EXAM 1: Breakdown

Exam Breakdown: 80 questions with 1 extra credit question; the breakdown below is an approximate
range for each lecture to get to 80 questions. The total points (denominator when calculating grades) is 100.
Each question is worth 1.25 points including the extra credit.
Lecture 1 ~ 12 - 16 questions
Lecture 2 ~ 15 - 17 questions
Lecture 3 ~ 15 - 17 questions
Lecture 4 ~ 15 - 17 questions
Lecture 5 ~ 15 - 17 questions
Lecture I

Highest law of the

land?
▫

US
Constitution

CMS
1. Human Health Services: FDA and CMS (Medicaid and Medicare) 2.
Dep of Justice: DEA, FBI, ATF (alcohol, tobacco, and firearms)
3. FTC
4. SEC (corporations)
5. Homeland Security: Coast Guard and FEMA What are the
state federal agencies that we have talked about?
▫ i. More AZ State board of Pharmacy, AZ department of Health Services, AHCCCS
Specifically:
1. Arizona Dept of Health Services (ADHS)
2. DPS: Sheriff and Local Police
3. AZ Attorney General
4. ASBP (pharm board)
5. AHCCCS

What are the two functions of the board of pharmacy?

▫ Board of pharmacy created by an Act signed into
law and the US Code and assigned to admin
▫ agency to oversee it
Legislative & Judicial functions
 i. Legislative – administration &
Enforcement, interpreting and defining the
scope of the statue; based on a statute that
gives the agency the authority to
promulgate the regulation, bearing a
reasonable relationship to public health,
safety, and welfare, force and effect of
law, unless in conflict with statute
ii. Judicial – disciplinary hearing, functioning as a judge when a statue is violated and
regulated
Who does the DEA report to at the administrative level and who’s the head of the agency?
▫ Department of Justice; US attorney General is the head of that agency (the President) What
was the enabling legislation that created the Food and Drug Administration?
▫ FDC
What was the A enabling legislation that created the State board of Pharmacy of AZ
▫ Pharmacy Practice Act (every agency has an act that creates it) Where
are the proposed federal regulations found?
▫ Federal
▫ After final Register notice in Register, goes to Code of Fed Regulations
Where to find proposed State regulations?
▫ AZ administrative register
Who takes care of the AZ administrative register and administrative code?
▫ Secretary of State (Katie Hobbs)
What is the purpose of Stare Decisis?
▫ Establish continuity of decision, expedite judicial decision-making; only applies to lower courts
within the jurisdiction that the precedent has been set
▫ Means to decide to abide by decided cases- case law, give respect to a previous decision
▫ Ie. AZ courts are not underneath Cali courts
i. Can appeal your circuit court but they can deny it
ii. Moving up courts: order is US District Courts, US Circuit Court of Appeals, and US
Supreme Court
What are the three criteria for an administrative law to be valid?
▫ Be within agency’s scope of authority
▫ Based on a statute that gives agency the authority to promulgate the regulation
▫ Bear a reasonable relationship to public health, safety, and welfare

hastobewithin
Who is involved in a criminal case? samestatetofollow
▫ State & accused
Who is involved in a civil case?
▫ Plaintiff & defendant
In a criminal case, what is the determinant?
▫ Guilty beyond reasonable
▫ Determined by doubt courts

