Class C Rules

Question 1

A facility will 101 beds or more, shall be

Answer 1

Under continuous on-site supervision of a pharmacist when the pharmacy is OPEN
Must have one full time PIC who can only be the PIC for one such facility and not a PIC for a Class A or B pharmacy

Question 2

A facility of 100 beds or fewer, shall

Answer 2

Have the services of a pharmacist at least part time or in a consulting basis, but the pharmacist must be in site at least once every 7 days
Must have a PIC who may be employed or under contract as a consultant and may be part time

Question 3

If an institution operates an outpatient pharmacy,

Answer 3

There must be a pharmacist on-site when it is OPEN and it must meet Class A rules including technician ratio

Question 4

Can a PIC be a PIC of multiple Class C institutions?

Answer 4

One pharmacist may be PIC of no more than 3 such facilities or 150 beds
A pharmacist can be a PIC of one facility with 101 beds or more and one facility less than 100 beds or fewer as long as the total beds does NOT exceed 150

Question 5

PIC responsibilities

Answer 5

Assuring the legal operation of the pharmacy
Providing appropriate level of pharmaceutical care services
Ensuring drugs are prepared and distributed safely and accurately as prescribed
Participating in development of a formulary for the facility
Supervising a system to ensure controls against drug diversion

Question 6

Pharmacist duties

Answer 6

Responsible for delegated acts performed by pharmacy techs and trainees
The distributing pharmacist is responsible for ensuring that the drug is prepared for distribution safely and accurately as prescribed unless you can identify who all worked on that script

Question 7

Pharmacy Technician Duties in a facility with 101 beds or more

Answer 7

Prepackaging and labeling unit and multiple dose packages
Preparing, packaging, compounding, or labeling prescription drugs pursuant to a medication order
Compounding nonsterile products after training
Compounding sterile products after training Class C-S
Bulk compounding or batch prep
Distributing routine orders for stock supplies to patient care areas
Entering medication orders and drug distribution info into system
Loading unlabeled drugs into automated compounding or counting devices
Accessing automated medication supply systems

Question 8

Pharmacy Technician Duties in a facility with 100 beds or fewer

Answer 8

Prepackaging and labeling unit and multiple dose packages
Bulk compounding or batch prep
Loading unlabeled drugs into automated compounding or counting devices
Compounding medium risk and high risk steril preparations after training

Question 9

Pharmacy Technician Duties in a facility with 100 beds or fewer (under direct or electronic supervision of a pharmacist)

Answer 9

Preparing, packaging, compounding, or labeling prescription drugs pursuant to a medication order
Compounding nonsterile products after training
Compounding low risk sterile products after training Class C-S
Distributing routine orders for stock supplies to patient care areas
Entering medication orders and drug distribution info into system
Accessing automated supply system

Question 10

Technician Ratio

Answer 10

None

Question 11

Tech Check Tech

Answer 11

A Class C pharmacy that has an on going clinical pharmacy program may allow tech to verify work if another technician relating to filling of floor stock and unit dose distribution systems if the patients orders have been previously reviewed by a pharmacist

Question 12

Define Rural Hospital

Answer 12

75 beds are fewer and located in a county with the population fewer than 50,000 or designated as a critical access hospital, rural referral center, or sole community hospital

Question 13

If a practitioner orders a prescription drug or device for a patient in a row hospital when the pharmacist is not on duty or when the pharmacy is closed,

Answer 13

A nurse or practitioner may withdraw that drugs from the pharmacy in sufficient quantity to fulfill that order but then the hospital pharmacist must verify the withdrawal and preform a drug regimen review no later than 7 days after

Question 14

And a roll hospital, pharmacy technicians may perform the following duties without direct supervision of a pharmacist:

Answer 14

Entering medication orders and drug distribution information into the computer system.
Preparing, packaging, or labeling prescription drug pursuant to a medication order if a licensed nurse practitioner or pharmacist verifies accuracy by electronic supervision before administration.
Filling medication carts in a rural pharmacy
Distributing routine orders for stock supply to patient care areas.
Accessing and restocking automated medication supply cabinets

Question 15

Absence of a pharmacist and the facility license for 100 beds or more:***

Answer 15

A designated licensed nurse or practitioner may remove drugs from the patients immediate therapeutic need
A pharmacist must verify withdraw as soon as possible but no more than 72 hours after**

Question 16

If medication is withdrawn when a pharmacist is not there what must be recorded?

