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

Wednesday, September 30, 2015

Congressman Kurt Schrader's Donors include McKesson Corp, Tropicana Animal Hospital, Pfizer Inc., Merck & Co. etc.

see www.opensecrets.org

https://www.opensecrets.org/politicians/contrib.php?cid=N00030071&cycle=2016&type=I&newMem=N&recs=100
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Congressman Matt Salmon's donors include Diamondback Drugs, Potter's House Apothecary and Express Scripts

see www.opensecrets.org at https://www.opensecrets.org/politicians/contrib.php?cid=N00006446&cycle=2016&type=I&newMem=N&recs=100
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Question of the Day September 30, 2015 Why would members of Congress fail to acknowledge GOA-15-671 or take a position that is contrary to those findings?


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IACP Ask Members to Take Action! Stop FDA’s Misguided Veterinary Compounding Guidance - International Academy of Compounding Pharmacists

Take Action! Stop FDA’s Misguided Veterinary Compounding Guidance - International Academy of Compounding Pharmacists
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Florida Board of Pharmacy Sterile Compounding Committee Announces upcoming meeting in October 2015

Notice of Public Workshop for 62-730.186 - Florida ...

www.dep.state.fl.us/.../6...
Florida Department of Environmental Protection
Sep 21, 2015 - Board with respect to any matter considered at this meeting or hearing, he/she will .... The Board of Pharmacy Sterile Compounding Committee announces a ...
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Florida Board of Pharmacy Update by Allison Dudley J.D. September 2015


Florida Board of Pharmacy Update

www.pharmview.com/resource/resmgr/ce.../07presentation_-_dudley.pdf
Sep 9, 2015 - presentation. Objectives. ▫ Summarize Rule changes for The Florida Board of. Pharmacy .... Standards of Practice for Compounding Sterile Products. 
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Shuttered Compounder Warned Over Sterility Issues

Despite having been closed for more than a year with no plan to reopen, the FDA issued a warning letter to Specialty Medicine Compounding Pharmacy for a litany of cGMP violations, including poor sterile processing controls.

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FDA 483s for Avella of Deer Valley, Inc. dba Avella, Outsourcing Facility issued 7/29/2015 and 7/31/2015

07/29/20153006345305Avella of Deer Valley, Inc. dba Avella483AZOutsourcing Facility09/29/2015
07/31/20153006345305Avella of Deer Valley, Inc. dba Avella483AZOutsourcing Facility09/29/2015
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Some Recent Comments from Readers:

Attix Pharmaceuticals + American Pharmaceutical Ingredients. Both have been run by the same person. Karl Jebailey. Same practices. Same story. FDA and the FL, MI, state boards need to piece this picture together. ALL PRODUCTS FROM CHINA. NON FDA INSPECTED FACILITIES. Putting U.S citizens at risk. on High Importance! Very Long List of Compounded Drugs from The Compounding Pharmacy of America found on FDA Enforcement Report dated September 23, 2015
Remove content | Delete | Spam
David Liu


www.attixpharmaceuticals.com www.darmerica.com Fast one past FDA? on High Importance! South Coast Specialty Compounding INC. dba Park Compounding Recall of Cisapride due to the manufacturer of the API: Attix Pharmaceuticals recalling because of the products potentially being contaminated with penicillin
James Olsen

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Washington Quality Assurance Commission July Meeting Minutes 2015


  • July 30 (PDF)
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Texas State Board of Pharmacy has new fees effective October 1, 2015


Updates, News & Notices
Texas State Board of Pharmacy Fees Effective October 1, 2015
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California Board of Pharmacy Cease and Desist order dated 9/16/2015 against US Compounding Inc. Conway, AR

US Compounding Inc., NSC 99495, Administrative Case AC 5624
Conway, AR 
Effective 9/16/2015 US Compounding Inc. shall immediately cease and desist from compounding sterile injectable products for shipment into California.
View Order
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California Board of Pharmacy Accusation filed 8/10/2015 against Unique Pharmaceuticals LTD, Temple, TX

