Thursday, January 7, 2016

FDA has two years of experience with self-registering compounding organizations. Is the agency ready to use them to address situations of access constraints from extreme pricing?


“Temporary Compounding” To Mitigate Off-Patent Monopolies


Executive Summary

FDA has two years of experience with self-registering compounding organizations. Is the agency ready to use them to address situations of access constraints from extreme pricing?



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meningitis-etc: NECC Bankruptcy Judge Disallows Dozens of Claims

meningitis-etc: NECC Bankruptcy Judge Disallows Dozens of Claims: By Walter F. Roche Jr. A federal bankruptcy judge Wednesday formally disallowed claims totaling more than $400 million in the case of the...

FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance

FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance

January 06, 2016 FDA Broadens Arsenal in Fight Against Kratom By Ricardo Carvajal –

Wednesday, January 6, 2016

MLB: There's no proof of any wrongdoing by Jeter's ex-trainer-Major League Baseball has been aware of the connection between controversial pharmacist Charles Sly and Derek Jeter’s former trainer, Jason Riley, according to an industry source. However, MLB has not uncovered evidence Riley has committed any wrongdoing.

MLB: There's no proof of any wrongdoing by Jeter's ex-trainer

nypost.com/.../mlb-theres-no-proof-of-any-wrongdoing-...
New York Post
4 hours ago - However, MLB has not uncovered evidence Riley has committed any wrongdoing. ... The two men founded Elementz Nutrition, a nutritional supplement ... He repeatedly argued the perception that “Everyone was using” during the

More background information on Elementz and Jason Riley

Remember a couple of years ago when the heroic Captain Sullenberger navigated US Airways Flight 1549 into the Hudson River after a suicidal bird almost succeeded in taking down an entire aircraft?  Ok.  Then, do you remember that image, taken from a Ferry, of the passengers standing on the wing of said aircraft as it slowly descended into icy waters?  Yeah.  Janis took that picture…as a 22-year-old kid, in New York City, on his way to retrieve his car from a New Jersey airport after meeting with some higher-ups about Elementz, a business he was launching that would help current and former athletes by improving the ethics behind the health products in the sports industry.  

***

So, what is Janis working on when he's not changing the world?  Well, changing the world, of course.  Elementz Nutrition (.com - if you want to check it out) started about three years ago when Janis and former IMG coach, Jason Riley, started a discussion about the lack of 'clean' products such as proteins, multivitamins and other sports products that athletes take to enhance their physicality on and off the field.  We're not talking steroids, we're talking products that help an athlete's body to be in prime shape during his/her career, but also, equally as important, is the fact that the Elementz Nutrition team is working on products that will enhance a body's longevity years after retirement.  The team was sick of 'shady' products that had adverse affects on players, as well as the fact that, generally, once an athlete is past prime playing age, they usually sustain some type of permanent damage that disables them from running at peak performance.  You know how it works: once an athlete stops playing sports, they often spend the rest of their life sustaining and nurturing bad knees, hurt shoulders or poor internal health from so-called performance enhancers.  Or, as Janis more succinctly puts it, 'I want to give athletes more time on the field, but also give them the ability to play with their kids long after their careers are over.'

***

Bikie gangs using gay lube oil to muscle in on ...

Bikie gangs using gay lube oil to muscle in on ... - Daily Mail

www.dailymail.co.uk/.../Bikie-gangs-gay-lube-oil-Outlaws-using...
Daily Mail
Mar 16, 2015 - ... steroid marketMailOnline US - news, sport, celebrity, science and health stories ... Bikie gangs and gay lube oil: Outlaws using ingenious ways to muscle in on $1 BILLION steroid market after police crack down on their cocaine trade. Bikie gangs ... By Frank Coletta for Daily Mail Australia. Published:

Most Read report: Longterm consequences of anabolic-androgenic steriod use is a medical/social/public health concern

Why Republicans Are Changing Their Approach To Drug...

Why Republicans Are Changing Their Approach To Drug Addicts

ThinkProgress-5 hours ago
... signed legislation that would make Naloxone, a drug that can reverse the effects of an heroin overdose, available at a pharmacy

6th Circuit offers Rx for dismissal: Well-documented performance ... HR.BLR.com-10 hours ago The 6th Circuit—which covers Kentucky, Michigan, Ohio, and Tennessee—recently upheld the dismissal of a retaliation lawsuit by a pharmacist even though he ...

6th Circuit offers Rx for dismissal: Well-documented performance ...

HR.BLR.com-10 hours ago
The 6th Circuit—which covers Kentucky, Michigan, Ohio, and Tennessee—recently upheld the dismissal of a retaliation lawsuit by apharmacist even though he ...

