The Law of Compounding Medications And Drugs

Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues

Saturday, April 30, 2016

Sale of complementary medicines unethical: Australian doctors

BioEdge-6 hours ago
Criticism is mounting in Australia about the sale of low-evidence complementary medicines in pharmacies. An ABC radio report last month censured the ...
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Valeant files tardy financial report

San Jose Mercury News-3 hours ago
Valeant cut ties with Philidor last fall amid allegations that Philidor created a network of "phantom pharmacies" to steer pharmacybenefit managers toward ...
Valeant Pharmaceuticals Files Overdue US 2015 Financial Report
New York Times-20 hours ago
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The Cost of Developing an FDA-Approved Drug Is Truly Staggering, Study Shows Chances are you're probably underestimating how much it really costs to take a drug from the lab to pharmacy shelves.

http://www.fool.com/investing/general/2016/04/30/the-cost-of-developing-an-fda-approved-drug-is-tru.aspx
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Diplomat to buy California-based TNH Advanced Specialty Pharmacy

pharmabiz.com-16 hours ago
Diplomat Pharmacy, Inc., the largest independent specialty pharmacy, has signed a definitive agreement to acquire Valley Campus Pharmacy, Inc., doing ...
- April 30, 2016 No comments:
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Buddy Carter's Speech on Compounding to the House

http://www.iacprx.org/news/news.asp?id=286847&hhSearchTerms="buddy and carter"
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Here’s What’s Happening with Drug Costs in Workers’ Compensation:The cost to payers for compounded medications averaged $1,769.45 per prescription in 2015.

http://insurancequotesonlinehq.com/2016/04/heres-whats-happening-with-drug-costs-in-workers-compensation.html
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FBI investigates expensive 'pain creams' billed to taxpayers by compounding pharmacies

FBI investigates expensive 'pain creams' billed to taxpayers ...

pix11.com/.../fbi-investigates-expensive-pain-creams-billed-to-tax...
WPIX
5 hours ago - Compounding pharmacies create their own drugs by combining two or more prescription ingredients into one product. Their use by current and former military
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Friday, April 29, 2016

Express Scripts to move faster to battle sudden drug price hikes

St. Louis Business Journal-13 hours ago
The pharmacy benefits manager (Nasdaq: ESRX) was discussing the benefit programs with its customers at its annual meeting Thursday in Florida, Chief ...
Express Scripts plans fiercer fight against sudden drug price hikes
Business Insurance-8 hours ago
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Does videotape support CVS or fired pharmacist?

ModernMedicine-21 hours ago
That's the question a Richmond, Va. jury will decide in a case involving a pharmacist who accuses the retail giant of defamation, false imprisonment, malicious ...
- April 29, 2016 No comments:
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Valeant tries corporate housecleaning

USA TODAY-7 hours ago
... be ugly," with some impairments and depressed earnings" as the company moves further into its prescription distribution deal withpharmacy giant Walgreens.
Valeant files overdue financial report, ending debt default, but its ...
In-Depth-Los Angeles Times-6 hours ago
Explore in depth (94 more articles)
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DEA National Prescription Drug Take-Back Day is April 30

Pharmacy Today, American Pharmacists Association, pharmacist.com-1 hour ago
To find the nearest participating pharmacy or law enforcement department, visit the DEA website and select “Locate a collection site near you.” The website also ...
How the DEA gets rid of unused pills from take-back events
In-Depth-Washington Times-8 hours ago
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PillPack ends spat with huge prescription benefits company

The Boston Globe-5 hours ago
Express Scripts Holding Co. had planned to remove PillPack from its network of approved pharmacies at the end of April, saying the smaller company violated 
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Pharma companies accused of manipulating patents

