The Law of Compounding Medications And Drugs: October 2016

Monday, October 31, 2016

ModernMedicine-5 hours ago

Mark Gilmore, partial owner of compounding and specialty pharmacy QMedRx in Maitland, Fla., is one of several compounders who have been accused by the ...

meningitis-etc: Anger, Frustration Grow as Victims Wait

meningitis-etc: Anger, Frustration Grow as Victims Wait: By Walter F. Roche Jr. Though miles apart Jack Pavlekovich and Joan Peay have some experiences in common, experiences they both wish th...

meningitis-etc: 2nd NECC Defendant Seeks Access to Civil Data

meningitis-etc: 2nd NECC Defendant Seeks Access to Civil Data: By Walter F. Roche Jr. A second defendant in the criminal case stemming from a deadly national fungal meningitis outbreak is seeking acce...

meningitis-etc: Amendment Sought to Ease Payments to Victims

meningitis-etc: Amendment Sought to Ease Payments to Victims: By Walter F. Roche Jr. Citing the recently negotiated multimillion dollar settlement with a Nashville clinic, lawyers for victims of the ...

10/17/2016	3012256766	Compounding Pharmacies of Louisiana Inc. dba Professional Arts Pharmacy	Closeout Letter	LA	Compounding Pharmacy	10/31/2016

October Journal 2016 - South Dakota Pharmacists Association

https://www.sdpha.org/.../SDPhA%20201610%20Fall%20Journal-Draft...

3 hours ago - nonsterile compounded drug preparations stored at controlled room temperature. The BUD shall ... The South Dakota Prescription Drug Monitoring Program (SD.

Recordkeeping Issues Cited in Form 483 for Belcher Pharmaceuticals

October 30, 2016

Recordkeeping and reporting issues were cited multiple times in a Form 483 received by Belcher Pharmaceuticals. Read More

FDA’s New Inspection Protocol Begins to Have Impact

October 30, 2016

The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More

Two Companies Get Warning Letters Over Misbranded Drugs, Product Specification

October 28, 2016Ajes Pharmaceuticals and Positive Power Nutrition have been hit with warning letters after the FDA conducted inspections. Read More

Posted on FDA website October 28, 2016 Pharmacy Compounding Advisory Committee

Pharmacy Compounding Advisory Committee

Pharmacy Compounding Advisory Committee Roster

A Conversation About Compounding Pharmacies... - SlideShare

www.slideshare.net/.../a-conversation-about-compounding-pharmacies-6...

2 hours ago - Compounding is standard pharmacy practice o Compounding is the preparation / formulation of medication not available from a manufacturer o Pharmacists combine different prescription and /or non-prescription ingredients to formulate a therapy which better suits a patient's needs.

Editorial: Drugs and insurance affordability will top the post-election agenda

Healthcare pricing concerns are making a late run for relevance as the presidential campaign heads down the homestretch. Unfortunately, too much attention is being paid to price hikes on the Obamacare exchanges, which affect only a thin sliver of the population. READ MORE

Friday, October 28, 2016

Feds probing Express Scripts' relationships with drugmakers ...

Crain's Chicago Business-16 hours ago

Federal investigators are looking into Express Scripts' dealings with pharma companies, charitable foundations and specialty pharmacies. The nation's largest ...

Could Express Scripts Holding Company Change Direction After ...
Frisco Fastball-18 hours ago

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Board of Pharmacy reviews legislative changes

Idaho Press-Tribune-4 hours ago

BOISE — The Idaho Board of Pharmacy agreed Thursday to pursue a legislative fix to Idaho's existing Prescription Monitoring Program, which is designed to ...

Express Scripts removes CVS, adds Walgreens to its retail ...

The Fort Campbell Courier-14 hours ago

Express Scripts Inc. is changing its retail pharmacy network that it manages on behalf of TRICARE. On Dec. 1, Walgreens pharmacy locations will join the ...

Apothecary By Design acquires Massachusetts fertility pharmacy

Press Herald-18 hours ago

Apothecary By Design acquires Massachusetts fertility pharmacy. This is the second acquisition this year for the Portland company, which specializes in ..

Imprimis Pharmaceuticals Registers its New Jersey Facility with the ...

