The Law of Compounding Medications And Drugs: October 2017

Tuesday, October 31, 2017

10/06/2017	Nexagen, LLC	Atlanta District Office	CGMP/Dietary Supplement/Adulterated	Not Issued *

10/16/2017	Kim Chemicals Private Ltd.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug	Not Issued *

10/17/2017	Town and Country Compounding and Consultation Services, LLC	New Jersey District Office	Compounding Pharmacy/Adulterated Drug Products	Not Issued *

10/18/2017	Accelerated Analytical Laboratories Inc.	Detroit District Office	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *

10/20/2017	Aztex Enterprises Ltd.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *

10/23/2017	Panther Sports Nutrition	New Jersey District Office	Unapproved New Drugs/Misbranded	Not Issued *

10/23/2017	Ironmag Labs	Los Angeles District Office	Unapproved New Drugs/Misbranded	Not Issued *

10/23/2017	Infantry Labs LLC	Detroit District Office	Unapproved New Drugs/Misbranded

Do Biosimilars Require Clinical Trials?

Applied Clinical Trials Online (press release) (blog)-Oct 30, 2017

FDA has mapped out a development pathway for biosimilars that relies primarily on structural analysis and preclinical and clinical pharmacology studies to ...

Drugmaker set to profit from an opioid it said was unsafe

WGNO-Oct 30, 2017

Endo contended that the new Opana ER and its hard coating deterred abuse, but this summer, the FDA disagreed. In June, the regulatory agency concluded that ...

Endo to receive royalties from generic opioid it once called 'unsafe ...
Becker's Hospital Review-21 hours ago

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Par Pharma Suit Tests FDA's Drug Pricing Pushback

Law360-14 hours ago

It accuses the FDA of creating an "unlawful regime" that will allow compounders to churn out huge quantities of blood-pressure drug vasopressin, despite Par ...

Question of the Day October 31, 2017 Should other companies join the Edno lawsuit or file similar lawsuits? Why or why not?

Endo files lawsuit to obtain FDA compliance with Drug Quality and ...

The Pharma Letter-30 minutes ago

"Endo welcomes FDA Commissioner Gottlieb's September 2017 press statement that FDA is working on a new compounding policy which we hope will include ...

UPDATE 1-Drugmaker Endo's 3rd-qtr earnings forecast tops estimates
Business Insider-Oct 30, 2017

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Monday, October 30, 2017

Amazon Should Tap Into Specialty Pharmacy

Seeking Alpha - 9 hours ago

Flurry Of Federal And State Probes Target Insulin Drugmakers And ...

Bonner County Daily Bee-5 hours ago

Insulin makers Eli Lilly, Novo Nordisk, Sanofi and top pharmacy benefit manager CVS Health are targets in the state investigations. Several of the financial filings ...

Amazon Disrupts Industry After Obtaining Wholesale Pharmacy Licenses

Updated List of Countries Viewing Blog 10/30/2017

Albania
Algeria
Angola
Antigua and Barbuda

Argentina
Armenia

Australia

Austria

Azerbaijan

Bahamas
Bahrain
Bangladen

Bangladesh

Barbados
Belarus

Belgium

Benin
Bermuda

Bosina & Herzegovina

Brazil
Brunei

Bulgaria
Burkina Faso
Canada
Cameroon

Cayman Islands

Chile

China

Columbia
Congo (Republic)