Unique Pharmaceuticals LTD, NRP 534 & NSC 99112, Administrative Case 5282
Temple, TX
Accusation Filed 8/10/2015; Case pending.
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California Board of Pharmacy Accusation and Petition to Revoke Probation Filed 8/10/2015 against Santa Clara Drug " The Compounding Shop"

Santa Clara Drug “The Compounding Shop”, PHY 51229, Administrative Case 5380
San Jose, CA
Accusation and Petition to Revoke Probation Filed 8/10/2015; Case pending.
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California Board of Pharmacy Accusations against California Pharmacy and Compounding Center filed 8/27/2015

California Pharmacy and Compounding Center, PHY 49828 & LSC 99542, Administrative Case 4628
Newport Beach, CA
First Amended Accusation Filed 8/27/2015; Case pending.
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New Jersey Board of Pharmacy Agenda for meeting held today, September 30, 2015

F]Board of Pharmacy - New Jersey Division of Consumer Affairs

www.njconsumeraffairs.gov/.../...
New Jersey Division of Consumer Affairs
12 hours ago - BOARD OF PHARMACY. PUBLIC SESSION AGENDA ... The Apothecary Shop, Dallas, TX – Out-of-State Pharmacy Applicant –. Discipline
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Oklahoma's governor stays executions at last minute

Oklahoma's governor stays Richard Glossip execution

CNN-1 hour ago
Oklahoma Gov. Mary Fallin stayed the execution of inmate Richard Glossip on Wednesday while the state reviews protocol questions, her office said. [Original ...
Breaking: Richard Glossip Execution Stayed By Oklahoma Governor
Democracy Now! (blog)-2 hours ago
Oklahoma Man Granted Last-Minute Delay in Execution
ABC News-4 hours ago
Richard Glossip and the End of the Death Penalty
Featured-The New Yorker-5 hours ago
Oklahoma governor issues last-minute stay and halts execution of ...
In-Depth-Washington Post-45 minutes ago
Conservative Oklahoma Governor Stays Richard Glossip's ...
Blog-Slate Magazine (blog)-30 minutes ago
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Michigan: Governor signs bill relating to pharmacy technicians

Gov. Snyder signs bills to save resources

UPMatters.com-1 hour ago
The governor also signed SB 468, sponsored by state Sen. Mike Green, which adjusts pharmacy technician licensure requirements first implemented in 2014.
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Inmate challenges execution oer use of secret drugs

Inmate challenges execution over use of 'secret' drugs

U.S. News & World Report-5 hours ago
It is unknown whether Virginia or Texas "know any pertinent information about the compounding pharmacy, including its ability to make a sterile injectable drug, ...
Judge calls for hearing hours before Virginia execution
Chattanooga Times Free Press-1 hour ago
Explore in depth (134 more articles)
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NACDS Expresses Concern with TRICARE Provisions in NDAA ... Pharmacy Times-1 hour ago

NACDS Expresses Concern with TRICARE Provisions in NDAA ...

Pharmacy Times-1 hour ago
"We have remained highly engaged in efforts to preserve pharmacy access and choice for TRICARE patients over the years, including consistent advocacy
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FIP reports highlight changing role of pharmacies, need for ... Drug Store News-3 hours ago DÜSSELDORF, Germany — The International Pharmacy Federation (FIP) on Wednesday released findings from two of its reports about the state of pharmacists

FIP reports highlight changing role of pharmacies, need for ...

Drug Store News-3 hours ago
DÜSSELDORF, Germany — The International Pharmacy Federation (FIP) on Wednesday released findings from two of its reports about the state of pharmacists
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Nine inmates on death row cite pain risk Arkansas Online-8 hours ago

Nine inmates on death row cite pain risk

Arkansas Online-8 hours ago
Specifically, Rosenzweig said the risk is high that the possible use ofcompounded drugs -- created in a pharmacy's lab
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Judge calls for hearing hours before Virginia execution U.S. News & World Report-1 hour ago

Judge calls for hearing hours before Virginia execution

U.S. News & World Report-1 hour ago
Texas prisons spokesman Jason Clark told AP last week that the three vials of pentobarbital given to Virginia were
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Who Supplies Lethal Injection Drugs? Inverse-27 minutes ago

Who Supplies Lethal Injection Drugs?

