21st Century Cures Act reboot keeps controversial changes for FDA

With the fast-tracked reboot of the 21st Century Cures Act, drug and device manufacturers may be about to win long sought revisions to the way the Food and Drug Administration approves and regulates their products.  READ MORE

Cures Act would give pass to lowest-quality Medicare Advantage plans 

If Congress passes the 21st Century Cures Act, the federal government would be barred from axing the worst performers in Medicare Advantage through 2018.  READ MORE

Trump's CMS pick is viewed as both patient advocate and foe

Verma has supported charging premiums to individuals above and below the poverty line and freezing beneficiaries out of coverage if they don't pay. But she could prove to be a knowledgeable ally to states looking to better control their Medicaid dollars.  READ MORE

In A Stunning Development, Congress Drops A Billion Dollars On The Heroin Crisis

http://www.msn.com/en-us/news/politics/in-a-stunning-development-congress-drops-a-billion-dollars-on-the-heroin-crisis/ar-AAkRXDq?li=AA5a8k&ocid=spartandhp

Trump pledged to protect Medicare; his choice for health secretary has other ideas

http://www.msn.com/en-us/news/politics/trump-pledged-to-protect-medicare-his-choice-for-health-secretary-has-other-ideas/ar-AAkVLCQ?li=AA5a8k&ocid=spartandhp

Save the date: Pharmacy Connect 2017

Australian Journal of Pharmacy (registration) (blog)-Nov 28, 2016

Following on from the success of the inaugural Pharmacy Connect in 2016, The Pharmacy Guild of Australia, NSW Branch has announced the 2017 event will ...

Form D Filing: Legacy Pharmacy $120000 Fundraising. Joshua ...

Frisco Fastball-6 hours ago

Legacy Pharmacy, Llc, Limited Liability Company just filed form D regarding $120,000 equity financing. The date of first sale was . Legacy Pharmacy was able to ...

New York pharmacy owner gets prison for massive opioid pill scheme

New York pharmacy owner gets prison for massive opioid pill scheme

Metro.us-4 hours ago

NEW YORK (Reuters) - The owner of two now-defunct New York City pharmacies was sentenced to four years in prison on Tuesday for engaging in what ...

Tricare patients' deadline to switch pharmacy is Dec. 1

Military Times-5 hours ago

Tricare patients who now use CVS should transfer their prescriptions to another pharmacy in the Tricare network, because if you have a prescription filled at a ...

For January execution of Ricky Gray, Virginia plans to use drug ...

Virginian-Pilot-7 hours ago

Furthermore, Virginia would become the first state in the country to use a version of Midazolam manufactured by a “compounding pharmacy” – one whose ...

Stocks mixed as energy companies fall, health care rises

News On 6-4 hours ago

Tom Price, a leading critic of President Barack Obama's sweeping health care law, to head the Department of Health and Human Services, according to a.

GOP could repeal, before replacing, Obamacare

WMTW Portland-4 minutes ago

Congress may vote to repeal President Barack Obama's health care law before coming up with a replacement, House Majority Leader Kevin McCarthy said ...

80 Percent Of Americans Want Health Law Changed Or Replaced ..

80 Percent Of Americans Want Health Law Changed Or Replaced ...

Kaiser Health News-5 hours ago

President-elect Donald Trump is eager to change the nation's health care law – and most Americans are eager for some changes, a new Gallup Poll released ..

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Poll: Voters want changes to Obamacare

Washington Examiner (blog)-Nov 28, 2016

Fifty-three percent of surveyed Americans say they disapprove of the major healthcare law, and only 42 percent said they approve, Gallup found. (AP Photo/J.

Poll: Most Americans Ready for Change in Obamacare
Newsmax-21 hours ago

View all

5 Things To Know About Rep. Tom Price's Health Care Ideas NPR-3 hours ago

5 Things To Know About Rep. Tom Price's Health Care Ideas
NPR-3 hours ago

Why Trump's Obamacare-Hating Health Pick Has an Uphill Battle
In-Depth-Vanity Fair-4 hours ago

Did the Pharmaceutical Industry Kill Prince?

Digital Music News-Nov 22, 2016

Then again, the drug Prince was taking — Fentanyl — was totally legal. Now, federal investigators are looking into the practices of a pharmaceuticals company ...

