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  • The Underappreciated Risks of Hospital IV Compounding
    A typical hospital room can be described as a patient lying in a bed with an IV drip bag hanging from a pole. But when you take a closer look at IV administration of fluids and medications, it is so much more than a common task. What can be viewed as an uneventful procedure, even […]
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  • USP 800: A Primer for Community Pharmacists
    In the evolving world of pharmacy practice, many are asking what is included in the key provisions of the United States Pharmacopeial Convention (USP) 800 when it comes to transport, storage, preparation, and compounding. For starters, it is important to understand that the USP is a scientific nonprofit organization that sets the standards for the […]
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  • Aseptic Enclosures in Attendance of Pack Expo Las Vegas 2017
    Aseptic Enclosures will be represented by Joe Skorcz, our new Project Engineer and Regional Manager.  Joe is directly responsible for Projects in our Northern Region, but will be available for requests concerning any region during the Pack Expo Las Vegas. At Aseptic Enclosures, we have a strong commitment to helping you improve your aseptic processing and […]
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  • Viral Safety Approaches For Advanced Therapy Medicinal Products
    The availability of plasma-derived medicinal products— one of the earliest achievements of medical biotechnology—has enabled great progress in the treatment of specialized conditions such as hemophilia and immune deficiencies. Yet early on, the biologic materials used to develop these products were also found to be vulnerable to infectious disease agents. Today, manufacturers safeguard these produ...
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  • FDA Links Naturopathic Turmeric Death To Contaminated Product
      Jade Erick, 30, died in March 2017 after California naturopathic doctor, Kim Kelly, gave her an intravenous (IV) preparation of curcumin, a chemical constituent in the Indian spice turmeric that is over-hyped in alternative medicine. An FDA report released yesterday found that Imprimis Pharmaceuticals (NASDAQ:IMMY), a compounding pharmacy based in San Diego, California, mixed the curcumin emulsi...
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  • Injections from Texas Pharmacy Linked to 43 Eye Injuries
      At least 43 people who had cataracts surgery in Texas developed severe eye problems after receiving injections of a drug that was compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered eye injections at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center or Park Central […]
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  • 2 men charged in pharmacy scheme plead guilty
    Two men charged with criminal activity in connection to a compound pharmacy scheme pleaded guilty Tuesday in federal court before U.S. District Judge Keith Starrett.     Jason May, 40, a pharmacist from Lamar County and co-owner of Advantage Pharmacy — one of several named in a civil forfeiture, was charged July 12 with one count of conspiracy […]
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  • Lawfirm to File Lawsuit Against King’s Compounding Pharmacy
      The doctor prescribed a series of injections into the middle of her ear. The lawsuit claims King’s Compounding Pharmacy improperly mixed the chemicals into a drug. The woman’s doctor then administered the drug to the woman in January of 2017. Immediately after the injection, the woman’s face began to burn with pain, her right […]
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  • Vet-Rx wary of new possible pharmacy regulations
    Bill Soderlund Jr., left, talks about Food and Drug Administration regulations that Vet-Rx complies with, while Bill Soderlund Sr., center, and state Sen. Nick Frentz listen. (Nancy Madsen/St. Peter Herald)     Bill Soderlund Jr. says he loves regulation. “When I pump a gallon of gas, I want to be sure it’s exactly a gallon […]
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  • PCAB Launches USP 800-based Distinction in Hazardous Drug Handling (HDH)
    Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has released the compounding industry’s first Distinction in Hazardous Drug Handling (HDH). Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), has released the compounding industry’s first Distinction in Hazardous Drug Handling (...
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  • Mom finds short-term solution in search for son’s life-saving drug
    With only a few tablets left of a prescription drug that helps prevent a life-threatening allergic reaction, Lorrena Clee of Lower Sackville, N.S., got a call from her pharmacist Wednesday with some good news for her son. The pharmacist said he tracked down 20 pills at a hospital pharmacy, which is equal to a 10-day supply for Clee’s […]
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  • Complicated medical situations sometimes call for compounded medications
    Do you have difficulty swallowing a pill? Is it hard getting your family pet to take their medicine? Do you have certain ingredients such as dyes, preservatives, gluten or sugar that you need to avoid? If you answered yes to any of these questions, you could benefit from the McLeod Choice Pharmacy’s nonsterile compounding service. […]
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  • How Vulnerable Are We to Prescription Pill Manufacturers?
    Several cases of contaminated medications have raised concerns about the quality of drugs manufactured in the United States. Last month, the former co-owner of a Massachusetts compounding pharmacy, whose tainted medicines are blamed for a deadly meningitis outbreak in 2012, was sentenced to nine years in prison. More than 60 people died and more than 700 people […]
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  • Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline
    Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. (Editor’s note: On June 30, FDA issued new draft guidance pushing back the enforcement deadline for product identifiers to Nov. […]
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  • NECC and Future of Compounding Pharmacy
    Compounding pharmacist’s case hinged on whether he was “willfully indifferent.   In 2012, a fungal meningitis outbreak killed more than 60 and left 732 people sickened. Many of those who survived face constant pain related to the illness. The cause of infection was large contaminated batches of injectable methylprednisolone acetate. The Trial Owner and head […]
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  • Achieving a Higher Standard of Practice for Sterile Compounding: What is your strategic direction?
      Sterile compounding, a critical component of hospital care delivery, has come under greater scrutiny in recent years following high-profile mishaps causing preventable patient injury. In response, the industry continues to up the ante on compliance with the United States Pharmacopeia (USP) 797 guidelines—the accepted standard that defines minimum practice standards for compounded sterile prepara...
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  • Alvogen Issues Voluntary Nationwide Recall
    Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into [...
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  • Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination
    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of thos...
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  • Brown’s Compounding owner charged with selling unapproved drug
    The owner and founder of a large compounding pharmacy that sold pain creams around the country and once employed more than 100 workers has been charged with introducing an unapproved drug into interstate commerce. Darby C. Brown’s company, Brown’s Compounding Center, on Wednesday was charged separately in federal court with health care fraud. Brown illegally sold […]
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  • An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilit
    Part of the Cleaning Validation for the 21st Century series By Andrew Walsh; Ester Lovsin Barle, Ph.D.; Michel Crevoisier, Ph.D.; David G. Dolan, Ph.D.; Andreas Flueckiger, MD; Mohammad Ovais; Osamu Shirokizawa; and Kelly Waldron Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a repres...
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  • Immediate Benefits Of Real-Time Microbial Monitoring
    Companies producing medicines and biotech products are concerned with airborne microbial contamination. They need to ensure that products and people are kept safe. The traditional, accepted method to test for microorganisms at critical locations in a process is the use of Active Air Samplers or Settling Plates. Typically, 1-meter-cubed samples are taken onto agar plates […]
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  • Could Compounding Pharmacists Solve the Sodium Bicarbonate Shortage?
    Sodium bicarbonate is becoming increasingly difficult for emergency rooms to obtain, potentially creating problems since few alternatives are available. One of these alternatives, sodium acetate, is also facing a shortage. According to the ASHP, the current sodium bicarbonate shortage is due to AmphastarPharmaceuticals falling short due to increased demand and Pfizer facing manufacturing delays on...
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  • Anticancer Drug Attached to Nanoparticle Targets Tumors Without Damaging Tissue
    Biosensor research from Kai Johnsson’s laboratory at Ecole Polytechnique Fédérale de Lausanne (EPFL) gave way to the startup, LUCENTIX, which created a biosensor that enables patients to easily track drug concentrations in their blood without the need for complex lab systems. The biosensor is a molecule made up of three components: a protein that can […]

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