2020 TN Law

How many members are on the board? Who comprises the board?

7; 6 pharmacists (1 racial minority, 1 \>60yo) and 1 consumer

How long must pharmacists have been practicing to be eligible for the BoP?

5 years

How long must the consumer on the BoP have been a TN resident in order to be eligible?

5 years

How long are the terms for BoP members?

6 years

T or F: BoP elected officials can serve multiple terms so long as they are not consecutive

false; 1 term only

What are the 3 elected positions within the board?

President, VP, director

How often must the board meet at minimum?

annually

Who is responsible for setting license requirements, administering licensing exams and doing pharmacy inspections?

BoP

The state encourages pharmacists to set up this, which reviews pharmacists' professional conduct, competence, and ability to practice

Peer Review Committee

T or F: Information provided to peer review committee is privileged

true

T or F: RPh are required to wear ID showing name and title at all times

true

How long does a RPh have to report a DUI to BoP?

10 days

What is the minimum age for a RPh?

21

How long must an out of state pharmacist have been practicing in order to reciprocate to TN?

12 months

How long is a RPh license good for?

2 years

If a PIC is going to be out of the pharmacy for more than 30 days, what 4 things must be sent to the board in order to switch PICs?

name and signature of old PIC, name and signature of new PIC, effective date, name and address of pharmacy

How long do inventory records need to be kept?

2 years

T or F: Under no circumstances can a RPh be PIC of 2 pharmacies

false; can with board approval

What are the hourly requirements for PICs?

50% of open hours or 40 hrs/week

Are on-duty pharmacists allowed breaks?

yes, can leave for 1 hour but no compounding or dispensing can occur

T or F: Counseling is required for outpatients and patients being discharged

true

T or F: Counseling is not required for refills

true, but offer must be made

What 10 things are required for drug counseling?

drug name, dosage form, SIG, duration, special precautions, side effects, self-monitoring, storage, refill info, what to do if missed dose

T or F: Patient profiles must be readily retrievable within 24 hours

False; must be immediately retrievable

What are the CE requirements for pharmacists?

30 hours; 15 must be live

All CE must be \_______ approved

ACPE

T or F: Extra CE hours may not be rolled over to the following cycle

true

What must one do to re-activate a pharmacy license that has been inactive for less than 1 year?

pay all fees, request license, do CE

What must one do to re-activate a pharmacy license that has been inactive for 1-5 years?

satisfy CE requirements, pay fees, pass MPJE and do 320 hours of internship

What must one do to re-activate a pharmacy license that has been inactive for \>5 years?

satisfy CE requirements, pay fees, pass MPJE, pass NABPLEX and do 320 hours of internship

What vaccinations are pharmacists allowed to do?

all vaccines, all ages with a protocol or prescription

How many internship hours are required for new grad initial licensure?

1700 hours after being enrolled in school

How many internship hours are allowed to be earned from school program?

1100 (out of 1700)

T or F: Interns must attain licensure from the state before practicing

false; no license required

How many internship hours are required for foreign grads?

500 hours within 6 months

If applicant fails MPJE/NAPLEX 3 times, what is required of them?

attend review course before next attempt

T or F: Pharmacy techs must register with the BoP

true

How often must techs renew their license?

every 2 years

What must be sent to the BoP when a tech is newly registered?

affadavit from employer attesting that employee read and understood TN pharmacy law

T or F: Certified techs may receive new or transferred oral orders

TRUE

What is the normal RPh to tech ratio? what is the max? do interns count in this ratio?

2:1, 4:1 if 2 techs certified; no

If a pharmacy was constructed after 7/1/98, what must it have per legislation passed that year?

consulatation area

What is the minimum size for a pharmacy?

180 sq ft

How must keys for the pharmacy be kept in a store?

sealed envelope with PIC signature

T or F: Pharmacies must have a separate license to do sterile compounding

true

Pharmacy license applications must be received by board \_______ before opening, and the business cannot open until it has been \_______________

30 days, inspected

What are the drug requirements/limitations for charitable pharmacies?

legend drugs, no CS, must be in tamper resistant packaging

Who approves policies and procedures for emergency kits?

PIC, committee of nurses/prescribers

What is a home care kit and when can it be used?

kit that contains drugs kept at patients home for use only by HCP for emergency situations; pharmacy must be notified whenever kit is opened

T or F: In an institution, a pharmacist must be on call 24/7

true

What is the maximum supply allowed for automated dispensing machines for after-hours use?

