MPJE NY LATEST STUDY GUIDE PAPER
QUESTIONS AND ANSWERS SURE A+
✔✔NDC - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔Must alert consumers of the specific tamper
resistant feature of package.
,✔✔Drugs EXEMPT from PPA - ✔✔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 - ✔✔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: - ✔✔-This package is for households w/o
young kids
-Package not child resistant
✔✔CRC Waivers - ✔✔-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 - ✔✔All non-rx drug products
-Contact lens, tabs
-Cosmetic liquid oral hygiene products
-Cosmetic vaginal products
✔✔Exceptions for tamper-res for OTC - ✔✔-Derms
-Dentrifrices
-Insulin
-Throat lozenges
-OTC administered by HCP in hospitals
-OTCs in vending machines
-Prodts via mail, package delivery service etc
✔✔SAUE - ✔✔senior adult use effectiveness
,✔✔Manu's packaging - ✔✔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 - ✔✔Must document waivers, don't need to have sig, pt can say it
orally.
✔✔Prescription Drug Marketing Act - ✔✔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 - ✔✔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 - ✔✔-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
✔✔Recall classifications - ✔✔Class 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? - ✔✔OC'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 - ✔✔1) 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
✔✔CMEA - ✔✔3.6g daily limit //
, 9g monthly limit //
7.5g monthly limit if MAIL SERVICE //
Must maintain: product name, quantity, name and addy, date and time, must ask for
photo ID. Doesnt apply to 60mg or less.
✔✔Can prescriber dispense? - ✔✔Prescriber cannot charge pt for more than 72 hrs of
meds dispensed EXCEPT=======
Prescriber working in hospital / dispense at no charge / greater than 10 miles from
pharmacy / dispense in institutional clinic / licensed under Art 135 (vets) of this title /
dispense under medical emergency / dispense drug reconstituted by prescriber /
dispense allergic extracts // dispense drugs covered under oncology or AIDS protocol
✔✔All prescription blanks MUST CONTAIN - ✔✔1) ONE SIGNATURE LINE //
2) Statement under lien: rx will be filled generically unless prescriber writes daw in box
below //
3) that box
4) Words DISPENSE AS WRITTEN under box
5) profession
6) Imprinted name of prescriber
✔✔Substitution - ✔✔1) Rx written by brand name,
2) DAW box empty,
3) drug is therapeutically equivalent,
4) less expensive.
****If OOS, give brand at generic price.
***If emergency, give brand at regular price and record on back: date/hour/nature of
emergency.
✔✔Emergency - ✔✔1) Alleviate severe pain.
2) Threaten disability.
3) Take life if not treated.
✔✔Dosage forms not interchangeable - ✔✔EC tabs
CR products
Injectable susp
suppositories
different delivery systems for aerosol and nebulizer drugs
✔✔Orange book - ✔✔A_ = no bioeq problems//
B_= docuemented bioequivalence problems!! ///
BX = insufficient data ///
O = oil solns // T = topical, C = tabs, caps, D = active ing and dose form, E = delayed
release oral, N = aerosol neb delivery system, R = suppository or enema, S = standard
deficiencies
QUESTIONS AND ANSWERS SURE A+
✔✔NDC - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔Must alert consumers of the specific tamper
resistant feature of package.
,✔✔Drugs EXEMPT from PPA - ✔✔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 - ✔✔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: - ✔✔-This package is for households w/o
young kids
-Package not child resistant
✔✔CRC Waivers - ✔✔-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 - ✔✔All non-rx drug products
-Contact lens, tabs
-Cosmetic liquid oral hygiene products
-Cosmetic vaginal products
✔✔Exceptions for tamper-res for OTC - ✔✔-Derms
-Dentrifrices
-Insulin
-Throat lozenges
-OTC administered by HCP in hospitals
-OTCs in vending machines
-Prodts via mail, package delivery service etc
✔✔SAUE - ✔✔senior adult use effectiveness
,✔✔Manu's packaging - ✔✔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 - ✔✔Must document waivers, don't need to have sig, pt can say it
orally.
✔✔Prescription Drug Marketing Act - ✔✔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 - ✔✔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 - ✔✔-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
✔✔Recall classifications - ✔✔Class 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? - ✔✔OC'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 - ✔✔1) 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
✔✔CMEA - ✔✔3.6g daily limit //
, 9g monthly limit //
7.5g monthly limit if MAIL SERVICE //
Must maintain: product name, quantity, name and addy, date and time, must ask for
photo ID. Doesnt apply to 60mg or less.
✔✔Can prescriber dispense? - ✔✔Prescriber cannot charge pt for more than 72 hrs of
meds dispensed EXCEPT=======
Prescriber working in hospital / dispense at no charge / greater than 10 miles from
pharmacy / dispense in institutional clinic / licensed under Art 135 (vets) of this title /
dispense under medical emergency / dispense drug reconstituted by prescriber /
dispense allergic extracts // dispense drugs covered under oncology or AIDS protocol
✔✔All prescription blanks MUST CONTAIN - ✔✔1) ONE SIGNATURE LINE //
2) Statement under lien: rx will be filled generically unless prescriber writes daw in box
below //
3) that box
4) Words DISPENSE AS WRITTEN under box
5) profession
6) Imprinted name of prescriber
✔✔Substitution - ✔✔1) Rx written by brand name,
2) DAW box empty,
3) drug is therapeutically equivalent,
4) less expensive.
****If OOS, give brand at generic price.
***If emergency, give brand at regular price and record on back: date/hour/nature of
emergency.
✔✔Emergency - ✔✔1) Alleviate severe pain.
2) Threaten disability.
3) Take life if not treated.
✔✔Dosage forms not interchangeable - ✔✔EC tabs
CR products
Injectable susp
suppositories
different delivery systems for aerosol and nebulizer drugs
✔✔Orange book - ✔✔A_ = no bioeq problems//
B_= docuemented bioequivalence problems!! ///
BX = insufficient data ///
O = oil solns // T = topical, C = tabs, caps, D = active ing and dose form, E = delayed
release oral, N = aerosol neb delivery system, R = suppository or enema, S = standard
deficiencies