Bernie Sanders attacks 21st Century Cures Act, pharmaceutical ...

STAT-8 minutes ago

Bernie Sanders attacks the 21st Century Cures Act and pharmaceutical industry ... “The greed of the pharmaceutical industry has no limit, and this bill includes ...

Bernie Sanders sees new medical research bill as $6.3 billion pharmaceutical 'handout' | Health Care

Dallas News‎ - 4 hours ago

"It's time for Congress to stand up to the world's biggest pharmaceuticalcompanies, not give them more ...

Roche to sell U.S. plant to Patheon, saving about 200 jobs

Roche to sell U.S. plant to Patheon, saving about 200 jobs

Pharma has 'hijacked' 21st Century Cures bill, Elizabeth Warren says

Pharma has 'hijacked' 21st Century Cures bill, Elizabeth Warren says

'Cures' bill gains momentum with wish-list provisions

'Cures' bill gains momentum with wish-list provisions 

The 21st Century Cures Act, an already sweeping package of legislation, appears to be getting a last-ditch push from several industry and advocacy groups that are counting on using the bill to get new traction on measures that have stalled.  READ MORE

Wockhardt woes grow as U.K. sterile plant rebuked by FDA warning letter

Wockhardt woes grow as U.K. sterile plant rebuked by FDA warning letter

10 Questions: Rep. Tom Price, MD (R-Ga.)

http://www.medpagetoday.com/Surgery/Orthopedics/44217

Trump picks anti-Obamacare Price to head Health and Human ...

USA TODAY-39 minutes ago

WASHINGTON — Making a major appointment on social policy, President-elect Donald Trump said Tuesday he will nominate Georgia congressman Tom Price ...

Tom Price, Obamacare Critic, Is Said to Be Trump's Choice for ...
New York Times-11 hours ago

Trump Taps Rep. Tom Price For Health And Human Services ...
Opinion-Daily Caller-1 hour ago

Donald Trump Chooses Tom Price as Health Secretary
In-Depth-Wall Street Journal-2 hours ago

Sources: Tom Price close to being named top health official in ...
Blog-Atlanta Journal Constitution (blog)-15 hours ago

Trump names Rep. Tom Price as next HHS secretary
In-Depth-Washington Post-11 hours ago

The owner of Atlantic Pharmacy has been held in a tiny jail cell in downtown Miami since his arrest in early November on charges of conspiring to fleece $37

Dwyane 'The Rock' Johnson's former South Florida home could be ...

Curbed Miami-22 hours ago

The owner of Atlantic Pharmacy has been held in a tiny jail cell in downtown Miami since his arrest in early November on charges of conspiring to fleece $37 ...

New Research: PBMs Save $941 Per Person Annually

Yahoo Sports-20 hours ago

28, 2016 /PRNewswire-USNewswire/ -- Pharmacy benefit managers (PBMs) are saving consumers and payers an average of $941 per person per year, ...

Must Read!! Family Medicine Pharmacy, LLC v. Trxade, Group, Inc. and Westminster Pharmaceuticals, LLC, Case No. 1:15-00590-KD-B--Preliminary Approval in Class Action Settlement

Preliminary Approval Granted In Class Action Settlement Involving ...

PR Newswire (press release)-17 hours ago

The case is Family Medicine Pharmacy, LLC v. Trxade, Group, Inc. and Westminster Pharmaceuticals, LLC, Case No. 1:15-00590-KD-B and alleges that ...

Are Coupons for Prescription Drugs a Good Idea?

U.S. News & World Report-22 hours ago

While getting a free prescription at the pharmacy may seem like a good thing, some argue these cards and coupons may ultimately push up health care costs for ...

Commentary: Rebates to PBMs are a hidden contributor to high drug ...

Pharmacy Today, American Pharmacists Association, pharmacist.com-52 minutes ago

B. Douglas Hoey, a registered pharmacist and CEO of the National Community Pharmacists Association (NCPA), notes in this opinion piece that "in the furor ...

Pharmacist Who Owns 'The Rock's' Former Mansion Awaits Trial

Pharmacist Who Owns 'The Rock's' Former Mansion Awaits Trial

WorkCompCentral (subscription)-7 hours ago

A Miami pharmacist used the proceeds from a $37 million conspiracy to defraud federal health insurance programs and purchase a French-style chateau ...

