-purpose: preventing manufacture, sale or transportation of adulterated/misbranded food and drugs
-requirements: food and drugs can't be contaminated or misbranded
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
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)
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)
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
1961 Thalidomide disaster
caused phocomelia
1962 Kefauver-Harris Amendment
amendment to FDA
-required drugs to be safe and effective
-established good manufacturing practices
-human testing (not pre-1938 drugs)
1965 Drug Abuse Control Amendments
classifications for drugs of abuse (e.g. narcotics, non-narcotics)
-beginning of scheduled drugs
1970 Comprehensive Drug Abuse Prevention and Control Act
created DEA
-created closed system to control manufacture, distribution, prescribing and dispensing of controlled drugs
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
1987 Prescription Drug Marketing Act
amendment to FDA
-addressed diversion of samples, drug coupons, exported drugs, wholesale distribution and drugs purchased by hospitals
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
1990 Omnibus Budget Reconciliation Act
required pt profiles for Medicaid recipients, DUR and offer to counsel for Medicaid pts
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
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
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
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
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
T/F: A drug with an INDA can be distributed, promoted, prescribed or dispensed
F (NDA, ANDA or SNDA)
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
refilling an Rx without the prescriber's consent is: adulteration or misbranding?
misbranding
dispensing an easy-open cap in place of a child-resistant cap (unless it was requested) is: adulteration or misbranding?
misbranding
dispensing cephalexin 250mg capsules instead of 500mg is: adulteration or misbranding?
adulteration
dispensing an expired Rx or OTC medication is: adulteration or misbranding?
Gotcha! Both
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)
T/F: An NDC # on the label means a drug has an approved NDA
F (NDC used for identification)
T/F: Nonlegend drugs do not require package inserts or PPI/MedGuides
T
T/F: Both Rx and OTC drugs are required to have NDC #'s on the label
T
T/F: Both Rx and OTC drugs are required to have lot #'s and expiration dates on them
F (not OTCs)
selling an OTC product without a lot # or expiration date is: adulteration or misbranding?
Gotcha! Neither
which pharmacy workers can order schedule III, IV or V drugs?
anyone working on behalf of the registrant
which pharmacy workers can order schedule II drugs?
initially: whoever signed the initial/renewel application
-via power of attorney: people designated by initial person
form 222 is used to order schedule: II, III, IV or V drugs?
II
if someone is granted power of attorney on behalf of a pharmacy's DEA registrant, which forms can they sign?
form 222
-form 222a
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
T/F: Nebraska law requires a signature or initials on the blue copy of the triplicate form
F (neither)
the triplicate form is valid for ___ days after it was signed
60
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)
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
T/F: The Drug Diversion Act addresses illegal use or transportation of both Rx and OTC drugs
F (Rx drugs only)
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
"own use" doctrine
hospitals can fill patients' drugs for lower prices than community pharmacies b/c of lower contract prices
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
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
T/F: Drug samples can be sent directly to community pharmacies with prescriber authorization
F (prescriber or hospital pharmacy only)
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
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
T/F: Compounding can be done ahead of time in anticipation of receiving Rx's based on past prescribing patterns
T
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
T/F: 503(a) pharmacies must register with FDA
F (503(b) pharmacies)
T/F: 503(a) pharmacies can compound OTCs
F (no Rx involved)
T/F: Traditional pharmacies can compound drugs for prescribers' general office use
F (specific pt only)
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
