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MPJE Federal Law

Random pieces of federal pharmacy law tested on the MPJE

QuestionAnswer
Pure Food and Drug Act of 1906 Prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded (DID NOT require manufacturers to list ingredients or directions for use on the label)
Food, Drug and Cosmetic Act of 1938 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
Grandfathered Drugs Any drug marketed prior to 1938 that was exempt from the labeling and proof of safety standards of Food, Drug and Cosmetic Act (2ndary to diethylene glycol-antifreeze-in sulfanilamide elixirs Ex: Digoxin, Nitroglycerin, Levothyroxine, phenobarbital
Durham-Humphrey Amendment of 1951 Amendment to FDCA. Established 2 drug classes. Prescription AKA Legend drugs and Nonprescription AKA OTCs
Legend drugs (Prescription)Durham-Humphrey Amendment Require med supervision to be taken safely & do not have to list adequate directions for use on label, but require "Caution Federal Law prohibits dispensing w/o an Rx" on manufacturer's label Adequate directions for use=directions from MD on label
Nonprescription DrugsDurham-Humphrey Amendment Did not require medical supervision and did require adequate directions for use on their labels.
Kefauver-Harris Amendment of 1962AKA Drug Efficacy Amendment D/t Thalidomide tranquilizer in Europe causing birth defects (flipper babies). Required all new drugs marketed to show efficacy as well as safety. Extended to products 1938-1962
Prescription drug advertising regulated by FDA Kefauver-Harris Amendment of 1962
Nonprescription drug advertising regulated by FTC Kefauver-Harris Amendment of 1962
Medical Device Amendment 1976 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
Orphan Drug Act 1983 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)
Drug Price Competition and Patent-Term Restoration ActAKAWaxman Hatch Amendment Congress streamilined drug approval process for generics & provided innovation drug manufacturers w/ incentives to develop new drug products -->Pioneer drug firm has +5 yrs of exclusivity to market after drug is approved
Prescription Drug Marketing Act of 1987 Rx wholesalers must be licensed by respective states Banned reimportation of Rxs made in US Banned sale,trade,purchase of Rx samples Specified storage,handling,recordkeeping for samplesProhibited resale of Rx drugs purchased by hospitals/HCfacilities
FDA Modernization Act of 1997(Part 1 (cannot fit it all on one)) 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..."
FDA Modernization Act of 1997 (Part 2 (could not fit it all on one)) No more "Warning-May be habit forming" requirement on label Manufacturers may publicly disseminate limited info about unapproved indications of drugs provided they issue a statement saying the indication is not approved/cleared by FDA
FDA Modernization Act of 1997(Part 3 (could not fit it all on two)) Encouraged peds studies of drugs by giving +6months of marketing exclusivity
USP/NF United State Pharmacopeia/National Formulary Published by private group. Includes monographs with standards of quality. Considered 2 separate entities, but printed together.
PF Pharmacopoeia Forum Bimonthly publication of proposed changes to USP/NF
HPUS Homeopathic Pharmacopoeia of the US Made by a private group. Updates info about homeopathic products or remedies.
INDA 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.
Phase I Small group of health volunteers. Looking at toxicology, pharmacokinetic, and pharmacologic properties AND assessing safety.
Phase II >/= 100 people with the disease or condition to determine effectiveness, adequate dosage, relative safety, and AEs
Phase III Even larger group of people from several geographical locations. Examining effectiveness as compared to a control. Led by clinicians at these remote sites.
Treatment INDs 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
NDA approval Company may market the drug.
Phase IV Post marketing surveillance. Health professionals should report any problems with drug. Manufacturer must submit yearly reports.
Fast Track status Drug Companies may request to speed approval rate of drug, but only if it would treat a serious or life-threatening condition and addresses an unmet medical need.
ANDA Abbreviated New Drug Application. Require less data. Require proof that pharmacokinetics, bioavailability & clinical activity are similar to innovator's product.
SNDA 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.
Type P new drug FDA therapeutic class FDA classification of new drugs. Represents major therapeutic gain b/c on other drugs effective of has significant advantages. P=PRIORITY Reviewed FASTER
Type S new drug FDA therapeutic class FDA classification of new drugs. Similar to other drugs on market. S=Standard.
Type 1 new drug FDA chemical class New molecular structure
Type 6 new drug FDA chemical class New therapeutic indication for a drug
Type AA potential use for HIV/AIDS. Fast tracked accordingly!
Type E For life-threatening or severely debilitating disease. Priority given usuallly.
Type N Nonprescription
Type V Orphan drug-->Treating a disease/condition that <200,000 people in US afflicted by
USAN US adopted names council. gives generic name for new drug. council sponsered by AMA, APhA, USPC. Final OK from Secretary of DHHS.
Drug Price Competition and Petent-Term Restoration Act of 1984 Waxman-Hatch Amendment
Waxman-hatch AmendmentAKA Drug Price Competition and Petent-Term Restoration Act of 1984 Gave 5 additional years to the already established 17 years patent exclusivity to drug companiesGave +6months to companies for peds studiesGave faster drug approval to generic companies-->don't have to wait for patent to expire to do research
NDC law 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
NDC directory Lists all NDCs and identity
Red Book Lists all NDCs and equivalents
Blue Book Lists all NDCs and equivalents
National Drug Code Directory Available from FDA website. Lists all NDCs and equivalents