Inverse-27 minutes ago
One potential source for these drugs are compounding pharmacies, companies with a uniquely tenuous relationship to consumer 
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Abbott due credit for community pharmacy friendship

Abbott due credit for community pharmacy friendship: Tambassis

Australian Journal of Pharmacy (registration) (blog)-12 hours ago
Pharmacy Guild national president George Tambassis has expressed thanks and appreciation to former Prime Minister Tony Abbott, “for his strong and ...
Tony Abbott saved community pharmacy: Guild
Pharmacy News-13 hours ago
Explore in depth (3 more articles)
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Congress Agrees to Boost Tricare Pharmacy CoPays

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    Congress Agrees to Boost Tricare Pharmacy Co-Pays in 2016 ...

    Military.com-4 hours ago
    U.S. lawmakers on Tuesday agreed to increase pharmacy co-pays that largely affect military retirees as part of a sweeping defense
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Fred's pharmacy in Mississippi offers telemedicine Memphis Commercial Appeal-1 hour ago Fred's Inc., in partnership with a Mississippi-based telemedicine company, offered its first

Fred's pharmacy in Mississippi offers telemedicine

Memphis Commercial Appeal-1 hour ago
Fred's Inc., in partnership with a Mississippi-based telemedicine company, offered its first
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Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions Regulatory Focus‎ - 22 mins ago Historically, compounding pharmacies were regulated by

Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions
Regulatory Focus‎ - 22 mins ago
Historically, compounding pharmacies were regulated by
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Dover Pain Clinic Doctor/Owner charged with Health Care Fraud

State charges Dover doctor with felony health care fraud

The News Journal-18 hours ago
A Dover pain doctor was charged with felony health care fraud last week after state investigators say he repeatedly billed agencies for services he did not ...
Dover Pain Doctor Charged With Health Care Fraud
news.delaware.gov-20 hours ago
Delaware Doctor Charged With Felony Health Care Fraud
WBOC TV 16-3 hours ago
Dover doctor charged with health care fraud
WMDT-18 hours ago
Dover Pain Clinic Owner Charged with Health Care Fraud
Delaware 105.9-9 hours ago
Explore in depth (13 more articles)
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FDA Pharmacy Compounding Advisory Committee Scheduled for October 27-28, 2015

Meetings: Pharmacy Compounding Advisory Committee

https://www.federalregister.gov/.../meetings-pharmacy-c...
Federal Register
3 hours ago - Meetings: Pharmacy Compounding Advisory Committee. An unpublished Notice by the Food and Drug Administration on 10/01/201
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Point-of-care testing: Emerging market, opportunity for pharmacists Pharmacy Today, American Pharmacists Association, pharmacist.com-22 hours ago A1C and cholesterol screenings aren't the only labs that fall into this category that a pharmacist could perform at the

Point-of-care testing: Emerging market, opportunity for pharmacists

Pharmacy Today, American Pharmacists Association, pharmacist.com-22 hours ago
A1C and cholesterol screenings aren't the only labs that fall into this category that a pharmacist could perform at the
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Australian Journal of Pharmacy: Pharmacy must stay relevant

Pharmacy must stay relevant, address women's needs: Carmen Peña

Australian Journal of Pharmacy (registration) (blog)-12 hours ago
FIP President Carmen Peña has called on pharmacists and pharmaceutical scientists around the world to ensure that the profession of pharmacy remains ...
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Lincoln pharmacist and owner of Tran Pharmacy pleads guilty in federal court to possibly state's biggest Medicaid fraud

Lincoln pharmacist pleads guilty to possibly state's biggest Medicaid ...

