Compounding Public-Private Partnership Will Cost $25 Million

Inside Health Policy-3 hours ago

FDA is requesting $25 million from congressional appropriators to create a compounding center of excellence, which would be a public-private partnership that performs market research and Good Manufacturing Practice training, the agency explains in a newly released budget justification document. The agency also wants ...

• China pushes generics over brands with another round of new pharma policies

• India’s drug regulatory body to create new database to monitor drug manufacturers

Urgent: Recall Notification Prothrombin Complex Concentrate (Human) Posted: 4/5/2018

• Urgent: Recall Notification Prothrombin Complex Concentrate (Human) 
  Posted: 4/5/2018

Washington State Pharmacy Quality Assurance Commission April 2018 Newsletter

• April

Oklahoma Board of Pharmacy action against Absolute Veterinary Compounding Pharmacy, #99- 7495 – Case No. 1498

Absolute Veterinary Compounding Pharmacy, #99- 7495 – Case No. 1498: Neither admits nor denies guilt on four counts including incorrectly filling or misfilling a prescription or drug order; failing to obtain a new license after change of name, ownership, and/or location; and failing to report to the Board all changes in any information required for licensure. $4,000 fine. Respondent’s license is placed on probation for one year until January 17, 2019.

quoted from the Oklahoma Board of Pharmacy April 2018 Newsletter

Oklahoma State Board of Pharmacy April 2018 Newsletter

• April

North Carolina Board of Pharmacy April 2018 Newsletter

• April

Nevada State Board of Pharmacy April 2018 Newsletter

• April

Louisiana Board of Pharmacy April 2018 Newsletter

• April

Delaware Board of Pharmacy April 2018 Newsletter

• April

Arizona Board of Pharmacy April 2018 Newsletter

• April

Ohio bans 'gag orders' on cheaper cash prices for prescriptions

The Columbus Dispatch-10 hours ago

State regulators ordered health insurers and their pharmacy benefits managers Wednesday to cease enforcement of gag orders preventing pharmacists from informing consumers of the lowest drug price available. In addition, the Ohio Department of Insurance prohibited charging consumers more for their prescription ...

Ohio pharmacists now must tell you about cheaper drug options ...
Cincinnati.com-1 hour ago

View all

Board Of Pharmacy Eyes Opioid Regulations

WLRN-6 hours ago

Members of the Florida Board of Pharmacy were told Monday that it shouldn't take long to alter regulations for pharmacists to comply with a new law aimed at combating the opioid epidemic. Board of Pharmacy counsel David Flynn told members of the board's Legislative Committee that, given the board's experience in past ...

Humco merges with global drug company

Texarkana Gazette-14 hours ago

The Fagron Group is a global pharmaceutical compounding company that offers personalized pharmaceutical care to hospitals, pharmacies, clinics and patients in 34 countries worldwide. Though Humco will be part of Fagron, the company says it will remain in Texarkana and retain the Humco brand. "Fagron's investmen

South Jersey Woman Admits Role In $50 Million Drug Fraud: Police

Patch.com-27 minutes ago

From January of 2015 through April of 2016, Lamonaca was among a group of conspirators who persuaded patients to obtain very expensive and medically unnecessary compounded medications from an out-of-state pharmacy, identified in the information as the "Compounding Pharmacy," according to authorities.

Linwood pharmaceutical representative latest to plead guilty in fraud ...

breakingac.com-27 minutes ago

LaMonaca and others recruited individuals covered by the Pharmacy Benefits Administrator, including public employees, to fraudulently obtain unnecessary compounded medications from the Compounding Pharmacy. LaMonaca obtained insurance information from those individuals and gave it to another conspirator, 

FDA's FY 2019 Justification: How Extra Funds Will be Used Regulatory Focus As discussed earlier, FDA's Office of Regulatory Affairs is also looking to establish a “Center of Excellence on Compounding for Outsourcing Facilities,” to provide education and training, conduct research to help inform regulatory decision-making, and implement programs to harmonize and strengthen ...

Humco and Fagron To Combine For Up To US $70 Million

PR Newswire (press release)-6 hours ago

AUSTIN, Texas, April 3, 2018 /PRNewswire/ -- Humco, a diversified, global pharmaceutical company, announced today that their Board of Directors has entered into a definitive merger agreement under which Humco will combine with Fagron, the global leader in pharmaceutical compounding and personalized medicine, ..