Pharmacy News-20 hours ago
Access to cheaper and better drugs is being hampered in Australia by canny manipulation of patent regulations by pharmaceutical companies, the Productivity .
- April 29, 2016 No comments:
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Prince Cops Search Singer's Pharmacy for Clues
TMZ.com‎ - 5 hours ago
Authorities descended on a Walgreens near Paisley Park and served a search warrant on the pharmacy, TMZ ...
Authorities raid Minnesota Walgreens where Prince reportedly picked up prescriptions for heavy-duty medications
New York Daily News‎ - 4 hours ago
- April 29, 2016 No comments:
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N.C. Drug Formulary Could Save $9 Million According to a WCRI study, North Carolina stands to reap huge savings by adopting a Texas-style workers' comp drug formulary. By: Nancy Grover | April 25, 2016

http://www.riskandinsurance.com/n-c-drug-formulary-save-9-million/
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FDA 483 dated 10/09/2015 Ambient Healthcare of Central Florida Inc. State Referral Letter FL Producer of Sterile Drug Products posted 04/29/2016

10/09/20153010810839Ambient Healthcare of Central Florida Inc.State Referral LetterFLProducer of Sterile Drug Products04/29/2016
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Federal judge enters order of permanent injunction against Paul W ...

FDA.gov-4 hours ago
“Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Janet Woodcock, director of the FDA's Center .
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New Board of Pharmacy Regulations Significantly Narrow the Sole Proprietor Exemption and Impose New Compounding Standards Friday, April 29, 2016 - See more at: http://www.natlawreview.com/article/new-board-pharmacy-regulations-significantly-narrow-sole-proprietor-exemption-and#sthash.GNeURvQo.dpuf



New Board of Pharmacy Regulations Significantly Narrow the Sole...

The National Law Review-4 hours ago
New regulations from the Ohio State Board of Pharmacy now require any prescriber ... Ohio law defines “compounding” as the preparation, mixing, assembling, ...
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Iowa Board of Pharmacy Meeting Scheduled for May 3-4, 2016

Board Meeting: May 3-4, 2016
05/03/2016 - 9:00am to05/04/2016 - 4:30pm
- April 29, 2016 No comments:
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Pharmacies Say Express Scripts Conspiracy Suit Has Legs



    Pharmacies Say Express Scripts Conspiracy Suit Has Legs ...

    www.law360.com/.../pharmacies-say-express-scripts-conspiracy-...
    Law360
    23 hours ago - Express Scripts' bid to escape an antitrust suit brought by compounding pharmacies who say it conspired with other pharmacy benefit managers to push them ...

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    “The American people must be protected from compounded sterile drugs that pose a risk to the public health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to deter compounding pharmacies that distribute adulterated or misbranded drugs and put patients at risk of significant harm.”

    quoted from https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-former-owner-and-operator-compounding
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    District Court Enters Permanent Injunction Against Former Owner and Operator of Compounding Pharmacies to Enjoin Distribution of Certain Sterile Drugs Products

    Department of Justice
    Office of Public Affairs

    FOR IMMEDIATE RELEASE
    Friday, April 29, 2016

    District Court Enters Permanent Injunction Against Former Owner and Operator of Compounding Pharmacies to Enjoin Distribution of Certain Sterile Drugs Products