Lincoln Journal Star-14 hours ago
A Lincoln pharmacist tearfully pleaded guilty Tuesday to health care fraud, admitting he bilked Nebraska's Medicaid program of $14.4 million in what is believed ...
Man pleads guilty to bilking $14M from Nebraska Medicaid
Grand Island Independent-5 hours ago
Explore in depth (9 more articles)
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UK Pharmacy Chain Boots to roll out Orion Health Software

UK pharmacy chain Boots to roll out Orion Health software

ZDNet-15 hours ago
UK pharmacy chain Boots has chosen technology from New Zealand-based Orion Health to support the delivery of in-store clinical services.
Orion Health inks technology deal with Boots UK
Scoop.co.nz-11 hours ago
Explore in depth (7 more articles)
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Washington State Pharmacies: The Next Frontier for Religious ... U.S. News & World Report-9 hours ago

Washington State Pharmacies: The Next Frontier for Religious ...

U.S. News & World Report-9 hours ago
Unlike Davis, pharmacists aren't employees of the state. And while they wouldn't be thrown in jail for refusing medication
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Editorial: Turning Up the Volume on Dietary Supplement Quality ... Nutritional Outlook-6 hours ago Will dietary supplement regulations look the same way in 10 years that they do today? Some hope so; some don't. Industryfolk are the first to say that this year's ...

Editorial: Turning Up the Volume on Dietary Supplement Quality ...

Nutritional Outlook-6 hours ago
Will dietary supplement regulations look the same way in 10 years that they do today? Some hope so; some don't. Industryfolk are the first to say that this year's ...
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About 500,000 settlement checks are being mailed by the FTC to consumers who paid for TriVita Inc.’s dietary supplement Nopalea. According to the FTC’s dietary supplement lawsuit, TriVita falsely advertised their cactus-based fruit drink Nopalea as a treatment for multiple health problems.

http://topclassactions.com/lawsuit-settlements/lawsuit-news/174434-ftc-mails-dietary-supplement-refund-checks/
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Tainted dietary supplements frequently hit the market - News - West Hartford News

Tainted dietary supplements frequently hit the market - News - West Hartford News
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Speak now or hold your peace: comment period begins for EPA’s proposed hazardous waste pharmaceuticals rule Quarles & Brady LLP (included in covered groups are pharmacies and retail sellers of dietary supplements)

http://www.lexology.com/library/detail.aspx?g=2e674723-b32a-4517-9ad5-1343fe15d75b
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Soccer's doping problem and its ramifications on Major League Soccer MLS Multiplex-18 hours ago ... for illegal substances

Soccer's doping problem and its ramifications on Major League Soccer

MLS Multiplex-18 hours ago
... for illegal substances (Jon Conway and Jeff Parke of the New York Red Bulls in 2008) with both players claiming that they had takendietary supplements.
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Can a company sue for a negative review?

Can a company sue you for a negative review?

CBS News-19 hours ago
For the past two years, the complaint continues, the company had marketed and sold its line of dietary supplements and food products directly to Internet ...
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‘A drug-level randomized controlled clinical trial for a supplement has never been the standa...

‘A drug-level randomized controlled clinical trial for a supplement has never been the standa...
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Hi-Tech Pharmaceuticals Files Lawsuit Against Dynamic Sports Nutrition and Brian Clapp Over Racketeer Influenced and Corrupt Organizations (RICO) and Deceptive Trade Practices

ATLANTA, Sept. 30, 2015 /PRNewswire/ -- A lawsuit has been brought over Racketeer Influenced and Corrupt Organizations (RICO), trademark infringement, and deceptive advertising allegations involving Dynamic Sports Nutrition's "bogus" steroids alternatives, D-anabol 25  DECA 200, TREN 75, and Pituitary Growth Hormone products. The lawsuit alleges that BuySteroids.com is a criminal enterprises riddled with false and deceptive advertisements. Brian Clapp, the owner of Steroid.com; Anabolics.com; Dianabol.com; BuySteroids.com; RoidStore.com; and  Dynamicsportsnutrition.com, has been misrepresenting their products and ingredients. The websites listed above create an illusion that it sells anabolic steroids — when it does not.  More at: http://www.prnewswire.com/news-releases/hi-tech-pharmaceuticals-files-lawsuit-against-dynamic-sports-nutrition-and-brian-clapp-over-racketeer-influenced-and-corrupt-organizations-rico-and-deceptive-trade-practices-300151338.html
- September 30, 2015 No comments:
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Calcium From Supplements or Dairy Doesn't Work

Calcium From Supplements or Dairy Doesn't Strengthen Bones ...

