charged in the deaths of 25 patients to use some of those patients records from a civil case...

meningitis-etc: Judge Limits Outbreak Testimony in Cadden Trial

meningitis-etc: Judge Limits Outbreak Testimony in Cadden Trial: By Walter F. Roche Jr. Federal prosecutors will not be allowed to present evidence of specific fungal meningitis outbreak deaths unless ...

Wednesday, January 4, 2017

BREAKING: Drug companies will be fined for overcharging 340B hospitals

The Obama administration has finalized a rule that imposes fines on drug companies that overcharge hospitals and clinics for medication purchased under the government's 340B drug discount program. READ MORE

Teva's $520M bribery settlement with the feds sparks shareholder lawsuit

Greek prosecutors raid Novartis offices, disclose wide-ranging probe into bribery allegations

The FDA's promo police slap four more pharmas in year-end enforcement spree

Compounding Pharmacies and Those Special Interest Groups that Support Them offer to help Vice President-elect Mike Pence and seek to undo advances made by FDA to prevent another NECC tragedy and while major fraud prosecutions continue including those that targeted Tricare and Veterans

http://www.nhia.org/documents/20161212-DQSATrumpTransitionLetter.pdf

Toll on Tennesseans Challenges BlueCross to Tackle State's Opioid ...

Chattanooga Magazine-38 minutes ago

BlueCross is also using its pharmacy and medical data to identify providers who appear to prescribe opioids at a higher rate than statewide benchmarks and to

Fred's Acquiring 865 Rite Aids

RIS News (blog)-20 hours ago

The transaction, if approved, is targeted to close during the first half of 2017 and will position Fred's Pharmacy as the third-largest drugstore chain in the United ...

Are pharmaceutical supply chains responsible for the opioid ...

Supply Chain Dive-Jan 3, 2017

Cardinal Health, which supplies drugs to 25,000 pharmacies and 70,000 hospitals nationwide, agreed to pay the Department of Justice $44 million to settle civil ...

Former Saginaw doctor sued in fatal crash case

ABC 12 News (press release)-15 hours ago

The doctor who prescribed the man's medication and the pharmacy are being sued for their role in the accident. It was back in March 2013 when a pick-up truck ...

What pharmacists do at NHS 111

The Pharmaceutical Journal-22 hours ago

O'Sullivan is the only pharmacist in charge of an NHS 111 service. He also sits on the National Integrated Pharmacy working group of NHS England (the body ...

Public's view sought on NHS' 111 service
Alton Herald-17 hours ago

View all

Morrisey Lawsuit Alleges Small-Town Pharmacy Fueled Prescription...

Morrisey Lawsuit Alleges Small-Town Pharmacy Fueled Prescription ...

The Parsons Advocate-21 hours ago

CHARLESTON — West Virginia Attorney General Patrick Morrisey's lawsuit against a Boone County pharmacy alleges it provided nearly 10 million doses of ...

Pharmacy seeks to dismiss suit alleging malpractice

Madison County Record-14 hours ago

Home Pharmacy Services, doing business as Omnicare of Belleville, filed a motion to dismiss the suit on Dec. 12 through attorneys James Abbott and Elizabeth ...

Pharmacy benefit managers could be in legislative crosshairs

Watchdog.org-17 hours ago

The first ones were formed in the 1970s to serve as intermediaries between the health plans that covered pharmaceutical prescriptions and the pharmacies that ...

Radiopharmacies Celebrate the New Year with Long-Awaited FDA ...

JD Supra (press release)-22 hours ago

With regard to compounding, that constitutes “minor deviation” and repackaging, the guidance states that the FDA will not take action for violations of the FD&C ...

Valley doctor indicted in $100 million Tricare fraud case - AZCentral.com

www.azcentral.com/story/money/business/health/2017/01/01/.../95969880/

23 hours ago - Federal prosecutors said the scheme involved prescribing "compounded" drugs such as pain, scar and migraine creams to military families covered by Tricare, ...

Proposed Changes to USP 797 and 795 Rules for Compounding

onlinecompliancepanel.com/webinar/.../JANUARY-2017-ES-WORLDCONALERT

12 hours ago - USP standards serve as a professional guide for compounding practices and medication administration. USP standard 797 will be finalized in February 2018 ..

Trial Begins for Former Compounding Pharmacy Executive Blamed for ...

www.necn.com/.../Barry-Caden-New-England-Compounding-Center-Trial-40963656...

35 mins ago - The trial for a former executive at a Massachusetts compounding pharmacy blamed for national meningitis outbreak that killed more than 60 people in 2012 is ...

West Virginia reaches $3.5M settlement with drug wholesaler

West Virginia officials have reached a $3.5 million settlement with a wholesaler accused of flooding the state with millions of prescription pain pills. READ MORE

Could delayed replacement save key parts of Obamacare?

Republicans who have long called for repealing the Affordable Care Act are pushing for more transition time and delays as they realize the massive consequences of their proposals. READ MORE

FDA Law Blog: January 03, 2017 In Time for the Holidays, FDA Grants PCPC’s Petition for Lead Levels in Lipstick and Externally Applied Cosmetics By Riëtte van Laack –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/01/in-time-for-the-holidays-fda-grants-pcpcs-petition-for-lead-levels-in-lipstick-and-externally-applie.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

Tuesday, January 3, 2017

FDA nails a third Wockhardt plant with a warning letter

January 3, 2017 | By Eric Palmer

The FDA sidelined U.S. biotech Cempra’s new generation antibiotic with a complete response letter last week over safety concerns, but also because of issues it has with the Wockhardt plant making the API for it.

