PTCB Federal Requirements Study Guide –
Latest 2025/2026 Exam Prep & Practice
Questions
Handling and Disposal of Pharmacy Substances and Waste - correct answerExtreme
caution should always be used - PPE and wear as outlined in SDS
Hazardous materials - correct answerany chemical or drug that poses potential harm to
the person preparing/coming in contact with
- OSHA has standards to protect employees- PPE
SDS- safety data sheets
- should be stored seperately from other materials often in a negative pressure room
- leakproof container labeled hazardous
- in case of accidental exposure, you should be aware of the equipment available and
follow all cleanup of hazardous materials -- spill kits for safe cleaning
-- report any accidents to supervisor
Non-hazardous materials - correct answerhandled with care, even though PPE is not
required
- may pose a risk to the environment if not disposed of correctly
-keep out of waterways (don't dump down drain)
-can range from materials used to prepare a compounded product to products that have
passed their intended expiration date
Pharmaceutical Substances - correct answer-any substance used for therapeutic
treatment - medications or the ingredients used to make them
- Hazardous: warfarin, tretinoin, finasteride, methotrexate
- Non-hazardous: amoxicillin, diphenhydramine, ranitidine, atorvastatin
- expired pharm subs can be sent back to manufacturer
- vaccines, syringes, and needles disposed in sharps container.
Controlled Substances - correct answermedications that carry a high risk for abuse and
misuse
- highly regulated by the DEA and categorized into schedules based on level of potential
abuse
- each pharmacy has a designated area (vault or locked cabinet) for certain controlled
medications are placed
Movement - correct answermovement of controlled substances from manufacturer to
pharmacy, then pharmacy to patient - highly regulated by DEA
-each step in the life cycle of a controlled substance must be traceable
,New prescriptions - correct answerschedule II prescriptions must be sent electronically
from the practitioner to the pharmacy or handwritten on a secure prescription blank
- Faxes are only acceptable for hospice/long-term care patients
- telephonic emergency schedule II prescriptions must be followed up with an electronic
or hard copy per DEA regulations
- To combat current opioid crisis, some states limit days supplu and amount that can be
prescribed to 100 MME per day
-Nothing on a schedule II prescription can be altered, even with confirmation from
practitioner
- Expiration date is based on state's regulations-- typically within 90 days of the written
date
- pharmacies must follow both federal and state laws- when each is different (i.e.,
expiration of a schedule II prescription) the stricter of the 2 must be followed.
-Schedule III-V prescriptions can be handwritten, electronically sent, faxed, and even
taken over the phone
Refills - correct answer-Schedule II prescriptions are not permitted to be written with any
refills
- Controlled substances cannot be filled early
Transfer of prescription - correct answer-schedule II medications cannot be transferred
from one pharmacy to another
- schedule III-Vs can be transferred between pharmacies one time only
- all transfers must occur between 2 pharmacists
-schedule III-V transfers are indicated by law for refill purposes only (non-transferable)
- following needs to be included when transferring a prescription:
-- original prescription date and dispensing date
-- number of refills remaining
--the name of the transferring pharmacist
--the DEA number, name, and address of the transferring pharmacy
DEA controlled substance schedules - correct answerSchedule I drugs have the highest
abuse potential but are not on the market as they are not acceptable medical treatments
and lack therapeutic benefit
- Schedule II drugs have the highest abuse potential for medications currently on the
market
- the risk for abuse and misuse lessens as the schedule number increases - schedule V
drugs have lowest risk
Calculations involved - correct answer- since controlled prescriptions have quantity and
day supply limitations, it is important to know how to calculate a prescription's days
supply
-pharmacist ultimately responsible, but tech should know to catch inconsistencies
before reaching final check.
- most common opioids and MME conversion factors
-- morphine=1
, --oxycodone=1.5
--hydrocodone=1
--codeine=0.15
- CDC website is a good resource
example of calculation involving a controlled medication - correct answerOxycodone 5
MG tab
1 tablet by mouth 3x daily as needed for chronic pain#84 tablets
Is this prescription valid for dispensing? calculations:
84 tabs total/3 tabs daily = 28 day supply
5 MG x 3 tabs daily= 15 MG of oxycodone daily
15 MG x 1.5 MME factor= 22.5MME
yes, prescription is valid- does not exceed 100 MME/day and 30-day max limit
Other regulations for controlled substances - correct answerDEA- Drug Enforcement
Agency
FDA- Food and Drug Administration
DEA - correct answercomprehensive drug abuse prevention and control act of 1970
(controlled substances act) -- handlers of all controlled substances need to maintain
accurate and up to date records and inventory - helps keep pharmacy aligned with
federal regulations as well and prevent drug diversion and misuse
- Pharmacies and practitioners must be registered with the DEA for
prescribing/dispensing a controlled substance -- each given a unique DEA #
-- add first, third and fifth together
-- add second, fourth, and sixth together
-- multiply the sum in the second step by 2
-- add the total from steps 1 and 3 together
-- Verify that the second digit of the sum in step 4 is the same as the last digit in the
DEA number
- Prescription monitoring program to keep track of controlled substance history-- helps
cut down on polypharmacy doctor shopping and early fills
FDA - correct answerresponsible for regulating the safety efficacy of medical devices,
drugs, and biologics
-FDA must approve of each medication before it can be put on market
- regulates the manufacturing, labeling, dispensing, and post-market surveillance.