Satellite PR News (press release)-1 hour ago

Section 503B of the new law allows outsourcing facilities to register with and submit to inspection by the FDA, produce certain finished compounded drugs to ...

Exclusive: Could Imprimis Pharmaceuticals Inc Go Up After ...

Press Telegraph-18 hours ago

The Firm operates through the business of developing drug therapies and providing such therapies through sterile and non-sterile pharmaceutical compounding ...

Compounding Pharmacy Makes a Difference

Specialty Pharmacy Times‎ - 36 mins ago

The everyday compounding pharmacist is there to meet the needs of patients—both human and animal.

Key Facts about “Abuse-Deterrent” Opioids

Drug Safety Oversight Board Meeting, May 19, 2016, Public Summary

Biosimilars in the US: Progress and Promise Presentation (PDF - 268KB)

FDA Law Blog: October 27, 2016 The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503B By James E. Valentine & Karla L. Palmer –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/10/the-update-continues-fdas-list-of-drugs-that-may-not-be-compounded-under-503a-and-503b.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

Proposed Rule; New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
October 28, 2016; 81 FR 74962

Thursday, October 27, 2016

Wedgewood Pharmacy Receives Marcum Innovator of the Year Award ...

www.businesswire.com/.../Wedgewood-Pharmacy-Receives-Marcum-Inn...

7 hours ago - Wedgewood Pharmacy, the largest U.S. compounding pharmacy specializing in animal health, was awarded the fourth annual Marcum Innovator of the Year ...

Interpharm gets FDA warning letter for Czech plant

FDA cites 'significant' sterility concern at Teva injectables plant

World News Wrapup: 27 October 2016

Australian Journal of Pharmacy (registration) (blog)-20 hours ago

The coroner concluded that an independent compounding pharmacy in ... Shah; the lawsuit also names an unidentified worker who compounded the medicine.

Pharmacy Owners, Physicians Charged in $100 Million Healthcare ...

Executive Insight-4 hours ago

“Fraud and abuse by pharmacies and medical providers that bill forcompounded prescriptions and/or medications is a significant threat to the DoD health care ...

DEA Administrative Hearings: “Open to the Public” Requires Notice to the Public Posted: 26 Oct 2016 08:03 PM PDT By John A. Gilbert, Jr. & Andrew J. Hull –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/10/dea-administrative-hearings-open-to-the-public-requires-notice-to-the-public.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

FDA Seeks Public Comments on Updating Tolerances for Residues of New Animal Drugs in Food

The U.S. Food and Drug Administration issued a proposal today to amend its 2012 proposed rule for New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.

The 2012 proposed rule included revisions to the animal drug regulations regarding tolerances for residues of approved and conditionally-approved new animal drugs in food. In addition to proposing to standardize, simplify, and clarify the standards of determination and codification style for tolerances, FDA proposed a new definition section. In direct response to comments received, the document issued today revises or removes some of the previously proposed definitions.

Wednesday, October 26, 2016

Hormonal doping and androgenization of athletes: a secret program of the German Democratic Republic government Werner W. Franke, Brigitte Berendonk Published July 1997

http://clinchem.aaccjnls.org/content/43/7/1262.full

FDA Delaying 'Miracle Drug' For Patients Relying On Feeding Tubes

Daily Caller-2 hours ago

The drug Domperidone was not approved by the FDA, but, until recently, was fairly easily obtained from compounding pharmacies, Goldwater Institute .

Freeing the False Claims Act

The Hill-2 hours ago

Yet the people who are most likely to know about anti-governmentfraud ... change, taxpayers' recovery of money from healthcare-related qui tam cases has ...

Pa. advances rules on medical marijuana law

Tribune-Review-14 hours ago

When they open in 2018, Pennsylvania's medical marijuana dispensaries must be staffed at all times by a doctor or pharmacist, according to preliminary state ...

Pennsylvania puts out draft regs for medical marijuana dispensaries
Allentown Morning Call-18 hours ago

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Express Scripts narrows profit outlook

Pharmacy Today, American Pharmacists Association, pharmacist.com-20 minutes ago

Express Scripts announced Tuesday a profit of $722.9 million for the third quarter, or $1.15 a share. That figure is up from $661.7 million, or 97 cents a share, ...

