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kyleannkelsey
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1906 Pure Food and Drug Act
- response to "The Jungle"
- -purpose: preventing manufacture, sale or transportation of adulterated/misbranded food and drugs
- -requirements: food and drugs can't be contaminated or misbranded
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1914 Harrison Narcotic Act
- controlled sale of opium, morphine and codeine
- -created narcotics black market and required people/facilities distributing them to register and follow recordkeeping standards
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1937 Sulfanilamide elixir tragedy
- diethylene glycol caused deaths but couldn't legally remove it from market for being unsafe
- -was removed because of misbranding (called "elixir" but contained no alcohol)
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1938 Food, Drug and Cosmetic Act
- response to sulfanilamide incident
- -required: proof of safety for drugs and directions for use on label
- -not required: proof of efficacy
- -exception: pre-1938 drugs didn't have to prove safety (e.g. phenazopyridine)
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1951 Durham-Humphrey Amendment
- established non-legend (OTC) and legend (Rx) drugs
- -prohibited refills w/out prescriber consent and authorized pharmacists to refill with consent
- -established minimum information required on prescription label
- -allowed pharmacists to accept oral orders from prescriber
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1961 Thalidomide disaster
caused phocomelia
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1962 Kefauver-Harris Amendment
- amendment to FDA
- -required drugs to be safe and effective
- -established good manufacturing practices
- -human testing (not pre-1938 drugs)
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1965 Drug Abuse Control Amendments
- classifications for drugs of abuse (e.g. narcotics, non-narcotics)
- -beginning of scheduled drugs
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1970 Comprehensive Drug Abuse Prevention and Control Act
- created DEA
- -created closed system to control manufacture, distribution, prescribing and dispensing of controlled drugs
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1984 Drug Price Competition and Patent-term Restoration Act
- created ANDA for multisource/generic drugs
- -allowed marketing of generics w/out conducting safety/efficacy studies but required GMP and proof of bioequivalence
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1987 Prescription Drug Marketing Act
- amendment to FDA
- -addressed diversion of samples, drug coupons, exported drugs, wholesale distribution and drugs purchased by hospitals
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1988 Clinical Laboratory Improvement Amendment
- applies to anyone who tests materials derived from human body
- -established quality-control standards
- -e.g. need CLIA waiver to stick pt's finger for glucose test but not if pt sticks own finger
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1990 Omnibus Budget Reconciliation Act
required pt profiles for Medicaid recipients, DUR and offer to counsel for Medicaid pts
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1994 Dietary Supplement, Health and Education Act
- dietary supps regulated but not evaluated by FDA
- -dietary supps not considered drugs
- -allows structure/function claims but not health claims
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1996 Health Insurance Portability and Accountability Act
- regulates how protected health information must be stored and when/ to whom it can be released
- -regulates transmission of health information by workers
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1997 Food and Drug Modernization Act
- amendment to FDA
- -replaced "Caution: federal law prohibits dispensing without prescription" with "Rx only"
- -clarified compounding guidelines
- -eliminated "this drug may be habit forming" from Rx narcotics/hypnotics
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2013 Drug Quality and Security Act
- distinguishes btwn traditional pharmacy compounding and large-scale operations (can register w/FDA as outsourcing facilities - similar to manufacturers)
- -created track-and-trace pathway
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INDA/NDA/ANDA/SNDA
- INDA: approval to start Phase I, II, III studies
- -NDA: drug is available for general use
- -ANDA: needed to market generics if patent runs out on brand
- -SNDA: switches drug from Rx to OTC
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T/F: A drug with an INDA can be distributed, promoted, prescribed or dispensed
F (NDA, ANDA or SNDA)
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a drug is dispensed to a pt without an Rx label or verbal directions for use. This is an example of: adulteration or misbranding?
misbranding
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refilling an Rx without the prescriber's consent is: adulteration or misbranding?
misbranding
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dispensing an easy-open cap in place of a child-resistant cap (unless it was requested) is: adulteration or misbranding?
misbranding
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dispensing cephalexin 250mg capsules instead of 500mg is: adulteration or misbranding?
adulteration
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dispensing an expired Rx or OTC medication is: adulteration or misbranding?
