FLORIDA MPJE EXAM SCRIPT 2026/2027 QUESTIONS AND
SOLUTIONS RATED A+
✔✔Hatch Waxman Amendment to FDCA stipulates - ✔✔This act:
- establishes abbreviated drug approval process for generics based on bioequivalence.
- added patent term equal to drug development review by FDA
- establishes Orange Book - lists all FDA approved drugs - cross reference with
generics.
AB rated may be substituted
BX/BC/BE are generics that may NOT be substituted
✔✔National Childhood Vaccine Injury Act - ✔✔This act:
- reports involving vaccines must be reported using VAERS form
- FL pharmacists can vaccinate
✔✔Prescription Drug Marketing Act - ✔✔This act:
- prohibits sale /trade/ purchase of drug samples
- states must license drug wholesalers
- patients cannot bring/order foreign drugs into US
- requires prescription drugs to bear the legend "Rx Only"
any drug without this legend is Misbranded.
✔✔Omnibus Budget Reconciliation Act is also known as? - ✔✔OBRA 90
✔✔Omnibus Budget Reconciliation Act - ✔✔This act mandates pharmacists conduct a
prospective drug use review and counsel all Medicaid Patients.
✔✔Prescription Drug User Fee Act - ✔✔This act states that manufacturers must pay a
user fee along with each drug that is marketed, facility that manufacturers drugs, and
each app from approval.
The money is used to hire drug reviewers and facilitate the drug approval process.
✔✔Dietary Supplement Health and Education Act - ✔✔This act allows dietary
supplements to be categorized as food and are not required to be proven safe or
effective, must follow cGMP
✔✔FDA Export Reform and Enhancement Act - ✔✔This act allows export of FDA
approved drugs if label meets other country's requirements. Allows export for clinical
investigation.
✔✔Health Insurance Portability and Accountability Act (HIPAA) - ✔✔This act limits
disclosure of patient health information to what is minimally necessary. May disclose for
treatment, payment or regular healthcare operations. May provide to patients upon
request (verbal auth ok). Employees must be trained. There need to be procedures and
,safeguards. Should appoint a responsible individual. Patient must authorize use of PHI
for marketing.
✔✔FDA Modernization Act - ✔✔This act is a manufacturer friendly set of laws. Allows
fast track approval of life saving drugs.
✔✔Drug Addiction Treatment Act - ✔✔This act allows authorized physicians to treat
drug addiction with buprenorphine (subutex/subuoxne) in office based practice where
pharmacist dispenses drugs. There is a 30 patient limit - can go up to 100 with meet
special requirements. Authorized physician unique provider number starting with X.
Methadone may be prescribed for pain OR opioid addiction (40mg tablets for addiction
only)
✔✔Medicare Prescription Drug Improvement and Modernization Act is also known as? -
✔✔Medicare Part D
✔✔Medicare Prescription Drug Improvement and Modernization Act - ✔✔This act
provides prescription drug coverage to Medicare patients with copays and donut hole.
Excludes: weight loss, fertility, cosmetic, hair growth, barbiturates, OTC, cold and cough
relief. It does reimburse pharmacists for MTM. Staff must have annual training on fraud,
waste and abuse.
✔✔Combat Methamphetamine Act - ✔✔This act restricts the sales of pseudoephedrine
(PSE).
3.6g per person per day
9g per person per 30 day period
Mail order may send 7.5g per person per 30 day period
Must be 18 years old, show ID, sign log book
Must be blister packed with no more than 2 per blister
Must be behind pharmacy counter, secured in pharmacy
Must show picture ID
Maintain logbook x 2 years
Products packaged for individual sale that contain less than 60mg PSE are exempt from
log book requirements.
Pharmacy personnel must have training and certifications.
✔✔Dietary Supplement and Non Prescription Drug Consumer Protection Act - ✔✔This
act requires manufacturers report serious ADRs to FDA for OTC and supplements
✔✔FDA Amendments Act - ✔✔This act is a group of drug laws that focused on drug
safety. It establishes risk evaluation and mitigation strategies (REMS) for drugs with
important health risks. Requires all prescription drugs to have side effects statement.