- requires black box warning --alert healthcare providers and consumers of serious
potential adverse affects or life-threatening risks -- i.e. opioid analgesics
- Opioid Analgesic Risk Evaluation and Mitigation (REMS) program that requires
adequate training in healthcare professionals
- in 2019, FDA required a label change on opioids to guide providers on dose tapering
prior to discontinuation due to reports of harm caused by abrupt discontinuation
-MedWatch
Latest 2025/2026 Exam Prep & Practice
Questions
Handling and Disposal of Pharmacy Substances and Waste - correct answerExtreme
caution should always be used - PPE and wear as outlined in SDS
Hazardous materials - correct answerany chemical or drug that poses potential harm to
the person preparing/coming in contact with
- OSHA has standards to protect employees- PPE
SDS- safety data sheets
- should be stored seperately from other materials often in a negative pressure room
- leakproof container labeled hazardous
- in case of accidental exposure, you should be aware of the equipment available and
follow all cleanup of hazardous materials -- spill kits for safe cleaning
-- report any accidents to supervisor
Non-hazardous materials - correct answerhandled with care, even though PPE is not
required
- may pose a risk to the environment if not disposed of correctly
-keep out of waterways (don't dump down drain)
-can range from materials used to prepare a compounded product to products that have
passed their intended expiration date
Pharmaceutical Substances - correct answer-any substance used for therapeutic
treatment - medications or the ingredients used to make them
- Hazardous: warfarin, tretinoin, finasteride, methotrexate
- Non-hazardous: amoxicillin, diphenhydramine, ranitidine, atorvastatin
- expired pharm subs can be sent back to manufacturer
- vaccines, syringes, and needles disposed in sharps container.
Controlled Substances - correct answermedications that carry a high risk for abuse and
misuse
- highly regulated by the DEA and categorized into schedules based on level of potential
abuse
- each pharmacy has a designated area (vault or locked cabinet) for certain controlled
medications are placed
Movement - correct answermovement of controlled substances from manufacturer to
pharmacy, then pharmacy to patient - highly regulated by DEA
-each step in the life cycle of a controlled substance must be traceable
,New prescriptions - correct answerschedule II prescriptions must be sent electronically
from the practitioner to the pharmacy or handwritten on a secure prescription blank
- Faxes are only acceptable for hospice/long-term care patients
- telephonic emergency schedule II prescriptions must be followed up with an electronic
or hard copy per DEA regulations
- To combat current opioid crisis, some states limit days supplu and amount that can be
prescribed to 100 MME per day
-Nothing on a schedule II prescription can be altered, even with confirmation from
practitioner
- Expiration date is based on state's regulations-- typically within 90 days of the written
date
- pharmacies must follow both federal and state laws- when each is different (i.e.,
expiration of a schedule II prescription) the stricter of the 2 must be followed.
-Schedule III-V prescriptions can be handwritten, electronically sent, faxed, and even
taken over the phone
Refills - correct answer-Schedule II prescriptions are not permitted to be written with any
refills
- Controlled substances cannot be filled early
Transfer of prescription - correct answer-schedule II medications cannot be transferred
from one pharmacy to another
- schedule III-Vs can be transferred between pharmacies one time only
- all transfers must occur between 2 pharmacists
-schedule III-V transfers are indicated by law for refill purposes only (non-transferable)
- following needs to be included when transferring a prescription:
-- original prescription date and dispensing date
-- number of refills remaining
--the name of the transferring pharmacist
--the DEA number, name, and address of the transferring pharmacy
DEA controlled substance schedules - correct answerSchedule I drugs have the highest
abuse potential but are not on the market as they are not acceptable medical treatments
and lack therapeutic benefit
- Schedule II drugs have the highest abuse potential for medications currently on the
market
- the risk for abuse and misuse lessens as the schedule number increases - schedule V
drugs have lowest risk
Calculations involved - correct answer- since controlled prescriptions have quantity and
day supply limitations, it is important to know how to calculate a prescription's days
supply
-pharmacist ultimately responsible, but tech should know to catch inconsistencies
before reaching final check.
- most common opioids and MME conversion factors
-- morphine=1
, --oxycodone=1.5
--hydrocodone=1
--codeine=0.15
- CDC website is a good resource
example of calculation involving a controlled medication - correct answerOxycodone 5
MG tab
1 tablet by mouth 3x daily as needed for chronic pain#84 tablets
Is this prescription valid for dispensing? calculations:
84 tabs total/3 tabs daily = 28 day supply
5 MG x 3 tabs daily= 15 MG of oxycodone daily
15 MG x 1.5 MME factor= 22.5MME
yes, prescription is valid- does not exceed 100 MME/day and 30-day max limit
Other regulations for controlled substances - correct answerDEA- Drug Enforcement
Agency
FDA- Food and Drug Administration
DEA - correct answercomprehensive drug abuse prevention and control act of 1970
(controlled substances act) -- handlers of all controlled substances need to maintain
accurate and up to date records and inventory - helps keep pharmacy aligned with
federal regulations as well and prevent drug diversion and misuse
- Pharmacies and practitioners must be registered with the DEA for
prescribing/dispensing a controlled substance -- each given a unique DEA #
-- add first, third and fifth together
-- add second, fourth, and sixth together
-- multiply the sum in the second step by 2
-- add the total from steps 1 and 3 together
-- Verify that the second digit of the sum in step 4 is the same as the last digit in the
DEA number
- Prescription monitoring program to keep track of controlled substance history-- helps
cut down on polypharmacy doctor shopping and early fills
FDA - correct answerresponsible for regulating the safety efficacy of medical devices,
drugs, and biologics
-FDA must approve of each medication before it can be put on market
- regulates the manufacturing, labeling, dispensing, and post-market surveillance.
- requires black box warning --alert healthcare providers and consumers of serious
potential adverse affects or life-threatening risks -- i.e. opioid analgesics
- Opioid Analgesic Risk Evaluation and Mitigation (REMS) program that requires
adequate training in healthcare professionals
- in 2019, FDA required a label change on opioids to guide providers on dose tapering
prior to discontinuation due to reports of harm caused by abrupt discontinuation
-MedWatch
