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Tuesday, July 21, 2015

FDA Chart of Guidances (Drugs) Compounding

Guidances (Drugs) Compounding

Safety Alerts for Human Medical Products 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter

Safety Alerts for Human Medical Products 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter

Press Release: IACP Files Formal Comments on Proposed FDA Memorandum of Understanding - International Academy of Compounding Pharmacists

Press Release: IACP Files Formal Comments on Proposed FDA Memorandum of Understanding - International Academy of Compounding Pharmacists

Recently Updated Advisory Committee Materials-Compounding Materials from June 2015 Meeting including slides

Recently Updated Advisory Committee Materials

2015 KRS Global Biotechnology, Inc 7/6/15-compounded drugs

2015 KRS Global Biotechnology, Inc 7/6/15

2015 Hoof Health LLC dba Hoof Effects 7/9/15

2015 Hoof Health LLC dba Hoof Effects 7/9/15

CVS fires back at claims by Hopkinton Drug - News - Hopkinton ...

  1. CVS fires back at claims by Hopkinton Drug - News - Hopkinton ...

    Wicked Local Hopkinton-16 hours ago
    HOPKINTON — CVS is firing back at the owner of Hopkinton Drug for alleging thepharmacy chain has violated safety regulations in compounding prescription ...

Monday, July 20, 2015

List of FDA Compounding Registered Outsourcing Facilities as of 07/10/15

Compounding Registered Outsourcing Facilities

PetMed Express D/B/A 1-800-PetMeds Announces Its First Quarter ...

PetMed Express D/B/A 1-800-PetMeds Announces Its First Quarter ...

CNNMoney-3 hours ago
Founded in 1996, PetMed Express is America's Largest Pet Pharmacy, delivering prescription and non-prescription pet medications and other health products ...

First-ever legal drone delivery takes place in the US


First-ever legal drone delivery takes place in the US

Mashable-11 hours ago
The operation kicked off with a fixed-wing aircraft, operated by NASA Langley Research Center pilots, carrying 24 packages of medicine from apharmacy in ...

KS : Pharmacist required to be in charge of pharmacy; compounding

Pharmacist required to be in charge of pharmacy; compounding

kslegislature.org › Home › Statute › Chapter 65 › Article 16
19 hours ago - Pharmacist required to be in charge of pharmacycompounding, filling and refilling of prescriptions; refusal to fill; brand exchange. [See Revisor's Note] In every ..

Friday, July 17, 2015

Waiting for the government

Waiting for the government

Pharmacy News-21 hours ago
A review of current HMR funding arrangements should be at the forefront of the planned review of 6CPA professional service programs, thePharmacy Guild of ...

Canadians Support Pharmacare Program That Includes Private ...

Canadians Support Pharmacare Program That Includes Private ...

Pharmaceutical Online (press release)-20 hours ago
According to the survey, 78% of Canadians feel that pharmacare should also cover services provided by pharmacists to dispense, monitor and counsel patients ...

Pharmacy clerk busted over patient data |

Pharmacy clerk busted over patient data | SanDiegoUnionTribune.com

The San Diego Union-Tribune-3 hours ago
The California State Board of Pharmacy has suspended the license of apharmacy technician accused of stealing data regarding 100 patients, which was used ...

FEI urges caution over use of muscle product in sport horses

FEI urges caution over use of muscle product in sport horses ...

horsetalk.co.nz › News
2 hours ago - Caution urged over compounded drugs in horses Warning over detection times and adverse effects when off-label drugs used.... UAE trainer gets 12-month ban  ...

China Ramps Up Inspections at Foreign Drug Plants

China Ramps Up Inspections at Foreign Drug Plants

Just as the U.S. Food and Drug Administration is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More

FDA Adds Another Indian Drugmaker to Import Ban List

FDA Adds Another Indian Drugmaker to Import Ban List

The FDA has banned all imports from Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility due to current good manufacturing practice violations, making it the latest in a growing list of Indian firms facing agency action. Read More

Indian Manufacturer Nosch Labs Hit With 483 for Not Rejecting APIs

Another Compounder’s Sterility Issues Result in Form 483

Another Compounder’s Sterility Issues Result in Form 483

A Montana compounder was hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. Read More

Judge: Missouri broke law keeping execution supplier secret : News ...