Ex-pharmacist gets 5- to 75-year prison term in second pill-mill case

Ex-pharmacist gets 5- to 75-year prison term in second pill-mill case

Herald-Mail Media-13 hours ago

MARTINSBURG, W.Va. — A former Martinsburg pharmacist twice convicted of improperly dispensing medications to customers was sentenced Monday in ...

OptumRx and CVS Pharmacy Partner to Expand Consumer Choice ...

Business Wire (press release)-1 hour ago

CHICAGO & WOONSOCKET, R.I.--(BUSINESS WIRE)--OptumRx and CVS Pharmacy are partnering to provide more convenient choices and lower costs for ..

Can Diplomat Pharmacy Turn Things Around in 2017?

Fox Business-2 hours ago

The new year probably can't begin soon enough for Diplomat Pharmacy (NYSE: DPLO) shareholders. Shares of the nation's largest independent specialty ...

GAO: FDA Makes Headway on Compounding Regulations, but ...

www.fdanews.com/articles/179442

9 hours ago - Outsourcing facilities and states have faulted the FDA for sluggish progress toward finalizing guidance documents on drug compounding and the differences 

Compounders on Capitol Hill 2016 - International Academy of Compounding Pharmacists

Compounders on Capitol Hill 2016 - International Academy of Compounding Pharmacists

Compounding issues: gov't watchdog releases drug compounding report

OutSourcing-Pharma.com‎ - 22 hours ago

FDA Acts on Dietary Fiber: Issues Draft Guidance and Report of Evidence for Twenty Six Isolated and Synthetic Non-digestible Fibers Posted: 28 Nov 2016 06:13 PM PST By Riëtte van Laack –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/11/fda-acts-on-dietary-fiber-issues-draft-guidance-and-report-of-evidence-for-twenty-six-isolated-and-s.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

November 10, 2016

Stonegate Pharmacy LP

Dallas District Office

Compounding Pharmacy/Adulteration/Misbranding

Not Issued *

November 10, 2016

Dongying Tiandong Pharmaceutical Co Ltd

Center for Drug Evaluation and Research

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Not Issued *

November 16, 2016

Prescription Lab Compounding Pharmacy

Los Angeles District Office

Compounding Pharmacy/Adulteration/Misbranding

Not Issued *

November 21, 2016

STI Pharma LLC

Philadelphia District Office

Postmarketing Adverse Drug Experience Reporting Requirements

Not Issued *

Tom Price, Obamacare Critic, Is Said to Be Trump Selection for Health Secretary

http://www.msn.com/en-us/news/politics/tom-price-obamacare-critic-is-said-to-be-trump-selection-for-health-secretary/ar-AAkSqZ9?li=AA5a8k&ocid=spartandhp

Raritan Pharmaceuticals Inc. Issues a Voluntary Nationwide Recall of Products Containing Belladonna Extract Due to the Possibility of the Presence of Belladonna Alkaloids

• Raritan Pharmaceuticals Inc. Issues a Voluntary Nationwide Recall of Products Containing Belladonna Extract Due to the Possibility of the Presence of Belladonna Alkaloids

Does a Trump presidency mean changes for pharma advertising?

Does a Trump presidency mean changes for pharma advertising?

FDA Issues Direct Final Rule Revising Categorization of Animal Drugs Used in Medicated Feeds –

The FDA is confirming the effective date of December 1, 2016, for the direct final rule amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species.

FDA Seeks Public Input on Next Steps to Help Ensure Judicious Use of Antimicrobials in Animal Agriculture –

The FDA is extending the comment period to continue seeking public input on establishing appropriately targeted durations of therapeutic use of medically important antimicrobial drugs in food-producing animals. The FDA is taking this action in response to requests for additional time to submit comments. The comment period will now close on March 13, 2017.

More Animal Health Updates

Web page launched for pharmacy fraud victims

Web page launched for pharmacy fraud victims

Montrose Daily Press-13 hours ago

Acting U.S. Attorney Bob Troyer announced in a recent news release his office has launched a website for victims of the FusionPharm fraud. The website ...