Could other providers upskill rural pharmacists?

Australian Journal of Pharmacy (registration) (blog)-20 hours ago

Since the third community pharmacy agreement, the focus has been on developing professional programs including interprofessional collaboration and working .

Rural pharmacist shortage is biting hard

Australian Journal of Pharmacy (registration) (blog)-6 hours ago

The issue of whether or not pharmacists should leave major cities in order to find work – or well paying work – has arisen again, with AJP readers highlighting a ..

Diplomat Pharmacy (DPLO) CFO Sean Whelan to Step Down; Paul ...

StreetInsider.com-16 hours ago

Diplomat Pharmacy, Inc. (NYSE: DPLO) today announced that Paul Urick has been promoted to Diplomat's president, effective Nov. 1, 2016. Gary Kadlec will ...

Diplomat Pharmacy Inc. (DPLO) Position Boosted by Riverbridge ...
The Cerbat Gem-16 hours ago

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Express Scripts gets subpoenas over drug company, pharmacy ties

STLtoday.com-15 hours ago

Express Scripts Holding Co., the nation's biggest pharmacy benefit manager, has received subpoenas requesting information about its relationship with ...

The Feds are starting to dig in at the biggest middle-man in the ...
Business Insider-15 hours ago

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Shoppers Drug Mart, Canada's largest pharmacy chain, applies for ...

Washington Times-16 hours ago

Obtaining medical marijuana in Canada could soon be as easy as strolling into the neighborhood pharmacy. Shoppers Drug Mart, the nation's largest drug store ...

Pharmacy applies to distribute medical marijuana
630ched.com-19 hours ago

Shoppers Drug Mart applies to be a distributor of medical marijuana
The Beacon Herald-14 hours ago

Shoppers Drug Mart formally applies to distribute medical marijuana
Highly Cited-CBC.ca-Oct 25, 2016

RNC Release Security Footage of Armed Robbery
International-VOCM-19 hours ago

Shoppers Drug Mart Marijuana Could Really Be A Thing
Highly Cited-Huffington Post Canada-21 hours ago

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UPDATE: Pharmacy manager pleads guilty to heatlhcare fraud

WCYB-17 hours ago

A former Kingsport pharmacy administrator pleaded guilty in federal court in Greeneville Tuesday after waiving her preliminary hearing earlier this month.

Former Walgreen's clinical pharmacy manager pleads guilty to fraud ...
Winchester Herald Chronicle-18 hours ago

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Fletcher: Another Look at Physician Dispensing

WorkCompCentral (subscription)-6 hours ago

Without a claim number and approval from the carrier, often, a pharmacy will ... dispense (with the exception of compounding drugs, which are not subject to a

Feds warn Ben Franklin pharma company about unsanitary conditions

Allentown Morning Call-3 hours ago

The FDA also says the company neglected to provide pertinent label information, such as "This is a compounded drug," on the product. The infractions violate

Purdue-related startup develops virtual cleanroom educational tool to ...

https://www.purdue.edu/.../purdue-related-startup-deve...

Purdue University

8 hours ago - "Sterile compounding meets an important health care need, however, concern associated with compounding errors in recent years has led to closer scrutiny of ...

Edge Pharmacy, 81 Fed. Reg. 72092 (Oct. 19, 2016)

https://www.deadiversion.usdoj.gov/fed_regs/actions/2016/fr1019.pdf

FDA Law Blog - DEA Administrative Decisions Update: DEA’s Questionable Practice of (Un)official Notice DEA Administrative Decisions Update: DEA’s Questionable Practice of (Un)official Notice Posted: 25 Oct 2016 07:40 PM PDT By Karla L. Palmer & Andrew J. Hull –

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/

CDER Statement: FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)

Tuesday, October 25, 2016

FDA’s Opioids Action Plan: A Midyear Checkup

Public Notification: Zi Su Body Fat Health II (紫苏瘦身营养素 II – Zi Su Shou Shen Ying Yang Su II) Contains Hidden Drug Ingredient

10/25/2016 12:48 PM EDT

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Zi Su Body Fat Health II, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.