INDIANA MPJE PRACTICE SOLUTION 2026
QUESTIONS WITH FULL SOLUTION GRADED
A+
◉ A rule having the force of law issued by an ADMINISTRATIVE
AGENCY. Answer: Regulation
◉ Where are regulations found (Federal)? Indiana?. Answer: 1. CFR
(code of federal regulations)
2. IAC (Indiana administrative code)
◉ Unsafe coloring agent or unsafe additive is an example of?.
Answer: Adulteration
◉ Directions when following are dangerous is an example of?.
Answer: Misbranding
◉ When are compounded drugs exempt from CGMP?. Answer: If the
compound is for:
1. An individual patient
2. Based on the receipt of a valid prescription
3. Compounded by a licensed pharmacist or licensed physician
,◉ Pharmacies cannot compound and distribute more than (%) of
total prescriptions dispensed or distributed. Answer: 5%
◉ Simplest device type that does not present unreasonable risk of
illness or injury?. Answer: Class I
◉ Examples of Class 1 devices?. Answer: Stethoscopes, scissors and
toothbrushes
◉ Devices that require special controls to assure the safety and
effectiveness of the device?. Answer: Class II
◉ Examples of Class II devices?. Answer: Syringes, tampons,
condoms, hemoglobin A1C immunoassays
◉ Devices that require premarket approval before marketing and
are of substantial importance in preventing impairment of human
health or presents a potential unreasonable risk of illness of injury?.
Answer: Class III
◉ Examples of Class III devices?. Answer: Pacemakers, replacement
heart valves and soft contact lenses
,◉ All new devices automatically fall into this class unless FDA
determines that they are substantially equivalent to other classes?.
Answer: Class III
◉ Currently the only BANNED device?. Answer: Prosthetic hair
fibers
◉ Examples of devices that require a prescription?. Answer: Contact
lenses and diaphragms
◉ FDA can require a manufacturer to recall a drug (T/F)?. Answer:
False. Manufacturers can voluntarily issue a recall or can be
requested by the FDA
◉ Gives Consumer Product Safety Commission authority to require
special packaging of hazardous substances?. Answer: Poison
Prevention Packaging Act
◉ Testing requirements that a package must meet to be considered
child resistant and qualify as special packaging?. Answer: 1. At least
90% of adults should be able to open the container without
significant difficulty
2. At least 85% of children under 5 who are not familiar with the
packaging, should not be able to open the container in five minutes
, 3. At least 80% of children under 5 still cannot open the package
after an adult shows them how to open the container in five minutes
◉ Which drugs are exempt from special packaging?. Answer: 1.
Drugs that are not in a dosage form intended for oral administration
(nasal sprays, eye drops and ointments)
2. Nitroglycerin
3. Isosorbide dinitrate
4. EES
5. Oral contraceptives
6. Cholestyramine/Colestipol powder/Colesevelam/ Sevelamer
carbonate
7. Unit dose KCl
8. NaF
9. Steroids
10. Pancelipase preparations
11. Mebendazole
12. Conjugated estrogens/hormone replacement therapy
13. Sucrase in glycol and water
◉ Who are package inserts for?. Answer: Healthcare professionals
QUESTIONS WITH FULL SOLUTION GRADED
A+
◉ A rule having the force of law issued by an ADMINISTRATIVE
AGENCY. Answer: Regulation
◉ Where are regulations found (Federal)? Indiana?. Answer: 1. CFR
(code of federal regulations)
2. IAC (Indiana administrative code)
◉ Unsafe coloring agent or unsafe additive is an example of?.
Answer: Adulteration
◉ Directions when following are dangerous is an example of?.
Answer: Misbranding
◉ When are compounded drugs exempt from CGMP?. Answer: If the
compound is for:
1. An individual patient
2. Based on the receipt of a valid prescription
3. Compounded by a licensed pharmacist or licensed physician
,◉ Pharmacies cannot compound and distribute more than (%) of
total prescriptions dispensed or distributed. Answer: 5%
◉ Simplest device type that does not present unreasonable risk of
illness or injury?. Answer: Class I
◉ Examples of Class 1 devices?. Answer: Stethoscopes, scissors and
toothbrushes
◉ Devices that require special controls to assure the safety and
effectiveness of the device?. Answer: Class II
◉ Examples of Class II devices?. Answer: Syringes, tampons,
condoms, hemoglobin A1C immunoassays
◉ Devices that require premarket approval before marketing and
are of substantial importance in preventing impairment of human
health or presents a potential unreasonable risk of illness of injury?.
Answer: Class III
◉ Examples of Class III devices?. Answer: Pacemakers, replacement
heart valves and soft contact lenses
,◉ All new devices automatically fall into this class unless FDA
determines that they are substantially equivalent to other classes?.
Answer: Class III
◉ Currently the only BANNED device?. Answer: Prosthetic hair
fibers
◉ Examples of devices that require a prescription?. Answer: Contact
lenses and diaphragms
◉ FDA can require a manufacturer to recall a drug (T/F)?. Answer:
False. Manufacturers can voluntarily issue a recall or can be
requested by the FDA
◉ Gives Consumer Product Safety Commission authority to require
special packaging of hazardous substances?. Answer: Poison
Prevention Packaging Act
◉ Testing requirements that a package must meet to be considered
child resistant and qualify as special packaging?. Answer: 1. At least
90% of adults should be able to open the container without
significant difficulty
2. At least 85% of children under 5 who are not familiar with the
packaging, should not be able to open the container in five minutes
, 3. At least 80% of children under 5 still cannot open the package
after an adult shows them how to open the container in five minutes
◉ Which drugs are exempt from special packaging?. Answer: 1.
Drugs that are not in a dosage form intended for oral administration
(nasal sprays, eye drops and ointments)
2. Nitroglycerin
3. Isosorbide dinitrate
4. EES
5. Oral contraceptives
6. Cholestyramine/Colestipol powder/Colesevelam/ Sevelamer
carbonate
7. Unit dose KCl
8. NaF
9. Steroids
10. Pancelipase preparations
11. Mebendazole
12. Conjugated estrogens/hormone replacement therapy
13. Sucrase in glycol and water
◉ Who are package inserts for?. Answer: Healthcare professionals