✔✔Ryan Haight Online Pharmacy Consumer Protection Act - ✔✔This act prohibits
internet prescriptions for controlled substances without in person medical evaluation.
,✔✔Family Smoking Prevention and Tobacco Act - ✔✔This act grants limited authority to
FDA involving tobacco (from ATF). Bans flavored cigarettes. Must disclose all
ingredients. Prohibits youth based marketing.
✔✔Biologics Price Competition and Innovation Act - ✔✔This act establishes generic
approval pathway for biologics (BLA).
✔✔Plan B OTC - ✔✔This allows Plan B to be available Rx and OTC. OTC only for
patients 17 and older with valid ID.
✔✔Overtime Pay Not Required - ✔✔This establishes that Pharmacists are considered
professionals and not entitled to overtime pay under the FLSA.
✔✔Define Drug Recalls - ✔✔Voluntary removal or correction of marketed product.
✔✔Class I Recall - ✔✔Reasonable probability that the use or exposure to a product
WILL cause serious adverse health consequences or death.
✔✔Class II Recall - ✔✔May cause temporary or medically reversible adverse health
consequences - possibility of severe effect is remote.
✔✔Class III Recall - ✔✔Not like to cause adverse health consequences.
✔✔Recall Strategy - ✔✔Consumer / Retail / Wholesale
Must use "urgent" for Class I & II bold red type "drug recall".
✔✔Who may initiate a Drug Recall? - ✔✔By the manufacturer or Government (FDA,
State Board of Health)
✔✔Federal Labeling Requirements or is Misbranded:
Glandular Preparations - ✔✔Label must read: No scientific evidence
✔✔Federal Labeling Requirements or is Misbranded:
Isoproterenol - ✔✔Label must read: severe paradoxical bronchoconstriction
✔✔Federal Labeling Requirements or is Misbranded:
OTC sore throat lozenges - ✔✔Label must read: if severe or persistent call physician,
may be severe
✔✔Federal Labeling Requirements or is Misbranded:
Ipecac - ✔✔Label must read: call for professional advise before using
, ✔✔Federal Labeling Requirements or is Misbranded:
Nonoxynol 9 - ✔✔Label must read: does not protect against HIV
✔✔Federal Labeling Requirements or is Misbranded:
Phenindione - ✔✔Label must read: causes agranulocytosis and hepatitis
✔✔Federal Labeling Requirements or is Misbranded:
Contains FD&C Yellow No 5 - ✔✔Label must read: (Tartrazine) as a color additive
✔✔Federal Labeling Requirements or is Misbranded:
Contains FD&C Yellow No 6 - ✔✔Label must read: as a color additive
✔✔Federal Labeling Requirements or is Misbranded:
Phenylketonurics - ✔✔Label must read: Contains phenylalanine __mg
Aspartame containing drugs
✔✔Federal Labeling Requirements or is Misbranded:
Contains sulfite - ✔✔Label must read: Systemic antibiotics to reduce the development
of resistance use only if proven or strongly suspected
✔✔Federal Labeling Requirements or is Misbranded:
Alcohol and OTC internal analgesics / antipyretics - ✔✔Label must read: Advises
consumers with history of heavy drinking to consult MD especially if have three or more
drinks per day. APAP can cause liver damage. NSAIDS - internal bleeding.
Combination can cause liver damage and stomach bleeding.
✔✔Federal Labeling Requirements or is Misbranded:
Phytonidione (Vitamin K) - ✔✔oral and injectable are prescription only.
✔✔Federal Labeling Requirements or is Misbranded:
Epinephrine - ✔✔injections require prescription
✔✔Federal Labeling Requirements or is Misbranded:
Isotretinoin - ✔✔30 day supply only. Females must use two methods of birth control,
one month prior and after. Must have two negative pregnancy tests prior to initiation of
therapy.
✔✔Federal Labeling Requirements or is Misbranded:
Thalidomide - ✔✔STEPS program to minimize fetal exposure of drug. Has restricted
distribution.
✔✔Define Misbranding - ✔✔Label is false or misleading.
