MPJE Flashcards
Created law that mandated safety of all drugs
Food Drug Cosmetic FDCA 1938
Created the FDA
Food Drug Cosmetic Act FDCA 1938
Created Rx/OTC
Durham-Humphrey Amendment 1951
Authorized verbal rxs and refills
Durham-Humphrey Amendment 1951
Law that required drugs to be safe AND effective
Kefauver-Harris amendment 1962
Created FDA oversight of drug advertisement
Kefauver-Harris amendment 1962
Increased safety of drugs & created GMPs
Kefauver-Harris amendment 1962
Bans the re-importation of drugs made in the US
PDMA 1987 (prescription drug marketing act)
Bans sale, trade, or purchase of drug samples
PDMA 1987 (prescription drug marketing act)
Mandates storage, handling, and record keeping requirements of samples
PDMA 1987 (prescription drug marketing act)
Only instance where a retail pharmacy may have samples
Pharmacy must be affiliated with a healthcare entity (i.e owned by hospital) (PDMA 1987)
Prohibits the resale of drugs purchased by hospitals and healthcare facilities (acquisition cost lower)
PDMA 1987 (prescription drug marketing act)
Created sterile compounding outsourcing facilities (503B facilities) following cGMPs regulated by FDA
No pt. specific compounding
DQSA - Drug Quality and Security Act 2013
Florida requirement for in-state 503B facility
Must obtain Special Sterile Compounding Permit
Florida requirement for out-of-state 503B facility
Must obtain Nonresident Sterile Compounding Outsourcing Facility Permit
Federally regulated outsourcing sterile facility
non patient specific
503B facility
Compounding (sterile) pharmacies not registered with FDA as outsourcing facility
503A pharmacy/facility
Does a 503A pharmacy need individual prescription to compound a sterile drug?
Yes!
What federal USP statute guides 503A pharmacies?
USP 797 quality standards for sterile compounding
How often must a 503B facility report drugs sold
Initially, then q6months
503B facility must report serious ADE within __ days
15
Law that provides “track and trace” system for drugs as they move through supply chain
Drug Supply Chain Security Act - DSCSA
Law that establishes standards for wholesaler licensure
Drug Supply Chain Security Act - DSCSA
Requires “Transaction data” between wholesalers and pharmacies
Drug Supply Chain Security Act - DSCSA
Requires pharmacies to report/properly handle illegitimate drugs
Drug Supply Chain Security Act - DSCSA
Exceptions to “distribution” (where pharmacy doesn’t need distribution license/pass on transaction data)
Same ownership, dispenser to dispenser for patient specific need, emergency medical reason, “minimal quantities” to licensed practitioner for office use
Adulteration v. Misbranding - Drug contains fility, putrid, or decomposed substance
Adulterated
Adulteration v. Misbranding - Prepared or held under unsanitary conditions
Adulterated
Adulteration v. Misbranding - Drug held in container that is poisonous/deleterious to drug
Adulterated
Adulteration v. Misbranding - Contains unsafe color additive
Adulterated
Adulteration v. Misbranding - Products claims to meet USP standards for strength & quality, but doesn’t
Adulterated
Adulteration v. Misbranding - Drug differs in strength or quality compared to what label states
Adulterated
Adulteration v. Misbranding - Label does not state name of mfr, packer, or distributor
Misbranded
Adulteration v. Misbranding - Label does not state name of drug
Misbranded
Adulteration v. Misbranding - Label does not state quantity
Misbranded
Adulteration v. Misbranding - Label does not state weight of active ingredient
Misbranded
Adulteration v. Misbranding - Label does not state “rx only” if rx only
Misbranded
Adulteration v. Misbranding - Route of admin not stated on label if not for oral use
Misbranded
Adulteration v. Misbranding - Pharmacist dispenses rx w/o authorization
Misbranded
Adulteration v. Misbranding - Pharmacist fills for wrong drug/str/sig
Misbranded
Adulteration v. Misbranding - Pharmacist fill for wrong str
Misbranded AND adulterated
Adulteration v. Misbranding - Pharmacist fills drug w/o REMS requirement
Misbranded
Adulteration v. Misbranding - Pharmacist dispenses expired drug
Adulterated. Also misbranded if pharmacist places a beyond use date that exceeds mfr expiration date
Recall type - reasonable probability of serious ADE/death
Class I
Recall type - May cause temporary/reversible ADE where serious ADE chance is remote
Class II
Recall type - Not likely to cause adverse health consequences
Class III
Patient package insert (lay person level) require for:
Oral contraceptives/estrogen containing products. If hospitalized/institutionalized, initially and every 30 days.
