Compounding Quiz #3 Flashcards
What is the general purpose of USP 795
-To provide compounders with guidance on applying good compounding practices for the preparation of non-sterile compounding formulations
What is the general purpose of USP 797
-To describe the conditions that will prevent harm or death to patients who receive compounded parenteral products
What is the general purpose of USP 800
-To provide standards for the handling of hazardous materials in healthcare settings
When were proposed revisions of USP 795, 797, and 800 scheduled to take effect?
-December 1st, 2019 but they were postponed
Who is responsible for the enforcement of USP standards in the state of New Mexico?
- Food and Drug Administration (FDA)
- New Mexico Board of Pharmacy BoP
A pharmacist prepares compounded progesterone 200mg capsules that do not contain peanut oil, pursuant to a prescriber’s prescription for a patient who is severely allergic to peanuts. Assuming that the pharmacist adheres to all other legal & regulatory requirements for preparing a compounded medication, does this meet the legal definition of compounding?
-YES
A pharmacist prepares memantine 5mg tablets based on a recipe from Forest Laboratories, the manufacturer of Namenda, and sells them as a compounded product. The compound does not differ from Forest Laboratories’ recipe. The compound is prepared pursuant to a prescriber’s prescription for a patient. Assuming that the pharmacist adheres to all other legal & regulatory requirements for preparing a compounded medication, does this meet the legal definition of compounding?
-NOPE
Dr. Deepa Singh regularly writes prescriptions for a Magic Mouthwash which contains one part each of diphenhydramine, nystatin, viscous lidocaine, and Maalox. The prescriber writes about 100 prescriptions per week for this product, and her patients often come to your pharmacy since you are right across the street from the prescriber’s office. You have a Master Formulation Record for “Dr. Singh’s Magic Mouthwash” and decide to prepare 20 bottles of Magic Mouthwash ahead of time, since you receive so many of these prescriptions. Assuming that you adhere to all other legal & regulatory requirements for preparing a compounded medication, does this meet the legal definition of compounding?
-YEET
From the ethical case readings, what is the first & last name of the pharmacist who was sentenced for diluting chemotherapy drugs?
-Robert Courtney
What is the maximum beyond-use-date (BUD) for an oral formulation which contains water, when stored at controlled cold temperatures?
-No more than 14 days
Which of the following is the minimum ISO classification for a laminar airflow workbench (aka “IV hood”)?
-ISO Class 5