NBCNews.com-14 hours ago
Most of the studies showed people over 50 get no benefit at all from taking either calcium supplements or from eating calcium in food. People were just as likely ...
Calcium supplements don't work, say experts
In-Depth-Telegraph.co.uk-14 hours ago
Explore in depth (82 more articles)
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Dietary Supplements and FDA Compliance: A 2015 Update on ... Nutritional Outlook-6 hours ago

Dietary Supplements and FDA Compliance: A 2015 Update on ...

Nutritional Outlook-6 hours ago
Unfortunately, in the five-odd years since dietary supplement cGMP practices went into full effect under 21 CFR Part
- September 30, 2015 No comments:
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Judge may split off meningitis duo


Judge may split off meningitis duo

Boston Herald-8 hours ago
... is considering trying two former New England CompoundingCenter executives accused of murder separate from 12 of their colleagues facing lesser charges.
- September 30, 2015 No comments:
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One-third of hormone users at menopause take unapproved, untested compounded drugs Cases of uterine cancer reported among users of compounded hormones THE NORTH AMERICAN MENOPAUSE SOCIETY (NAMS)

One-third of hormone users at menopause take unapproved ...

EurekAlert (press release)-9 hours ago
CLEVELAND, Ohio (September 30, 2015)--A third of US women who take hormones at menopause are using compounded hormones, shows a new national ...
Survey: One-third of US women use compounded hormones at ...
News-Medical.net-1 hour ago
Explore in depth (7 more articles)
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This morning the Today Show announced it will be airing a story on dietary supplements and holding off before you reach for them


- September 30, 2015 No comments:
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FDA Law Blog: September 29, 2015 Back from Break: FDA Issues Letter to Pathway Genomics for Cancer Screening LDT; Proposed Legislative Alternatives to FDA Framework Continue to Emerge By Jamie K. Wolszon & Jeffrey N. Gibbs –


http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/09/back-from-break-fda-issues-letter-to-pathway-genomics-for-cancer-screening-ldt-proposed-legislative-.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29
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Tuesday, September 29, 2015

FDA urged to improve oversight of animal drug compounding fda.einnews.com/.../288894491-fda-urged-to-improve-oversight-of-ani... 4 hours ago - The U.S. Food

FDA urged to improve oversight of animal drug compounding

fda.einnews.com/.../288894491-fda-urged-to-improve-oversight-of-ani...

4 hours ago - The U.S. Food and Drug Administration (FDA) should
- September 29, 2015 No comments:
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A blog dedicated to educating pharmacists, doctors, veterinarians, and the general public about the law in the United States relating to compounded medications for both humans and animals

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Compound Ingredient Supplier Fagron Holding USA LLC to Pay $22.05 Million to Resolve Allegations of False and Inflated Average Wholesale Prices for Ingredients Used in Compounded Prescriptions

Department of Justice U.S. Attorney’s Office Western District of Texas FOR IMMEDIATE RELEASE Thursday, November 7, 2019 ...