PPPA
Poison Prevention Packaging Act 1970
Law that created mandate for child resistant containers for all drugs and some OTC drugs
Poison Prevention Packaging Act 1970
Exemptions to PPPA (page 44)
Contraceptives, estrogens, medroxyprogesterone, SL NTG, effervescent ASA/APAP, UD potassium, Sodium Fluoride (264mg max/package)
Exemptions to PPPA (page 44)
Cholestyramine, Erythromycin, Prednisone (105mg max/package), Medrol (84 mg max/package)
Exemptions to PPPA (page 44) Prednisone mg
105mg/package
Exemptions to PPPA (page 44) Medrol mg
84mg/package
Exemptions to PPPA (page 44) Sodium Fluoride mg
Sodium Fluoride (264mg max/package)
Authority to schedule controlled substances (federal)
US Attorney General
Authority to schedule controlled substances (Florida)
Florida AG may add/delete/reschedule
Codeine or opium not mixed with other drug is schedule
Schedule II
Codeine solution C-V limit
2mg/1mL (like Robitussin w/codeine = 100mg/10mg/5mL)
Codeine C-III limit (tablet)
90mg/tablet mixed with other drug like apap
Codeine solution C-III limit (liquid)
18mg/1mL
Opium C-V limit
1mg/1ml
Opium C-III limit solution (federal)
5mg/ml
Opium C-III limit solid dosage (federal)
25mg/tablet
Opium C-V limit (Florida)
1mg/ml if greater concentration, CII
Pharmacies and practitioners must register w/DEA every ___ years
3
Form ___ is used to register w/DEA
224
Form ___ is used to renew w/DEA
224a
DEA number for dispensers (pharmacies/practitioners) start with ______
A, B, or F
Mid-level practitioners DEA # starts with _____
M
Verify DEA #
Add 1st, 3rd, 5th #; Add 2nd, 4th, and 6th # & x by 2, add two sums, and last number should be last # DEA
If full amount of CII can’t be filled by wholesaler, the order may be partial and sent to pharmacy within ___
60 days
Theft or significant loss must be reported to DEA within ___
1 business day in writing
Florida law requires theft or significant loss be reported to _____
DEA within 1 business day, BOP within 1 business day (by PDM/CP), and county sheriff within 24 hours
To report theft or significant loss to the DEA, form ___ is used
106
Disposal or destruction of controls uses form ___
41
Form 41 procedure (disposal destruction of controls) other than Class I institutional
Fill and sign. Must be done by PDM or Consultant pharmacist of record and a witness and sent to closest DEA office within 1 business day
To report illegitimate drugs, form ______ is used
Form FDA 3911
Per CMS regs, LTC facilities must have a Medication Regiment Review _____ by a consultant pharmacist
Every 30 days
Irregularities in LTC facility found on Medication Regiment Review must be reported to
Attending MD, Medical Director, DON
Inventory of controls
Exact # for CII, estimated # for CIII-V unless bottle holds more than 1000 doses
Controlled substance records must be kept for ___ years
2
Rx records must be kept for _____
4 years from the last date of fill
Central record-keeping for controls are permitted EXCEPT for _____
Executed 222 forms, prescriptions, or inventories
How many CE hours must a pharmacist take relating to opioids/controls?