    The U.S. District Court for the Middle District of Florida entered a permanent injunction against Paul W. Franck, who has owned and operated numerous compounding pharmacies, to enjoin the distribution of certain sterile drugs products, the Department of Justice announced today.
    “The American people must be protected from compounded sterile drugs that pose a risk to the public health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  “The Department of Justice will continue to work aggressively with the FDA to deter compounding pharmacies that distribute adulterated or misbranded drugs and put patients at risk of significant harm.”
    The department filed a complaint in the District Court at the request of the Food and Drug Administration (FDA), alleging that Franck violated the federal Food, Drug and Cosmetic Act (FDCA) by causing drugs to become adulterated and misbranded while such drugs were held for sale after shipment of one or more of their components in interstate commerce. 
    As alleged in the complaint, Franck has owned and operated numerous compounding pharmacies in the state of Florida over the past 20 years and he was responsible for providing final approval for all decisions concerning manufacturing and quality operations.  The complaint alleged that the defendant and/or his employees manufactured, processed, packed, labeled, held and/or distributed drugs, including sterile drugs such as antibiotics, antivirals, cardiovascular drugs, drugs for pain management and total parental nutrition. 
    In conjunction with the filing of the complaint, Franck agreed to settle the case.  The permanent injunction entered by the court requires that Franck cannot manufacture, hold or distribute any sterile drugs at or from his facility unless and until his facility, equipment, processes and procedures used to manufacture, hold, or distribute drugs are established, maintained, operated and administered in conformity with the permanent injunction and all applicable laws and regulations and are adequate to prevent such drugs from becoming adulterated or misbranded as defined in the order.  Franck must also, among other things, establish and maintain a system to report to FDA all adverse drug experiences associated with his drugs.      
    The complaint alleged that a FDA inspection of Franck’s Lab Inc., doing business as Trinity Care Solutions in May 2014, found conditions establishing that the drugs manufactured and distributed by the defendant were adulterated.  For example, FDA observed dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the sterile manufacturing area, the area where non-sterile gowns were stored and donned, and the sink where employees prepared for sterile processing.  In addition, as alleged in the complaint, FDA found other insanitary conditions, such as lack of sufficient physical barriers to prevent the introduction of contamination from nearby construction; lack of positive air pressure in the clean room relative to surrounding rooms which compromises the cleanliness of the clean room’s air; and materials around the laminar flow hood’s vent that were not cleanable and were potential sources of viable and non-viable particles.  The complaint alleged that the defendant violated the FDCA by causing articles of drug to become adulterated, in that they are prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health, while such drugs were held for sale after shipment of one or more of their components in interstate commerce.
    The complaint also alleged that FDA inspected the defendant’s pharmacy, Franck’s Lab Inc. dba Franck’s Compounding Pharmacy, between March and May 2012.  As alleged in the complaint, FDA initiated this inspection following reports of eye infections in patients who had been administered an injectable sterile eye solution, Brilliant Blue G (BBG) and/or injectable drug products containing triamcinolone (triamcinolone drugs) that had been compounded by Franck’s Lab.  As alleged in the complaint, FDA laboratory analysis of samples of the defendant’s compounded BBG collected during this inspection revealed that the drug was contaminated with a fungus as well as other microorganisms, and these fungus-type organisms matched the clinical isolates from patients who developed eye infections after administration of this drug. 
    The complaint alleged, among other things, that the defendant violated the FDCA by causing drugs to become adulterated in that they consisted in whole or in part of a filthy, putrid, or decomposed substance, while such drugs were held for sale after shipment of one or more of their components in interstate commerce and that because the defendant’s purportedly sterile drugs contained microbiological contamination, the defendant’s labeling for such drugs was false or misleading.  According to the complaint, as of March 2013, the U.S. Center for Disease Control had identified 47 cases of eye infections among 45 patients in nine states linked to exposure to the defendant’s BBG and/or triamcinolone drugs.
    In addition, as noted in the complaint, the defendant has conducted a number of recalls of drugs over the years manufactured and distributed from his pharmacies.    
    As part of the proposed consent decree submitted to the court, the defendant represented that as of the date of the entry of the decree, he is not engaged in the manufacture, holding, or distribution of any drugs, nor he is causing the manufacture, holding, or distribution of drugs.  The permanent injunction provides that if the defendant intends to resume manufacturing, holding or distributing any drugs at or from his facility, he shall notify FDA in advance of doing so.
    The permanent injunction includes limited, precise exceptions for drugs for animal use or any drug for which the defendant is the sponsor of a new drug application approved by FDA.
    “Mr. Franck risked the health of the American public by compounding drugs under unacceptable conditions,” said Director Janet Woodcock of the FDA’s Center for Drug Evaluation and Research.  “Today’s action reflects the FDA’s continued efforts to take appropriate and aggressive enforcement action against those who put patients’ health at risk by choosing not to follow the law.”
    The government is represented by Trial Attorney Roger Gural of the Civil Division’s Consumer Protection Branch, with the assistance of Senior Counsel Michele Svonkin of the Department of Health and Human Services’ Office of General Counsel – Food and Drug Division.
    15-512
    Civil Division
    Topic: 
    Consumer Protection
    Updated April 29, 2016
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    Thursday, April 28, 2016

