ANSWERS GRADED A+
✔✔Dr. Cox calls in an oral prescription for a schedule II medication for an emergency
situation. How many days from the date of calling in the prescription does Dr. Cox have
to send a written prescription for the emergency quantity dispensed? - ✔✔CII's can be
called in for emergency situations. The pharmacist must write these prescriptions down
immediately. The prescriber must send a written prescription to the pharmacy for the
quantity dispensed with "authorization for emergency dispensing" written on the
prescription within 7 days. This includes being post-marked within the 7 day period. The
pharmacist must attach this prescription to the emergency oral prescription. If the
prescription is not delivered appropriately, the pharmacist must notify the Department.
✔✔Requirements to buy sudafed - ✔✔18 yo and 1 form of ID
✔✔How long to keep PHI (protected health info) authorization? - ✔✔Kept for 6 years
✔✔HIPAA requires that PHI be kept & used only for certain purposes (unless pt
authorization is obtained) - ✔✔Treatment
Payment
Health Care Operations (ex. AE reporting, formulary development, audits)
✔✔CII Rx - valid for - ✔✔90 days after the date of issuance
NO refills on Rx
✔✔CIII-CV - valid for - ✔✔6 months (or 5 refills - whichever comes first)
✔✔Non-CS Rx - valid for - ✔✔1ST FILL has to be within 12 months of the date the rx
was written
Refills have up to 15 months of the date the rx was written
✔✔USP 800 - ✔✔Hazardous drugs
✔✔USP 795 - ✔✔Non-Sterile compounding
✔✔USP 797 - ✔✔Sterile compounding
✔✔503A - ✔✔Traditional Compounding (usually non-sterile) - follows state law & needs
pt-specific Rx
✔✔503B - ✔✔Outsourcing facilities (sterile) - can choose to register with FDA (optional)
but HAS to follow cGMP requirements
NO pts - customer is the doctor, hospital/clinic
,✔✔Non-sterile formulations - ✔✔Oral, topical, nasal
✔✔Sterile formulations - ✔✔IV, eye/ ear drops, bladder irrigations, IM/SQ
✔✔Source for hazardous drugs - ✔✔NIOSH
✔✔PEC - ✔✔Laminar flow hood or biological safety cabinet (for chemo prep)
✔✔SEC - ✔✔The "buffer" room that contains the hoods & equipment
✔✔Hazardous drugs - ✔✔Need to be made in containment hoods (C-SEC, C-PEC) &
NEGATIVE air pressure
✔✔Sterile HD ACPH - ✔✔At least 30 ACPH
✔✔Non-Sterile HD ACPH - ✔✔At least 12 ACPH
✔✔Air changes per hour - ✔✔The # of times that the air is replaced in the room per
hour
✔✔PEC (Hood) ISO - ✔✔ISO 5 (cleanest air) & unidirectional flow
✔✔Negative Air - ✔✔The air is going to stay within the hood instead of going towards
the compounder
✔✔Key HDs - ✔✔Chemo agents
Hormones
Transplant Drugs
Finasteride, Dutasteride
Warfarin
MTX
Methimazole, PTU
HIV antiretrovirals
Fluconazole/ Voriconazole
Isotretinoin
Ganciclovir/ Valganciclovir (for cytomegalovirus)
✔✔Non-HD preparations requires _____ type of air pressure - ✔✔Positive
✔✔CSP made inside isolator (glovebox) inside a segregated compounding area - max
BUD - ✔✔12 hours
✔✔CACI air pressure - ✔✔Negative
, ✔✔CAI air pressure - ✔✔Positive
✔✔Sterile, non-HD prep - ✔✔Don't need external vent
Positive pressure
Horizontal laminar airflow (or CAI glovebox)
✔✔Sterile, HD prep - ✔✔Need external vent
Negative pressure
Biological safety cabinet (or CACI glovebox)
✔✔CAI/ CACI can be located in - ✔✔SCA (segregated compounding area - doesn't
have to be a cleanroom)
✔✔Hand hygiene, garbing/ gloving - tested with - ✔✔Gloved fingertip test
✔✔Sterile compounding methods - tested with - ✔✔Media fill test
✔✔How many classes of recalls? - ✔✔III
Class I - serious AE or death
Class II - temporary or medically reversible AE
Class III - not likely to cause serious AE
✔✔NDC - 3 segment code (National Drug Code) - ✔✔1234 = manufacturer
567 = medication ID
90 = ID of package
✔✔Compounded product - what is the acceptable amount of CS in a compounded
product? - ✔✔Can't be > 20% CS
✔✔USP 795: preserved aqueous dosage forms BUD - ✔✔35 days
Emulsions, gels, creams, solutions, sprays, suspensions
✔✔USP 795: non-preserved aqueous BUD - ✔✔14 days
Ex: Amoxicillin suspension
✔✔USP 795: non-aqueous oral liquid dosage forms BUD - ✔✔90 days
✔✔USP 795: non-aqueous non-oral liquids (ex. solid dosage forms) - ✔✔180 days
Tablets, capsules, powders, suppositories, lozenges
✔✔USP 797: Immediate use product BUD - ✔✔Within 4 hours
✔✔What govt agency is responsible for all CS laws? - ✔✔Drug Enforcement
Administration (DEA)