What is the objective

case?
of a criminal criminal punish
▫
Punish
civil compensate
What is the determinant for a civil case?
▫ preponderance of evidence, must be 49:51%
▫ Det by courts and arbitration
What is the ob jective of a civil case?
▫ Compensate
If she asks about administrative:
▫ ASBP in matter of defendant and is based on determination of Admin Agency (ASBP)
▫ Can get your license revoked, usually a hearing officer, etc
In most of the malpractice cases for adults, what is the statute of limitation in AZ?
▫ 2 Years
▫ Definition of statute of lim (bc I don’t know what that is)
i. Time limit in which a suit must be filed and brought before a
governing body from the date when the problem first
started/recognized
ii. None for murder
When does the clock start for the statute of limitations for a minor? ▫ Once they turn 18
What are the phases of public policy cycle?
▫ Problem definition/idea, agenda setting, policy formulation/adoption, implementation, evaluation
What are the public policy instruments?
▫ Used for achieving a behavior change, realize social, political, or economic conditions, public
service
i. Doing Nothing: self-corrective problem
ii. Info-based:knowledge transfer, communication
1. Least coercive: posters, Ads
iii. Expenditure-based:money used as a direct instrument to achieve outcome
1. Grants, vouchers
iv. Regulations: government’s role to command and prohibit actions
1. Defines norms
v. Acting directly: provide direct service to achieve outcome
1. Education, parks and rec, public health/CDC
Lecture II

Where does congress derive its authority for drug distribution from what piece?
▫ (of the US Interstate commerceConstitution)
▫ Can clause apply to foreign nationals, US States,
and Indian Tribes What does the supremacy clause of the constitution mean?
 ▫ Whichever is stricter is the one that takes precedence
Did the food drug and cosmetic act (FDCA) originate the definition for misbranding and adulteration or
expand it?

▫ No, theyexpanded misbranding and adulteration

What does the FDCA also regulate?
▫ Drug development, manufacturing, and marketing
▫ Includes all duties done by the Du
rham-Hum Amendment, Kefauver
-Harris Amendment and
Medical Device Amendment
i. Est FDA
ii. Reg drug dev, manufacturer, and marketing
iii. Products must be SAFE and properly labeled to be introduced into interstate commerce iv.
Defined label and labeling
1. Must include ADE, directions, etc
v. Expanded Def of adult and misbranding
1. Supreme court ruled to do this
2. Applies to drugs, cosmetics and devices vi. Defines what is a
food, drug, cosmetic, dietary supp and devices
1. Devices and cosmetics are under FDA
What does the Durham- /Prescriptions Drug Amendment do?
▫ Humphrey
Established Rx & OTC, prescriptions being orally transmitted, prescribers may authorize refills
(written or oral)
▫ Rx drugs req medical supervision, only sold in pharmacies and pharmacies are exempt from
labeling req.. But sold on Rx basis only, contain adequate directions from prescriber, drug
containers need “Caution: Fed law prohibits dispensed without a prescription” or “Rx Only”
What does the Kefauver -Harris Amendment/Drug Efficacy Amendment do?
▫ Led by flipper babies occurring with thalidomide
▫ Established that the effectivedrugs must be
i. So now, drugs must be safe (FDCA) and effective (KF)
▫ Est CGMP
▫ for RX drugs switched advertising from FTC → FDA
▫ More controls on investigations by req consent from subjects
▫added adverse
▫ Drugs from reporting 1938-1962 deemed safe but not effective and will be
reviews What is the difference between adulteration and misbranding?
▫ Adulteration – drug’s strength, purity, and quality
i. Product IS adulterated:
1. Filthy, putrid, or decomposed
2. Prepared, packed, or held in unsanitary conditions
3. Container is poisonous
4. Drugs strength, quality or purity differs from label AND compendia standards
5. Unsafe color additive
 ii. Product MIGHT be adulterated, even if pure, if:

Bolger 1. Prepared, packed or held in possible contaminated conditions

2. Exposed to a container that may have been contaminated
3. Manu under cond not with CGMP current guidelines
▫ Misbranded – representation made by the manufacturer on the label or labeling
i. Labeling is false or misleading in any way
ii. Req info is missing from label or labeling
1. Names, directions, info for use, manufact, packer, or distributer, no rx only or
caution label

Ie. If it is adulterated, it is misbranded 99% of the time. If misbranded, not necessarily

adulterated.