    Must Read! Must Watch! DOD, FBI investigate expensive 'pain creams' billed to taxpayers Posted: Apr 28, 2016 1:11 PM CDT Updated: Apr 28, 2016 8:00 PM CDT Read more: http://www.cbs5az.com/story/31841696/dod-fbi-investigate-expensive-pain-creams-billed-to-taxpayers#ixzz47B6dmg34


    - April 28, 2016 No comments:
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    Public Citizen Sues FDA Over Redacted Advisory Committee Info | RAPS

    Public Citizen Sues FDA Over Redacted Advisory Committee Info | RAPS
    - April 28, 2016 No comments:
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    New Mexico Enhancing Out-of-Competition Drug Testing Program

    New Mexico Enhancing Out-of-Competition Drug Testing Program
    - April 28, 2016 No comments:
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    Prescription drug compounding is beginning to turn a corner ...

    www.riskandinsurance.com/compounding-coming-age/
    11 hours ago - By definition, compounding is a practice through which a licensed pharmacist or physician (or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist) combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
    - April 28, 2016 No comments:
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    Intl Academy of Compounding Pharmacists Contributors ...

    https://www.opensecrets.org/.../pacgave2.p...
    Center for Responsive Politics
    13 hours ago - Intl Academy of Compounding Pharmacists. Summary ...
    - April 28, 2016 No comments:
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    Adamis Pharmaceuticals: Multi-Year Highs After Recent USCompounding Acquisition
    Seeking Alpha
    Adamis acquires US Compounding, a compounding pharmacy with $20M+ yearly revenues and FDA approved manufacturing
    - April 28, 2016 No comments:
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    FDA Seeks Public Comments on Approval Process for Combination Drug Medicated Feeds – Reopening of Comment Period - http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm459067.htm


    - April 28, 2016 No comments:
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    OSBP 2016 CE CONFERENCE

    The Oklahoma State Board of Pharmacy will be hosting a half-day continuing education conference on Thursday, June 23, 2016.  This event, including lunch, is being funded entirely by the Board to further its mission of protecting the health, safety and welfare of the citizens of Oklahoma.
    A "Review of USP Chapter <797> for the Pharmacy Professional" will bepresented by Heith A. Crosby, Pharm.D., Ph.D., RCCP-SC (Registered Cleanroom Certification Professional in Sterile Compounding).  The program is approved for three (3) hours of ACPE-accredited continuing education.  Lunch is included with registration and will be served at noon with the program starting promptly at 1:00 p.m.  Attendance is limited to the first 300 pharmacists who register.
    Date & Location:
    Thursday, June 23, 2016
    Oklahoma Sports Hall of Fame Event Center
    4040 N Lincoln Blvd
    Oklahoma City, OK
    Sign-In:
    11:00 am - 12:00 pm
    Lunch: (no cost- included with free registration)
    12:00 pm - 1:00 pm
    Program:
    1:00 pm - 4:30 pm
    REGISTRATION:
    Reservations will be accepted on a first-come basis. Email the following information to sdozal@pharmacy.ok.gov to reserve a spot:
    • Name
    • OK  DPh License #
    • e-Profile ID #
    • Birth Month/Day
    View Conference Flyer:
    OSBP 2016 CE Conference - OKC
    - April 28, 2016 No comments:
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    Suspicious' prescription led to lawsuit

    Suspicious' prescription led to lawsuit

    Virginia Lawyers Weekly-54 minutes ago
    Tighter rules on some kinds of drug prescriptions have put pharmacists and law enforcement on alert for efforts to evade controls. Sometimes their suspicions 
    - April 28, 2016 No comments:
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    Legislative report