FDA slaps warning letter on Crescita plant sold by Valeant

United States: Fraud On The FDA Doesn't Fly Under The FCA Either

Reed Smith

Ever since Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), held that state-law claims alleging fraud on the FDA are preempted, plaintiffs have been attempting to find some other way...

FDA Announces Implementation of GFI #213, Outlines Continuing Efforts to Address Antimicrobial Resistance

Today, the U.S. Food and Drug Administration announced that it has completed the implementation of Guidance for Industry #213, a process begun in 2013 to transition antimicrobial drugs with importance in human medicine (medically important antimicrobials) that are used in the feed or drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for production (e.g., growth promotion) purposes.

Twelve Indicted in More than $100 Million Health Care Fraud involving prescribing compounded drugs

Twelve Indicted in More than $100 Million Health Care Fraud

Contemporary Clinic-2 hours ago

According to federal prosecutors, the scheme involved prescribing compounded drugs such as pain, scar, and migraine creams to military families covered by ...

FDA Pushes for Removal, Addition of Substances to 503A Bulks List

Specialty Pharmacy Times-9 hours ago

The FDA has created a new proposed rule that adds 6 bulk drug substances to an existing list of substances that can be used in compounding. It has also ...

Texas sues feds over confiscated execution drugs

Dallas News-2 hours ago

As execution drugs have become harder to obtain, the state has turned to compounding pharmacies to make them, has sought drugs from foreign providers and ...

Man Blamed for National Meningitis Outbreak Heads to Court

Man Blamed for National Meningitis Outbreak Heads to Court | KXVA ...

www.fox15abilene.com/news/health/man-blamed-for-national...to.../381613864

4 hours ago - A former executive at a Massachusetts compounding pharmacy blamed for a national meningitis outbreak is headed to court.

Electronic Drug Product Reporting for Human Drug Compounding .

Electronic Drug Product Reporting for Human Drug Compounding ...

regulations.justia.com/regulations/fedreg/2017/01/03/2016-31789.html

9 hours ago - Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; .

Mesa Doctor Charged In $100 Million TRICARE Compounding Drug Fraud Scheme

Mesa Doctor Charged In $100 Million TRICARE Fraud Scheme ...

https://arizonadailyindependent.com/.../mesa-doctor-charged-in-100-million-tricare-fr...

17 hours ago - CMGRX primarily marketed compounded pain and scar creams to current and former U.S. military members and their families on behalf of various compounding ...

Virginia says drugs are safe, execution should continue

Virginia says drugs are safe, execution should continue | News OK

newsok.com/virginia-says-drugs-are-safe-execution-should-continue/.../1142031

39 mins ago - RICHMOND, Va. (AP) — The drugs from a secret compounding pharmacy that Virginia plans to use in a lethal injection this month were appropriately prepared ...

"The trials are expected to shed new light on an opaque corner of U.S. health care: thousands of compounding pharmacies that make drugs but aren’t subject to the same federal quality standards as pharmaceutical companies."

quoted from

Trials of Compounding Pharmacists Facing Murder Charges Draw ...

www.wsj.com/.../trials-of-compounding-pharmacists-facing-murder-charges-draw-closer

Trials of Compounding Pharmacists Facing Murder Charges Draw Closer Wall Street Journal · 4 hours ago

Trials of Compounding Pharmacists Facing Murder Charges Draw Closer

Wall Street Journal · 4 hours ago

Monday, January 2, 2017

Oklahoma Board of Pharmacy Minutes from September 28, 2016 Meeting

September 28, 2016

Oklahoma Board of Pharmacy Meeting Scheduled for January 25, 2017

Troubling Pharmacies: series links

Staunton News Leader-9 hours ago

Under the story links you'll find information about how to check the board's case ... Augusta Health officials explain the corrective process after state inspectors ...

End bait-switch that allows pharmacy benefits to go poof

Orlando Sentinel-Jan 1, 2017

More than 13 million Floridians (about 65 percent of our population) live with at least one chronic health condition. Although it's no secret that chronic conditions ...

Inspections a source of anxiety for big, small pharmacies

Washington Times-10 hours ago

(AP) - Ray's Health Mart Pharmacy in Staunton has a clean inspection record. Danny Ray, the pharmacist-in-charge, also has no history of violations as a

[PDF]Federal Register/Vol. 82, No. 1/Tuesday, January 3, 2017/Notices

https://www.gpo.gov/fdsys/pkg/FR-2017-01-03/pdf/2016-31789.pdf

4 hours ago - FDA–2013–N–1428]. Electronic Drug Product Reporting for. Human Drug Compounding. Outsourcing Facilities Under Section. 503B of the Federal Food, Drug, ...

Sixth Circuit allows lethal injection drug makers to remain anonymous

JURIST-Dec 31, 2016

... protocols to evaluate drugs manufactured or compounded by an anonymous source," thereby preventing a demonstration of potential harm caused by the use

Trials To Watch In 2017

Law360 (subscription)-6 hours ago

Executives for the New England Compounding Center are facing second-degree murder charges for selling contaminated vials of an injectable... To view the full ...

"The indictment also alleged that marketing group employees would contact Tricare's pharmacy-benefits consultant, Express Scripts, to find out whether certain drugs were covered. These employees then would adjust the prescriptions to maximize payments from Tricare "without any regard for the medical necessity for the prescriptions.'"

quoted from http://www.usatoday.com/story/news/nation-now/2017/01/01/phoenix-doctor-indicted-100-million-fraud-case/96072826/

Pharmacist heads to trial over fatal meningitis outbreak
WDEF News 12-1 hour ago