PTCB FEDERAL REQUIREMENTS STUDY GUIDE
Handling and Disposal of Pharmacy Substances and Waste - Answer Extreme caution should always be
used - PPE and wear as outlined in SDS
Hazardous materials - Answer any 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 - Answer handled 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 - 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 - Answer medications 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 - Answer movement 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 - Answer schedule 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 - Answer -Schedule II prescriptions are not permitted to be written with any refills
- Controlled substances cannot be filled early
Transfer of prescription - Answer -schedule II medications cannot be transferred from one pharmacy
to another
Handling and Disposal of Pharmacy Substances and Waste - Answer Extreme caution should always be
used - PPE and wear as outlined in SDS
Hazardous materials - Answer any 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 - Answer handled 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 - 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 - Answer medications 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 - Answer movement 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 - Answer schedule 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 - Answer -Schedule II prescriptions are not permitted to be written with any refills
- Controlled substances cannot be filled early
Transfer of prescription - Answer -schedule II medications cannot be transferred from one pharmacy
to another