    Ozark County Times-17 hours ago
    SB 875 - Allows a pharmacist to select an interchangeable biological product when filling a biological product prescription. SB 838 - Allows the court to order a .
    - April 28, 2016 No comments:
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    6 measles cases reported in Memphis area, exceeding rest of US

    Pharmacy Today, American Pharmacists Association, pharmacist.com-17 minutes ago
    The number of measles cases in 2016 had been held to just four nationwide until last week, when an outbreak in the Memphis area spawned six new cases in 
    - April 28, 2016 No comments:
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    Pfizer to pay $784.6 million to resolve drug discount case

    Pfizer to pay $784.6 million to resolve drug discount case

    Pharmacy Today, American Pharmacists Association, pharmacist.com-14 minutes ago
    Pfizer has agreed to pay $784.6 million to resolve a 14-year-old lawsuit claiming its Wyeth unit overcharged the government by hiding the discounts it was giving ..
    - April 28, 2016 No comments:
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    Families, lawmakers call for FDA ban on powdered caffeine

    Pharmacy Today, American Pharmacists Association, pharmacist.com-14 minutes ago
    Sens. Richard Blumenthal (D-CT), Sherrod Brown (D-OH), and Dick Durbin (D-IL) are urging FDA to ban powdered caffeine. The agency issued a warning about ...
    - April 28, 2016 No comments:
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    Lawmakers blast Valeant for price-gouging tactics

    Pharmacy Today, American Pharmacists Association, pharmacist.com-14 minutes ago
    Members of the Senate Committee on Aging on Wednesday accused Valeant Pharmaceuticals of gouging patients to reward Wall Street investors. Throughout a .
    - April 28, 2016 No comments:
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    Harvard mumps outbreak grows to 40 cases

    Pharmacy Today, American Pharmacists Association, pharmacist.com-14 minutes ago
    The Massachusetts Department of Health reports that an outbreak of mumps at Harvard University has increased significantly since mid-March, with a total of 40 ...
    - April 28, 2016 No comments:
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    House panel approves bipartisan drug abuse legislation

    House panel approves bipartisan drug abuse legislation

    Pharmacy Today, American Pharmacists Association, pharmacist.com-13 minutes ago
    The House Judiciary Committee on Wednesday overwhelmingly approved federal grants that would bolster state and local efforts against the abuse of opioid ...
    - April 28, 2016 No comments:
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    Valeant Chief Says It Made Mistakes on Aggressive Drug Pricing

    New York Times-14 hours ago
    ... practice of buying companies, slashing costs and raising prices, as well as its relationship to a mail-order pharmacy, Philidor. It has since cut ties with Philidor.
    Valeant's Michael Pearson Admits Aggressive Drug-Price Increases ...
    In-Depth-Wall Street Journal-13 hours ago
    Explore in depth (265 more articles)
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    A federal judge in Texas has blocked a Texas pharmacy

    Pharmacy stuck in Cialis patent war between Eli Lilly, German firm

    Reuters-1 hour ago
    A federal judge in Texas has blocked a Texas pharmacy chain's early exit from the patent war between Eli Lilly and a German pharmaceutical firm over the use ...
    - April 28, 2016 No comments:
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    Where’d You Get That Number? The Process Behind Therapeutic Drug Guidelines In Racing by Natalie Voss | 04.27.2016 | 8:41pm


    http://www.paulickreport.com/news/ray-s-paddock/whered-get-number-process-behind-therapeutic-drug-guidelines-racing/
    - April 28, 2016 No comments:
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    INTERNATIONAL ACADEMY OF COMPOUNDING PHARMACISTS PAC donations to the House and Senate

    Intl Academy of Compounding Pharmacists Summary ...

