The White House 2016 Budget Includes Big Funding for Antibiotic Resistance BY MARYN MCKENNA 01.31.15 | 8:40 AM

Next week, President Barack Obama will unveil his full budget request for the coming fiscal year. When he does, he’ll also reveal details of how his administration plans to fund the national strategy for combating antibiotic resistance that the White House released last autumn.

Here’s what we know so far, based on a fact sheet that the White House released earlier this week:

The total request is $1.2 billion, “nearly doubling” current funding, and intended for multiple agencies within the Department of Health and Human Services. Here’s how that breaks down:

• $650 million shared by the National Institutes of Health and the Biomedical Advanced Research and Development Authority;
• $280 million for the Centers for Disease Control and Prevention;
• $85 million at the Department of Veterans Affairs;
• $77 million for the US Department of Agriculture;
• $75 million for the Department of Defense;
• $47 million for the Food and Drug Administration.
• more

'Right to Try' bill would give access to experimental drugs

1. 'Right to Try' bill would give access to experimental drugs

   Northwest Herald-20 hours ago

   It can be years before drugs leave the clinical-trial phase and get approval by the FDA. Connelly said the 2014 movie "Dallas Buyers Club," based on an AIDS ...

Lab-developed tests don't need new layer of oversight, and other

1. Lab-developed tests don't need new layer of oversight, and other ...

   ModernHealthcare.com-20 hours ago

   (“Why the FDA should regulate lab tests,”) That is a good thing. The average person should come to understand how something that may seem of remote ...

Billerica pharmacy to pay $1.5M for Medicaid billing errors The Lowell Sun

The Lowell Sun

UPDATED:   01/31/2015 06:34:36 AM EST0 COMMENTS

BOSTON -- A Billerica pharmacy has agreed to pay more than $1.5 million to settle allegations it improperly billed and received payments from the state's Medicaid program when it automatically refilled prescription medications that were not requested by MassHealth patients or caregivers.

Neighborhood Diabetes, Inc., listed at 600 Technology Park Drive, unit 201, will pay more than $1.5 million in restitution to the state for the overpayments, and be subject to additional reporting requirements to ensure compliance in the future.

Read more: http://www.lowellsun.com/news/ci_27432073/billerica-pharmacy-pay-1-5m-medicaid-billing-errors#ixzz3QS6xynTr

Concerns continue with compounding pharmacies

Concerns continue with compounding pharmacies

www.digitaljournal.com/life/health/concerns...compounding.../424821

17 hours ago - Digital Journal has reported on the various issues surroundingcompounding pharmacies over ... Compounded sterile medications are higher riskdrug products.

House Committee Unveils Drug Development Incentives, FDA Regulatory Overhaul

House Committee Unveils Drug Development Incentives, FDA Regulatory Overhaul

January 27, 2015

The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More

Poor Validation of APIs Result in 483 for Manufacturer

Poor Validation of APIs Result in 483 for Manufacturer

January 30, 2015

A Japanese active pharmaceutical ingredient manufacturer received a Form 483 for poor validation of its manufacturing methods and supplier controls. Read More

Educational Conference 2015-IACP

Educational Conference 2015 - International Academy of ...

www.iacprx.org/?page=12

6 days ago - The American College of Apothecaries (ACA), the International Academy ofCompounding Pharmacists (IACP) and the American College of Veterinary ...

January 26, 2015 FTC Proposes Amendments to Fair Packaging and Labeling Act Rules

If your company sells consumer products, you’ll want to take a look at the Federal Trade Commission’s (FTC’s) proposed amendments to its Fair Packaging and Labeling Act (FPLA)rules announced on January 22, 2015. The most significant proposed change is eliminating the rules on certain price representations -- the cents off, introductory offer, andeconomy size rules -- because they are no longer common in the marketplace and the Commission has other means for policing deceptive price representations. more

Fourth Question of the Day January 31, 2015 How many false and misleading claims by compounding pharmacies will we see the Federal Trade Commission Take on this year? How many compounding pharmacy websites need to clean up and remove these type of claims from their websites? Are the organizations that represent these groups advocating for compliance in this area or will they oppose any regulation by the FTC?