Judge: Missouri broke law keeping execution supplier secret : News ...
KTVO-1 hour ago
(AP) -- A circuit judge has ruled that Missouri violated open records laws by refusing to disclose thepharmacies that ...

Compounding Pharmacies Market - Global Industry Analysis and Forecast 2015 - 2021 | Medgadget Medgadget.com (blog



Compounding can be defined as the mixing of different drugs by a pharmacist in the licensed laboratory. Compound medications are prescribed by a ..

Federal agents search records, drug inventories at Martinsburg, WV ... State Journal-19 hours ago

Federal agents search records, drug inventories at Martinsburg, WV ...
State Journal-19 hours ago
Federal authorities have searched a Martinsburgpharmacy to “verify the correctness of controlled substance inventories ...

Employee Or Contractor? New U.S. Guidelines Could Reclassify Workers NPR‎ - 17 hours ago

Missouri Department of Corrections cannot shield pharmacy by saying it is part of execution team By RACHEL LIPPMANN • 15 HOURS AGO

Thursday, July 16, 2015

Court upholds public's right to know pharmacy used to supply ...

Court upholds public's right to know pharmacy used to supply ...

www.stltoday.com/...pharmacy.../article_085e08b6-42c6-5b87-bbce-6edec...
8 hours ago - The Missouri Department of Corrections broke the law by failing to reveal thepharmacy that supplied the drugs used to administer the death penalty, according ...

On July 10, 2015, Imprimis Pharmaceuticals, Inc. (the "Company") entered into a Stock Purchase Agreement (the "Purchase Agreement") to acquire all of the outstanding capital stock of JT Pharmacy, Inc. D/B/A Central Allen Pharmacy ("CAP")

  • Summary of IMPRIMIS PHARMACEUTICALS, INC. - Yahoo! Finance

    biz.yahoo.com/e/150716/immy8-k.html
    5 hours ago - CAP is a compounding and retail pharmacy located in Allen, Texas and licensed to conduct pharmacy operations in the state of Texas. The Purchase Agreement ...
  • Pharmacy Accreditation: Establishing Discipline and Consistency

    Pharmacy Accreditation: Establishing Discipline and Consistency

    www.insidepatientcare.com/.../151-pharmacy-accreditation-establishing-dis...
    21 hours ago - In addition, Catamaran recently partnered with United CompoundingManagement, an independent compounding management company, and is in the process ...

    Norman Transcript-7 hours ago Oklahoma officials are considering setting up a compounding pharmacy to


    Regulatory uncertainty and overreach stifling, AG Pruitt says

    Norman Transcript-7 hours ago
    Oklahoma officials are considering setting up a compounding pharmacy to ... Creating a compounding lab would allow all sides to participate and know a drug's ...

    “This case was developed as part of a broader effort by our office to identify and target unscrupulous compounding pharmacies,” said U.S. Attorney Bentley. “Since the beginning of the year, we have been focusing on pharmacies that have abused the TRICARE program and defrauded the government.”

    Senate panel advances funding Bill for FDA-The bill contains $20.5 billion in discretionary funding, which is $65 million below the current level and $1.1 billion below President Obama’s request. The bulk of the measure contains $123.3 billion in mandatory funding.

    FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... Status, Ongoing. Recalling Firm, Abrams Royal Pharmacy II, LLC. City, Plano.

    Enforcement Reports > July 15, 2015 - Food and Drug Administration

    www.accessdata.fda.gov/.../enforce_rpt-Product-Tabs.cfm?...D...
    14 hours ago - FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... Status, Ongoing. Recalling Firm, Abrams Royal Pharmacy II, LLC. City, Plano.

    Dietary Supplements - Adverse Event Reporting

    Dietary Supplements - Adverse Event Reporting

    FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... Status, Ongoing. Recalling Firm, Abrams Royal Pharmacy II, LLC. City, Plano.