FDA orders mandatory recall for kratom products due to risk of salmonella

	Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall
	Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products. Continue reading.

	CVM releases eSubmitter Webinar Series
		Beginning on May 23, 2018, the Center for Veterinary Medicine (CVM) will host a three-part webinar series to provide information on the new animal drug application approval process. CVM’s Office of New Animal Drug Evaluation (ONADE) is hosting this webinar series to address the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS) registration processes as well as to provide information on how to use the eSubmitter tool. Since the release of eSubmitter in March 2011, the number of electronic submissions has increased. The purpose of these webinars is to support the use of eSubmitter in the new animal drug application approval process as we move to 100% electronic submission on October 1, 2018, with the anticipated reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). Each webinar listed below will be live-cast and recordings will be available on FDA.gov shortly after the presentation date. Read entire article. More Animal Health Topics

03/08/2018

3010490167

Edge Pharmacy Services, LLC

483

VT

Outsourcing Facility

04/02/2018

03/13/2018

3013935808

Rocky Mountain Pharmacy Inc

483

MT

Producer of Sterile Drug Products

04/02/2018

03/05/2018

3013736415

SCA Pharmaceuticals, LLC.

483

CT

Outsourcing Facility

04/02/2018

02/28/2018

Clover Custom Blending LLC

Dallas District Office

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

3/01/2018

Pharmacy Resources Incorporated

Los Angeles District Office

Compounding Pharmacy/Adulterated Drug Products

Not Issued *

03/08/2018

Medaus, Inc.

Dallas District Office

Compounding Pharmacy/Adulterated Drug Products

Not Issued *

03/13/2018

Biotek, Inc.

Denver District Office

Unapproved New Drugs/Misbranded

Not Issued *

03/15/2018

Keshava Organics Pvt. Ltd.

Center for Drug Evaluation and Research

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Not Issued

US Targets Opioid Prescribing Doctors, Pharmacy Sellers in State ...

Sputnik International-5 hours ago

WASHINGTON (Sputnik) - US authorities have arrested 28 people for illegally prescribing and distributing opioids and opened 188 active investigations, the US Department of Justice said in a press release on Monday. These measures were taken as a part of a nationwide 45-day analysis in February and March of .

Florida Board of Pharmacy holds controlled substance standards ...

WTXL ABC 27-22 minutes ago

They plan to do this by cracking down on the process a pharmacist goes through when prescribing controlled substances. "The number of deaths has skyrocketed over the past 10 to 12 years that have been mostly attributed to opioids," said Jon Hickman, a Florida Board of Pharmacy member. "So, we're going to do what we ..

Walmart is looking at buying PillPack, an online pharmacy, for under ...

CNBC-47 minutes ago

Sources say Walmart is looking at scooping up PillPack, a start-up that helps manage prescriptions by packaging pills together and delivering them, for less than $1 billion. Amazon also courted the online pharmacy start-up, the sources said. PillPack is a strategically important start-up, given its focus on customer service for ...

CNBC: Walmart looking to buy online pharmacy startup PillPack
Seeking Alpha-17 minutes ago

Walmart, Not Amazon, May Turn Out To Be The Real Health Care ...
Investor's Business Daily-1 hour ago

4 reasons Walmart would want to buy insurer Humana
CBS News-12 hours ago

Here's What a Possible Walmart/Humana Deal Could Mean for Your ...
TheStreet.com-6 hours ago

Walmart, Humana move closer as separate upheavals threaten
In-Depth-Philly.com-5 hours ago

Endo International Places Second Temporary Hold on Compounding ...

www.pharmalive.com/endo-international-places-a-second-temporary-hold-on-compo...

7 hours ago - The FDA's guidance, Endo said, states that because “compounded drug products are subject to a lower regulatory standard than FDA-approved drugs, they should only be used by patients whose medical needs cannot be met by an FDA-approved drug.”

2018 complete drug list (formulary) - UnitedHealthcare Community Plan

https://www.uhccommunityplan.com/.../en/2018-TN-Formulary-H0251-002-EN.pdf

16 hours ago - prescription medication customized to the needs of an individual patient. Generally compounded drugs are non-formulary drugs (not covered) by your plan. You may need to ask for and receive an approved coverage determination from us to have your compounded drug covered. Compounded drugs may be Part D eligible.