Deputies detonate dangerous acid found at Lake City pharmacy

ActionNewsJax.com‎ - 20 hours ago

Deputies found a dangerous acid while cleaning out a pharmacy in Lake City on Saturday.

Pharmacy issues nationwide recall of drug products over sterility ...

www.rightinginjustice.com/.../pharmacy-issues-nationwide-recall-of-drug-products-o...

5 hours ago - The pharmacy says it will begin notifying health care facilities email and phone and is ... Compounding Pharmacy issues massive recall due to sterility concerns ...

State looking into possible link between dirty drugs, patient death ...The completed investigation found that while the pharmacy compounding areas were generally in compliance, it also uncovered problems that could compromise drug sterility which, "puts patients at potential risk."

State looking into possible link between dirty drugs, patient death at ...

KOMO News-Nov 22, 2016

Only one of two DOH investigations is complete. The completed investigation found that while the pharmacy compounding areas were generally in compliance, ...

NECC defendant seeks trial delay in Framingham meningitis case

Milford Daily News-Nov 26, 2016

Glenn Adam Chin, former supervisory pharmacist at the New England Compounding Center, departs federal court on Sept. 11, 2014, in Boston. Prosecutors say ...

Two Vacancies on the FDA Pharmacy Compounding Advisory Committee

Pharmacy Compounding Advisory Committee

• Pharmacy Compounding Advisory Committee Roster

FDA Law Blog: States in the Mix: GAO Releases Report to

FDA Law Blog: States in the Mix: GAO Releases Report to ...

www.fdalawblog.net/.../states-in-the-mix-gao-releases-report-to-congressional-commit...

23 hours ago - By Karla L. Palmer – The Government Accountability Office (GAO) released a detailed Report last week addressing FDA's efforts to regulate compounding since ...

Federal Judge Halts Overtime Rule Until a final decision is reached, employers may continue to follow the existing overtime rule

https://www.shrm.org/resourcesandtools/legal-and-compliance/employment-law/pages/judge-blocks-flsa-overtime-rule.aspx

Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance

• Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance

Ontario health minister vows increased transparency for pharmacy ...

Toronto Star-15 hours ago

But the coroner's report concluded “logic would dictate that baclofen was substituted for tryptophan at the compounding pharmacy in error.” The family met ...

Family of boy who died after prescription error told health minister is ...
International-CBC.ca-7 hours ago

A Battle to Change Medicare Is Brewing, Whether Trump Wants It or Not

http://www.msn.com/en-us/news/politics/a-battle-to-change-medicare-is-brewing-whether-trump-wants-it-or-not/ar-AAkIRb2?li=AA5a8k&ocid=spartandhp

One expert says seniors would lose with Ryan's Medicare plan

http://www.msn.com/en-us/money/personalfinance/one-expert-says-seniors-would-lose-with-ryans-medicare-plan/ar-AAkELrp?li=BBmkt5R&ocid=spartandhp

NGS Billing for Compound Drugs - National Government Services

https://www.ngsmedicare.com/.../billing%20for%20compound%20drugs%20changed...

14 hours ago - The new code for 2016 dates of service for compounded drugs is J7999. The description of J7999 is “Compounded Drug, Not Otherwise Classified.” If you ar

Is America ready for a major Medicare overhaul?

Is America ready for a major Medicare overhaul? 

Donald Trump and the GOP signaled they will move rapidly to turn Medicare into a “premium-support” system that pays private plans and the traditional program a fixed amount per beneficiary. Some healthcare leaders may welcome that, but they want to see more details before they take a...  READ MORE

Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry (PDF - 123KB)

• Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry (PDF - 123KB)

FDA Law Blog: November 22, 2016 HHS OIG’s Latest Work Plan: What to Look Out for in FY2017 By Serra J. Schlanger

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/11/hhs-oigs-latest-work-plan-what-to-look-out-for-in-fy2017.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

Pfizer plots $200M consolidation for St. Louis employees, will add 80 jobs

Pfizer plots $200M consolidation for St. Louis employees, will add 80 jobs

Wockhardt woes grow as U.K. sterile plant rebuked by FDA warning letter

Wockhardt woes grow as U.K. sterile plant rebuked by FDA warning letter

Sun Pharma moves on Russia with deal for control of JSC Biosintez

Sun Pharma moves on Russia with deal for control of JSC Biosintez