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      • Congressman Kurt Schrader's Donors include McKesso...
      • Congressman Matt Salmon's donors include Diamondba...
      • Question of the Day September 30, 2015 Why would m...
      • IACP Ask Members to Take Action! Stop FDA’s Misgui...
      • Florida Board of Pharmacy Sterile Compounding Comm...
      • Florida Board of Pharmacy Update by Allison Dudley...
      • Shuttered Compounder Warned Over Sterility Issues
      • FDA 483s for Avella of Deer Valley, Inc. dba Avell...
      • Some Recent Comments from Readers:
      • Washington Quality Assurance Commission July Meeti...
      • Texas State Board of Pharmacy has new fees effecti...
      • California Board of Pharmacy Cease and Desist orde...
      • California Board of Pharmacy Accusation filed 8/10...
      • California Board of Pharmacy Accusation and Petiti...
      • California Board of Pharmacy Accusations against C...
      • New Jersey Board of Pharmacy Agenda for meeting he...
      • Oklahoma's governor stays executions at last minut...
      • Michigan: Governor signs bill relating to pharmacy...
      • Inmate challenges execution oer use of secret drug...
      • NACDS Expresses Concern with TRICARE Provisions in...
      • FIP reports highlight changing role of pharmacies,...
      • Nine inmates on death row cite pain risk Arkansas ...
      • Judge calls for hearing hours before Virginia exec...
      • Who Supplies Lethal Injection Drugs? Inverse-27 mi...
      • Abbott due credit for community pharmacy friendshi...
      • Congress Agrees to Boost Tricare Pharmacy CoPays
      • Fred's pharmacy in Mississippi offers telemedicine...
      • Two-Day FDA Advisory Committee Meeting to Address ...
      • Dover Pain Clinic Doctor/Owner charged with Health...
      • FDA Pharmacy Compounding Advisory Committee Schedu...
      • Point-of-care testing: Emerging market, opportunit...
      • Australian Journal of Pharmacy: Pharmacy must stay...
      • Lincoln pharmacist and owner of Tran Pharmacy plea...
      • UK Pharmacy Chain Boots to roll out Orion Health S...
      • Washington State Pharmacies: The Next Frontier for...
      • Editorial: Turning Up the Volume on Dietary Supple...
      • About 500,000 settlement checks are being mailed b...
      • Tainted dietary supplements frequently hit the mar...
      • Speak now or hold your peace: comment period begin...
      • Soccer's doping problem and its ramifications on M...
      • Can a company sue for a negative review?
      • ‘A drug-level randomized controlled clinical trial...
      • Hi-Tech Pharmaceuticals Files Lawsuit Against Dyna...
      • Calcium From Supplements or Dairy Doesn't Work
      • Dietary Supplements and FDA Compliance: A 2015 Upd...
      • Judge may split off meningitis duo
      • One-third of hormone users at menopause take unapp...
      • This morning the Today Show announced it will be a...
      • FDA Law Blog: September 29, 2015 Back from Break...
      • FDA urged to improve oversight of animal drug comp...
      • Destroying Certain Imported Drugs: A New Rule to P...
      • USP seeks feedback on one of two national standard...
      • FDA Warning Letter: Specialty Medicine Compoundin...
      • FDA Warning Letter Red Mill Farms, LLC Unapproved ...
      • FDA Warning Letter TruVision Health LLC DMBA/Label...
      • FDA Warning Letter: New Dawn Nutrition, Inc. Dieta...
      • Hundreds of hospitals are believed to have settled...
      • Great Read! Especially Regarding Marketing and Ki...
      • Focus on Reducing Opioid Abuse, Misuse May Harm Tr...
      • License of Woodlands pain medicine doctor listed a...
      • New Report Shows Not Just Drug Wholesales causing ...
      • Hillary Clinton Wants to Legalize Prescription Pil...
      • Drug firms need to explain the prices The Boston G...
      • FDA asks veterinarians to participate in survey ab...
      • Imprimis Pharmaceuticals Upgraded at Zacks (IMMY) ...
      • New Clemency Hearing set for GA Female Death Row I...
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      • Webinar: FDA Inspections for Compounders:
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This blog is not affiliated with any company nor does it or has it ever represented any particular company's views. The opinions expressed in this blog are those solely of the author unless indicated otherwise.Nothing contained on this Blog shall constitute legal advice nor be construed as a representation to be reasonably relied upon. This blog site is published by and reflects the personal views of the Author. No representation is made about the accuracy of the information, which solely constitutes the Author’s personal view on these issues. The information contained in this blog site is provided only as general information and personal opinions, and blog topics may or may not be updated after being initially posted. To make informed legal decisions, you should always consult with your own lawyer for your personal legal needs.
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