Month: May 2018

Conatining Bloodstream Infections

  Pharmacy compounding is the process of combining drug ingredients to prepare medications that are not commercially available or to alter commercially available medications to meet specific patient needs such as dye-free or liquid formulations. Pharmacists traditionally have prepared medications to fulfill individual prescription requests or manipulated reasonable quantities of human drugs on receipt of …

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DSM Montgomery ISO7 Sampling Room

    Aseptic Enclosures were approached by DSM Montgomery, to design and develop an ISO 7 8×12 Sampling room. The sensitive instruments and procedures that are carried out, needed ISO 7 classification for particulate as well as protection from molecular, electromagnetic and magnetic contamination of the sampling procedure. Aseptic Enclosures designed and supplied a Sampling …

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FDA Alters Course on Definition of Compounding “Facility” in Final Guidance

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned …

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Mold Discovered in Injectable Antibiotic Prompts Nationwide Recall

AuroMedics Pharma announced a voluntary recall of 1 lot of Linezolid injection 600mg/300mL flexible bags at the hospital level after it was found to contain white particulate matter identified as mold. The mold discovery was following a product complaint where the contents of 1 flexible bag from a batch was found to contain white particulate …

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New FDA recall guidance released

The FDA has released guidance to improve recall processes so the public are better equipped  to protect themselves from recalled medicines. 2018 saw the FDA release draft guidance that sheds light on the body’s policy on warnings and notifications regarding recalled products. Drug recall  As mentioned in Douglas Steam’s recent FDA blog who is the FDA’s Director, Office of …

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