Pharmaceutics Final Exam Flashcards
What are the two components of an Investigational Drug Service, what are the components
Studies: inpatient and clinical research centers (outpatient not needed)
Fees: IDS not self-supporting, fees outlines in IDS contract, IDS will provide a budget estimate based on how many subjects planned to be enrolled, negotiable based on amount of funding received
How are IDS medications prepared
All study medication will be prepared according to the approved study protocol, parenteral products are prepared aseptically ISO 5 clean room. All investigational agens will be accessible 24 hours a day for adherence to study protocol
What is requred when monitoring drug storage temperatures
MUST have continuous monitoring or temperatures and notification system, TempTRak, 24/7 monitoring of room temp humidity regrigerators and freezers, Pager goes off in case of excursion, IDS also notifited via page,email and text
What are fundementals that GMPs are concerned with
Purity, safety, quality, strength, and identity
What are the 6 Ps that GMPs are concerned with
People, plant, procedures, Products, Process, Profits
What is the FDA’s role in the drug development and manufacturing process
Regulates new and old drugs approved for the market, monitor drugs on market, inspects pharmaceutical manufacturers
What are the two major titles of DQSA in relation to 503 A
Compounding Quality Act and Drug Supply Chain Security Act
What are components of the compounding quality act
Requries the FDA to engage in two-way communication with state regulators, preserve and protect the practice of traditional pharmacy compounding, everyone compounding must be licensed, prescription for an identified individual patient is required, compliance with USP chapters
What are components of drug supply chain security act
Track and Trace program: placing unique product identifiers on individual drug packages,having lot level detail in paper or electronic format
What are the types of 503A compounding practices
Hospital/Health-system pharmacises, infusion clinics, home infusion therapy pharmacies, ambulatory infusion suites, long-term care pharmacies, ambulatory surgery centers
What is covered in FD&C Act in relation to 503A pharmacies
Compound drug have not underone premarket review and should only be used when an FDA-approved product is not available to meet medical needs, drug products being compounded must be in compliance with USP chapters on pharmacy compounding, bulk drug substances, drug products withdrawn or removed from the market
What are the differences between 503A and 503B pharmacy
Unlike a 503A facility, 503B compounding pharmacies must validate every process according to CGMP, 503B produce multiple batches and submit them for testing, FDA regulates 503B while state board or pharmacy regulate 503A
What is covered in the DQSA in relation to 503B pharmacies
Permits entities engaged in compounding of sterile drugs to register as outsourcing facilities, must comply with cGMPs requirements, report to the FDA twice a year talk about a products produce in the past 6 months, voluntarily register
What is covered in the FD&C Act in relation to 503B pharmacies
FDA outlines guidance for outsourcing facilites, FDA’s expectations that are regarded with compliance with cGMP requirements, more stringent than USP chapter 797
What are the labeling requrements for 503B compounded products
“Compounded drug”, drug not for re-sale, established drug name, list of ingredients (inactive and active), lot numbers, FDA contact information for adverse