T/F: Medical Device Amendment was the first law to give extensive authority over medical devices?
▫ TRUE
▫ Before this law, FDA had little authority over devices
i. We can now have classification of devices by function AND risk, premarket approval and
testing, est of performance standards, conformance with GMP reg, adherence to record and reporting
requirements ii. Class I (low risk, needles, gloves)- Class III (high risk, like pacemakers, and valves)
Under the Prescription drug marketing Act (PDMA)/ Dingle Bill, can hospital resell drugs purchased
from manufacturers and wholesalers to community pharmacies?
▫ NO
▫ Because: protection of pub health, secondary wholesale distribution schemes, unfair comp, reimport of Rx drugs,
dist of Rx samples
Who has the exception to re -import drugs?
▫ Manufacturer
s
▫ Under PDMA
Are Pharmacists allowed to distribute drug samples?
▫ NO
▫ Under PDMA: no to sale, trade, or purchase of rx samples
i. And no pharmacy can distribute samples (exception: hosp entity pharmacy where a
practitioner auth sample and adequate records kept) ii. Before PDMA: too many
samples, less records, and improper sales
Are pharmacists allowed to traffic prescription drugs coupons?
▫ No
▫ Under PDMA
i. Can get 10 years in prison and/or 250K Fine!!
ii. Not even just across the border but also sold for profit with coupons, etc Are stated
required to license drug wholesalers?
▫ Yes
Can a community pharmacy keep drug samples in the pharmacy?
 ▫ No

Did the Dietary Supplement Health and Education Act (DSHEA) strip the FDA of pre-market
approval
for dietary supplements?
▫ Ye
i. Also, the act s defined the supplement to be a drug when there are drug claims in the promotion
ii. Supplements must state the disclaimer that the product has not been eval by FDA and not
intended to diagnose, txt, cure, or prevent disease
What agency is responsible for the enforcement of the poison prevention packaging act?
▫ Consumer Product safety commission (CPSC)

1. Agency is also resp for:recalls

a. Protecting children from poisonings
b. Hazardous subst
c. Economic poison
d. Household fuel
e. Food, drug, cosmetic
i. Rx: human Oral use and others necessary
Does the poison prevention packaging act (PPPA) apply to all prescription drugs or only oral human
drugs?
▫ Oral human drugs
i. Dr. Gurney said Read the question carefully
ii. See above question on what else it covers
iii. In addition to:
1. Controlled drugs
2. Drugs switched from Rx to OTC
3. Aspirin and acetaminophen
4. Methyl salicylate
5. Iron-containing and supplements 6. Lidocaine, dibucaine, and minoxidil or
child resistant containers?
Can I re-use
NO non-threaded plastic containers
▫
i. Can reuse threaded, and pref glass

raithuman
protective package 1. Must dispense with new safety
closure
Is there an exception for oral contraceptives, estrogen/progesterone containing products to the poison
prevention packaging act?
▫ Yes, if they’re in the memory/mnemonic devices
i. Other exceptions include: drugs to institutionalized patients, sublingual Nitro tablets,
aerosol containers, Medrol tablets, K+ supplements Are OTC products an exception to the PPPA?
▫ Yes, it is the product, not the overarching brand
 i. OTC must be in child resistant with exception being one package size of an OTC product
for the elderly or handicapped may be in non-child resistant
1. Must say for households without young children or not child resistant

individual patients themselves

can

Can prescribers make blanket requests for patients for non-child resistant packaging for their patients?
▫ NO, but
i. Prescribers may request that a single rx order be in non-safe packaging, but not a blanket request!
macy for an inspection during normal business
Does the FDA need a warrant to walk into the phar hours?
▫ NO
i. They do not need to state the reason for the inspection either
Who appoints the board members for the AZ state board of pharmacy (ASBP) or any of the other

