Ch. 8: Compounding Laws/Rules Flashcards
1
Q
Nonsterile Compounding
A
- Compounding of nonsterile preps pursuant of prescription/med order for patient from a practitioner in a Class A/C/E pharmacy
- Compounding, dispensing, delivering reasonable quantity of nonsterile products in a Class A/C/E pharmacy to office
- Compounding/distributing nonsterile products by Class A for a Class C
- Compounded by Class C and distribution of products to another Class C under common ownership
2
Q
Compounded Products CAN….
A
- Be premade based on routine, regularly observed prescribing patterns
- Made if not available from distribution channels in a timely manner, this is documented, and prescriber requests it is compounded
- Enter agreement to compound/dispense for another pharmacy if that pharmacy complies with centralized Rx dispensing rule
3
Q
Compounded Products CANNOT…
A
-Copy commercially available products
4
Q
Nonsterile Compounding Pharmacies must…
A
- Class A prescription/analytical balance and weights (subject to TSBP inspection)
- Compounded product must have normal label requirements AND principal ingredient of prep and statement that product has been compounded
- Written standard operation procedures to ensure uniform process
- MAY add flavoring if conditions are met and there is documentation that flavoring doesn’t alter clinical outcomes (NO OTC unless Rx provided)
- Max of [20%] for final compounds if CS used (per DEA)
5
Q
Nonsterile Compounding Pharmacists
A
- Must obtain CE for pharmacist completed compounding
- Inspect/approve components, containers, closures, labeling and other materials used for compounding
- Review all compounding records for accuracy
- Conduct in-process/final checks
- Responsible for proper maintenance, cleanliness, and use of all equipment used in compounding process
6
Q
General Sterile Compounding Rules
A
- TSBP similar to <797>
- Compounded pursuant to prescription of based on prescribing patterns
- Can also be used for research, teaching, or chemical analysis
- NOT for sale/distribution
- Can be off-use by A-S to C/S OR C/S to another C/S if under same ownership
7
Q
Nonsterile Products - Office Use
A
- Must have written agreement with practitioner or pharmacy
- Can distribute to physicians, Class C pharmacies, or vets
- Specific record keeping requirements and recall procedures
- “For Institutional/Office Use Only - NOT for Resale” or “Compounded Product” if distributed to Vets
8
Q
Sterile Compounding Training Requirements (11)
A
Didactic/experiential training including:
- Aseptic technique
- Critical area contamination factors
- Environmental monitoring
- Facilities
- Equipment/supplies
- Sterile prep calculations/terminology
- Sterile prep compounding documentation
- Quality assurance procedures
- Aseptic preparation procedures
- Handling of cytotoxic/hazardous drugs (if applicable)
- General conduct in clean room
9
Q
Sterile Initial Training/CE - Pharmacist
A
- Pharmacists require 20 hours of instruction through CoP or ACPE course and on-the-job training (cannot be transferred to another pharmacy UNLESS common ownership)
- 2 CE hours required if sterile compounding (4 hours if high-risk compounding)
10
Q
Sterile Initial Training/CE - Tech
A
- Pharmacists require 40 hours of instruction through ACPE or ASHP accredited course and on-the-job training requiring 40 hours of instruction/experience
- 2 CE hours required if sterile compounding (4 hours if high-risk compounding)
11
Q
Sterile Evaluation/Testing
A
- All personnel must be training/pass media-fill tests for aseptic technique assessment
- All shall complete initial competency evaluation and fingertip sampling procedure no fewer than 3x before initially being allows to compound for patient use
- Fingertip sampling necessary for ALL risk levels
- All testing/evaluations are conducted during orientation or training, when QA yields unacceptable results, and annually for low/medium risk/twice per year for high risk
12
Q
Media-Fill Tests
A
- Must be conducted at each pharmacy where individuals compound low/medium risk products
- Can only be conducted at one pharmacy under common ownership provided each pharmacy is operating under equivalent policies/procedures and testing is conducted under MOST CHALLENGING conditions
- Conducted at EACH pharmacy individual prepares High-risk compounds for
- No prep for patients can be done until this is returned UNLESS pharmacist temporarily compounds sterile products while supervising tech compounding sterile products without media fill test (Pharmacist must complete media-fill within 7 days of commencing work at pharmacy)
13
Q
Low Risk
A
- Compounded with aseptic manipulation
- Entirely within ISO 5 or better conditions
- All sterile products used and max of 3 manufactured products utilized in one compound
14
Q
Low Risk BUD
A
- 48 hours room temp
- 14 days refrigerated
- 45 days if frozen
15
Q
Medium Risk
A
- Multiple individual/small doses of sterile products are combined to prepare product to give to multiple patients or multiple times to one patient (Batching)
- Involves complex aseptic technique that takes unusually long time to compound
- Ex: TPN fluids (mult. inj), filling reservoirs/infusion devices with multiple products, batching