Endo Agrees to Extend Temporary Stay of FDA Litigation | BioSpace

https://www.biospace.com/.../endo-agrees-to-extend-temporary-stay-of-fda-litigation/

10 hours ago - In the new draft guidance, FDA also announced that if a "bulk drug substance is a component of an FDA-approved drug," prior to authorizing bulk compounding using that substance, "FDA intends to conduct a threshold review" to determine both (1) whether "an attribute of the FDA-approveddrug product makes it medically ...

Florida pharmacy owner gets 13 years for health care fraud

WCTV-5 hours ago

(AP) - The owner of a Florida pharmacy was sentenced to 13 years in prison for a health care kickback scheme. U.S. Attorney Maria Chapa Lopez of the Middle District of Florida said 53-year-old Larry Howard was sentenced on Friday and ordered to pay $4.3 million in restitution and surrender two properties he purchased ...

Orlando Pharmacy Owner Gets 13 Years For Health Care Fraud

WUSF News-6 hours ago

Federal prosecutors say Howard owned Orlando-area Fertility Pharmacy, and that he was involved in a kickback scheme with two others meant to funnel patients to doctors pre-selected by Howard. The doctors would prescribe expensive pain medications and scar creams that cost up to $17,000 per bottle. The medications 

Support grows for doctor indicted in compound pharmacy scheme

WDAM-TV-16 hours ago

Just shy of 1,000 likes, the 'Support Albert Diaz, MD' Facebook page is overflowing with posts from people recalling their experiences with him. On March 2, he was found guilty of 16 charges in a compound pharmacy scheme to defraud TRICARE--- a healthcare program for uniformed service members and their families of ...

AmerisourceBergen Corporation (NYSE:ABC) Files An 8-K ...

Market Exclusive-5 hours ago

There is compelling patient need and significant market demand for safe and effective compounded sterile preparation products. .... segments, including the operations of AmerisourceBergen Drug Corporation (ABDC) and AmerisourceBergen Specialty Group (ABSG), which distributes specialty drugs to their customers

Cantrell Drug Still Feeling Heat of FDA | Arkansas Business News ...

www.arkansasbusiness.com/article/121407/cantrell-drug-still-feeling-heat-of-fda

13 hours ago - Cantrell Drug, already reorganizing under bankruptcy court protection, went to court in early March to stop the U.S. Food & Drug Administration from proceeding with its suit, filed on Feb. 28, to halt Cantrell's production and distribution of compounded drugs.

Walmart may have designs on Humana: Here's what could happen ...

https://www.cnbc.com/.../walmart-may-have-designs-on-humana-heres-what-could-ha...

23 hours ago - Walmart has been making forays into consumer health care for more than a decade. Now, the nation's largest retailer may be looking to play a bigger role in the sector by acquiring Medicare insurance giant Humana — just as its rival Amazon is increasingly making its own moves in the health care market.

Humana, health insurer shares surge on Walmart's potential bid

https://www.cnbc.com/.../humana-health-insurer-shares-surge-on-walmarts-potential-b...

5 hours ago - Shares of Anthem, UnitedHealth and Medicaid-provider Centene rise in premarket trading after sources confirm early deals talks between Walmart and Humana. ... Major health insurance stocks rose across the board Monday, the first day of trading since reports revealed Walmart has ..

Here's What a Possible Walmart/Humana Deal Could Mean for Your Retirement Paying for healthcare costs could be among your biggest concerns after retiring. Here's how the possible tie-in might change the way you access care.

https://www.thestreet.com/story/14541436/1/what-a-possible-walmart-humana-deal-could-mean-for-your-retirement.html

FDA Study Reveals Presence of Pharmaceutical Drugs in Some dietary supplements

FDA Study Reveals Presence of Pharmaceutical Drugs in Some ...

WholeFoods Magazine-Mar 30, 2018

Washington, D.C. — A U.S. Food and Drug Administration (FDA) pilot study using portable screening devices has revealed the presence of pharmaceutical drugs in products marketed as dietary supplements. The FDA recently concluded a six-month pilot at two international mail facilities (IMFs) where the FDA monitors the ...