POM WONDERFUL, LLC, ET AL., PETITIONERS v. FEDERAL TRADE COMMISSION, RESPONDENT Decided January 30, 2015 by United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT

here

A Victory for Consumers: Appeals Court Sides With FTC In POM Wonderful False Advertising Case By Mary Beth Quirk January 30, 2015

here

United States: Dietary Supplement Company Settles FTC False Advertising Suit For $9 Million: As evidenced by this settlement, the FTC continues its offensive against dietary supplement companies for claims made in connection with advertising and marketing campaigns. It is critical that product providers and marketers remain abreast of ever-evolving regulations in the dietary supplement and marketing space, or risk bearing substantial (and perhaps even personal) liability.

here

Huge Case by Federal Trade Commission for misleading ads regarding supplements

Green Coffee Bean Ads Are Judged Misleading - The ...

www.peoplespharmacy.com/.../green-coffee-bean-ads-are-judged-mislea...

 Rating: 3.6 - ‎7 votes

2 days ago - The FTC has ruled that ads touting green coffee bean extract as a weight loss ... The People's Pharmacy January 29, 2015 Health Concerns Add a Comment ... The Federal Trade Commission has barred misleading advertisements for green ..

AG: $360K prescription drug ring busted; Several charged

AG: $360K prescription drug ring busted; Several charged ...

www.wpxi.com › News › Local

WPXI

2 days ago - "I commend the Westmoreland County task force for following the trail of ... for a year from her employer, Norwin Pharmacy, and sold them to Michele Garufi.

Third Question of the Day January 31, 2015 Should reimbursement coverage under Medicare be allowed for compounded preparations made by outsourcing facilities? Should state health plans and others (who don't already allow it) consider allowing coverage for compounded medications that come from those outsourcing facilities on the FDA-registered list?

Second Question of the Day January 31, 2015 Will this be the year we see a Federal and State Law Enforcement Taskforce to deal with compounding pharmacies that are illegally billing, violating the statutes, rules and regulations, and committing other civil and criminal acts?

Question of the Day January 31, 2014 In order to get Congress to pass provider status for pharmacist will compounding pharmacist have to give up the legislation to pass a "fix" of the DQSA? Is there enough interest and votes in Congress to get both done this year?

Why Did CVS Pharmacy Get Into Trouble with N.J. Div. of Consumer Affairs? WEDNESDAY, 28 JANUARY 2015 18:31

BY JEFF LAMM

SPECIAL TO NEWJERSEYNEWSROOM.COM

NEWARK – Acting Attorney General John J. Hoffman, the New Jersey Division of Consumer Affairs, and the State Board of Pharmacy today announced a settlement with CVS Pharmacy Inc. in which the company will pay more than $500,000 and will take steps to protect New Jersey consumers from purchasing medications, infant formula, or other items if they are exposed to elevated temperatures for prolonged periods of time.

The settlement follows two separate 2012 incidents in which CVS pharmacies in Scotch Plains and Clark experienced air conditioning outages for multiple days. The stores continued to operate after inside temperatures exceeded the maximum recommended for the storage of drugs and other items for extended periods of time.

Potentially affected items were sold between June 20, 2012 and July 27, 2012 at the CVS at 514 Park Avenue in Scotch Plains; and between July 10, 2012 and July 20, 2012 at the CVS at 60 Westfield Avenue in Clark.

Certain medications may lose effectiveness if exposed to elevated temperatures for prolonged periods of time. No injuries or illnesses resulting from the 2012 incidents have been reported.

“We have taken an incident in which the public was exposed to potential harm, and turned it into an opportunity to create model practices for pharmacies across New Jersey,” Acting Attorney General John J. Hoffman said. “Under this settlement, CVS will keep a close eye on the temperatures at its New Jersey pharmacies, and will act immediately to remove affected medications before they are sold to the public. Failure to do so will be punishable under New Jersey’s laws governing consumer fraud and pharmacy operations.” more

Feds arrest Perry county pharmacist on drug charge

Feds arrest Perry county pharmacist on drug charge: The U.S. attorney's office in Little Rock has announced the arrest of Christopher Watson, a pharmacist in Perryville, for distributing controlled narcotics without a legal prescription.

NABP Task Force on Pharmacy Technicians

Task Force on Pharmacy Technicians - National Association ...  

https://www.nabp.net/.../tfph...

National Association of Boards of Pharmacy

3 days ago - Recognizing that the State Boards of Pharmacy regulate the practice ofpharmacy, and that non- pharmacist personnel currently assist in the practice of ...