2 CE
Every pharmacy must maintain a summary record of control substances dispensed for last ___ days and made available w/in _____ hours
60 days , 72 hours
Summary record of controlled substances includes:
Name of drugs, volume dispensed, specific patients, specific prescribers
Fraudulent controlled substance rxs must be reported to ____ within _______
sheriff/chief law enforcement within 1 business day/24 hours (whatever is later)
Optometrists can only prescribe the following controls:
Ultram, Tylenol w/codeine #3 (max 72 hour supply unless consulting w/md)
PAs can prescribe up to a ___ day supply of CII
7 day
PA can prescribe mental health control to minor?
No!!!!
APRN can prescribe up to a ___ day supply of CII
7 day - does not apply to psychiatric CII written by psychiatric APRN
Can PA/APRN prescribe in pain management clinics?
No!!!
APRN can prescribe mental health control to minor?
No!!! Exception psych specialist
Can a pharmacist fill a control for an out of state doctor?
Only if rx is validated AND is for a chronic/recurrent condition
Can a pharmacist fill and out of state rx for non control?
Yes, but only for chronic/recurrent condition
Is a telehealth rx permitted for controls in Florida?
Yes, but only for A) Psych B) Hospital Inpatient C) Hospice D) Nursing Home
Is E-prescribing mandatory?
Yes!!!
Notable exceptions to e-prescribing
Emergency to pt, hospice/nursing home pt, price shopping
Can a control and non control appear on the same hard copy blank?
No!!!
Refills permitted for CII?
No!!!!
Verbal for CII permitted?
No! Except for emergencies
Verbal for CIII-V permitted?
Yes
Max quantity for a verbal CIII rx?
30 days
Faxes for CIII-V?
Yes, but must bear prescribers original signature
All prescriptions (including CII) must be filled within ____
1 year after issue date or earliest fill date
In general, do quantity limits apply to CII?
No
Max amount of CII PA/APRN can prescribe?
7 days, except for psych APRN for psych CII
Instances where CII may be faxed to pharmacy and function as original rx
Home infusion/IV pain, LTCF, Hospice
A pharmacist may issue up to a ___ supply of CII from a verbal emergency rx
72 hours
A doctor has ____ days to send covering rx for verbal emergency rx
7 days; must state “authorization for emergency dispensing”
CII acute pain max day supply
3 days, with exceptions
Exception to 3 day acute pain CII
7 day max if exception! Permitted if greater than 3 days clinically indicated, “acute pain exception” noted on rx, prescriber documents in pt record
For treatment of non acute pain using CII, prescriber must indicate
“Non-acute pain” on face of rx
Greater than 7 day supply for opioid CII for acute pain?
No, except for Injury Severity Score of >9; prescriber must also write for antagonist (Naloxone)
C-V OTC max codeine per 48 hours
120mg/4oz
C-V OTC max opium per 48 hours
240mg/8oz
Consultant pharmacist course hour requirement
12
Consultant pharmacist requirement initial licensure
Take a course no less than 12 hours, take cognitive test, “intern” w/consultant pharmacist for at least 40 hours for no more than 3 months (no more than 1 year after taking course/test)
Consultant pharmacist preceptor requirement
Must be CPoR (consultant pharmacist of record) at institutional pharmacy & 1 year experience. Max 2 students at a time
CE requirements for pharmacist
30/2 years. 10 must be live. 2 must be in med error. 2 must be in validating controlled substances. 3 must be in vaccines/epi if vaccinator. Initial renewal - 1 hour HIV/AIDS
Consultant pharmacist who wish to monitor and order labs must complete a ___ hour cert course initially
3 hour
PMP not required for patients under ___ years of age
16
PMP not required for patients under ___ care
Hospice
Max Day supply for optometrist to prescribe control
72 hour, unless consult with ophthalmologist (MD)
Optometrists can prescribe oral carbonic anhydrase inhibitors for a max of
72 hours (acetazolamide, methazolamide)
Pharmacy tech CE requirement
20/2 years. 2 must be in med error. 4 must be live. 1 hour HIV/AIDS (first renewal)
BOP constituency
9 members. 7 are pharmacists. 2 are retail. 2 are institutional. 3 are random pharmacists. 2 are random people having no affiliation w/pharmacy whatsoever. All must be residents of Florida. Pharmacists must be residents for at least 4 years. One constituent must be 60 or older.