    Enforcement Reports > July 15, 2015 - Food and Drug Administration

    www.accessdata.fda.gov/.../enforce_rpt-Product-Tabs.cfm?...D...
    14 hours ago - FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... Status, Ongoing. Recalling Firm, Abrams Royal Pharmacy II, LLC. City, Plano.

    FBI — United States Settles False Claims Act Allegations ..compounding pharmacy

    1. FBI — United States Settles False Claims Act Allegations ...

      https://www.fbi.gov/.../united-states-settle...
      Federal Bureau of Investigation
      19 hours ago - JACKSONVILLE, FL—U.S. Attorney A. Lee Bentley, III announces that the United States has settled allegations that a Jacksonville-based compoundingpharmacy knowingly billed the government for improper and medically unnecessary compounding pain prescriptions.

    FDA may tap Google to beef up drug-safety monitoring: Endo whistleblower nabs $33.6M from feds for 'extraordinary' work in FCA suit

    More Collaboration, Research Needed to Develop Cures

    More Collaboration, Research Needed to Develop Cures

    IND Standardbred Trainer Suspended 10 Years

    IND Standardbred Trainer Suspended 10 Years

    Tom Coburn said Congress is partly to blame for "beating up" the FDA in the past.

    http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/52614

    House lawmakers introduce federal 'right to try' bill


    House lawmakers introduce federal 'right to try' bill
    The "right to try” campaign that would allow terminally ill patients access to potentially lifesaving, yet unapproved drugs is going national. Three House Republicans have introduced a bill that would ban federal regulators from taking action against those seeking access to such therapies.  READ MORE

    Senate subcommittee advances $20.5B bill funding Agriculture, FDA ...more work needed some say because no funding relating to compounding and other issues

    Senate subcommittee advances $20.5B bill funding Agriculture, FDA ...

    The Hill › policy › finance › 247885-sen...
    Mobile-friendly - 1 day ago - Senate Appropriations subcommittee on Tuesday advanced a bill that would fund the Department of Agriculture ...

    The FY2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill was today given subcommittee approval, making the $143.8 billion measure available for consideration Thursday by the Senate Committee on Appropriations.



    Subcommittee Approves FY2016 Agriculture Appropriations Bill

    WASHINGTON, D.C. – The FY2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill was today given subcommittee approval, making the $143.8 billion measure available for consideration Thursday by the Senate Committee on Appropriations.
    Read more

    DOJ Files Civil Complaint Against Dietary Supplement Maker


    DOJ Files Civil Complaint Against Dietary Supplement Maker

    The Department of Justice brought enforcement action against a dietary supplement company over alleged safety issues and unlawful disease claims, as the department faces pressure from a bipartisan duo of senators to more  
     www.insidehealthpolicy.com

    House Passes Cures Bill With Mandatory NIH/FDA Funding, Policy Rider Language Intact The House passed the 21st Century

    House Passes Cures Bill With Mandatory NIH/FDA Funding, Policy Rider Language Intact

    The House passed the 21st Century Cures Act 344-77, in the process shooting down amendments that would have made the bill's funding hikes for FDA and the National Institutes of Health discretionary and would have stripped language that subjects the funding to appropriations policy riders. 

    On Tuesday afternoon this week, the Senate Ag/FDA appropriations subcommittee marked up its FY 16 bill. The top-line is a $40 million increase for FDA, about $10 million more than the House mark.

  • Senate Ag/FDA Subcommittee Marks Up FY 16 Appropriation Bill ...

    strengthenfda.org › 2015/07/15 › senate-...
    13 hours ago - On Tuesday afternoon this week, the Senate Ag/FDA appropriations subcommittee marked up its FY 16 bill. The top-line is a $40 million increase for FDA, about $10 million more than the House mark.
  • Wednesday, July 15, 2015

    Important! The Sixth Circuit Further Defines “Advertisement” Under the Telephone Consumer Protection Act 7/14/2015byJoel Gottesman | BakerHostetler

