MPJE NY Questions (Correct Answers)
Waiting period for MPJE after failing Correct Answers30 days
Adjusting drug regimen shall not... Correct Answersinclude substuting or selecting a
different drug which differs from that initially prescribed by pt's physician unless
substitution is authorized in order or protocol.
RPH can make changes to pt's drug therapy Correct AnswersIF authorized in protocol
Ordering or performing route patient monitoring fxns Correct Answersmay be necessary
in drug therapy management.
If MD disagrees with professional judgment of RPH Correct AnswersJudgment of the
MD shall prevail
MD part of agreement/protocol authorizing collaborative drug therapy management
must be Correct Answersemployed with same facility where RPH is employed/affiliated.
Cannot use collab drug therapy management if Correct Answerspt or pt's rep consents
IN WRITING to such management.
Label Correct AnswersInfo on immediate container (must be on outside wrapper if
exists)
Labeling Correct AnswersIncludes all info ON or accompanying drug/device
Misbranding Correct AnswersLabeling = misleading or fails to reveal facts. Like
misleading advertising.
Device Correct AnswersInstruments, apparatus, contrivances including: components,
parts, accessories intended:
---For use in diagnosis, cure, mitgation, tx, prevention of dx in man or animals; or
---To affect the structure or any fxn of the body of man or animals
Administer Correct AnswersA pt specific order or non-pt specific regimen prescribed or
ordered by MD or NP who has practice site in the county.
Electronic RX Correct AnswersCreated, recorded, or stored by electornic means, issued
with electronic signature
Original hard copy RX Correct AnswersIf created electronically must be transmitted
from MD to RPH by FAX --> MUST BE MANUALLY SIGNED.
Electronic Signature Correct AnswersElectronic sound/symbol/process, attached to
electornic RX, executed by person with intent to sign RX.
Limited Permits - Pharmacy Interns - permits employments to pharm interns Correct
Answers-Issued to student enrolled in last 2 years of registered program in pharmacy.
-Intern may practice as RPH under supervision of RPH
-Must be posted at site of employment
-Expires 5 years from date of issue
-May be renewed ONCE for a period not to exceed TWO YEARS with permission from
BOP
-Must be relinquished if not licensed within this time.
Authorized prescribers Correct Answers-Physicians - MD, DO
-Physician assistants (RPA)
-Podiatrists (DPM)
-Dentists (DMD, DDS)
-Vets (DVM)
-Optometrists (O.D)
,-Nurse Practitioners, Certified (CNP)
-Mid-Wives (F)
NDC Correct AnswersXXXXX-XXXX-XX
1) Label code, assigned by FDA, the manufacturer.
2) Product code - strength, dosage form, and formulation
3) Package code - package size
Anti-tampering act Correct Answers1) Tamper with interstate commerce with intent to
injure person
2) Taint with intent to injure business
3) False info
4) Conspire to tamper
Anti-Tampering Correct AnswersHx: Passed by congress in 1984 d/t deaths bc of OTC
meds contaminated with cyanide.
Tamper resistant package - has indicators or barriers to entry - if breached/missing -
expect to show visible evidence that tampering occurred.
1) Distinctive by design, cant be duplicated.
2) Use 1 or more indicator or barrier to entry that employ a characteristic.
OTC Labeling Tamper Resistant Correct AnswersMust alert consumers of the specific
tamper resistant feature of package.
Drugs EXEMPT from PPA Correct AnswersPg 12 for list. Cannot reuse any part of CRC
in NYS. May reuse glass if new safety closure used.
CPSC - consumer product safety commission
OTC drugs that require CRC Correct Answers1) APAP
2) ASA / Ibuprofen / ketoprofen / naproxen
3) Dibucaine
4) Diphenhydramine
5) Ethylene glycol > 10%
6) Glue removers containing acetonitrile
7) Human rx drugs
8) Lidocaine
9) Loperamide
10) Methyl salicylate liq > 5%
11) Methyl alcohol
12) Mouthwash w/ 3g or more of ethanol per pckage
13) Perm wave neutralizers w/ Na bromate or K bromate
14) Petroleum distillates
Can market one size container w/o cap if it states: for households without young
children.
If package not child resistant must state: Correct Answers-This package is for
households w/o young kids
-Package not child resistant
CRC Waivers Correct Answers-Pt can do req for individual rx or do blanket waiver for all
-MD can only do Non-CRP for one at a time, no blanke.