regulatory boards? can suspendlicensewhilewaiting

▫ Governor
i. Appointed for a 5-year term ii. They can only
serve max of 2 consecutive terms The purpose of the board to
protect who?
▫ Public (including health, safety and welfare)
How many Techs, public, and pharmacists are on the board?
▫ 1 tech, 2 public members, 6 pharmacists (1 hospital and 1
community) i. If she asks:
1. Technician
a. Practicing tech in AZ or other jurisdiction for 5 years
b. Licensed as a tech in AZ and resident of AZ for at least 5 years
2. Pharmacist
a. Licensed for at least 10 years
b. Licensed and resident of AZ for at least 5 years
3. Consumers
a. Resident of AZ for at least 5 years
What are the two conditions for the six pharmacists? ▫
One hospital and one community
What are the sole responsibilities of the ASBP compared to the joint responsibilities with another
executive branch agency?
▫ Sole: establishing standard of practice, investigations, and display actions, and licensing &
permitting
▫ Joint: (with AZ Dept of Health Services)
i. Regulation of:
1. hospital pharmacies
2. long-term care facilities
 3. Outcomes
4. third-party plans
T/F: The board summarily suspend the license pending the hearing if they believe there is a risk to
public healthy safety and welfare that require immediate action.
▫ TRUE

Lecture III

Definition of a drug
▫ Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in ;
man or otherand
animals
▫ ) intended to affect Articles (other thanthe structure or any function of the body of man or other animals; and
▫ Articles intended food for use as a component of any articles specified in clause (A), (B), or
(C)
▫ Recognized in USP, Homeopathic Pharmacopeia, NF, or supplements to them
Official compendia recognized by the FDCA; they exist as:
▫ United States Pharmacopeia (USP)

▫ National Formulary storage rpackage

▫ Homeopathic Pharmacopeia
What does the official compendia do?
▫ Establish quality standards for drugs and related items
i. Ie. temp control
▫ Establish standards for storage and packaging of drugs
i. Ie. Specific bottles to dispense in
Definition of a Food:
▫ Articles used for food or drink for man or other animals
▫ Chewing gum
▫ Articles used for components of any such article
What are special dietary foods? Foods for special dietary needs, bc of physical, physiological,
pathological, or other conditions ▫ Infant formula

monopra
no
▫ Artificial sweeteners publicnopreapproval
▫ Caloric supplements (Ensure, etc) exclusivity process

nbahasa
rat contraceptive Yes fee boxalabening packagemea
t
Yes▫ If she asks, Medical Foods are
under medical supervision and include diet management (ie. Food without phenylalanine for phenylketonuria)
If trying to get a drug approved, what if the final step that has to be filed with FDA?
 ▫ NDA
i. Submit an IND before phase I and clinical studies
ii. NDA after Phase III is done

happeneT
When is an SNDA used? idk what
▫ Switch from rx to otc
▫ Or add another indication
▫ Or changes to update information for an already approved drug
What does parallel track mean?
▫ Individual patient access to investigational drugs for serious conditions
i. Approval to treat an indv pt ii. Approval is conditional upon completion of post-
marketing (P-IV) Clinical studies When are phase 4 clinical trials done?
▫ After it has been approved and is on the market
▫ Never ending
▫ Some mandated by the FDA
Do manufacturers that are trying to produce an authorized generic, do they need to file an NDA, ANDA,
or SNDA?
▫ NO, they don’t have to file anything!
i. There is another process where they can file an ANDA- generic drug application- not req
to prove safety and efficacy- must be a bioequivalent
ii. The authorized generic pathway- without these applications- brand sells rights to make
generic to someone with 180 days exclusivity
If an OTC were to be added to the market using the monograph process, is there a timeline?
▫ NO! -- it’s a public process, no pre-market approval needed (because using specific recipe), NO
MARKET EXCLUSIVITY, no user fees, final monograph open to everyone, active ingredient
specific and eval by otc drug category, no timeline, may req studies, no premarket review of
trade
i. NDA process, on the other hand:
1. Pre-market app, confidential filing, user fee, market exclusivity, mandated FDA
timelines, may require clinical studies, approved label is unique, approved NDA
is license to market, trade name is reviewed