Costa Rica

Cote d'lvoire

Croatia

Cyprus

Czech Republic
Czechia

Denmark
Dominica
Dominican Republic

Ecuador

Egypt

Estonier
Ethiopia
Falkland Islands (Islas Malvinas)
French Polynesia

Fiji

Finland

France

Gabon
Georgia
Greece

Guatemala

Germany
Ghana

Guadeloupe
Guam

Holland

Hong Kong

Honduras

Hungary

India

Indonesia
Iran

Iraq

Ireland

Isle of Man

Israel

Italy

Jamaica

Kazakhstan

Kenya

Latvia
Lithuania
Laos
Luxembourg
Macau

Macedonia

Malaysia

Malta
Maredonia Fyrom
Mauritius

Mexico

Micronesia

Moldavo

Mongolia
Montenegro

Morocco
Mozambique

Nepal

Netherlands

Netherlands Antilles

New Zealand
Nicaragua

Nigeria
Norway

Oman

Pakistan

Panama

Philippines

Poland

Puerto Rico

Peru

Portugal

Qatar
Romania
Reunion

Russia

Saudi Arabia
Senegal

Serbia

Seychelles

Singapore
Sint Maarten

Slovakia

Slovenia

South Africa

South Korea

Spain
Sri Lanka
Suriname

Sweden

Switzerland

Taiwan

Tanzania

Thailand

Trinidad & Tobago
Tunisia

Turkey

Turks and Cacaos
Turkmenistan

Uganda

Ukraine

United Arab Emirates

United Kingdom

United States

Uruguay

Venezuela

Vietnam

Zimbabwe

DEA Hiring Diversion Investigators Again

Diversion Investigator (Recent Graduate)

Drug Enforcement Administration

Department of Justice

DEA - US Locations, United States

Starting at $35,359 (GS 07-09)
Permanent • Full Time

Work pressure a factor in Boots pharmacist's death

Australian Journal of Pharmacy (blog)-7 hours ago

Local member of Parliament Kevan Jones had been contacted by the family of Alison Stamps, a “young and talented” pharmacist who lost her life to suicide after ...

Aussie pharmacy giant Chemist Warehouse tipped to open first NZ ...

New Zealand Herald-11 hours ago

Australia pharmacy giant Chemist Warehouse is tipped to open its first New Zealand store this week. The Auckland store is set open in St Luke's Wagener Place ...

Chemist Warehouse set to open first store in St Lukes
Stuff.co.nz-12 hours ago

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California confronts opioid addiction, an 'epidemic of despair'

CALmatters-10 hours ago

Compounding the issue in rural areas that the economic recovery didn't reach ... Eventually, he found someone who worked in a pharmacy and sold him the pills .

FDA Law Blog - Is FDA’s Interim Policy on Section 503B’s So-Called “Bulks List 1” Illegal? Did FDA Overstep its Statutory Authority? The U.S. District Court for the District of Columbia May Soon Decide…. Is FDA’s Interim Policy on Section 503B’s So-Called “Bulks List 1” Illegal? Did FDA Overstep its Statutory Authority? The U.S. District Court for the District of Columbia May Soon Decide…. Posted: 29 Oct 2017 02:46 PM PDT By Karla L. Palmer – On October 26, 2017,

Is FDA’s Interim Policy on Section 503B’s So-Called “Bulks List 1” Illegal? Did FDA Overstep its Statutory Authority? The U.S. District Court for the District of Columbia May Soon Decide….

Posted: 29 Oct 2017 02:46 PM PDT

By Karla L. Palmer –

Sunday, October 29, 2017

Kudos to Florida Board of Pharmacy on their Excellent Website and Ease of Finding Meeting Information. Next Meeting November 3, 2017 Multidisciplinary Board Fact Finding Workgroup on Controlled Substances

Next Meeting:

November 3, 2017

Multidisciplinary Board Fact Finding Workgroup on Controlled Substances

Meeting Location:
Rosen Plaza Hotel
9700 International Drive

Orlando, FL 32819
Meeting Materials

FAR Notice (PDF) | Agenda (PDF) | Public Book (PDF)
Date

Meeting Type

Materials

November 16, 2017

Probable Cause Panel

FAR Notice (PDF) | Agenda (PDF)

November 30, 2017

Probable Cause Panel

FAR Notice (PDF) |

December 11, 2017

Rules Committee

FAR Notice (PDF) |

December 11, 2017

Legislative Committee

FAR Notice (PDF) |

December 12, 2017

Compounding Committee Meeting

FAR Notice (PDF) |

December 12, 2017

Controlled Substance Standards Committee

FAR Notice (PDF) |

December 11 - December 13, 2017

Board Meeting

FAR Notice (PDF) |

Oklahoma State Board of Pharmacy Minutes from Meeting on August 30, 2017

August 30, 2017

Florida Compounding Pharmacy Broke GMP Rules, FDA Says |

Florida Compounding Pharmacy Broke GMP Rules, FDA Says | 2017 ...

www.fdanews.com/.../184152-florida-compounding-pharmacy-broke-gmp-rules-fda-...

14 hours ago - A Florida compounding pharmacy did not meet the criteria for exemption from FDA rules on good management practices, and it violated those rules, the FDA ...