BOP members serve terms of ___ years
4
MPJE is required when a pharmacist license is placed on retired status for ____ years or more
5 years or more if actively practicing in another state
If not practicing, NAPLEX also required
Methods of obtaining CE
ACPE program, Board Hearing in Risk Management (5 day/10 per cycle), Volunteering (5 CE), post-professional programs from school of pharmacy (5CE/semester hour), Expert Witness for DOH (5CE), Presenter of live CE
Consultant pharmacist - initial course requirement
12 hour course
After completing initial course of 12 hours, consultant pharmacist must complete ____ hours of specific training
40 hours
Consultant pharmacist who wish to monitor and order labs must complete a ___ hour cert course
3 hour
Consultant pharmacist must complete ____ hours of CE for CE renewal in addition to the regular 30 hours
24 hours
Consultant pharmacist who wish to monitor and order labs must complete a ___ hour cert course upon license renewal
1 hour
____ hours internship are required for pharmacist licensure
2080 hours
Pharmacy techs must be ____ years old to register
17
Pharmacy tech CE requirement
20/2 years. 2 must be in med error. 4 must be live. 1 hour HIV/AIDS
A delinquent pharmacist license must be renewed within ____ years
2 years
MPJE/NAPLEX is required when a pharmacist license is placed on retired status for ____ years or more
5 Years or more
MPJE is required when a pharmacist license is placed on retired status for ____ years or more
5 years or more if actively practicing in another state
Pharmacist:Tech ratio
Law says 1:1. However, clarification states that: sterile is 3:1, non-sterile is 6:1, and non-dispensing is 8:1
Non-pharmacy entities that may dispense rx drugs
Vet office, Medical Oxygen supplier
Pharmacist wishing to immunize must complete ____ hours of CE in vaccination upon initial licensure
20 hours INCLUDING CPR
To maintain immunizer license, a pharmacist must complete ___ hours of vaccine or epipen CE
3 hours
A pharmacist may enter a protocol w/physician to vaccinate if they have ______ of liability insurance
$200,000 or more
Pharmacist immunization records must be maintained for ____ years
5 Years
Can Florida pharmacists vaccinate minors?
No!
CQI committee must review QA related events at least every ____
3 months
Pharmacy inspection is required ____ during first year of operation
twice
A pharmacy that has passed inspection for 3 years straight requires inspection every _____
2 years
A pharmacy that fails inspection must be inspected ___
annually
Customized medication packet beyond use date:
120 days (or less if mfr expiration date is less)
Customized medication packet must contain
Physical descriptions of drugs
Information for electronic prescription storage must be back up at least ______
Weekly
Central Fill/originating pharmacy label requirements
Both have to be on the label. Name and address of originating pharmacy must be on label. Central fill pharmacy may be identified by code.
May a central fill pharmacy fill for controls?
No!!!!
A pharmacist may enter a collaborative practice with a physician to treat chronic health conditions provided they complete a ____ hour course initially
20 hour (8 live) - also worth 20 ce
A pharmacist may enter a collaborative practice with a physician to treat chronic health conditions provided they maintain _____ in liability insurance
$250,000
Pharmacist mediated collaborative practice records must be maintained for ____ years
5 years
Collaborative practice agreements are for a duration of ____ years if not renewed
2 years
A pharmacist who wishes to enter collaborative practice must complete ____ hours of CE in addition to regular CE requirements upon renewal
8 CEs
Minor, non chronic conditions a pharmacist (with written protocol from physician) may diagnose/treat
Flu, Strep, Lice, Skin conditions (ringworm etc), minor uncomplicated infections
A pharmacist who wishes to diagnose/treat minor, non-chronic conditions must initially complete
20 hour course (8 live)
Appointment of new PDM/PDM who leaves must be reported within ____
10 days
Retail pharmacies must be open a minimum of ___ hours per week
20 hours
Pharmacist may issue emergency refill for all medications
Yes, except CII
Nuclear Pharmacist must have ____ hours in didactic training
200
Nuclear pharmacist must have a _____ hour internship
500
Nuclear pharmacist must have ____ hours of CE upon renewal
24
Florida Negative Forulary
Conjugated Estrogens, (Thorazine) Chlorpromozine, (Creon) Pancrelipase, Theophylline
Immediate Use CSP
Not made in a cleanroom/SCA. Max 3 sterile ingredients & 2 entries into one container.