LIE (misfiled, mislabeled)
SOLUTIONS RATED A+
✔✔Hatch Waxman Amendment to FDCA stipulates - ✔✔This act:
- establishes abbreviated drug approval process for generics based on bioequivalence.
- added patent term equal to drug development review by FDA
- establishes Orange Book - lists all FDA approved drugs - cross reference with
generics.
AB rated may be substituted
BX/BC/BE are generics that may NOT be substituted
✔✔National Childhood Vaccine Injury Act - ✔✔This act:
- reports involving vaccines must be reported using VAERS form
- FL pharmacists can vaccinate
✔✔Prescription Drug Marketing Act - ✔✔This act:
- prohibits sale /trade/ purchase of drug samples
- states must license drug wholesalers
- patients cannot bring/order foreign drugs into US
- requires prescription drugs to bear the legend "Rx Only"
any drug without this legend is Misbranded.
✔✔Omnibus Budget Reconciliation Act is also known as? - ✔✔OBRA 90
✔✔Omnibus Budget Reconciliation Act - ✔✔This act mandates pharmacists conduct a
prospective drug use review and counsel all Medicaid Patients.
✔✔Prescription Drug User Fee Act - ✔✔This act states that manufacturers must pay a
user fee along with each drug that is marketed, facility that manufacturers drugs, and
each app from approval.
The money is used to hire drug reviewers and facilitate the drug approval process.
✔✔Dietary Supplement Health and Education Act - ✔✔This act allows dietary
supplements to be categorized as food and are not required to be proven safe or
effective, must follow cGMP
✔✔FDA Export Reform and Enhancement Act - ✔✔This act allows export of FDA
approved drugs if label meets other country's requirements. Allows export for clinical
investigation.
✔✔Health Insurance Portability and Accountability Act (HIPAA) - ✔✔This act limits
disclosure of patient health information to what is minimally necessary. May disclose for
treatment, payment or regular healthcare operations. May provide to patients upon
request (verbal auth ok). Employees must be trained. There need to be procedures and
,safeguards. Should appoint a responsible individual. Patient must authorize use of PHI
for marketing.
✔✔FDA Modernization Act - ✔✔This act is a manufacturer friendly set of laws. Allows
fast track approval of life saving drugs.
✔✔Drug Addiction Treatment Act - ✔✔This act allows authorized physicians to treat
drug addiction with buprenorphine (subutex/subuoxne) in office based practice where
pharmacist dispenses drugs. There is a 30 patient limit - can go up to 100 with meet
special requirements. Authorized physician unique provider number starting with X.
Methadone may be prescribed for pain OR opioid addiction (40mg tablets for addiction
only)
✔✔Medicare Prescription Drug Improvement and Modernization Act is also known as? -
✔✔Medicare Part D
✔✔Medicare Prescription Drug Improvement and Modernization Act - ✔✔This act
provides prescription drug coverage to Medicare patients with copays and donut hole.
Excludes: weight loss, fertility, cosmetic, hair growth, barbiturates, OTC, cold and cough
relief. It does reimburse pharmacists for MTM. Staff must have annual training on fraud,
waste and abuse.
✔✔Combat Methamphetamine Act - ✔✔This act restricts the sales of pseudoephedrine
(PSE).
3.6g per person per day
9g per person per 30 day period
Mail order may send 7.5g per person per 30 day period
Must be 18 years old, show ID, sign log book
Must be blister packed with no more than 2 per blister
Must be behind pharmacy counter, secured in pharmacy
Must show picture ID
Maintain logbook x 2 years
Products packaged for individual sale that contain less than 60mg PSE are exempt from
log book requirements.
Pharmacy personnel must have training and certifications.
✔✔Dietary Supplement and Non Prescription Drug Consumer Protection Act - ✔✔This
act requires manufacturers report serious ADRs to FDA for OTC and supplements
✔✔FDA Amendments Act - ✔✔This act is a group of drug laws that focused on drug
safety. It establishes risk evaluation and mitigation strategies (REMS) for drugs with
important health risks. Requires all prescription drugs to have side effects statement.