Adulteration Refers to composition-Contains any filthy, putrid, or decomposed substance-prepared, packaged, or held under unsanitary conditions (contaminiation risk)-manufactured at < GMPs-contains unapproved color additive
Adulteration cont. -contains drug w/ strength, purity, or quality < official standards-container composed of deleterious substance that may leach into product-Contains any ingredient as sub for active ingredient
Misbranded 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
Misbranded cont. -one or > active ingredient NOT identified-"Rx only" missing on manufacturer label-Missing precautionary statement concerning drug that is subject to deterioration-Missing quantity of container contents
Misbranded cont. -Inadequate directions for use of nonRx drugs OR does not include appropriate warnings required to protect those using med or package- Not = to USP/NF specifications-Offers sale of drug under another name
Misbranded in terms of pharmacies Pharmacy dispenses Rxonly drug without Rx
Package Insert Part of label. Considered misbranded without this.
Manufacturer label Federal Law Requirements 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!!!
Manufacturer label Federal Law Requirements cont. 6 Fed legend "Caution: Fed law prohibits dispensing without Rx" or "Rx only"7 Non oral route must be specified8 Special storage directions if appropriate9 Manufacturer's lot# or control#10 Expiration date
Manufacturer label ingredients 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
FD&C Yellow No 5 AKA tartrazine Special Label Warning Requirements Allergic reactions possible
Aspartame Special Label Warning Requirements Phenylketonurics:Contains phenyalanine__mg per__(dosage unit)
Sulfites Special Label Warning Requirements usually a preservative. Allergy warning.
Mineral oil Special Label Warning Requirements Use only at bedtime.Not in infants except if advised by MD.Discouraged in pregnancy.
Wintergreen oil AKA Methyl Salicylate Special Label Warning Requirements if >5% of product, Use other than directed may be dangerous and should be kept out of reach of children
Sodium Phosphates Special Label Warning Requirements < 90mL per OTC container
Isoproterenol Inhalation Product Special Label Warning Requirements User should not exceed the Rx'd dose and MD must be contacted if breathing difficulty persists
!!Ipecac Syrup Special Label Warning Requirements!! 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-->
!!Ipecac Syrup Special Label Warning Requirements!! "Warning:Keep out of reach of children.Do not use in unconscious persons or for poisoning w/ corrosives (lye, strong acids) petroleum distillates such as kerosene, gasoline, cleaning fluids or strychnine"Dose=15mL if >1 y/oSOLD ONLY IN 30mL packages!
Acetophenetidin AKA Phenacetin Special Label Warning Requirements Warning about possible kidney damage when taken in large amounts for long time
Salicylates (including aspirin) Special Label Warning Requirements Warning about Reye's Syndrome
Internal Analgesics and antipyretics Special Label Warning Requirements Warn consumers to consult with MD before taking if they consume >/=3 EtOH drinks/day
Code of Federal Regulations CFR Requires manufacturers to imprint SOLID ORAL dosage forms Rx or NonRx with code that identifies manufacturer and drug products.
Rx Drug Marketing Act 1987 AKA Dingle Billmade to correct drug diversion
Dingle Bill AKA Drug Marketing Act of 1987 -Requires proper storage of drugs and maintenance of appropriate distribution records-Prohibits shipping b/t states w/o being registered in state from wh/they are being shipped-Prohibits re-importation to US except by the manufacturer
Dingle Bill AKA Drug Marketing Act of 1987 cont. -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
Dingle Bill AKA Drug Marketing Act of 1987 cont. -provides for vouchers/coupons that may be filled from pharmacy stock at manufacturer's expense or at reduced cost to pt
Dingle Bill AKA Drug Marketing Act of 1987 cont. -permits pharmacies in healthcare facilities to receive Rx drug samples only if licensed Rxer has requested them and records maintained of their dispostion. They must be stored separately from normal drug stock
Dingle Bill AKA Drug Marketing Act of 1987 cont. -Prohibits drug products from being resold by hospitals or other healthcare facilities if they were purchased at special prices-sales reps responsible for inventory of samples/must take inventory/yr
Dingle Bill AKA Drug Marketing Act of 1987 cont. -allows practitioners licensed to Rx to receive samples provided that a WRITTEN REQUEST is made with name, address, medical specialty, signature, name of drug, quantity, manufacturer and date of request. Manufacturers must have receipt Xs 3 yrs
DEA Form 222 Required for each sale or transfer of a schedule I or II controlled substanceMay be obtained only by persons registered to handle controlled substances AND to EXPORT them
DEA Form 222 cont 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
DEA Form 222 cont. Individuals other than the registrant may complete the form on behalf of the registrant if allowed to do so by power of attorney
Filling Orders on DEA Form 222 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
Filling Orders on DEA Form 222 Registered compounders giving to off-site locations in conjunction with narcotic tx program at compounding location
Ordering with a DEA Form 222 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
Ordering with a DEA Form 222 cont. 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
Ordering with a DEA Form 222 cont. Purchaser must record on original Form copy # 3 the amount of commercial or bulk containers received on each item and dates they were received
DEA Form 222 colors Brown=copy1-->Supplier Green=copy2-->DEA Blue=copy3-->Purchaser
Endorsing an Order from DEA Form 222 If supplier 1 can't fill all or part of order w/in specified time, can ENDORSE to supplier 2 but must put name and address of supplier 2 on back of Form and supplier 1 cannot fill any part of order
Created by: krissyNI2H on 2009-10-09



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