Question

Operational Standards: §291.74

a. How often does a Class C pharmacy have to register with TSBP?

b. How does a Class C Pharmacy maintain security of Schedule II controlled substances & other drugs requiring additional security?

c. What equipment and supplies are needed in a Class C pharmacy?

d. What must be maintained in a Class C Library?

e. How should a Class C pharmacy handle prescription drug samples?

f. What are the proper storage ranges (oC & oF) for Cold, Refrigerator, Freezer, Cool, Rm Temp, Warm, and excessive Heat?

g. How does a Class C Pharmacy handle drugs that are expired, outdated, &/or unusable?

h. In what quantities can a Class C pharmacy pre-package drugs?

i. What is the minimum information required on an IV admixture label?

j. When can drugs be given to patient and what allows them to be distributed? (f5A)

k. What does “Institutional pharmacies shall be exempt from the labeling provision and patient notification requirements of §562.006 & §562.009” mean?

l. What records must be kept in regards to the use of floor stock? Who can remove floor stock drugs?

m. What is an institutional “formulary?”

Answer 1

Class C pharmacy or institutional pharmacy has following operational standards :-

a. A class C Pharmacy should register annually or biennially. It should be following procedures of section 291.1, related to pharmacy license applications. If it changes the ownership then also it has to be notified 10 days earlier and to apply new license under 291.3. and other matter is changing of managers under 291.3.

b.There are many security requirements that has to be fullfilled.

• It should have a very advanced security system, not only manual but electronic. Only authorised person should have access over it.
• It should have locked storage system for schedule II controlled substances.
• It should also have sufficient safeguards against against robbing and theft and should have maintainence of records.

c. Following equipment and supplies should be supplied

• It should have refrigerator or freezer to store drugs that has to be kept under certain temperature.
• Equipments like printer etc should be also present for data processing.

d. Following things must be maintained in Library.

• It should have current coppies of Act,rules and regulations as given by Texas Phrmacy, Texas dangerous drugs, Federal controlled substances and Texas controlled substances.
• A drug interaction reference or general information reference should be maintained.
• Current or updated reference of injected drugs.
• weight and measure conversion chart.
• Antidote information of neares regional poison control and its phone no.

e. Following points can be included to handle prescriptions.

• It must be in accordance to 291.33 except some medications like inhalers, insulin pen, topical creams etc.
• Drugs should be given to the patient only on the prescription of any recognised practitioner.
• It should contain clear information of patient's and practitioner's name, drug name and strength,directions to use, duration and also name and phone no of the pharmecy.