Random pieces of federal pharmacy law tested on the MPJE
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
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| Pure Food and Drug Act of 1906 | show 🗑
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| show | Required any new drug be proven safe when used according to directions on label before being marketed Required adequate directions for use on the label & warnings about habit-forming drugs w/in the products "Grandfathered" Drugs, po Rxs & Refills
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| Grandfathered Drugs | show 🗑
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| Durham-Humphrey Amendment of 1951 | show 🗑
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| Legend drugs (Prescription)Durham-Humphrey Amendment | show 🗑
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| Nonprescription DrugsDurham-Humphrey Amendment | show 🗑
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| Kefauver-Harris Amendment of 1962AKA Drug Efficacy Amendment | show 🗑
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| Prescription drug advertising regulated by | show 🗑
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| show | FTC Kefauver-Harris Amendment of 1962
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| show | Better classification of med devices according to specific function, established performance standards, pre-market approval requirements, coformance with GMP and requires adherence to record/reporting requirements
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| show | Provided various tax and licensing incentives to manufacturers that made development of such drugs more appealing. Rare Disease=affects<200,000 people in USA(in general)
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| Drug Price Competition and Patent-Term Restoration ActAKAWaxman Hatch Amendment | show 🗑
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| Prescription Drug Marketing Act of 1987 | show 🗑
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| show | Fast-track review of NDAs to tx serious/lifethreatening conditions Individual states regulate compounding Pharmacies exempt for fed GMP standards & NDAs "Rx only" to replace "Caution: Federal law prohibits..."
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| FDA Modernization Act of 1997 (Part 2 (could not fit it all on one)) | show 🗑
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| show | Encouraged peds studies of drugs by giving +6months of marketing exclusivity
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| show | United State Pharmacopeia/National Formulary Published by private group. Includes monographs with standards of quality. Considered 2 separate entities, but printed together.
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| show | Pharmacopoeia Forum Bimonthly publication of proposed changes to USP/NF
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| show | Homeopathic Pharmacopoeia of the US Made by a private group. Updates info about homeopathic products or remedies.
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| show | Investigational new Drug Application. First form that must be submitted to the FDA before a drug may be administered to humans. Includes all preclinical data (animal studies). FDA decides w/in 30 days.
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| Phase I | show 🗑
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| show | >/= 100 people with the disease or condition to determine effectiveness, adequate dosage, relative safety, and AEs
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| show | Even larger group of people from several geographical locations. Examining effectiveness as compared to a control. Led by clinicians at these remote sites.
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| show | Treatment Investigational New Drugs. Allow admin of investigation new drug to patietns that have not been enrolled, but they must have an imminent lifethreatening stage of illness for wh/ no cure exists or present drugs suck. DRUG IN phase II OR III only
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| NDA approval | show 🗑
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| show | Post marketing surveillance. Health professionals should report any problems with drug. Manufacturer must submit yearly reports.
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| Fast Track status | show 🗑
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| ANDA | show 🗑
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| show | Supplemental New Drug Application. Manufacturer submits when they want to change the synthesis procedure, manufacturing locations, packaging, labeling, dosage form, strength, use, etc. MADE BY COMPANY WHO SENT IN NDA.
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| Type P new drug FDA therapeutic class | show 🗑
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| show | FDA classification of new drugs. Similar to other drugs on market. S=Standard.
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| show | New molecular structure
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| show | New therapeutic indication for a drug
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| Type AA | show 🗑
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| show | For life-threatening or severely debilitating disease. Priority given usuallly.
