Essentials of USP Flashcards
Which drugs does the U.S. Pharmacopeia include?
Prescription Non-prescription Dietary supplements Veterinary drugs Healthcare products
The name of the non-governmental non-profit organization that’s activities include creation of standards, patient safety, healthcare information, and verification of products?
United States Pharmacopeia
Official definition of 797?
USP Chapter 797
Official and enforceable focuses on sterile preparations, describing conditions and practices to prevent harm or death in patients that could result from
- Microbial contamination (non sterility)
- Excessive bacterial endotoxins
- Variability in the intended strength of correct ingredients that exceeds stated limits
- Unintended chemical and physical contaminants
- Ingredients of poor quality in compounded sterile preparations
What is the term for the accepted standard recognized by other health care providers in the same field of medicine under similar circumstances?
Standard of care
Does the FDA have the right to inspect pharmacy?
Yes they defer to the states to regulate pharmacy but have authority to inspect pharmacy and enforce USP standards
National Association of Boards of Pharmacy Model Rules and Practice Act
Joint Commission
Pharmacy Compounding Accreditation Board
United States 1st Pharmacopeia?
797
What year did USP 797 become official and enforceable?
2008
What year was the first U.S. Pharmacopeia developed?
1820
Who does 797 apply to?
The standards apply to all persons who prepare CSPs and all places where CSPs are prepared
Do 797 standards apply to clinical administration of CSPs?
No
Definition of a “compounded sterile preparation” in USP Chapter 797?
(1) Compounded biologic, diagnostic, drug, nutrient, or Radiopharmaceutical dosage unite that must be sterile when administered to patients, which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalation so injections, powder for injection, irritations, metered sprays, and ophthalmic preparations
(2) manufactured sterile products that are prepared strictly according to manufacturers’ labeling or prepared differently than published labeling
What is achieving and maintaining sterility and overall freedom from contamination of a CSP dependent on?
Personnel performance
Quality status of components incorporated
Process utilized
Environmental conditions
Responsibilities of Compounding Personnel?
Active quality control and assurance
Deficiencies in Compounding can be rapidly identified and corrected
Beyond-use date validation
Ingredients are correct identity, quality, and purity
Ensure personnel adequately skilled, educated, trained to perform and document functions
Maintain appropriate cleanliness, accuracy
Ensuring CSP accurately identified, packaged, sealed, dispensed and distributed
Primary engineering controls?
Hood, Isolator, LAFW, PEC, CAI, CACI, BSC
Name for “The Magic Box” fallacy
Cleaning hood
Rules in hood?
No cosmetics or artifices nails
Remove jewelry and piercings
Garb from dirtiest to cleanest (don shoe covers, hair covers, face masks)
Wash hands
Dry hands with non-shedding towel or electric hand dryer
Don disposable gown
How often should training and evaluation be performed for high risk compounding?
Semiannual
What are written procedures for double-checking compounding accuracy?
Compounding Accuracy Checks-include label accuracy and accuracy of the addition of all products or ingredients; used containers and syringes should be quarantined with final product until double check is performed; double check should be performed by person other than the compounder
The name of the area where compounding activity is performed?
Buffer area
Area where personnel hand hygiene and garbing procedures, staging, order entry, CSP labeling, and other particulate generating activities are performed?
Ante area
ISO Air Quality?
ISO Class 8-ante area
ISO Class 7-buffer area
ISO Class 5-PEC/hood
Limits are articles in 0.5 m and larger per cubic meter
What ISO class is the buffer area?
ISO 7
What class is the ante area?
Class 8
What class is PEC/hood?
Class 5
How often should the walls, ceilings, and shelves be cleaned?
Monthly
How often should the floors, counters and work surfaces be cleaned?
At least daily
When should cleaning procedures be performed in an ISO 5 environment?
- At the beginning of each work shift
- At the beginning of each batch
- At least every 30 minutes
- When surface contamination is known or suspected
How often should airborne testing be conducted for hoods, clean rooms, and ante-areas?
Minimum of every 6 months
What is designed to demonstrate that the primary and secondary engineering controls, disinfecting procedures and work practices are suitable?
Environmental testing
What procedure is based on chemical stability and assumed sterility?
Beyond use dating
What is BUD based on two factors?
Drugs chemical stability in conjunction with microbiological limits
Use stability dating only if shorter than sterility BUD
Category of high risk would be good at room temperature for?
24 hours
How long can a high risk category be refrigerated?
3 days
Freezer for high risk category?
45 days
How long can low, medium and high risk items be in the freezer?
45 days
What’s the dating for immediate use drugs?
Room temp-1 hour
Refrigerator-1 hour
Freezer-N/A
What’s the dating for low risk category drugs?
Room temp-48 hours
Refrigerated-14 days
Freezer-45 days
Dating for low w/ 12 hour BUD?
Room temp-12 hours or less
Refrigerator-12 hours or less
Freezer-N/A
Dating for medium risk category?
Room temp-30 hours
Refrigerator-9 days
Freezer-45 days
Dating for high risk category?
Room temp-24 hours
Refrigerator-3 days
Freezer-45 days
CSP Risk Categories?
Immediate-Use CSPs Low-Risk Level Low-Risk Level with 12 hour or less BUD Medium-Risk Level High-Risk Level
What exemptions apply to immediate Use CSPs when these requirements are met?
- CSP involves simple transfer of not more than 3 sterile non-hazardous packages and not more than 2 entries into any one container
- No delays/interruptions in preparation
- Aseptic technique is strictly followed
- Administration begins within 1 hour of the start of preparation.
- Unless immediate and compete witnessed administration the CSP must be properly labeled.
- Destroyed if not administered within 1 hour time limit.
How soon must administration begin for immediate-USE CSPs?
1 hour
Example of a low risk CSP?
Reconstitution of cetriaxone 1 gram and transfer to 50 mL NS minibag
What involves only transfer, measuring, and mixing using not more than 3 packages and not more than 2 entries to a single container?
Low risk CSP-manipulation limited to ampuls, vials, transfer from sterile syringes to administration containers-in absence of sterility testing storage periods cannot exceed 48 hours at room temp, 14 days refrigerate, and 45 days frozen (-25 to 10)
Which risk level must be in a segregated compounding area not in a high traffic area?
Low-Risk Level with 12-hour BUD
Term for admixtures compounded using multiple additives and/or small volumes such as batch preparations?
Medium risk CSP
Examples of meds risk CSP?
TPN, CSPs requiring more than 3 packages
Term for no sterile ingredients utilized before terminal sterilization?
High risk CSP
Example of non sterile bulk drug, mixing in no sterile devices, exposure to non ISO 5 air>1 hour?
High risk CSP
What’s the BUD for multiple dose vials?
28 days after initial entry unless specified otherwise by the manufacturer
How long are single dose vials good for in an ISO 5 environment?
6 hours
Opened or punctured in worse than ISO 6 conditions?
Must discard within 1 hour
What are hazardous drug requirements?
Requires appropriate gloves be worn at all times hazardous agents are handled, not just compounded. Requires all agents be prepared in a BSC or CACI in a ISO 5 environment within a ISO 7 negative pressure room with an ISO 7 ante area