k
What are the components of ‘LABELING’? blac box
▫ The label PLUS any ‘accompanying’ information such as package insert, the patient package
insert, med guide, or other materials like consumer info (box itself too) What are the 8 components
required on manufacturers label?
▫ Drug name
▫ Established name *generic or chemical
▫ Strength
▫ Recommended dosage
 ▫ Lot number
▫ Expiration date
▫ Quantity
▫ Legend statement: “Rx only” or “caution: federal law prohibits dispensing without prescription”
Regarding REMS (risk evaluation and mitigation strategies), the FDA may require a manufacturer to
implement special procedures to reduce these risks which include: (some have to do all 4 and most only
require one or two of them-any combo)
▫ Communication
▫ plan
Medication
▫ Elements to assure guide safe use (ETASU)
▫ Implementation system
What are the components of an NDC number?
▫ First five digits=
▫ Middle four digits= manufacturer/labeler/distributor drug product
▫ Last tw o digits= package size and type of
drug Which law -digit NDC?requires an 11
▫ HIPPA
i. -digit code FDA req a
Understand that the NDC 10 —like transaction information, drug supply portionis
required for lots of shit
of DSCSA, to track where things are going in the process
▫ NDC number used for a lot, like processing 3rd party claims, tracking dist of products, universal
product identifier, DOES NOT indicate that the drug has received FDA approval
Are manufacturers required to put NDC’s in linear barcode format on a label?
▫ YES! -- also part of track and
T/F: The drug facts trace label on OTC product is different from a prescription drug
product
▫ TRU
i. OTC E for patients to educate themselves on the product (will be on OSCE probably.. Or the
Prescription requirements when someone brings one to the pharmacy)
1. Active ingredient
2. Purpose
3. Uses
4. Warnings
5. Directions
6. Other info: storage
7. Inactive ingredients
8. Qs and Comments
9. Name and address of manu
10. Net quantity
ii. doctors Rx

1. A couple of questions up
Does the FDA have statutory authority to recall all drug products?
▫ NAY!
FDA has statutory authority to mandate recalls for:
▫ Devices
▫ Biologics
▫ Tobacco products
▫ Infant formula
▫ Human tissue intended for transplantation
▫ Interstate milk shipments
What is worse, Class 1 or Class 3 drug recall?
▫ Class 1—somebody could
i. Serious health die consequences
ii. Recall stocks in pharmacies and notify pts with this drug 1. Class II: product may cause
temp or reversible effects
a. Recall stocks
2. Class III: unlikely to cause adverse health conseq
a. Recall may be because of misspelling on label: Misbranded!
What would violate the true statement principles required for prescription advertising from
manufacturers?
▫ Its false or misleading
▫ The ad contains information that favors effectiveness information over side effects and
contraindications
▫ If it excludes material fact
Drug price competition and patent restoration act (PTRA) of 1984
▫ Created the ANDA for generic drug
approvals
▫ Allows FDA to grant innovator drugs patent-term extensions
▫ Exclusivity= exclusive marketing rights granted by the FDA upon approval of a
i. Granted with drug NDA approval
Patents and market exclusivity are different
▫ Exclusivity can extend life of a product before generic competition comes in
How long are patents valid for?
▫ 20 years, issued by patent office
T or F: One of the requirements of post-marketing surveillance is that manufacturers are required to report any
serious adverse drug reactions to FDA.
▫ True
i. For ANY event, if reported to them, they must report even if not about the drug they
made
ii. Manufacturers have AERS
 iii. Pharmacies have MedWatch and ISMP-MERP Compounding Quality Act of DQSA,
title 1:
▫ Drug compounding (applies to human consumption only)- NOT ANIMALS!!
i. Ensured safety of compounded drugs
ii. For human use
iii. 503B for outsourcing facilities iv. Applies to licensed pharmacists, practitioners,
outsourcing
DQSA, Title 1 also created 503b outsourcing facilities that can-do large-scale compounding or for office
use?
▫ True
Drug Manufacturers are not allowed to promote their drug product through direct-to-consumer
mechanisms.
▫ FALSE

Lecture IV

How long is your intern license good for?