    Last month, in a case of first impression, the Sixth Circuit Court of Appeals issued an opinion finding that unsolicited faxes intended strictly for informational purposes were not “advertisements” and therefore not actionable under the Telephone Consumer Protection Act (“TCPA”), 47 U.S.C. 227 et. seq.
    Sandusky Wellness Center v. Medco Health Solutions, No. 14-4201 (6th Cir. June 3, 2015) concerns Sandusky Wellness Center, a healthcare provider, and Medco Health Solutions, a pharmacy benefit manager that acts as an intermediary between employers, health plan sponsors and drug companies. Services provided by Medco include keeping and updating a list of medicines, known as a formulary, that are available through a given healthcare plan. More

    Trainer Sues Compounding Pharmacy, Supplier Over Positives

    Trainer Sues Compounding Pharmacy, Supplier Over Positives

    Medicare Part D fraud draws scrutiny in House

    1. Medicare Part D fraud draws scrutiny in House

      ModernHealthcare.com-Jul 13, 2015
      The hearing follows a flurry of activity drawing attention to the issue, including charges filed against 44 people across the country for Medicare Part D fraud in ...

    From Antitrust Law Daily, July 10, 2015 Compounding pharmacy states valid conspiracy claims against prescription benefit manager By Greg Hammond, J.D.



    • July 10, 2015
      A compounding pharmacy could move forward with claims that a prescription benefit manager conspired to restrain trade, in violation of the Sherman Act and New York antitrust law. The federal district court in St. Louis determined that the pharmacy ad

      Compounding pharmacy states valid conspiracy claims against pres

      www.dailyreportingsuite.com/antitrust/news/compounding_pharmacy_state...
      6 days ago - compounding pharmacy could move forward with claims that aprescription benefit manager conspired to restrain trade, in violation of the Sherman Act and New York antitrust law. T. ... The federal district court in StLouis determinedthat the pharmacy adequately alleged an unlawful agreement or ...

    $12 million healthcare fraud case in downtown Houston


    1. $12 million healthcare fraud case in downtown Houston

      Healthcare Finance News-Jul 10, 2015
      Six people involved in an alleged $12 million conspiracy to commithealthcare fraud have been arrested in Houston, according to the U.S. Attorney's Office, ...
      Six Houston-area residents charged in alleged healthcare fraud
      Texas Dentists for Medicaid Reform (blog)-Jul 10, 2015

    FCC issues controversial TCPA Declaratory Ruling

    FCC issues controversial TCPA Declaratory Ruling

    Lexology (registration)-5 hours ago
    A “collect call service provider does not make or initiate a call when a caller ... a risk of fraud or identity theft” and information on “steps consumers can take to ... For healthcare calls, the FCC clarifies that the “provision of a phone number to a ...

    Justice Department Ramps Up Corporate Criminal Prosecutions of ...

    Justice Department Ramps Up Corporate Criminal Prosecutions of ...

    Corporate Crime Reporter-10 hours ago
    It means preserving our financial security by fighting fraud. ... the people who have dedicated their careers to bringing safe and healthy food to consumers ... about an issue – food safety – that I and the Department of Justice care deeply about.

    Misunderstood Or Fraud? Why Doctors Should Never Recommend Homeopathy

    Misunderstood Or Fraud? Why Doctors Should Never Recommend ...

    Science 2.0-8 hours ago
    Misunderstood Or Fraud? Why Doctors ... Therefore, it seems unreasonable, even unethical, for healthcare professionals to recommend its use." Citation: BMJ ...

    Federal agents executing search warrant at Anesthesia Business

    Federal agents executing search warrant at Anesthesia Business ...

    MLive.com-4 hours ago
    U.S. Department of Health and Human Services Assistant Special Agent Joe Napolitano briefs the media on the latest following a healthcare fraud investigation ...

    CMS fraud unit uncovers $820 million in healthcare scams in past 3 ...


    1. CMS fraud unit uncovers $820 million in healthcare scams in past 3 ...

      Healthcare Finance News-8 hours ago
      In future years, CMS plans to expand the Fraud Prevention System and its algorithms to identify lower levels of non-compliant health careproviders who would ...