Low Risk CSP
Mixed according to 797. Single dose for single patient
Medium Risk CSP
Mixed according to 797. Batch for multiple patient, single patient with multiple doses, or TPN
High Risk CSP
Mixed according to 797. Starter ingredient is not sterile -or- any risk mixed without complete garb
CSP must be within ____ % of stated potency on label
10%
For high risk CSP, gloved fingertip test & media fill tests are done at least every ____ months
At least every 6 months
For medium and low risk CSP, gloved fingertip test & media fill tests are done at least every ____ months
At least every 12 months
Initial qualification fingertip test CFU
3 sets (6 plates) with 0 CFU
Requalification fingertip test CFU
1 set (2 plates) no more than 3 CFU/plate
Sterile compounding area temperature should not exceed ___ C
20C
Examples of PEC (Primary Engineering Control) for CSPs
“Hoods” Laminar Airflow Bench and/or biological safety cabinets
PEC ISO rating must be
ISO5
PECs must have _______ airflow
Unidirectional
ALL Buffer rooms must be ISO ____
ISO7
Anteroom that opens into a positive pressure buffer room must be
ISO8
Anteroom that opens into a negative pressure buffer room must be ISO
ISO7
SCA (segregated compounding area) ISO rating is ______
Not applicable - no ISO rating required as these rooms are purpose built standalone rooms
SEC (Secondary engineering control) is _____
Anteroom/buffer room
PEC and SEC must be certified every ____ months
Every 6 months
Order for PPE for CSP
Cover Head/Hair > don Mask > don Shoe covers > Wash hands > step to clean side of room > don gown > alcohol hands > don sterile gloves
Sterilization of high risk CSP starting w/non-sterile products is achieved by ________
Terminal sterilization (autoclaving) or filtration
In-use time for SDV if opened and maintained inside ISO 5 environments (PEC)
6 hours
In-use time for SDV if opened or maintained outside ISO 5 environments (PEC)
1 hour
In-use time for MDV
28 days (without regard to being opened/maintained ISO5)
In-use time for ampules
Use and discard
BUD for CSP for immediate use
1 hour
BUD for low risk CSP made in SCA
12 hours (whether room temp or refrigerated)
BUD for low risk CSP at room temperature
48 hours
BUD for medium risk CSP at room temperature
30 hours
BUD for high risk CSP at room temperature
24 hours
BUD low risk CSP under refrigeration
14 days
BUD for medium risk CSP under refrigeration
9 days
BUD for high risk CSP under refrigeration
3 days
BUD for all categories of risk stored frozen
45 days
BUD for high-risk CSP @ RT/refrigeration
24 hours/3 days
BUD for low-risk CSP @ RT/refrigeration
48 hours/14 days
BUD for medium-risk CSP @ RT/refrigeration
30 hours/9 days
Action level (CFU) for ISO5 air/surface
> 1/3
Action level (CFU) for ISO7 air/surface
> 10/5
Action level (CFU) for ISO8 air/surface
> 100
Additional HD requirements to SEC
Appropriate air exchange, external venting
Pharmacies must comply with a patient request for PHI under HIPAA within ____ days
30 days
Pharmacies must amend PHI requested by patient within ____ days
60 days
Patients must be notified of a HIPAA breach within ____ days