72 hour supply (pre-packaged)

How often must automated dispensing machines be inventoried?

at least monthly

In emergency situations when a pharmacist is not present, who is allowed in a pharmacy? What are they allowed to take?

authorized person accompanied by security guard or an additional authorized person; amount needed for immediate dose plus 1 additional dose (RPh to verify when arrive)

T or F: Certified techs are allowed to fill automated dispensing machines without a pharmacist

false; must have RPh supervision

What is the max supply an ER physician can prescribe?

pre-packaged supply not to exceed 12 hour supply

PIC is responsible for inspection of ALL drugs in the institution at least \_________, including emergency kits. These records must be kept for \_________

monthly; 2 years

How often must P&P be reviewed for sterile compounding?

annually

T or F: Pharmacists must be available 24/7 for CSPs?

true

All CSPs should be made in Class \_____ laminar airflow hood, which should be running for at least \____________ prior to compounding

100, 30 min

What is the main unique aspect of CSP labeling as opposed to regular labels?

ID of pharmacist on it

What type of hood needs to be used for hazardous compounding?

Class II Type A vertical laminar air flow hood

What additional training is required for pharmacists who do sterile compounding?

must be annually certified

A toll free telephone number must be availble during business hours of a pharmacy, which is defined as a minimum of \_____________?

40 hours, 6 days per week

A pharmacy can sell medications from one pharmacy to another as long as sale or trade does not exceed \____ of total sales revenue over the past \____________

5%, 12 months

Inventories of all transactions must be maintained for \_______. Records may be kept off-site but must be retrievable within \_______

2 years, 2 days

T or F: ALL prescriptions written in Tennessee must be written on Tamper-Resistant blank

true

Do pharmacists have authority to adjust day supply?

yes, can change from 30 --\>90 day supply without notifying prescriber as long as refills available

What is corresponding responsibility?

pharmacists shares liability with prescriber for dispensing a prescription that has an obvious danger to intended consumer

T or F: Pre-printed or digital signatures are allowed for printed/typed Rx

False; both must be signed as well as written Rx

How long must daily rx printout records be kept?

2 years

Rx computer must be able to produce a hard copy printout of records within \___________

48 hours

How must CS records be marked in patient profile?

asterisk, redlined or in some way visually marked from legend rx

What must be written on copies of rx given to patients?

"COPY FOR INFORMATION ONLY"

What 7 things are required for transferring RX, in addition to the prescription info?

name/address of pharmacy, RX\#, DW, OR, LF, RR,name of RPh

What are the exceptions for accepting returned drugs?

unit dosed packaging, unopened commercial prepackaged drugs, and when pharmacist professional judgement deems integrity of product has not been affected

T or F: Faxed prescriptions shall only occur at the option of the patient

true

What is the day supply limit for emergency supply?

3 days

What is a legend drug?

item which federal law prohibits dispensing without rx from licensed prescriber

When is a product considered to be adulterated?

filthy, decomposing drug, container made of poisonous substance, or when it is not the strength as listed

When is a drug considered to be misbranded?

when the labeling is false or inadequate

Pharmacists must immediately inform \__________ of any robbery, embezzlement, theft, burglary, fire or other disaster

BoP

T or F: Needles/syringes can be sold to any person, without a prescription

false; MUST show medical need and be sold by RPh or RPh supervision

T or F: Lot \#'s may NOT be mixed in an automated dispensing machine

true

Can legend drug samples be provided to pharmacies? CS drug samples?

yes, both can be provided with a written request from a prescriber

What book determines if generic substitute is A rated?

FDA Orange Book

When generic substitution occurs, the label must state "\_______________________________________________"

Generic drug name substituted for brand name drug

What drug class requires notification to patient and prescriber before switching manufacturers?

anti-epileptics (if pt. controlled)

T or F: In order to dispense CS in Tennessee you only need a DEA registration

false; must get a CS registration from the board

Who gets to determine the schedules for CS in Tennessee?

commissioner of mental health and developmental disabilities

How long does the commissioner have to schedule a substance that the DEA has recently deemed controlled?

30 days

T or F: Prescribers are required to check PDMP before dispensing any CS

False; only benzos or opioids

How often must entities that dispense report to the PDMP? any exceptions?

daily; yes, vets only every 14 days

What are the 4 exceptions for reporting to PDMP?

administered in office, part of treatment program, drug sample, inpatients

Which copies go where for Form 222's?

Brown copy - supplier, green copy - DEA, blue copy - buyer

T or F: Unexecuted DEA Form 222's may be kept off-site

true

T or F: Once Form 222's are signed, they may be stored offsite

false

T or F: Voided/Defective Form 222's may be discarded as long as they are discarded in the PHI secured bin

false, must be retained

What does the supplier have to do if they receive a Form 222 with a line error?

can fill all other lines, but must send form to DEA explaining why that line wasn't filled

What is the limit of POA's for signing Form 222's for 1 pharmacy?

unlimited

T or F: CSOS expands ability to order to 20 items instead of Form 222's 10 item limit

false; no line limit