    https://www.opensecrets.org/.../lookup2.ph...
    Center for Responsive Politics
    19 hours ago - Official PAC Name: INTERNATIONAL ACADEMY OF COMPOUNDINGPHARMACISTS PAC (COMP PAC) Location: MISSOURI CITY, TX
    - April 28, 2016 No comments:
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    Wednesday, April 27, 2016

    FDA Publishes Three Draft Guidance Documents Related to ...

    www.nabp.net/.../fda-publis...
    National Association of Boards of Pharmacy
    5 hours ago - “Hospital and Health System Compounding Under the Federal Food, Drug, and ... or health system pharmacies for use within the hospital or health system
    - April 27, 2016 No comments:
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    NABP 112th Annual Meeting Covers Timely Pharmacy Practice and Regulation Topics and Offers Up to Eight Contact Hours of CPE Credit

    http://www.nabp.net/news/nabp-112th-annual-meeting-covers-timely-pharmacy-practice-and-regulation-topics-and-offers-up-to-eight-contact-hours-of-cpe-credit
    - April 27, 2016 No comments:
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    At Least 52 People Hospitalized, 13 Dead In California After Overdosing On Counterfeit Painkiller


    https://consumerist.com/2016/04/27/at-least-52-people-hospitalized-13-dead-in-california-after-overdosing-on-counterfeit-painkiller/
    - April 27, 2016 No comments:
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    Alberta Pharmacists Cannot Impose Ban On Reward Point ...

    Huffington Post Canada-6 hours ago
    A Court of Queen's Bench judge has ruled the regulator of Albertapharmacists does not have the legal power to impose a ban on consumer loyalty program
    - April 27, 2016 No comments:
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    Fresenius Kabi USA recalls one lot of bupivacaine HCl injection

    Pharmacy Today, American Pharmacists Association, pharmacist.com-8 hours ago
    Fresenius Kabi USA has launched a voluntary recall of one lot of bupivacaine HCl (Sensorcaine-MPF) injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL .
    - April 27, 2016 No comments:
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    Follow UK with general practice pharmacists: PSA

    Australian Journal of Pharmacy (registration) (blog)-20 hours ago
    The Australian Government should follow the UK and provide funding support for integrating pharmacists into general practice clinics, according to the PSA
    - April 27, 2016 No comments:
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    Former UConn pharmacist faces 173 charges for forging prescriptions

    Becker's Hospital Review-48 minutes ago
    An internal audit conducted last April found numerous items, including controlled substances, ordered by Mr. Olzinkski were missing from the pharmacy's ..
    - April 27, 2016 No comments:
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    Valeant Was Too Aggressive in Raising Drug Prices, CEO Says
    Wall Street Journal-15 hours ago
    It has faced concerns over its ​now-ended ​ties to a mail-order pharmacythat former employees said used aggressive
    - April 27, 2016 No comments:
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    Phone-throwing, swearing pharmacist loses unfair dismissal appeal
    Australian Journal of Pharmacy (registration) (blog)-1 hour ago
    A pharmacist who threw a phone and verbally abused his business partner and told a staff member to “go and tell more
    - April 27, 2016 No comments:
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    GROUPS LOBBY SENATE AG APPROPRIATORS ON DRUG COMPOUNDING — Six groups are calling on Senate appropriators today to ensure that the language in the FY 2017 agricultural spending bill "does not impede FDA’s ability to ensure patient safety" by hampering new guidance on drug compounding. The groups — an unusual coalition that includes the American Public Health Association, Biotechnology Industry Organization, Generic Pharmaceutical Association, Pew Charitable Trusts, Pharmaceutical Research and Manufacturers of America and Trust for America’s Health Read more: http://www.politico.com/tipsheets/politico-pulse/2016/04/what-valeants-ceo-will-tell-the-senate-today-213990#ixzz473Tua2uu


    - April 27, 2016 No comments:
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    What Valeant's CEO will tell the Senate today
    Politico-4 hours ago
    GROUPS LOBBY SENATE AG APPROPRIATORS ON DRUG COMPOUNDING — Six groups are calling
    - April 27, 2016 No comments:
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