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ceutics exam 1
slide deck 1 and 2
| Question | Answer |
|---|---|
| dosage form is called a preparation | compounding |
| dosage form is called a product | manufacturing |
| prepared in limited quantities as a result of a physicians prescription order based on the prescriber-patient-pharmacist-compounder relationship | compounding |
| mass produced from natural or synthetic bulk chemicals and marketed for resale by pharmacies, practitioners, and others | manufacturing |
| regulated by state boards of pharmacy | compounding |
| regulated by the US Food and Drug Administration | manufacturing |
| the prep, mixing, assembling, altering, packaging, and labeling of a drug, drug delivery device , or device in accordance with a licensed practitioners rx, order, based on ____ relationship in the course of professional practice | USP |
| the term compounding does not include mixing, reconstituting, or other such acts that are preformed in accordance with directions contained in approved labeling provided by the products mfr and other manufacturer directions consistent with that labeling | FDA |
| person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient | FDA |
| is reconstitution compounding? USP and FDA | USP - Yes, FDA - No, USP's definition encompasses almost any manipulation |
| is repackaging compounding? USP and FDA | USP - Yes, FDA - No, FDA has its own guidance |
| Is tablet splitting compounding? USP and FDA | USP - No , FDA - No, check your state pharmacy regulations for any applicable requirements |
| Is preparing for immediate administration compounding? USP and FDA? | USP - No, FDA - No, is neither compounding nor repackaging |
| T or F, compounding drugs are not FDA approved | true |
| professional practice act by the state, states own pharmacy compounding laws, compliance with USP-NF standards, Self regulation by pharmacy compounding accreditation board (PCAB) | SBOP , prime regulator |
| FD&C ACT (503A), Drug quality and security act (DQSA), FDA Guidance Documents (Current thinking, nonbinding) | FDA, Regulatory framework |
| <795> non sterile compounding, <797> sterile preparations, official compounding preparations | standard settings |
| chapters <1> through <999> | enforceable |
| chapters <1000> through <1999> | informational |
| USF NF <795> good compounding practices (GCPs) for ______ | non sterile preparations |
| USP NF <797> good compounding practices (GCPs) for ______ | Sterile preparations |
| USP NF <800> Hazardous Drugs Handling In ______ setting | healthcare |
| CFR Part 210 | General GMP requirements |
| CFR part 211 | GMP for finished Pharmaceuticals |
| CFR Part 58 | GLP for Nonclinical Laboratory Studies |
| Good Manufacturing Practices (GMPs) | establish requirements for all aspects of pharmaceutical manufacturing and apply to foreign and domestic manufacturers |
| Good Laboratory Practices (GLPS) | are principles that provide a framework within which laboratory studies are planned, preformed, monitored, recorded, reported, and archived |
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