PharMerica settles kickback allegations for $2.5 million Louisville Business First-5 hours ago PharMerica (NYSE: PMC), the second-largest nursing home pharmacy in the U.S., in December agreed to pay $2.5 million

PharMerica settles kickback allegations for $2.5 million

Louisville Business First-5 hours ago
PharMerica (NYSE: PMC), the second-largest nursing homepharmacy in the U.S., in December agreed to pay $2.5 million

2016 NABP Survey of Pharmacy Law Now Available

2016 NABP Survey of Pharmacy Law Now Available

 Topics: Survey Of Pharmacy Law
Serving as a convenient reference for individuals seeking an overview of the laws and regulations that govern pharmacy practice in 53 jurisdictions, the updated 2016 Survey of Pharmacy Law is now available

WADA to publish second part of doping probe

WADA to publish second part of doping probe - Network Ten

tenplay.com.au/news/2016/.../wada-to-publish-second-part-of-doping-prob...
4 hours ago - The World Anti-Doping Agency's (WADA) independent commission will publish the second part of its report into allegations of widespread doping in athletics

US Marshals seize dietary supplements containing kratom 01/06/2016 03:06 PM EST



The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.

Trunity Is Now True Nature Holdings, Inc., Completes Restructuring ... CNNMoney-1 hour ago ACQUISITION OF NEW COMPOUNDING PHARMACY BUSINESS We have acquired 100% of the membership interests of Newco4pharmacy, LLC, ...

Indiana Board of Pharmacy Record for Charles David Sly Pharmacy Intern License issued 4/27/2010 and Expired 5/1/2013

Charles David Sly
Address Information
Brownsburg IN 46112
License Information
License No:45016282A
Profession:Pharmacy Board
License Type:Pharmacy Intern
Obtained By Method:Application
Issue Date:4/27/2010
Expiration Date:5/1/2013
License Status:Expired
Previous Action
Previous Action - None
Related Licenses
No Prerequisite Information

source accessed on January 6, 2016 https://mylicense.in.gov/everification/Details.aspx?agency_id=1&license_id=1409022&

Fill' Policies Partial-fill policies could limit the amount of unused medication in homes. Framingham, MA

Must Read Report: How much of this also applies in sports in the United States?

Organised Crime and Drugs in Sport - Australian Crime ...

https://www.crimecommission.gov.au/.../or...
Australian Crime Commission
The ACC also received information from the Australian Sports Anti-. Doping ....sophisticated sports doping programs due to the expense and complexity of their ..

Physicians and the Sports Doping Epidemic - AMA Journal ... journalofethics.ama-assn.org/2014/07/oped1-1407.html Consequently, the pro-steroid lobby of the sports world is now dwarfed by the enormous lobbying operation being waged by “anti-aging” doctors...

Physicians and the Sports Doping Epidemic - AMA Journal ...

journalofethics.ama-assn.org/2014/07/oped1-1407.html
Consequently, the pro-steroid lobby of the sports world is now dwarfed by the enormous lobbying operation being waged by “anti-aging” doctors, their (often

Question of the Day January 6, 2016 Does there need to be an updated Mitchell Report? Do other sports including the NFL, NBA, tennis etc. also need similiar investigations and congressional hearings? Does there need to be investigations and hearing into who is supplying the api, and teaching and training in the preparation and use of PEDs? Why or why not? Will those who dope always be one-step ahead of the rules and the testing until the source of the chemicals to make the drugs is addressed?


The Mitchell Report | The largest doping scandals in sports ...

The Mitchell Report | The largest doping scandals in sports ...

https://in.news.yahoo.com/...doping.../the-mitchell-report-p...
Yahoo! News
Jun 6, 2013 - View the picture 'The Mitchell Report' from the photo gallery 'The largestdoping scandals in sports history' on Yahoo News India. In December

Timeline of A-Rod's doping demise -

Timeline of A-Rod's doping demise - NY Daily News

www.nydailynews.com/.../timeline-a-rod-doping-demise-artic...
Daily News
Apr 13, 2013 - Dec. 15, 2007: The Mitchell Report outs nearly 100 MLB players as dopers, but Alex Rodriguez is not named. Jose Canseco insists that A-Rod

Flashback: Clemens Lied to Congress About Doping, Indictment Charges www.nytimes.com/2010/08/.../sports/.../20clemens.... The New York Times Aug 19, 2010 - Clemens Lied About Doping, Indictment Charges ... that he had been unfaithful to his wife after published reports tied him to other women. .... Forced Action With Testimony (August 19, 2010);

Clemens Lied to Congress About Doping, Indictment Charges

www.nytimes.com/2010/08/.../sports/.../20clemens....
The New York Times
Aug 19, 2010 - Clemens Lied About Doping, Indictment Charges ... that he had been unfaithful to his wife after published reports tied him to other women. .... Forced Action With Testimony (August 19, 2010); SPORTS OF THE TIMES; Pettitte's

New IAAF road map includes doubling anti-doping budget Reuters-

New IAAF road map includes doubling anti-doping budget

Reuters-9 hours ago
The measures include increasing the anti-doping budget to $8 million ... the independent commission of the World Anti-Doping Agency (WADA) ...
Sebastian Coe doubles IAAF's anti-doping budget as part of his ...
International-Mirror.co.uk-5 hours ago
Explore in depth (123 more articles)

Tennis Has a Steroid Problem: Jason Riley?

