MPJE NY |Brand New Expert Exam
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Waiting period for MPJE after failing - Answer✅✅30 days
Adjusting drug regimen shall not... - Answer✅✅include 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 - Answer✅✅IF authorized in protocol
Ordering or performing route patient monitoring fxns - Answer✅✅may be
necessary in drug therapy management.
If MD disagrees with professional judgment of RPH - Answer✅✅Judgment of the
MD shall prevail
MD part of agreement/protocol authorizing collaborative drug therapy management
must be - Answer✅✅employed with same facility where RPH is employed/affiliated.
,Cannot use collab drug therapy management if - Answer✅✅pt or pt's rep consents
IN WRITING to such management.
Label - Answer✅✅Info on immediate container (must be on outside wrapper if
exists)
Labeling - Answer✅✅Includes all info ON or accompanying drug/device
Misbranding - Answer✅✅Labeling = misleading or fails to reveal facts. Like
misleading advertising.
Device - Answer✅✅Instruments, 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 - Answer✅✅A pt specific order or non-pt specific regimen prescribed or
ordered by MD or NP who has practice site in the county.
Electronic RX - Answer✅✅Created, recorded, or stored by electornic means, issued
with electronic signature
Original hard copy RX - Answer✅✅If created electronically must be transmitted
from MD to RPH by FAX --> MUST BE MANUALLY SIGNED.
Electronic Signature - Answer✅✅Electronic sound/symbol/process, attached to
electornic RX, executed by person with intent to sign RX.
Limited Permits - Pharmacy Interns - permits employments to pharm interns -
Answer✅✅-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 - Answer✅✅-Physicians - MD, DO
-Physician assistants (RPA)
-Podiatrists (DPM)
-Dentists (DMD, DDS)
-Vets (DVM)
-Optometrists (O.D)
-Nurse Practitioners, Certified (CNP)
-Mid-Wives (F)
,NDC - Answer✅✅XXXXX-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 - Answer✅✅1) 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 - Answer✅✅Hx: 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 - Answer✅✅Must alert consumers of the specific
tamper resistant feature of package.
Drugs EXEMPT from PPA - Answer✅✅Pg 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 - Answer✅✅1) 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: - Answer✅✅-This package is for
households w/o young kids
-Package not child resistant
CRC Waivers - Answer✅✅-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 - Answer✅✅All non-rx drug products
-Contact lens, tabs
-Cosmetic liquid oral hygiene products
-Cosmetic vaginal products
Exceptions for tamper-res for OTC - Answer✅✅-Derms
-Dentrifrices
-Insulin
-Throat lozenges
-OTC administered by HCP in hospitals
-OTCs in vending machines
-Prodts via mail, package delivery service etc
SAUE - Answer✅✅senior adult use effectiveness
Manu's packaging - Answer✅✅1) 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 - Answer✅✅Must document waivers, don't need to have sig, pt can
say it orally.
Prescription Drug Marketing Act - Answer✅✅1) 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 - Answer✅✅Only 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 - Answer✅✅-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
Questions with 100% Correct Clear
Verified Answers All Graded
A+|Latest Premium Update|100%
Guaranteed Success.
Waiting period for MPJE after failing - Answer✅✅30 days
Adjusting drug regimen shall not... - Answer✅✅include 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 - Answer✅✅IF authorized in protocol
Ordering or performing route patient monitoring fxns - Answer✅✅may be
necessary in drug therapy management.
If MD disagrees with professional judgment of RPH - Answer✅✅Judgment of the
MD shall prevail
MD part of agreement/protocol authorizing collaborative drug therapy management
must be - Answer✅✅employed with same facility where RPH is employed/affiliated.
,Cannot use collab drug therapy management if - Answer✅✅pt or pt's rep consents
IN WRITING to such management.
Label - Answer✅✅Info on immediate container (must be on outside wrapper if
exists)
Labeling - Answer✅✅Includes all info ON or accompanying drug/device
Misbranding - Answer✅✅Labeling = misleading or fails to reveal facts. Like
misleading advertising.
Device - Answer✅✅Instruments, 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 - Answer✅✅A pt specific order or non-pt specific regimen prescribed or
ordered by MD or NP who has practice site in the county.
Electronic RX - Answer✅✅Created, recorded, or stored by electornic means, issued
with electronic signature
Original hard copy RX - Answer✅✅If created electronically must be transmitted
from MD to RPH by FAX --> MUST BE MANUALLY SIGNED.
Electronic Signature - Answer✅✅Electronic sound/symbol/process, attached to
electornic RX, executed by person with intent to sign RX.
Limited Permits - Pharmacy Interns - permits employments to pharm interns -
Answer✅✅-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 - Answer✅✅-Physicians - MD, DO
-Physician assistants (RPA)
-Podiatrists (DPM)
-Dentists (DMD, DDS)
-Vets (DVM)
-Optometrists (O.D)
-Nurse Practitioners, Certified (CNP)
-Mid-Wives (F)
,NDC - Answer✅✅XXXXX-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 - Answer✅✅1) 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 - Answer✅✅Hx: 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 - Answer✅✅Must alert consumers of the specific
tamper resistant feature of package.
Drugs EXEMPT from PPA - Answer✅✅Pg 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 - Answer✅✅1) 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: - Answer✅✅-This package is for
households w/o young kids
-Package not child resistant
CRC Waivers - Answer✅✅-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 - Answer✅✅All non-rx drug products
-Contact lens, tabs
-Cosmetic liquid oral hygiene products
-Cosmetic vaginal products
Exceptions for tamper-res for OTC - Answer✅✅-Derms
-Dentrifrices
-Insulin
-Throat lozenges
-OTC administered by HCP in hospitals
-OTCs in vending machines
-Prodts via mail, package delivery service etc
SAUE - Answer✅✅senior adult use effectiveness
Manu's packaging - Answer✅✅1) 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 - Answer✅✅Must document waivers, don't need to have sig, pt can
say it orally.
Prescription Drug Marketing Act - Answer✅✅1) 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 - Answer✅✅Only 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 - Answer✅✅-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