▫ 5
years
i. If intern doesn’t complete education within 6 years of date of issue of intern license, not
eligible for relicensing unless board approval obtained How soon do you have to notify the board on employment
status change:

▫
days
pickstatus
change
How long to notify on change in address? immediately
▫ 10
Do you need to days report IPPE and APPE hours to the board?
▫ No, the school does
Do you need a fingerprint clearance card?
▫ Ye
To be an intern s preceptor:
▫ Min 1 year experience as an actively practicing pharmacist
▫ Needs an unrestricted, current license
▫ If found guilty of violating law, etc, enters into agreement satisfactory to board

Teacher and
▫ mentor Responsible yintem
▫ Review policies and procedures
▫ Provide opportunity and skill development
▫ Provide timely and realistic feedback
▫ Resp for actions of intern
Pharmacy licensure:
▫ Reciprocity:
 i. Use Original Board License and take the state MPJE ii. Does not need to prove
schooling/graduating from because already have license Residency iii. Do not
have to worry about submitting training hours because already have license
DO

liveinstate iv. need to prove no restrictions, suspensions, and that

you are in good standing and you did pass the NAPLEX at some point
▫ Getting original license
i. Do prove your original intern hours, 1500 hours
ii. Do prove ACP accredited school
iii. Do pass NAPLEX and State MPJE
1. Or do score transfer of NAPLEX and then take that state’s MPJE
▫ Universal Recognition
i. Emergency licensure
ii. Based on original board license
iii. Take state MJPE
iv. Needs to be living in this state
v. Needs to have practiced in another state for at least one year
Licensing for a Technician Trainee:
▫ Eligibility:
i. 18 years
ii. High school diploma or old equivalent
iii. Good moral character iv. Fingerprint card
▫ License:
i. Valid for 36 months (3 years)
1. If not done with eligibility req by then- no longer eligible for license
ii. No renewal or
reissue

iii. No exam required??? Check

please
If she asks... Pharmacy Tech license:
▫ Meet tech trainee requirements
▫ Complete training program
▫ Pass the PTCB or the ExCPT
▫ Complete fingerprint card
▫ If in remote dispensing pharmacy:
i. 2 hour CE program on remote pharmacies
ii. At least 1000 hours as a tech in outpatient setting
iii. May not perform extemporaneous sterile or non-sterile
compounding iv. May prep commercially avail meds for
dispensing (like reconstitution)
How frequently do licenses need to be renewed for pharmacist and technician:
▫ 2-every 2 years) on yearsNovember 1st
(Biennial
i. Not biannual (twice a year)
▫ Ends in odd number: renew in odd year
▫ Ends in even number: renew in even year
Hours of CE to complete for renewals cycles, every 2 years:
▫ Pharmacis
t

II postmarketing
hours CE
i. Phase
1. Including 3 hours opioid, etc ae
▫ P
i. technician
20 hours CE
1. Including 3 hours opioid, etc

▫ Immunizations: animals

TitleIDQ
Need 2 hours CE
i.

▫ Tobacco Cessation Prescribing:

i. Need 2 hours CE

mum : nitrite
Naloxone
Dispensing
▫

i. No Ce required
ii. But, need to complete 1 hour of training
1. AzPA does it for free
If I’m the PIC, how fast do I need to tell the board I’m not the PIC anymore: ▫ Immediately/24
hours
How fast should the employer tell the board of the PIC resigning or a new one starting: ▫
Immediately/24 hours
If I am the director of hospital pharmacy, what should I put in my permit application:
▫ Hospital’s Dep of Health Services License
▫ Number of Beds
▫ Manager/administrator’s Name
Do all pharmacies have to participate and complete Quality Assurance Programs(CQA) in AZ?
▫ HELL YEAH
▫ If she asks... Pharmacies that already meet these requirements because of other licensing: i.
Hospital
1. License from Dept of health services ii.
Certified by CMS (Medicaid and care)
 iii. Accredited by Joint Commission iv. Accredited by
American Osteopathic Association Are CQA records subject to
subpoena or discovery?
▫ NO
CQA Responsibilities:
▫ Developed, implemented, and utilized
▫ Every 2 years policies and procedures
▫ reviewed
Policies and procedures readily available to employees and for inspection by the
▫ Medication error board data is
utilized and reviewed regularly ▫ All documents to CQA maintained for 2 years
Community Pharmacy Requirements (she specified ones bolded)
▫ Min area: 300 sq ft for 3 people