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| show | Nonprescription
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| Type V | show 🗑
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| USAN | show 🗑
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| Drug Price Competition and Petent-Term Restoration Act of 1984 | show 🗑
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| Waxman-hatch AmendmentAKA Drug Price Competition and Petent-Term Restoration Act of 1984 | show 🗑
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| show | National Drug Code. Not required on any manufacturer/unit dose/prescription labels!Can be reassigned after 5 years from teh last commercial shipment of a drug by the manufacturer
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| NDC directory | show 🗑
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| show | Lists all NDCs and equivalents
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| show | Lists all NDCs and equivalents
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| National Drug Code Directory | show 🗑
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| Adulteration | show 🗑
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| Adulteration cont. | show 🗑
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| show | Refers to label. If label-is false or misleading-missing name or locations of manufacturer/packer/distributor-missing word, statement or other info required by law to be displayed in prominent readable manner
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| Misbranded cont. | show 🗑
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| Misbranded cont. | show 🗑
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| Misbranded in terms of pharmacies | show 🗑
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| Package Insert | show 🗑
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| show | 1 Name of manufacturer/packer/distributor2 Address " " " "3 Name of drug4 Net quantity (weight, quantity or dosage units in package)5 Weight of each active ingredient in each dosage unit-->mEqs if electrolyte replacement Tx!!!
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| Manufacturer label Federal Law Requirements cont. | show 🗑
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| show | Alphabetical. Separate active ingredients. Exception to labeling are flavors and fragrances which can just be listed by a generic name like Red Dye.Inert gases may not be listed either at times
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| show | Allergic reactions possible
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| show | Phenylketonurics:Contains phenyalanine__mg per__(dosage unit)
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| Sulfites Special Label Warning Requirements | show 🗑
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| Mineral oil Special Label Warning Requirements | show 🗑
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| show | if >5% of product, Use other than directed may be dangerous and should be kept out of reach of children
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| show | < 90mL per OTC container
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| Isoproterenol Inhalation Product Special Label Warning Requirements | show 🗑
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| show | Boxed statement in RED TYPE "For emergency to cause vomiting in poisoning. Before using call MD, poison prevention center or hospital ER immediately for advice" + another statement-->
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| !!Ipecac Syrup Special Label Warning Requirements!! | show 🗑
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| Acetophenetidin AKA Phenacetin Special Label Warning Requirements | show 🗑
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| show | Warning about Reye's Syndrome
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| show | Warn consumers to consult with MD before taking if they consume >/=3 EtOH drinks/day
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| show | Requires manufacturers to imprint SOLID ORAL dosage forms Rx or NonRx with code that identifies manufacturer and drug products.
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| Rx Drug Marketing Act 1987 | show 🗑
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| Dingle Bill AKA Drug Marketing Act of 1987 | show 🗑
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| show | -Requires state license of wholesalers-Rstricts sale, purchase, or trade of prescription drug samples and bars retail pharmacies from receiving any Rx drug samples-Allows starter packs to be distributed free of charge to pharmacies-provides vouchers
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| show | -provides for vouchers/coupons that may be filled from pharmacy stock at manufacturer's expense or at reduced cost to pt
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| Dingle Bill AKA Drug Marketing Act of 1987 cont. | show 🗑
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| Dingle Bill AKA Drug Marketing Act of 1987 cont. | show 🗑
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| Dingle Bill AKA Drug Marketing Act of 1987 cont. | show 🗑
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| DEA Form 222 | show 🗑
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| show | Only 1 supplier per form Each line of the form must contain only 1 drug productOrders for carfentanil, etorphine hydrochloride, diprenorphine must contain only these substances on the form
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| DEA Form 222 cont. | show 🗑
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| show | Only person registered as manufacturer or distributor on controls I & II OR Rph D/Cing a pharmacyPerson registered to conduct chemical analysis or research w/ Is and IIs can give to another registered to do the same
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| Filling Orders on DEA Form 222 | show 🗑
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| show | Give 1st and 2nd copy to supplier and keeps 3rd copy for themselvesOrder can be partially filled with the remaining quantity shipped w/in 60daysForm no longer valid after 60days from time executed by purchaser
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| show | Orders shipped only to purchaser at address on Form 222Supplier sends 2nd copy of form to DEA by end of month during wh/ order was filled or if in partial fills, to DEA at the close of the month during which the final portion was shipped
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| Ordering with a DEA Form 222 cont. | show 🗑
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| DEA Form 222 colors | show 🗑
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| Endorsing an Order from DEA Form 222 | show 🗑
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krissyNI2H
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