Pharmacists Society of the State of New York, Inc.: Webinar Compounding Pharmacies and Investigations

Wednesday, February 18, 2015
Compounding Pharmacies and Investigations 2/18/2015 Location: Live Webinar     Export to Your Calendar   Register

Question of the Day January 30, 2015 Have PBMs done a good job of asking the right questions of compounding pharmacies so as to eliminate any possible criminal and/or civil liability on their part for health care fraud? What else can they do to protect the public, consumers and the legal, legitimate compounding pharmacies from those compounding pharmacies charging for added, unneccessary APIs and for unncessary compounded preparations when commerically available drugs are available?

A Moving Target? Understanding the RMTC’s Progress | Paulick Report – Thoroughbred Horse Racing News

A Moving Target? Understanding the RMTC’s Progress | Paulick Report – Thoroughbred Horse Racing News

Drugs dispensed by docs may well be dangerous

Drugs dispensed by docs may well be dangerous

State Bill Requiring Notice when compounded drugs are dispensed Fails to Pass in 2014 but may be reintroduced

Compounding of drug products; notice. (HB1119)

https://www.richmondsunlight.com/bill/2015/hb1119/

2 hours ago - Requires pharmacists to notify patients to whom compounded drugproducts are dispensed that the drug product has been compounded. This bill is carried over ...

Companion Senate Bill for Federal Provider Status Introduced

Companion Senate Bill for Federal Provider Status Introduced

www.iacprx.org/.../Companion-Senate-Bill-for-Federal-Provider-Status-I...

6 hours ago - Protecting, Promoting & Advancing Pharmacy Compounding ... but also to obtain complete coverage of all compounded preparations within Medicare Part D.

White House proposes $215 million, new regs for precision medicine

White House proposes $215 million, new regs for precision medicine

The White House is proposing $215 million in new funds and new regulations in a sweeping effort involving the NIH, the FDA and the ONC to help fulfill the promise of what President Barack Obama has termed precision medicine.  READ MORE

FDA Enforcement Reports January 28, 2015 (a number of sterility issues with Walgreens Infusion Services Products)

Enforcement Reports January 28, 2015

FDA CVM Guidance for Industry Guidances Under Development for 2015 (including possible guidance for animal compounds)

Guidance for Industry Guidances Under Development for 2015

United States enters consent decree prohibiting illegal distribution of Luvena Prebiotic products January 30, 2015

For Immediate Release

January 30, 2015

Release

At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.

The consent decree broadly prohibits Laclede from distributing unapproved or improperly labeled (misbranded) drugs and devices in interstate commerce. This action follows a complaint for permanent injunction that the U.S. Department of Justice filed at the request of the FDA on June 25, 2014. The complaint alleged that the company was illegally distributing over-the-counter vaginal drug products without required FDA approval, despite repeated warnings. The products in question were:

• Luvena Prebiotic Vaginal Moisturizer & Lubricant
• Luvena Prebiotic Feminine Wipes
• Luvena Prebiotic Enhanced Personal Lubricant
• Luvena Prebiotic Daily Therapeutic Wash 

The consent decree entered today specifies, among other things, that Laclede may not market any products that contain the term “prebiotic” or “actibiotic” on its labels or packages without obtaining the FDA’s approval. In addition, Laclede may not market any of its products currently the subject of premarket notifications submitted per section 510(k) of the Federal Food, Drug, & Cosmetic Act, including those referencing “lubrication.” 

“The FDA’s drug approval and device clearance processes are essential to ensuring that medical products marketed in the United States are safe and effective for their intended use,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will take strong enforcement action whenever companies attempt to bypass these critical processes.”

For five years following the consent decree, Laclede must also notify the FDA before it markets any new Luvena product and before it modifies any Luvena product labeling. Laclede may not market such products until the FDA notifies the company that it is in compliance with the law.

If the FDA determines that Laclede fails to comply with the consent decree, the agency may take appropriate measures to ensure compliance, including ordering the company to cease manufacturing and distributing its products, recall its products or pay liquidated damages.        

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

Third Question of the Day January 29, 2015 Is the 72 hour in California for Veterinary Compounded Preparations a good rule that all states should have in place? Why or why not?

for a discussion of the 72 hour rule see Compounded Medications and Veterinary Practice:Important Laws, by Grant Miller, DVM, CVMA Director of Regulatory Affairs

Georgia Vet College to Host Conference in March

Georgia Vet College to Host Conference in March

Second Question of the Day January 29, 2015 If there is so much confusion in the compounding industry about office use, MOUs, the drug lists etc. why does there appear to be more hiring going on than ever? Doesn't is seem more like compounding pharmacies are doing more business than ever after the DQSA? Is this because consumers are demanding compounded drugs? If not, what is the reason?