✔✔Ryan Haight Online Pharmacy Consumer Protection Act - ✔✔This act prohibits
internet prescriptions for controlled substances without in person medical evaluation.
,✔✔Family Smoking Prevention and Tobacco Act - ✔✔This act grants limited authority to
FDA involving tobacco (from ATF). Bans flavored cigarettes. Must disclose all
ingredients. Prohibits youth based marketing.
✔✔Biologics Price Competition and Innovation Act - ✔✔This act establishes generic
approval pathway for biologics (BLA).
✔✔Plan B OTC - ✔✔This allows Plan B to be available Rx and OTC. OTC only for
patients 17 and older with valid ID.
✔✔Overtime Pay Not Required - ✔✔This establishes that Pharmacists are considered
professionals and not entitled to overtime pay under the FLSA.
✔✔Define Drug Recalls - ✔✔Voluntary removal or correction of marketed product.
✔✔Class I Recall - ✔✔Reasonable probability that the use or exposure to a product
WILL cause serious adverse health consequences or death.
✔✔Class II Recall - ✔✔May cause temporary or medically reversible adverse health
consequences - possibility of severe effect is remote.
✔✔Class III Recall - ✔✔Not like to cause adverse health consequences.
✔✔Recall Strategy - ✔✔Consumer / Retail / Wholesale
Must use "urgent" for Class I & II bold red type "drug recall".
✔✔Who may initiate a Drug Recall? - ✔✔By the manufacturer or Government (FDA,
State Board of Health)
✔✔Federal Labeling Requirements or is Misbranded:
Glandular Preparations - ✔✔Label must read: No scientific evidence
✔✔Federal Labeling Requirements or is Misbranded:
Isoproterenol - ✔✔Label must read: severe paradoxical bronchoconstriction
✔✔Federal Labeling Requirements or is Misbranded:
OTC sore throat lozenges - ✔✔Label must read: if severe or persistent call physician,
may be severe
✔✔Federal Labeling Requirements or is Misbranded:
Ipecac - ✔✔Label must read: call for professional advise before using
, ✔✔Federal Labeling Requirements or is Misbranded:
Nonoxynol 9 - ✔✔Label must read: does not protect against HIV
✔✔Federal Labeling Requirements or is Misbranded:
Phenindione - ✔✔Label must read: causes agranulocytosis and hepatitis
✔✔Federal Labeling Requirements or is Misbranded:
Contains FD&C Yellow No 5 - ✔✔Label must read: (Tartrazine) as a color additive
✔✔Federal Labeling Requirements or is Misbranded:
Contains FD&C Yellow No 6 - ✔✔Label must read: as a color additive
✔✔Federal Labeling Requirements or is Misbranded:
Phenylketonurics - ✔✔Label must read: Contains phenylalanine __mg
Aspartame containing drugs
✔✔Federal Labeling Requirements or is Misbranded:
Contains sulfite - ✔✔Label must read: Systemic antibiotics to reduce the development
of resistance use only if proven or strongly suspected
✔✔Federal Labeling Requirements or is Misbranded:
Alcohol and OTC internal analgesics / antipyretics - ✔✔Label must read: Advises
consumers with history of heavy drinking to consult MD especially if have three or more
drinks per day. APAP can cause liver damage. NSAIDS - internal bleeding.
Combination can cause liver damage and stomach bleeding.
✔✔Federal Labeling Requirements or is Misbranded:
Phytonidione (Vitamin K) - ✔✔oral and injectable are prescription only.
✔✔Federal Labeling Requirements or is Misbranded:
Epinephrine - ✔✔injections require prescription
✔✔Federal Labeling Requirements or is Misbranded:
Isotretinoin - ✔✔30 day supply only. Females must use two methods of birth control,
one month prior and after. Must have two negative pregnancy tests prior to initiation of
therapy.
✔✔Federal Labeling Requirements or is Misbranded:
Thalidomide - ✔✔STEPS program to minimize fetal exposure of drug. Has restricted
distribution.
✔✔Define Misbranding - ✔✔Label is false or misleading.
LIE (misfiled, mislabeled)