60 days
Tamper evident packaging is required for all OTCs except
Toothpaste, lozenges, insulin, dermatological preparations
Adipex Schedule
4
Phenobarbital Schedule
4
Ultram Schedule
4
BZD schedule
4
Fiorinal schedule
3
Amobarbital schedule
2
Pentobarbital schedule
2
Suboxone/Subutex schedule
3
Ketamine schedule
3
Soma schedule
4
Diethylpropion schedule
4
Butrans schedule
3
Lyrica schedule
5
Loss or theft of PSE must be reported within ___ days
15 days
Form 41, used to document destruction of controls, must be delivered to nearest DEA office within ____
1 day
Destruction of controls does not require form 41 if the destroying pharmacy is a class _____
Class 1 pharmacy (nursing home) provided there are two witnesses
Pharmacies may offer “take backs” of CDS if they modify ______
their registrations to act as a collector
CDS inventory is required when:
Pharmacy initially opens for business, every two years, newly scheduled/change in schedule
Records of controlled substances must be maintained for ____
2 years
Hard-copy printout of controlled drug dispensing must be made within ____ hours
72 hours OR daily signed log book must be kept
Hard-copy printout of controlled drug dispensing must include previous _____ days of dispensing
60
Types of APRNS
Clinical Nurse Specialist (CNS), Certified Registered Nurse Anesthetist (CRNA), Certified Nurse-Midwife (CNM), Certified Nurse Practitioner (CNP)
_____ are exempt from mandatory counterfeit proof rx pads when prescribing CDS
Vets!
Faxes as originals for CIIs are permitted for
LTCF, hospice, home infusion/iv pain
30 day rule for partial filling of CII
Permitted if patient requests! Up to a 30 day supply
60 day rule for partial filling of CII
Permitted for LTCF and terminally ill patients. Must be completed within 60 days
Who can dispense CII
Only community pharmacies (including community pharmacy attached to a hospital)
Who can dispense CIII
Only community pharmacies (including community pharmacy attached to a hospital)
DATA waived patient amount for physicians
30, 100, or 275
DATA waived patient amount for PA/APRN
Initial = 30; after one year, may be increased to 100
DATA-waived practitioners are those who can prescribe
Suboxone/Subutex
PSE Hcl daily limit not base
36 120mg tablets
PAs may not prescribe:
anesthetics or radiographic contrast materials exception in hospital
An intern who is a foreign pharmacy graduate is supervised at a ratio of 1 pharmacist: ____ inter
1 intern (1:1 ratio)
Foreign pharmacy graduates must complete ___ hours of supervised work activity to be eligible for licensure
500 hours
If rx is for an animal, ______ must appear on the rx
Owner name and animal specie
To become consultant pharmacist:
Take 12 hour course (including cognitive test), 40 hours of precepted work
To renew consultant pharmacist license:
Take 24 consultant pharmacist CE (1 CE must be in ordering lab tests if desired) in addition to regular 30 hours required
Passing an on-site inspection is required when:
New pharmacy is opened, new ownership, change of address/location
Is a pharmacy permit transferable?
No!