Saturday, October 28, 2017

Question of the Day October 28, 2017 Will Amazon sell prescription animal drugs if it ventures into the human prescription drug arena? Does it also plan to eventually offer compounded medications? Should it? Why or why not?

How Much Can Amazon Make In The PBM Business?

Seeking Alpha-14 hours ago

Investment Thesis: To assess the value of the Pharmacy Benefits Manager (NYSEMKT:PBM) business to Amazon (AMZN) we analyzed the margins of the ..

Amazon Granted Wholesale Pharmacy Licenses Fueling RX Drug .

Amazon Granted Wholesale Pharmacy Licenses Fueling RX Drug ...

Hot Hardware-12 hours ago

It seems that soon Amazon could be expanding its offerings with pharmacy items, as it has now gained wholesale pharmacy licenses in what is seemingly ...

Pharmacy: Amazon's newest frontier?
Bend Bulletin-21 hours ago

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Central Kentucky pharmacist sentenced to 8 years for distributing painkillers

Central Kentucky pharmacist sentenced to 8 years for drug ...

Lexington Herald Leader-13 hours ago

A Central Kentucky pharmacist who owned and operated Hometown Pharmacy of Georgetown was sentenced Friday to eight years in federal prison for ...

Pharmacist gets 8 years for distributing painkillers
Seattle Times-6 hours ago

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Amazon's Push Into Pharmacy Business Is Full of Promise and Pitfalls

Wall Street Journal-17 hours ago

A move by Amazon.com Inc. AMZN 13.22% into the $412 billion pharmacy business would shake up how generations have gotten their medicines, but success ...

Great Read! CVS is plotting a $66 billion takeover — and it has a lot to do with ...

CVS is plotting a $66 billion takeover — and it has a lot to do with ...

Markets Insider-12 hours ago

Speculation that Amazon might be getting into the pharmacy business has been rampant for months — and it came to a head, coincidentally, on Thursday when ...

CVS Bid For Aetna Followed Long Hunt -- WSJ
In-Depth-Fox Business-21 hours ago

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Here's Why Endo International Stock Dropped as Much as 13.8

Here's Why Endo International Stock Dropped as Much as 13.8 ...

Madison.com-17 hours ago

What the heck is bulk compounding? A pharmaceutical drug is essentially comprised of two components: the active pharmaceutical ingredient, or API (the ...

Endo International plc (ENDP), RH (RH)
Alive For Football-13 hours ago

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Friday, October 27, 2017

President Trump Blamed Criminals, Drug Companies, Mexico and China for the Opioid Crisis

https://www.msn.com/en-us/news/politics/president-trump-blamed-criminals-drug-companies-mexico-and-china-for-the-opioid-crisis/ar-AAu60c5?li=AA5a8k&ocid=spartanntp

Endo moves to protect Vasostrict franchise with FDA lawsuit; shares ...

Seeking Alpha-10 hours ago

Category 1-listed products can be freely compounded because they do not present a significant safety risk in compounding. Endo Chief Legal Officer Matthew .

October 27, 2017 11:57 am The GOP Doesn’t Even Have the Courtesy to Hide Its Sociopathic Priorities By Eric Levitz @EricLevitz

http://nymag.com/daily/intelligencer/2017/10/the-gop-is-no-longer-trying-to-hide-its-inhuman-priorities.html?utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Intelligencer%20-%20October%2027%2C%202017&utm_term=Subscription%20List%20-%20Daily%20Intelligencer%20%281%20Year%29

Here's why CVS wants to buy Aetna for $66 billion

Chicago Tribune-3 hours ago

CVS Health is reportedly in talks to buy the nation's third largest health insurer, Aetna, in a deal that would allow the pharmacy giant to expand into an entirely ...

Amazon Threat Causes Shakeout in the Health-Care Industry
Bloomberg-21 hours ago

CVS Health introduces safe medication disposal inside CVS ...
Pharmacy Today, American Pharmacists Association, pharmacist.com-4 hours ago

CVS Reportedly Bids $66 Billion On Aetna As Amazon Gains ...
Retail TouchPoints-2 hours ago

CVS makes more than $66 billion bid for Aetna: sources
Reuters-20 hours ago

CVS Health Is in Talks to Buy Aetna -- 4th Update
In-Depth-Fox Business-16 hours ago

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