Pharmaceutical Compounding Quiz 5
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Questions and Answers

Which USP chapters are enforceable by law?

Numbered less than 1000

According to the New Mexico regulations on compounding of sterile products, which of the following are included under 'Training'? (Select all that apply)

  • Documentation of training (correct)
  • Frequency of training (correct)
  • Topics of training (correct)
  • Personnel to be trained (correct)

    • What is the USP chapter for Pharmaceutical Compounding - Sterile Preparations?

    797

    What is the USP chapter for Hazardous Drugs—Handling In Healthcare Settings?

    <p>800</p> Signup and view all the answers

    What is the USP chapter for Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging?

    <p>825</p> Signup and view all the answers

    What is the USP chapter for Pharmaceutical Compounding - Nonsterile Preparations?

    <p>795</p> Signup and view all the answers

    The DQSA of 2013 created 503B outsourcing facilities. They are regulated by?

    <p>FDA</p> Signup and view all the answers

    Before compounding pediatric omeprazole from capsules, what training is needed?

    <p>Specified in USP</p> Signup and view all the answers

    What did the New England Compounding incident in 2012 involve?

    <p>Fungal infections from contaminated injectables</p> Signup and view all the answers

    According to the FDA, which of the following are included as compounding? (Mark all that apply)

    <p>Mixing three ingredients for an IV solution</p> Signup and view all the answers

    What is the definition of compounding?

    <p>Combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient</p> Signup and view all the answers

    What is the definition of manufacturing?

    <p>Production, preparation, propagation, conversion, processing, packaging, repackaging, or labeling of a prescription drug</p> Signup and view all the answers

    What is a compounding pharmacy?

    <p>Traditional compounding by pharmacist or physician</p> Signup and view all the answers

    What is a 503B pharmacy?

    <p>Outsourcing facility</p> Signup and view all the answers

    Where to find NM BOP regulations for non-sterile and sterile compounding?

    <p>Regulation 164.64.110.134</p> Signup and view all the answers

    Who began diluting chemotherapy drugs?

    <p>Robert Courtney</p> Signup and view all the answers

    What was the impact of pain creams on Medicare fraud?

    <p>Medicare spending increased from 13.2 million to 323.5 million; legal not ethical</p> Signup and view all the answers

    What was the price change of Daraprim and how did it relate to compounding?

    <p>The price of Daraprim increased from 13.50 per pill to $750 per pill; Express Scripts partnered with Imprimis Pharmaceuticals to produce a $1 capsule</p> Signup and view all the answers

    Study Notes

    USP Chapters

    • USP chapters numbered less than 1000 are legally enforceable.

    New Mexico Regulations on Compounding

    • Training includes frequency of training, topics covered, documentation practices, and personnel involved.

    Pharmaceutical Compounding Guidelines

    • USP Chapter 797 pertains to sterile preparations.
    • USP Chapter 800 addresses hazardous drug handling in healthcare settings.
    • USP Chapter 825 focuses on radiopharmaceuticals regarding preparation, compounding, dispensing, and repackaging.
    • USP Chapter 795 deals with nonsterile preparations.

    503B Outsourcing Facilities

    • Established by the DQSA of 2013 and regulated by the FDA.

    Compliance Training for Compounding

    • Interns need training specified in USP before compounding prescriptions.

    New England Compounding Incident

    • Involved fungal infections caused by contaminated injectable medications stemming from a compounding pharmacy.

    FDA Guidelines on Compounding

    • Compounding includes preparing a dye-free version of a commercially available cough syrup on written orders and mixing ingredients for IV solutions.

    Definitions

    • Compounding: Combining, mixing, or altering ingredients for personalized medication.
    • Manufacturing: Encompasses the entire production and labeling process of a prescription drug.
    • Compounding Pharmacy: Involves traditional compounding by pharmacists or physicians.
    • 503B Pharmacy: Refers to an outsourcing facility.

    New Mexico BOP Regulations

    • Regulations for non-sterile and sterile compounding can be found in Regulation 164.64.110.134.

    Dilution of Chemotherapy

    • Robert Courtney infamously diluted chemotherapy drugs before administering them to patients.

    Medicare Fraud Involving Pain Creams

    • Medicare spending surged from $13.2 million to $323.5 million due to fraudulent activities related to pain creams; actions were legal but not ethical.

    Economic Aspects of Compounding

    • Price of Daraprim escalated from $13.50 to $750 per pill; Imprimis Pharmaceuticals, in collaboration with Express Scripts, created a $1 alternative capsule.

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    Description

    Test your knowledge on pharmaceutical compounding and the regulations surrounding it. This quiz covers enforceable USP chapters and training requirements for compounding sterile products. Perfect for students and professionals in the pharmaceutical field.

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