Retail pharmacy wholesale distributor distributes _____ % or less
Distributes 30% or less of total annual purchases of rx drugs
Retail pharmacy wholesale distributor may distribute to:
Other retail pharmacies, modified class II pharmacy, or licensed healthcare practitioner
Immunization records must be retained for ____ years
5 years
CQI committee reviews CQI related events no fewer than every _____ months
3 months
A hard copy printout summary of dispensed controls covering the previous 60 day period, shall be made available within ____ following a request for it by any law enforcement personnel entitled
to request such summary under authority
72 hours
If pharmacy does not have a bound log book, a hard copy print out of rx summary must be printed within ___
72 hours of the date dispensed and signed within 7 days
Hard copy printout of rxs must be produced within _____ hours for DOH official
48 hours
Pharmacist CE required for collaborative practice
20 initially, 8 on renewal
C-SCA are used to compound
Hazardous drugs (USP 800)
Summary records for CQI must be kept for _____
4 years
Examples of references
USP/NF, Facts, Remingtons, US Dispensatory
Max day supply of NSAIDS orderable by a pharmacist
6
Max day supply Pyridium orderable by a pharmacist
2
Minimum patient age orderable by pharmacist for antihistamines
6 Years and older
Minimum patient age orderable by pharmacist for decongestants
6 years and older
Drug therapy management
Can participate w/ physician, PA, dentist, podiatrist - not aprn. Requires CQI
Collaborative practice records must be maintained for _______
5 years
A pharmacist must complete ____ CE related to collaborative practice each renewal
8 CE in addition to regular CE requirements
A pharmacy may delay commencement of operation by notifying the BOP in writing within ______
14 days
A pharmacy that commences operations must notify the board in writing within ____
2 days
A pharmacy must commence operations within ____ after obtaining permit, or write to BOP indicating why not
6 months
A pharmacist may substitute a biologic product if it both
biosimilar AND interchangeable per the FDA
T or F - pharmacy must have a consultation area that is signed as such
True - OBRA 90
Upon closing a pharmacy, the permit must be returned to ______
The Board of Pharmacy
Upon closing a pharmacy, the permit must be returned within ______
10 days to the BOP
Upon closing a pharmacy, CDS registration and blank 222 forms are returned to ____
Miami DEA regional office
Unclaimed Rxs may be returned to pharmacy stock, but must be used within _____
1 year
ER prescriber may dispense up to a ____ supply of medication if community pharmacy services are not available
1 day
Automated systems (ie Pyxis) require a prospective DUR unless the medications are
override medication, low-risk override medication, physician controlled medication
For override medications, a pharmacist must perform a _______ DUR
retrospective
Daily audit records for automated systems (i.e Pyxis) are required to be maintained for ______
60 days if non controlled, 4 years if controlled.
Contents of emergency med kits for nursing homes are determined by facility ______
consulting pharmacist, DON, medical director
If controlled substances are constituents of an automated pharmacy system (ie Pyxis) in LTCF, Hospice, or correctional facility, a _______ is required
separate DEA registration in the name of the provider pharmacy
For sterile compounding, Florida law adopts ____ chapters of USP
797, 71 (sterility), 85 (endotoxin), 731 (loss on drying)
BOP must be notified within ___ days if commencement/cessation of practice was a result of investigation in another jurisdiction
20 days
All crimes must be reported to the BOP within _____
30 days
Fines must be paid to BOP within
90 days
Minor violations are called
Notice of deficiencies (are not disciplinary actions)
Who investigates complaints against pharmacies/cists/techs/interns made to BOP
Medical QA division of Florida DOH
Medical QA division of Florida DOH makes a final decision re:disciplinary action within
6 months
A pharmacist seeking to administer long acting antipsychotic medications must obtain ____ CE
8 CE
Can a dispensing practitioner dispense CII or CIII?
No, but there are exceptions (pg 262)
T or F - Rxs are required for syringes/needles
No, if 18 or older. Yes if under 18
Dispensing practitioner max CIII amount for post surgery is a _____ day supply
14 day supply
Donor, recipient, and destruction records must be maintained at least _____ by the participant facility for cancer drug donations
3 years
Retention of signed Notice of Privacy Practices is required for _____ years
6 years
Summarization of Quality-Related Events must be maintained for ____ years.
4
Required elements for PMP
- Prescribing practitioner name, DEA and NPI number -Date of the prescription
- Date Rx filled and the method of payment
- Name, address, telephone number, and date of birth of patient
- Name, NDC number, quantity, and strength of the controlled substance dispensed
- Name, DEA number, pharmacy permit number, and address of the pharmacy
- Whether drug was dispensed as an initial Rx or a refill, and the number of refills ordered
- Name of the individual picking up the Rx and type and issuer of the ID provided
Any pharmacy desiring to discontinue business activities altogether or with respect to controlled substances (by transferring such business) must submit in person or by registered or certified mail (return receipt requested) to the DEA _____ days in advance of the date of the proposed transfer
14