Plus 60 sq ft
person If
i. for additional
3people
▫

Hospital
pharmacy
500 sq feet
Compounding and Dispensing Counter
▫ Working area for compounding and dispensing
▫ Area for pt counseling
▫ Narcotic safety cabinet
▫ Security standards
 ▫ Drug storage and security
▫ Hot and Cold water
▫ Separate and review expired and non-expired drugs
▫ Restroom within 100 feet
▫ Fridge
▫ Register
▫ Graduates
▫ Mortar and pestle
▫ Spatulas
▫ Balance
▫ Ointment tile
▫ Red C stamp
▫ Copy of pharm practice act, admin rules, and CS act
▫ Prof reference library
▫ Label assortments
▫ Antidote and interaction info ▫
Poison control phone number

manager abedpitsnine
▫
i. Dependent on beds, and type of hospital, etc
ii. Board may require more
▫ Must be locked
▫ Sanitation, ventilation, temp and moisture control, security and separation of products
▫ Reference library
▫ Hot and cold water
▫ Fridge and Freezer
▫ Laminar air flow hood
All permits must be displayed in the pharmacy:
▫ Tru
All licenses must be e displayed in the pharmacy
▫ Fals
▫ Privacy issue e and issue related to stalking and restraining orders ( ) Limited Services
pharmacies and what they are:
▫ Correctional Facility
▫ Mail-Order Pharmacy
▫ LT Care
▫ Sterile Pharmaceutical Products Pharmacy
▫ Nuclear Pharmacy
 Closing pharmacy Down, what time frame does the permit holder need to notify the DEA: ▫
14 days before close
If I am the pharmacy owner whose pharmacy is closing, am I responsible for returning the all the the

permits and certificates”: Tseller

▫ Yes
▫ NOT the new owner!
Who is responsible for removing all the shit in and outside the pharmacy before closing:
▫ The PIC of the current pharmacy permit holder Does
everyone need an ID badge?
▫ Ye
Are permits s renewing on the same cycle as licenses?

▫ Yes owners unethical

▫ Biennial (every 2 years)

▫ On or before November 1st pharmacists unprofessional

▫ Permits are non-transferable
i. Each site must have a separate permit
A pharmacy and a pharmacy staff are both convicted of committing fraud.
▫ The permit holders (owners) committed: Unethical Conduct
▫ The license holders (pharmacists) committed: Unprofessional Conduct

Lecture V

− Prescriptive authority CANNOT be delegated by the prescriber to an employee or agent of the

prescriber o *Unless state law has specifically granted the person this authority (PA’s,
pharmacist, etc.)
− RX order requirements for: (on FACE of prescription) o : Date of issue, full name and address of
patient, full name and address and phone # of prescriber, drug (name, strength, dosage form),
quantity, directions for use, prescriber signature, refills, DEA number only if controlled o
− Which of the following is TRUE
Human
regarding RX Orders must be for a legitimate medical purpose—TRUE
prescription ALL prescriptions
Animal: ownershave to be onpet
name, tamper resistant paper—FALSE
orders? o o species
▪ Only for Medicaid
o All NON controlled patients prescriptions are valid for ONE year from when they are
written—TRUE
− T/F: a prescription faxed/emailed by the patient can serve as original Rx order—FALSE (must have
original prescription order presented to pharmacy)
 − T/F: a prescriber may fax a prescription order from ANY fax machine location—FALSE (must be from