Medisca is Hiring

Compounding Pharmacist

Medisca - Arizona - +7 locations

Provide Direction on Pharmacy Compounding. If you feel that you have the skills required for this Compounding Pharmacist position and would like to join the... 5 days ago - save job - email - more...

Account Executive - new

Medisca - Colorado

Identify key accounts and successfully convert their business to MEDISCA. Gather information on compounding needs, close sales & forecast future requirements.... 3 hours ago - save job - email - more...

Production Technician

MEDISCA - Irving, TX - +1 location

We recognize that our success as a quality-assured supplier of compounding equipment depends on our employees; If you feel that you have the skills required for... 7 days ago - save job - email - more...

Outside Sales Representative

Medisca - Denver, CO

Identify key accounts and successfully convert their business to MEDISCA. Gather information on compounding needs, close sales & forecast future requirements.... 1 day ago - save job - email - more...

Warehouse Clerk

MEDISCA - Irving, TX

We recognize that our success as a quality-assured supplier of compounding ingredients, equipment and devices depends on our employees;... 7 days ago - save job - email - more...

Pharmacy Technician with Prior Authorization & Non-Sterile C... - new

Advanced Rx Management - Hattiesburg, MS

Medisca, Freedom or PCCA compounding training certification a plus. Serves as a coach or trainer to other compounding pharmacy technicians when designated.... Easily apply 3 hours ago - save job - email - more...

Fagron Is Hiring

Sales Manager

Fagron, Inc. - Saint Paul, MN

FAGRON OFFERS A COMPREHESIVE BENEFITS PACKAGE, WHICH INCLUDES:. Is currently seeking a Sales Manager to join our talented sales team, and lead our sales efforts... Easily apply 2 days ago - save job - email - more...

Quality Control Analyst

Fagron, Inc. - Saint Paul, MN

Fagron is a professional and ambitious company with multiple growth opportunities. Fagronintends to further reinforce its market leadership with an active buy... Easily apply 2 days ago - save job - email - more...

Purchasing Supervisor

Fagron, Inc - Saint Paul, MN

Fagron is a young, professional and ambitious company with multiple growth opportunities.Fagron intends to further reinforce its market leadership with an... Easily apply 9 days ago - save job - email - more...

Vice President of Sales and Marketing

Fagron North America - Miami, FL - Miami, FL 33131 (Downtown area)

This role reports to the Executive Vice President of Fagron North America and will be part of the executive team at the Fagron North America corporate... International Academy of Compounding Pharmacists - 22 days ago - save job - email - more...

Vice President of Procurement

Fagron North America - Miami, FL - Miami, FL 33131 (Downtown area)

This role reports to the Executive Vice President Fagron North America and will be part of the Executive team at the Fagron North America corporate headquarters... International Academy of Compounding Pharmacists - 22 days ago - save job - email - more...

Diamondback Drugs is hiring

Inside Sales/Customer Service Representative

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. Under general supervision of the National Sales &... Jobing - 9 hours ago - save job - email - more...

Pharmacist

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Post by Jobing - Diamondback Drugs is the leader in custom compounding for veterinaryprescribers and patients nationwide.... Jobing - 5 days ago - save job - email - more...

Pharmacy Tech Inventory Specialist

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Post by Jobing - Diamondback Drugs is the leader in custom compounding for veterinaryprescribers and patients nationwide.... Jobing - 9 hours ago - save job - email - more...

Assistant Inventory Control Specialist

Diamondback Drugs  4 reviews - Scottsdale, AZ

Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. Managing all bulk transfers from chemical storage to... CareerBuilder - 23 days ago - save job - email - more...

Certified Pharmacy Technician

Diamondback Drugs  4 reviews - Scottsdale, AZ 85251 (South Scottsdale area)

Post by Jobing - Diamondback Drugs is the leader in custom compounding for veterinaryprescribers and patients nationwide.... Jobing - 5 days ago - save job - email - more...

Certified Pharmacy Tech

Diamondback Drugs  4 reviews - Scottsdale, AZ

Diamondback Drugs is the leader in custom compounding for veterinary prescribers and patients nationwide. Compounding experience a plus for Compounding position... CareerBuilder - 17 days ago - save job - email - more...