Gotcha! Both
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required legend drug labeling for manufacturers, packagers and distributors
- 1. label on drug container
- 2. package insert
- 3. PPI or MedGuide*
- *only required for some drugs (OCPs, etc)
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T/F: An NDC # on the label means a drug has an approved NDA
F (NDC used for identification)
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T/F: Nonlegend drugs do not require package inserts or PPI/MedGuides
T
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T/F: Both Rx and OTC drugs are required to have NDC #'s on the label
T
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T/F: Both Rx and OTC drugs are required to have lot #'s and expiration dates on them
F (not OTCs)
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selling an OTC product without a lot # or expiration date is: adulteration or misbranding?
Gotcha! Neither
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which pharmacy workers can order schedule III, IV or V drugs?
anyone working on behalf of the registrant
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which pharmacy workers can order schedule II drugs?
- initially: whoever signed the initial/renewel application
- -via power of attorney: people designated by initial person
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form 222 is used to order schedule: II, III, IV or V drugs?
II
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if someone is granted power of attorney on behalf of a pharmacy's DEA registrant, which forms can they sign?
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3 components of triplicate form
- original: tan, sent to and kept by supplier
- -duplicate: green, sent to supplier and then DEA by end of the month
- -3rd copy: blue, retained to record # and date of packages received for each item
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T/F: Nebraska law requires a signature or initials on the blue copy of the triplicate form
F (neither)
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the triplicate form is valid for ___ days after it was signed
60
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transferring of schedule II, III, IV and V drugs between registrants (e.g. pharmacy --> prescriber)
- schedule II:
- form 222
- -schedule III, IV, V: written invoice
- -for occasional transfers only (<5% of all scheduled drugs dispensed/year)
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Drug Diversion Act
- products manufactured domestically and exported can only be reimported by original manufacturer
- -prohibits buying Rx drugs from other countries
- -exceptions for 90 DS of drug for personal use
- 1. drug not approved in US and treats serious condition
- 2. drug won't be commercially distributed by importer
- 3. drug isn't considered risky
- 4. proof that drug is for tx of condition
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T/F: The Drug Diversion Act addresses illegal use or transportation of both Rx and OTC drugs
F (Rx drugs only)
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Drug Supply Chain Security Act
- stops counterfeit, diverted or stolen Rx drugs from entering supply chain
- -requires verification of suspicious products
- -tracing information for 6 years
- -ok to transfer drugs btwn hospitals/pharmacies when wholesaler is out of stock (need invoices)
- -<=5% of revenue ($) can be transfers
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"own use" doctrine
hospitals can fill patients' drugs for lower prices than community pharmacies b/c of lower contract prices
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T/F: A transfer of clindamycin 300mg from CUMC pharmacy to Target pharmacy during a major drug shortage is done at AWP, not contract pricing
T
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starter pack vs drug sample
- starter pack: 3-4 DS that pts can use while pharmacy is ordering new drug
- -drug sample: states "sample, not for sale", requested by prescriber and sent to prescriber or hospital pharmacy only
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T/F: Drug samples can be sent directly to community pharmacies with prescriber authorization
F (prescriber or hospital pharmacy only)
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T/F: Expired Rx drug samples must be destroyed by a prescriber's office or sent back to the wholesaler - they can't be given to community pharmacies
T
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manufacturing vs compounding
- manufacturing: not part of traditional pharmacy practice b/c is not done under a specific Rx for a specific patient
- -compounding: for a specific Rx or for teaching (i.e. not dispensing) purposes
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T/F: Compounding can be done ahead of time in anticipation of receiving Rx's based on past prescribing patterns
T
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Drug Quality and Security Act (Compounding Quality Act)
- defines 503(b) pharmacies as outsourcing facilities where products are compounded in large quantities w/out individual Rx's
- -503(b) pharmacies must register w/FDA
- -distinct from traditional 503(a) pharmacies
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T/F: 503(a) pharmacies must register with FDA
F (503(b) pharmacies)
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T/F: 503(a) pharmacies can compound OTCs
F (no Rx involved)
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T/F: Traditional pharmacies can compound drugs for prescribers' general office use
F (specific pt only)
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white vs brown bagging
- white: pharmacy delivers compound directly to clinic/practice for use by specific pt
- -brown: pt brings compound acquired from pharmacy to clinic
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