practice location) hasonespearlocation

− T/F: The prescriber's agent may orally transmit a prescription to a pharmacist—TRUE
− T/F: —A pharmacist or intern are the only individuals allowed to take a new Rx over the phoneTRUE
− T/F: A technician may receive a refill prescription as long as there are no changes to the prescription —
TRUE
− Regarding prescription transfers:
o How many times can you transfer a non-control?
i. As many as there are refills o As the receiving pharmacist, do I need the name of
the sending pharmacist? ii. Yes o As the receiving pharmacist, do I need the date of first
dispensed and the number of refills remaining? o Yes
o The receiving pharmacist must record “transfer” on the face of the prescription o The sending
pharmacist must record “VOID” on the prescription
being transferred o Who is allowed to handle NON
control prescription transfers? scope
o Pharmacists and interns

m
o Can interns do control substance transfers?
o Yes
− How long do you have to keep prescription orders in AZ? o 7 years from last date filled
▪ 10 for Medicaid is she asks
− For control substance image orders, an electronic image is NOT sufficient to meet storage —must have hard
requirement copy!
sAll prescriptions must be serial numbered, dated and filed in the order which compounded or
−
dispensed
− Electronic
image record keeping system, I must maintain the original hard copy of non-controlled prescriptions for 30 days-

FALSE norequirementodays
− Medicare stipulates that orders covered by Medicare must be kept for 10 years from date last filled
− Can an Arizona pharmacist can fill all prescription orders, both controlled and non-controlled, from a
prescriber in Russia?
o No, controlled substances cannot be filled from another country. Just non-controlled − Which
of the following is true regarding the transfer of a controlled prescription order?
o Controlled prescriptions may only be transferred one time (True)
o Technicians may accept a receive controlled substance prescription orders (False) o Interns may
accept and receive controlled substance prescription transfers (True) − A reference listed (RL)
drug, with an AB2 rating needs a generic substitution. What generic rating
MUST be substituted for the reference listed drug o
AB2
− What is the definition of pharmaceutically equivalent vs therapeutically
equivalent? o Pharmaceutical equivalent: drug products have the same
ingredient form, route, strength, and active
s
o Therapeutic equivalent: pharmaceutically equivalent + bioequivalent
 areo (Bioequivalent= products display comparable bioavailability at site of action under similar
conditions)

hacking− If a drug has an AB rating, what kind of issue has been resolved?
o Bioequivalence issue
− In AZ, can a pharmacist use professional judgement and do prescription order adaptation for
noncontrolled and controlled substance prescription orders?
o No, professional judgment can only be used for non-controls
− What do we have to check when doing retrospective review by the DUR board?
o Duplicates
o Contraindications

o Frequency of refills allergies

o Is the drug appropriate
− A pharmacist is dispensing Augmentin 500 mg (brand), what is required to be on the prescription?
o Pharmacy name and address
o Directions for use o Prescribers name
o ** name of drug and quantity DO NOT legally need to be on the prescription*
− When is a pharmacist requiredto do an oral consultation with the patient?
o New drug
o New strength or direction o If requested by patient or caregiver o Professional judgement
warrants
− Is there an age restriction on what age pharmacists can immunize? o
Yes, 0-2 years old cannot be vaccinated by a pharmacist
− Do all pediatric vaccines require a prescription order? o
No, most just require parent approval
− What 5 vaccines ALWAYS require a prescription order?
o Japanese Encephalitis
o Cholera o Rabies o Typhoid o Yellow fever
− True or false: pharmacists have to report vaccines and immunization administrations to the Arizona
State Immunization Information system
o True
− Since she has to make up a few ,questions
other important info not covered in the review
− FDAorange book, therapeutic equivalent (TE) codes
− FDA purple book lists of licensed biological products with reference product
Bio exclusivity and
similarity
or interchangeability
evaluation
s

Revieherkanoot
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