Class B, D, E, F, G, H Rules

Question 1

Nuclear pharmacy

Answer 1

Regulated by the Texas Department of State Health Services through the Radiation Control Program

Question 2

Authorized Nuclear Pharmacist Requirements

Answer 2

BPS certified nuclear pharmacist
OR
Completed 700 hours of a structured education program including 200 hours of didactic training and 500 hours of supervised experience

Question 3

Nuclear pharmacist to technician ratio

Answer 3

1:4 provided that one is a certified technician

Question 4

Outer container labeling requirements for Class B

Answer 4

Name, address, and phone number of the pharmacy.
Date dispensed.
Directions for use.
Prescription number.
Name of the patient, if known or for physician use if the name of the patient is not known.
Radiation symbol.
The words “caution – radioactive material” or “danger radioactive material”
The name of the radio pharmaceutical or it’s abbreviation. Amount of radioactivity in millicuries or microcuries or bequerels
Initials or identification card of the person preparing and the nuclear pharmacist checking the product.
If a liquid, volume in milliliters.
Requested calibration date and time.
Expiration date and time

Question 5

Inner container label requirements for Class B

Answer 5

Standard radiation symbol.
The words “caution – radioactive material” or “danger radioactive material”
Name of radiopharmaceutical or at abbreviation.
Prescription number

Question 6

Refills of radioactive prescriptions

Answer 6

None allowed

Question 7

Define Clinic

Answer 7

A facility or location other than a physicians office for a limited types of dangerous drugs or devices restricted to those listed in and approved for the clinics formulary are stored, administered, provided, or dispensed only to outpatients of the clinic

Question 8

Define license

Answer 8

A copy of class D pharmacies policies and procedure manual and formulary is required as part of the license application

Question 9

PIC Requirements and Responsibilities for Class D

Answer 9

Employed or under written agreement as a consultant
May be a PIC for numerous clinics
Responsibilities: continuous supervision, not on site, documented on site visits, development of a formulary

Question 10

Define supportive personnel

Answer 10

Responsible for provision of drugs according to written policy and procedures and completion of the drug label

Question 11

Class D formulary may include:

Answer 11

Anti-infective drugs. 
Musculoskeletal drugs. 
Vitamins. 
Obstetric and gynecological drugs. 
Topical drugs. 
Serums, toxoids, and vaccines.

Question 12

Class D formularies may not include:

Answer 12

Nalbuphine (Nubian)
Drugs to treat ED
Controlled substances

Question 13

Class D Expanded Formulary

Answer 13

May petition the board for an expanded formulary if serving at least 80% indigent patients
Supportive care must be licensed nurses or practitioners
Must have policies for drugs that require special monitoring
Quarterly, a retrospective random drug regimen reviews must be done
If the pharmacy provides antipsychotics drugs, therapy MUST be initiated by a physician and then a practitioner can monitor ongoing therapy with physician exams annually

Question 14

Class D Provision of Drug Requirements

Answer 14

Drugs are pre-packaged and labeled with the name and address of the clinic, name and strength of the drug, quantity, lot number and expiration date, directions for use, and appropriate ancillary labels
Drugs are provided by a specific designated supportive personnel Who completes the label with the patients name, any information necessary to complete directions for use, data provision, practitioners name
Patient counseling shall be provided at the time of provision

Question 15

Class D Supervision Requirements

Answer 15

PIC, consultant pharmacist, or staff pharmacist must personally visit the clinic at least monthly.
Clinics operated by state or local government’s or funded by government sources may petition for an alternative visitation schedule

Question 16

Class E Pharmacies

Answer 16

Nonresident, not located in Texas, pharmacies whose primary business is to dispense a prescription drug or device under a prescription drug order and deliver the drug or device to patients in Texas

OUT OF STATE PHARMACY!!!

Question 17

Class E Requirements

Answer 17

License is in good standing
PIC must be a Texas licensed pharmacies
Must be able to provide dispensing records within 72 hours of TSBP request
Required to comply with provisions of TSBP rules relating to purpose, definitions, personnel, operation standards, and records
Patient Counseling is required through written information and a statement that a pharmacist will be available with a tollfree number
Sterile compounding E-S

Question 18

Class F Pharmacy

Answer 18

A Freestanding Emergency Medical Care Facility
Freestanding facility that is licensed by the Texas Department of State Health Services to provide emergency care to patients

Question 19

Pharmacist of Class F Institution

Answer 19

Must have one PIC who is employed or contracted at least part time or on a consulting basis

Question 20

Class F Operational Standards

Answer 20

Pharmacy/storage area must be enclosed and lockable
Authorized individuals may enter the pharmacy/storage areas
Locked storage of C2
In the absence of a pharmacist, only a designated licensed nurse or practitioner may remove drugs from the pharmacy in sufficient quantities for the immediate therapeutic need of a patient
If full time pharmacist, withdrawal must be verified within 72 hours
If part time or consultant pharmacist, the pharmacist must conduct an audit of patient charts according to the schedule set out but at least once every calendar week
Perpetual inventory for all controls - verified at least weekly
Invoices of dangerous drugs and controlled substances must be dated and initialed or signed by the person receiving the drug. The pharmacist verify that the controlled drugs listed on the invoice were added to the pharmacy’s perpetual inventory by recording his or her initials and the date
Prepackaging required for outpatient medications not to exceed 72 hours
Retrospective drug regimen review must be conduct at least every 31 days to verify proper usage

Question 21

Class G Pharmacy

Answer 21

License is issued to a facility established for the primary purpose of processing prescription drug or medication drug orders on behalf of another pharmacy, a health care provider or a payor

ORDER ENTRY

Question 22

What can a Class G Pharmacy do?

Answer 22

Does NOT process, store, or dispense drugs
Receive, interpret, or clarify prescription drug or medication drug orders
Data entering and transferring of Prescription Drugs or medication order information
Preforming drug regimen review
Obtaining refill and substitution authorizations
Verifying accurate prescription data entry
Interpreting clinical data for prior authorizations for Dispensing
Preforming therapeutic interventions
Providing drug information concerning a patient’s prescription

Question 23

Class G Pharmacist to Technician Ratio***

Answer 23

1:8 with only one technician trainee

Question 24

Class H Pharmacy

Answer 24

Drug delivery
Owned by a hospital district and is located in a county without another pharmacy
Deliver filled prescriptions for Dangerous Drugs for the class A pharmacy and may not delivery controlled substances