Introduction to Sterile Preparations

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6 Terms

1
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DQSA

503 A and 503 B

2
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503 A

  • Traditional compounding pharmacies

  • need Rx

  • Compounder: RPh and MD

  • Compliance USP 795,797, and 800

  • No drugs removed from market

  • No difficult compounds

  • No commercially available products

  • Regulated by state and FDA

3
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503 B

  • outsourcing facility

  • no Rx

  • supervised by licensed pharmacist

  • regulated by the federal and inspected by FDA every 6 months

  • compliance: cGMP

  • no drugs removed from market

  • no difficult compounds

  • no commercially available products

4
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Minibag Plus

per USP 797- this is compounding

5
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Intravenous Product

vial (powder), vial (liquid), ampule, multi-dose vial, SVP, LVP

6
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Cardioplegia contents

  1. carrier fluid/diluent

  2. medication to arrest the heart (lidocaine or potassium)

  3. mixed with blood

  4. buffers pH

  5. blocks calcium accumulation