***MUST DOCUMENT WAIVER REQUESTS.
MUST HAVE Tamper-resistant seals OTC Correct AnswersAll non-rx drug products
-Contact lens, tabs
, -Cosmetic liquid oral hygiene products
-Cosmetic vaginal products
Exceptions for tamper-res for OTC Correct Answers-Derms
-Dentrifrices
-Insulin
-Throat lozenges
-OTC administered by HCP in hospitals
-OTCs in vending machines
-Prodts via mail, package delivery service etc
SAUE Correct Answerssenior adult use effectiveness
Manu's packaging Correct Answers1) Meds must be in CRC
2) Bulk packaging to be repackaged by RPH doesnt have to be in special packaging
3) Unit packaging from manu must comply with CRC
Waiver for CRC Correct AnswersMust document waivers, don't need to have sig, pt can
say it orally.
Prescription Drug Marketing Act Correct Answers1) Proper storage / handling of drugs.
2) Establish maintenance of records
3) Prohibits interstate commerce unless registered with shipping state
4) Bans reimportation of Rx Drugs (except same manu)
5) Bans sale/trade/purchase of samples.
6) Bans traffic in counterfeiting drug coupons
7) Prohibits resale of rx drugs by hospital for drugs purchased at special prices
8) Mandates storage/records of drug samples
9) MD's request for samples in writing
10) Criminal and civil penalties
Samples Correct AnswersOnly practitioners can receive. Pharmacies can receive if
requested by practitioner. Written request needed:
1) Name, add, professional designation, sig of MD
2) drug name, quantity, and manu
3) date.
***Manu's must keep ANNUAL inventory. Must keep records for THREE years.
Drug Recall Correct Answers-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
Recall classifications Correct AnswersClass I: Cause serious adverse health
consequences/death.
Class 2: Cause temp or medically reverisble adverse health consquences.
Class 3: Not likely to cause adverse health probs
Package inserts? Correct AnswersOC's, IU devices, estrogen containing products,
progestational drug products . In COMMUNITY pharmacy - need inserts EVERYTIME
product refilled. In INSTITUTION - req only on intial dispensing and Q 30 days.
OTC Labels - KNOW THIS Correct Answers1) Product name
2) Name and addy of manu or distributor
3) list of active or other ing (not amt?)
4) amt of contents (strength of ACTIVE ing)
5) adequate warnings
6) adequate directions for use
Waiting period for MPJE after failing Correct Answers30 days
Adjusting drug regimen shall not... Correct Answersinclude substuting or selecting a
different drug which differs from that initially prescribed by pt's physician unless
substitution is authorized in order or protocol.
RPH can make changes to pt's drug therapy Correct AnswersIF authorized in protocol
Ordering or performing route patient monitoring fxns Correct Answersmay be necessary
in drug therapy management.
If MD disagrees with professional judgment of RPH Correct AnswersJudgment of the
MD shall prevail
MD part of agreement/protocol authorizing collaborative drug therapy management
must be Correct Answersemployed with same facility where RPH is employed/affiliated.
Cannot use collab drug therapy management if Correct Answerspt or pt's rep consents
IN WRITING to such management.
Label Correct AnswersInfo on immediate container (must be on outside wrapper if
exists)
Labeling Correct AnswersIncludes all info ON or accompanying drug/device
Misbranding Correct AnswersLabeling = misleading or fails to reveal facts. Like
misleading advertising.
Device Correct AnswersInstruments, apparatus, contrivances including: components,
parts, accessories intended:
---For use in diagnosis, cure, mitgation, tx, prevention of dx in man or animals; or
---To affect the structure or any fxn of the body of man or animals
Administer Correct AnswersA pt specific order or non-pt specific regimen prescribed or
ordered by MD or NP who has practice site in the county.
Electronic RX Correct AnswersCreated, recorded, or stored by electornic means, issued
with electronic signature
Original hard copy RX Correct AnswersIf created electronically must be transmitted
from MD to RPH by FAX --> MUST BE MANUALLY SIGNED.
Electronic Signature Correct AnswersElectronic sound/symbol/process, attached to
electornic RX, executed by person with intent to sign RX.
Limited Permits - Pharmacy Interns - permits employments to pharm interns Correct
Answers-Issued to student enrolled in last 2 years of registered program in pharmacy.
-Intern may practice as RPH under supervision of RPH
-Must be posted at site of employment
-Expires 5 years from date of issue
-May be renewed ONCE for a period not to exceed TWO YEARS with permission from
BOP
-Must be relinquished if not licensed within this time.