Tennis Has a Steroid Problem: Jason Riley?: An interesting twist in the Al Jazeera doping report brings tennis into the mix. Michael Powell of The New York Times reports that "...

Japan Possibly Following Germany With Anti-Doping Law ...

Japan Possibly Following Germany With Anti-Doping Law ...

https://swimswam.com/japan-possibly-following-germany-with-anti-dopi...
23 hours ago - On the heels of Germany's law now rendering athletic doping criminal, the country of Japan is also considering similar legislation to discourage

Blame Capitalism for Doping in Sports : And where are these drugs coming from, anyway? Drug development and distribution in the U.S. is a privatized Wild West. If the way private doctors doled out prescriptions were more tightly regulated, drugs would be harder for people to get their hands on.

Blame Capitalism for Doping in Sports | Al Jazeera America

america.aljazeera.com/.../blame-capitalism-for-doping-in-sport...
Al Jazeera
8 hours ago - Players who take performance-enhancing drugs are only responding to the incentives of the free market"

Authorities shift sports doping investigation to Vancouver ... www.theglobeandmail.com

Authorities shift sports doping investigation to Vancouver ...

www.theglobeandmail.com › Sports
The Globe and Mail
10 hours ago - Brandon Spletzer was featured in an Al Jazeera documentary on

Baxter Initiates Voluntary Recall of Two Lots of IV Solutions due to Potential Presence of Particulate Matter

No Pharmacy Duty, No Pharmacy Liability

No Pharmacy Duty, No Pharmacy Liability

Lexology (registration)-7 hours ago
As we noted yesterday, we aren't much for New Year's resolutions. But this blogger was recently invited to the home of friends who have a slightly different

Pharmacy charged meds for dead to TennCare

Pharmacy charged meds for dead to TennCare

Humphrey on the Hill (blog)-1 hour ago
NASHVILLE, Tenn. (AP) — A Nashville company will pay as much as $7.8 million in a settlement related to accusations that it charged Medicare and TennCare ...

Nashville pharmacy to pay millions to settle False Claims case Nashville Business Journal (blog)

Nashville pharmacy to pay millions to settle False Claims case

Nashville Business Journal (blog)-40 minutes ago
A Nashville pharmacy specializing in HIV and AIDS-related medicine will pay up to $7.8 million to settle allegations it overbilled Medicare

Pharmacy to pay up to $7.8M to settle False Claims allegations

Nashville Post (subscription)-2 hours ago
The owners of an independent local pharmacy that specializes in HIV and AIDS-related medications have agreed to pay up to $7.8 million 

Omnicell Completes Acquisition of Aesynt PR Newswire (press release)

Omnicell Completes Acquisition of Aesynt

PR Newswire (press release)-33 minutes ago
... to the Omnicell family will add distinct capabilities in central pharmacy robotics, ... With leading solutions for sterile compounding, enterprise-wide inventory

Tuesday, January 5, 2016

Cadila to buy Zoetis animal drugs and feed plant in India for ... www.fiercepharmamanufacturing.com/...buy-zoetis.../2016-01-05 11 hours ago - Cadila Healthcare is buying the Zoetis manufacturing site in Haridwar for about $29 million in a deal that will give the India drugmaker production

Cadila to buy Zoetis animal drugs and feed plant in India for ...

www.fiercepharmamanufacturing.com/...buy-zoetis.../2016-01-05

WHO Opposes Global Control of Ketamine

WHO Opposes Global Control of Ketamine

Following the Names in the Doping Report--New York Times Story

Jason Riley's LinkedIn Profile Shows One of His Projects Started in 2011 ....was TufMed. Has anyone heard of TufMed or used its products?

Starting 
TUFMED is an American athletic biotechnology company concerned with the development of natural injury first aid and recovery products for elite athletes.
"Sports hurt. Get over it."

Charles David Sly Pharmacist Intern License in Florida

CHARLES DAVID SLY

License Number: PSI29533

Data As Of 1/5/2016 

Profession
Pharmacist Intern
License
PSI29533
 License Status
CLEAR/
License Expiration Date
License Original Issue Date
07/31/2012
Address of Record
14406 SUNDIAL PLACE
LAKEWOOD RANCH, FL 34202
Discipline on File
No
 Public Complaint
No

New York Times Finds Link That Lends Credence To Charlie Sly’s Doping Claims To Al Jazeera « CBS Boston

New York Times Finds Link That Lends Credence To Charlie Sly’s Doping Claims To Al Jazeera « CBS Boston

Nationals’ Ryan Zimmerman sues Al Jazeera over doping report

FDA 483 dated 10/07/2015 Cape Apothecary Inc. 483 MD Producer of Sterile Drug Products

December 23, 2015 Cadila Healthcare Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *

December 23, 2015Cadila Healthcare LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *