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Exam (elaborations)

Washington MPJE + Federal Latest 2023 Graded A+

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Washington MPJE + Federal Latest 2023 Graded A+ DEA 224 Registration for: - Retail pharmacies - Hospitals/clinics - Practitioners - Teaching Institution - Mid-Level Practitioners Retail pharmacy registration 224 Hospital registration 224 Clinic registration 224 Practitioner registration 224 Teaching institution registration 224 Mid-Level practitioner registration 224 DEA 225 Registration for: - Manufacturers - Distributors - Researchers - Analytical laboratories - Importers - Exporters Manufacturer registration 225 Distributor registration 225 Researcher registration 225 Analytical laboratory registration 225 Importer registration 225 Exporter registration 225 Registration for Narcotic Treatment Programs 363 Ordering Schedule I and II drugs 222 Reporting theft or significant loss of controlled substances 106 Record of controlled substances destroyed 41 Labeling on prescription drugs is written for... healthcare providers Labeling on OTC drugs is written for... patients If any required OTC labeling information is missing, the drug is considered misbranded Requirements for an OTC drug label 1) Principal Display Panel 2) Statement of Identity - drug name + pharmacological category/intended action (*should be on principal display panel*) 3) Net quantity of contents (weight, measure or numerical count) 4) Name AND address of manufacturer/packager/distributor 5) Adequate directions for self-use 6) "Drug Facts" Panel This should be on the Principal Display Panel of an OTC drug Statement of Identity = drug name + pharmacologic category/intended action Is the "Drug Facts" Panel on OTCs FDA approved? Yes In an NDC require on the OTC labeling? Requested but *not required* Adequate directions for self use include: - dosing - preparation - frequency - duration - time - route Required elements of "Drug Facts" Panel 1) Active Ingredient (including quantity per dose) 2) Purpose (pharmacologic category/intended use) 3) Uses (indications) 4) Warnings 5) Directions (for specific age groups/populations) 6) Other information (Electrolyte labeling, inactive ingredients) 7) Contact information ("Questions" + phone #)

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Institution
Washington MPJE
Course
Washington MPJE

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Uploaded on
March 4, 2023
Number of pages
152
Written in
2022/2023
Type
Exam (elaborations)
Contains
Questions & answers

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