Authorized prescribers Correct Answers-Physicians - MD, DO
-Physician assistants (RPA)
-Podiatrists (DPM)
-Dentists (DMD, DDS)
-Vets (DVM)
-Optometrists (O.D)
,-Nurse Practitioners, Certified (CNP)
-Mid-Wives (F)
NDC Correct AnswersXXXXX-XXXX-XX
1) Label code, assigned by FDA, the manufacturer.
2) Product code - strength, dosage form, and formulation
3) Package code - package size
Anti-tampering act Correct Answers1) Tamper with interstate commerce with intent to
injure person
2) Taint with intent to injure business
3) False info
4) Conspire to tamper
Anti-Tampering Correct AnswersHx: Passed by congress in 1984 d/t deaths bc of OTC
meds contaminated with cyanide.
Tamper resistant package - has indicators or barriers to entry - if breached/missing -
expect to show visible evidence that tampering occurred.
1) Distinctive by design, cant be duplicated.
2) Use 1 or more indicator or barrier to entry that employ a characteristic.
OTC Labeling Tamper Resistant Correct AnswersMust alert consumers of the specific
tamper resistant feature of package.
Drugs EXEMPT from PPA Correct AnswersPg 12 for list. Cannot reuse any part of CRC
in NYS. May reuse glass if new safety closure used.
CPSC - consumer product safety commission
OTC drugs that require CRC Correct Answers1) APAP
2) ASA / Ibuprofen / ketoprofen / naproxen
3) Dibucaine
4) Diphenhydramine
5) Ethylene glycol > 10%
6) Glue removers containing acetonitrile
7) Human rx drugs
8) Lidocaine
9) Loperamide
10) Methyl salicylate liq > 5%
11) Methyl alcohol
12) Mouthwash w/ 3g or more of ethanol per pckage
13) Perm wave neutralizers w/ Na bromate or K bromate
14) Petroleum distillates
Can market one size container w/o cap if it states: for households without young
children.
If package not child resistant must state: Correct Answers-This package is for
households w/o young kids
-Package not child resistant
CRC Waivers Correct Answers-Pt can do req for individual rx or do blanket waiver for all
-MD can only do Non-CRP for one at a time, no blanke.
***MUST DOCUMENT WAIVER REQUESTS.
MUST HAVE Tamper-resistant seals OTC Correct AnswersAll non-rx drug products
-Contact lens, tabs
, -Cosmetic liquid oral hygiene products
-Cosmetic vaginal products
Exceptions for tamper-res for OTC Correct Answers-Derms
-Dentrifrices
-Insulin
-Throat lozenges
-OTC administered by HCP in hospitals
-OTCs in vending machines
-Prodts via mail, package delivery service etc
SAUE Correct Answerssenior adult use effectiveness
Manu's packaging Correct Answers1) Meds must be in CRC
2) Bulk packaging to be repackaged by RPH doesnt have to be in special packaging
3) Unit packaging from manu must comply with CRC
Waiver for CRC Correct AnswersMust document waivers, don't need to have sig, pt can
say it orally.
Prescription Drug Marketing Act Correct Answers1) Proper storage / handling of drugs.
2) Establish maintenance of records
3) Prohibits interstate commerce unless registered with shipping state
4) Bans reimportation of Rx Drugs (except same manu)
5) Bans sale/trade/purchase of samples.
6) Bans traffic in counterfeiting drug coupons
7) Prohibits resale of rx drugs by hospital for drugs purchased at special prices
8) Mandates storage/records of drug samples
9) MD's request for samples in writing
10) Criminal and civil penalties
Samples Correct AnswersOnly practitioners can receive. Pharmacies can receive if
requested by practitioner. Written request needed:
1) Name, add, professional designation, sig of MD
2) drug name, quantity, and manu
3) date.
***Manu's must keep ANNUAL inventory. Must keep records for THREE years.
Drug Recall Correct Answers-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
Recall classifications Correct AnswersClass I: Cause serious adverse health
consequences/death.
Class 2: Cause temp or medically reverisble adverse health consquences.
Class 3: Not likely to cause adverse health probs
Package inserts? Correct AnswersOC's, IU devices, estrogen containing products,
progestational drug products . In COMMUNITY pharmacy - need inserts EVERYTIME
product refilled. In INSTITUTION - req only on intial dispensing and Q 30 days.
OTC Labels - KNOW THIS Correct Answers1) Product name
2) Name and addy of manu or distributor
3) list of active or other ing (not amt?)
4) amt of contents (strength of ACTIVE ing)
5) adequate warnings
6) adequate directions for use
