NY MPJE EXAM 2024/2025 WITH 100%
ACCURATE SOLUTIONS
CSA - Precise Answer ✔✔Controlled Substances Act (enforced by the
DEA)
Poison Prevention Packaging Act - Precise Answer ✔✔Sets child-
resistant drug packaging requirements, under US Consumer Product
Safety Commission
HIPAA - Precise Answer ✔✔set by the department of health and human
services
CMEA - Precise Answer ✔✔Control Methamphetamine Epidemic Act
(CMEA)- pseudoephedrine containing product requirements
Hatch-Waxman Act - Precise Answer ✔✔included the ANDA approval
process for generic drugs
includes review of product's chemistry, manufacturing controls, labeling
(does not include pre-clinical animal studies and clinical studies with
human subjects; uses bioequivalency analysis instead of bioavailability
data)
FDC Act - Precise Answer ✔✔Food Drugs and Cosmetics Act (1938)
,The Orange Book - Precise Answer ✔✔FDA's Approved Drug Products
with Therapeutic Equivalence Evaluations
contains approved drugs ONLY (unapproved drugs will have NDC but
will not be listed)
Prescription Drug advertising - Precise Answer ✔✔monitored by the
FDA
OTC Drug advertising - Precise Answer ✔✔monitored by the
COnsumer PRoduct Safety Commission (under the e
FDA AD minimum requirements - Precise Answer ✔✔- min. one
approved use
- generic name
- brief summary, major statement, or 'adequate provision' of drug risks
Sherman Antitrust act of 1890 - Precise Answer ✔✔outlawed
monopolies
Pure Food and Drug Act of 1906 - Precise Answer ✔✔Also known as
the Wiley Act
- mandated accurate labeling
,-ingredients must meet standards of strength, quality, and purity in the
USP And NF
- must list dangerous ingredients
- no adulterated or misbranded drugs could be sent through interstate
commerce
Food Drug and Cosmetic act 1938 - Precise Answer ✔✔enacted due to
the sulfanilamide incident
- required the manufacturer prove safety
- allows FDA to conduct inspections (manufacturer and distributor)
- established penalties for mislabeling
- all ingredients must be listed on the label
Public Health Service Act of 1944 - Precise Answer ✔✔PHS Act
defined biological products (biologics)-- approved under BLA (biologics
license application)
requires that biologics be approved for purity, potency and safety
Durham-Humphrey Amendment of 1951 - Precise Answer ✔✔first time
to have a clear distinction between OTC and prescription drugs
, RX drugs:
- habit-forming
- considered unsafe for use except under expert supervision due to
toxicity concerns
- limited to Rx use only under a manufacturer's new drug application
- required 'legend' stating "Caution: Federal law prohibits dispensing
without a prescription" (now: Rx only)
- OTC drugs require Drug Facts Label
- Unit dose labeling requirements established
Drug Facts Label Requirements for OTCs - Precise Answer ✔✔safety in
pregnancy and breast feeding, calcium, sodium, magnesium, potassium
content, and US contact information to report ADR
Kefauver-Harris Amendments of 1962 - Precise Answer ✔✔Required
manufacturer to prove safety AND efficacy for claims in the product's
labeling.
Required manufacturers to maintain records of adverse events associated
with drugs and report them to the FDA
Created the NDA and supplemental sNDA
IRB was established for INDs; Studies can only begin after IND is
reviewed by FDA and local IRB
ACCURATE SOLUTIONS
CSA - Precise Answer ✔✔Controlled Substances Act (enforced by the
DEA)
Poison Prevention Packaging Act - Precise Answer ✔✔Sets child-
resistant drug packaging requirements, under US Consumer Product
Safety Commission
HIPAA - Precise Answer ✔✔set by the department of health and human
services
CMEA - Precise Answer ✔✔Control Methamphetamine Epidemic Act
(CMEA)- pseudoephedrine containing product requirements
Hatch-Waxman Act - Precise Answer ✔✔included the ANDA approval
process for generic drugs
includes review of product's chemistry, manufacturing controls, labeling
(does not include pre-clinical animal studies and clinical studies with
human subjects; uses bioequivalency analysis instead of bioavailability
data)
FDC Act - Precise Answer ✔✔Food Drugs and Cosmetics Act (1938)
,The Orange Book - Precise Answer ✔✔FDA's Approved Drug Products
with Therapeutic Equivalence Evaluations
contains approved drugs ONLY (unapproved drugs will have NDC but
will not be listed)
Prescription Drug advertising - Precise Answer ✔✔monitored by the
FDA
OTC Drug advertising - Precise Answer ✔✔monitored by the
COnsumer PRoduct Safety Commission (under the e
FDA AD minimum requirements - Precise Answer ✔✔- min. one
approved use
- generic name
- brief summary, major statement, or 'adequate provision' of drug risks
Sherman Antitrust act of 1890 - Precise Answer ✔✔outlawed
monopolies
Pure Food and Drug Act of 1906 - Precise Answer ✔✔Also known as
the Wiley Act
- mandated accurate labeling
,-ingredients must meet standards of strength, quality, and purity in the
USP And NF
- must list dangerous ingredients
- no adulterated or misbranded drugs could be sent through interstate
commerce
Food Drug and Cosmetic act 1938 - Precise Answer ✔✔enacted due to
the sulfanilamide incident
- required the manufacturer prove safety
- allows FDA to conduct inspections (manufacturer and distributor)
- established penalties for mislabeling
- all ingredients must be listed on the label
Public Health Service Act of 1944 - Precise Answer ✔✔PHS Act
defined biological products (biologics)-- approved under BLA (biologics
license application)
requires that biologics be approved for purity, potency and safety
Durham-Humphrey Amendment of 1951 - Precise Answer ✔✔first time
to have a clear distinction between OTC and prescription drugs
, RX drugs:
- habit-forming
- considered unsafe for use except under expert supervision due to
toxicity concerns
- limited to Rx use only under a manufacturer's new drug application
- required 'legend' stating "Caution: Federal law prohibits dispensing
without a prescription" (now: Rx only)
- OTC drugs require Drug Facts Label
- Unit dose labeling requirements established
Drug Facts Label Requirements for OTCs - Precise Answer ✔✔safety in
pregnancy and breast feeding, calcium, sodium, magnesium, potassium
content, and US contact information to report ADR
Kefauver-Harris Amendments of 1962 - Precise Answer ✔✔Required
manufacturer to prove safety AND efficacy for claims in the product's
labeling.
Required manufacturers to maintain records of adverse events associated
with drugs and report them to the FDA
Created the NDA and supplemental sNDA
IRB was established for INDs; Studies can only begin after IND is
reviewed by FDA and local IRB
