Part 9 labeling requirements Flashcards

1
Q

Dispensing label for a medical or prescription order shall bear which of the following information

A. Name, address and telephone number of the pharmacy practice site 
B. RPh initials 
C. Serial number 
D. Name of the patient 
E. Patient address 
F. Name of the product 
G. Expiration date (if applicable)
H. Name of prescriber 
I. Prescriber address 
J. directions for use 
K. number of refills 
L. date originally dispensed and/or refill date
A
A. Name, address and telephone number of the pharmacy practice site 
C. Serial number 
D. Name of the patient 
F. Name of the product 
G. Expiration date (if applicable)
H. Name of prescriber 
J. directions for use 
L. date originally dispensed and/or refill date
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2
Q

Any repackaging of prescription drugs and devices and related materials must be supervised and controlled by a pharamcist with ___ and __ verification and documentation

A

with in-process and end-process verification and documentation

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3
Q

Prescriptions drugs which are repackaged by INSTITUTIONAL pharmacies SHALL be labeled to include??

A. Name of the drug
B. Strength of the drug
C. Quantity of the prescription drug 
D. Serial number 
E. Expiration date 
F. directions for use 
G. Manufacturer's name 
H.  Lot or control number 
I. Cautionary notations (refrigerate, shake well, not for injection) if applicable
A
A. Name of the drug
B. Strength of the drug
C. Quantity of the prescription drug 
E. Expiration date 
G. Manufacturer's name 
H.  Lot or control number 
I. Cautionary notations (refrigerate, shake well, not for injection) if applicable 

A batch number assigned by the pharmacy may be placed on the label in lieu of the manufacturer’s name and lot number

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4
Q

All repackaging must be performed by

A. Pharmacist
B. pharmacy intern
C. pharmacy technician under the supervision of a pharmacist

A

A. Pharmacist
B. pharmacy intern
C. pharmacy technician under the supervision of a pharmacist

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5
Q

Within what time frame must the PIC notify the TN board of pharmacy a loss of prescription drugs, or controlled substances?

A. Immediately 
B. 1 day 
C. 48 hours 
D. 72 hours 
E.  1 week
A

A. Immediately

If theft or robbery then the local law enforcement should also be contacted

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6
Q

Within what time frame must the PIC notify the DEA a loss of controlled substances?

A. Immediately 
B. 1 day 
C. 48 hours 
D. 72 hours 
E.  1 week
A

B. 1 day and then on a DEA form #106

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7
Q

Which of the following should be contacted if zolpidem is stolen from the pharmacy?

A. TN board of pharmacy
B. DEA
C. FBI
D. Local law enforcement

A

A. TN board of pharmacy
B. DEA
D. Local law enforcement

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8
Q

Medications may be returned to, and received by, the pharmacy/pharmacist if received expressly for the purpose of ___, provided the pharmacy is equipped for doing so.

A

For the purpose of DESTRUCTION of the returned medication

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9
Q

Who is approved to destroy CS?

A. Manufacturer 
B. BOP inspector 
C. DEA agent 
D. Pharmacist 
E. Reverse Distributor
A

B. BOP inspector
C. DEA agent
E. Reverse Distributor

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10
Q

Within what time frame should the owner or PIC of a pharmacy return or destroy non controlled drugs or devices that are outdated, defective, or deteriorated?

A. Immediately 
B. 1 day 
C. 48 hours 
D. 72 hours 
E.  1 week 
F. 30 days
A

A. Immediately

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11
Q

Instruments and/or devices intended for INJECTION SHall be stored in an area NOT accessible to the public, and SHALL be sold only ___ by a Pharmacist OR intern OR technician under the direct supervision of a pharmacist

A. pursuant to a prescription
B. on proof of medical need

A

B. on proof of medical need

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12
Q

Where can insulin be stored?

A

MUST be stored in an area not accessible to the public.

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13
Q

Who can sell insulin?

A. Pharmacist
B. pharmacy intern
C. pharmacy technician under the supervision of a pharmacist

A

A. Pharmacist
B. pharmacy intern
C. pharmacy technician under the supervision of a pharmacist

This counts for OTC insulin’s as well

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14
Q

The __ of each drug contained within a Automated dispensing device must be listed or posted on the device

A

The LOT number of each drug

LOT numbers may NOT be mixed!!!

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15
Q

An automated dispensing device may be loaded by

A. Pharmacist
B. pharmacy intern
C. pharmacy technician under the supervision of a pharmacist

A

A. Pharmacist
B. pharmacy intern
C. pharmacy technician under the supervision of a pharmacist

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