Answer 16

Name of patient. 
Name, strength, and dosage form of device or drug. 
Dose prescribed. 
Quantity taken. 
Time and date taken. 
Signature.

Question 17

Absence of a pharmacist in a facility license for 100 beds or fewer

Answer 17

A designated licensed nurse or practitioner may remove drugs from the patients immediate therapeutic need
If a full time pharmacist is employed, the pharmacist must verify withdraw as soon as possible but no more than 72 hours after**
If a part time or consultant pharmacist is employed, the pharmacist must verify withdrawal as soon as possible but no more than seven days after withdrawal
Same with floor stocking systems of distribution

Question 18

Class C library requirements

Answer 18

Laws and rules including Texas pharmacy act, dangerous drug act, Texas controlled substances act, and federal controlled substances act
Drug interaction reference
General drug information reference
Injectable drug products reference
Basic antidote information and a phone number of the nearest poison control center
Metric apothecary weight and measure conversion chart

Question 19

Operational requirements

Answer 19

Formulary is required
Pre-packaging of drugs is allowed for distribution to other Class C pharmacies under common ownership with specific recordkeeping requirements being met
Written policy and procedures of drug distribution systems are required
Drug regimen review must be conducted on a prospective basis when a pharmacist is on duty and on a retrospective basis when a pharmacist is not on duty within 72 hours for a full-time pharmacist or within seven days for a part-time or consultant pharmacist
For stock records must be reviewed by pharmacist at least every 30 days
A perpetual inventory of C2 controlled substances is required

Question 20

Emergency room requirements

Answer 20

When a pharmacist is on duty, any drugs dispense for outpatient must be dispensed by pharmacist. What a pharmacist is not on duty, dangerous drugs and controlled substance is must be supplied to patients admitted to the emergency room under the following conditions: only drugs on an emergency room drug list may be provided and drugs are supplied in pre-packaged quantities not to exceed 72 hour supplies

Question 21

Prepackaged Labeling Requirements***

Answer 21

Date supplied
Name of practitioner
Name of patient
Directions for use
Prescription number
Pharmacist job verify the contents of the emergency room drug list records at least once every seven days***

Question 22

Automated Compounding or Counting Devices

Answer 22

Must be calibrated and tested for accuracy

May be loaded by a pharmacy technician but must be verified by a pharmacist

Question 23

Automated Medication Supply Systems

Answer 23

Pyxis
Must be tested and verified for accuracy
Must have continuous monitoring and tests accuracy at least every 6 months or when an upgrade or change is done
Must operate under a written policies and procedure
May be restocked by a technician provided the medication had been checked by a pharmacist or the system has product bar coding system
Must have a written plan for recovery

Question 24

Record Requirements

Answer 24

Kept for 2 years
Must be supplied within 72 hours upon request
C2 must be separated from others
C-3, C4, C5 records must be maintained separately or be readily retrievable
Outpatient pharmacy records must be maintained under class a rules
Must maintain patient medication records for each patient
Computer system must be able to produce a hard copy printout of an audit trail of all the drugs distributed in the facility within 72 hours of a request

Question 25

Class C Pharmacies in a Free Standing Ambulatory Care Facility (ASC)**

Answer 25

Very similar to class F
If a full-time pharmacist is employed, drugs withdrawn must be reviewed within 72 hours. If the facility has a part-time or consultant pharmacist, the pharmacist must conduct an audit of patient charts according to the schedule set out in the pharmacy policy and procedure manual but at least once every calendar week
Must maintain a perpetual inventory of all controlled substances
Invoices of dangerous drugs and controlled substance must be dated and initialed by the person receiving the drugs and a pharmacist must verify that controlled substances were entered into the perpetual inventory with his or her initials
The pharmacist must conduct an audit by randomly comparing the distribution records with the medication orders at least every 30 days****
Drugs may only be supplied and prepackaged quantities not to exceed a 72 hour supply from the approved drug list***