Federal Law MPJE All Answers Correct

Federal Law MPJE All Answers Correct 3 options for filing paper prescriptions ️1. 3 buckets: Schedule II, Schedule III-V, Non-CS 2. 2 buckets: Schedule II, Schedules III-V + non-CS (Mark schedules with RED C) 3. 2 buckets: Schedule II-V with red C, Non-CS 5% rule ️Pharmacies can distribute 5% of annual controlled substance doses dispensed without registering with DEA as a distributor in a 12-MONTH PERIOD A room designated for compounding hazardous drugs (HD) requires positive or negative pressure? ️Negative (sucks all the bad fumes away, chemo hood) Abbreviated New Drug Application (ANDA) ️the process by which applicants must scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs in the same way as the innovator drug Accelerated Approval ️For drugs with long-term endpoints that are hard to measure during clinical trials such as morality rate. Adulteration ️1) Contains something bad/decomposed 2) Prepared under unsanitary conditions/may have been contaminated 3) Did not follow cGMP 4) Is stored in a place that inhibits inspection 5) Contains a contaminant or unsafe additive 6) Strength or purity differs from its official compendium or label After opening a component used for Compounded Sterile Products (CSPs), how long are you allowed to use them? ️1. Ampule: Use immediately and discard remainder 2. Single-dose vial: If in ISO 5 - 6 hours, if not - 1 hour 3. Multi-dose vial: In and out of ISO 5 - 28 days Age requirement to pick up a CS ️18 YOA Alcohol, Tobacco, and Firearms (ATF) ️regulatory & enforcement emphasis. responsible for guns, explosives, labels on wine, etc. (NOT PART OF PHARMACY) Aspirin ️- Require a warning on aspirin and other salicylate products, including risk of Rey's syndrome in children - Containers of 81 mg (1.25 gr) aspirin may not contain more than 36 tablets to prevent overdose poisoning Average sale price (ASP) ️- defined as the manufacturer's sales of a drug to all purchasers in a calendar quarter divided by the total number of units of the drug sold by the manufacturer in that same quarter Benefits and restrictions of a 503A facility ️- 503A facilities can pre-emptively compound (anticipatory) but only pursuant to a prescription or medication order. - Regulated by states/USP standards Benefits and restrictions of a 503B facility ️Outsourcing facility (503B) Can compound (w/o a prescription) - Regulated by FDA/cGMP. - Exempt from: premarket approval, adequate directions for use, and track-and-trace provisions. - May not compound a bulk drug unless on a shortage or bulk list. Breakthrough Therapy ️A process designed to expedite development and review of drugs which may demonstrate substantial improvement over available therapy. BUD for Non-aqueous solution ️6 months BUD for water-containing oral formulations ️14 days refrigerated BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations ️30 days Called in C-II ️- Immediately written by Pharmacist - Quantity only enough for emergency period - Require hard copy prescription from prescriber within 7 days after emergency supply - MUST contain "authorization for emergency dispensing" and date of the oral order written on the script - Report to DEA if not received in timely manner Can you store ingredients in a storage room on the floor? ️No, they must be elevated from the floor by at least 6? inches. Categories of Compounded Sterile Preparations (CSP) ️1. Immediate: Transfer of 3