Ch. 8: Compounding Laws/Rules

Question 1

Nonsterile Compounding

Answer 1

• 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

Question 2

Compounded Products CAN….

Answer 2

• 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

Question 3

Compounded Products CANNOT…

Answer 3

-Copy commercially available products

Question 4

Nonsterile Compounding Pharmacies must…

Answer 4

• 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)

Question 5

Nonsterile Compounding Pharmacists

Answer 5

• 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

Question 6

General Sterile Compounding Rules

Answer 6

• 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

Question 7

Nonsterile Products - Office Use

Answer 7

• 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

Question 8

Sterile Compounding Training Requirements (11)

Answer 8

Didactic/experiential training including:

1. Aseptic technique
2. Critical area contamination factors
3. Environmental monitoring
4. Facilities
5. Equipment/supplies
6. Sterile prep calculations/terminology
7. Sterile prep compounding documentation
8. Quality assurance procedures
9. Aseptic preparation procedures
10. Handling of cytotoxic/hazardous drugs (if applicable)
11. General conduct in clean room

Question 9

Sterile Initial Training/CE - Pharmacist

Answer 9

• 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)

Question 10

Sterile Initial Training/CE - Tech

Answer 10

• 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)

Question 11

Sterile Evaluation/Testing

Answer 11

• 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

Question 12

Media-Fill Tests

Answer 12

• 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)

Question 13

Low Risk

Answer 13

• 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

Question 14

Low Risk BUD

Answer 14

• 48 hours room temp
• 14 days refrigerated
• 45 days if frozen

Question 15

Medium Risk

Answer 15

• 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

Question 16

Medium Risk BUD

Answer 16

• 30 hours room temp
• 9 days refrigerated
• 45 days if frozen

Question 17

High Risk

Answer 17

• Nonsterile products used to prepare sterile product
• Sterile ingredients/devices/components exposed to air quality inferior to ISO 5 for >1 hour
• Nonsterile water containing preparations exposed >6 hours before being sterilized
• Ex: Dissolving bulk powder to make solutions which will be terminally sterilized

Question 18

High Risk BUD

Answer 18

• 24 hours room temp
• 3 days refrigerated
• 45 days if frozen

Question 19

Sterile Compounding Environment

Answer 19

• Compounded in primary engineering device capable for maintaining ISO 5
• Devices include laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and C-CAI
• Low/medium risk compounding must have clean room meeting specific requirements (ante/buffer room)
• High risk additionally must have the primary engineering device buffered with separations that maintain positive pressure of 0.02-0.05 inches water column

Question 20

Laminar Air Flow Hoods

Answer 20

• Primary Engineering Control Device

- Must be certified AT LEAST Q6mo

Question 21

Biological Safety Cabinets

Answer 21

• Primary Engineering Control Device
• If used for hazardous drugs, must be Class II or III vertical cabinet in ISO 7 area
• If nonhazardous, must be in buffer area

Question 22

Compounding Aseptic Isolaters

Answer 22

• Primary Engineering Control Device

- Must be placed in ISO Class 7 buffer area UNLESS certain conditions met

Question 23

C-CAI

Answer 23

• ISO 7 if used for low/medium risk products unless conditions met
• ISO 8 minimum if used for high-risk hazardous meds

Question 24

Labeling Sterile Med/Product (4)

Answer 24

Label requirements for Class of pharmacy (A, B, C, or E) AND

• Generic/brand name of principal active ingredient
• BUD determined by USP <797>
• If no BUD data entered for product, use previously specified dates unless for immediate use (within 1 hour) OR low-risk made in SCA (within 12 hours, regardless of storage)
• Statement for outpatient Rx that states it was compounded

Question 25

Compounding Process

Answer 25

- All significant processes shall be covered in standard operating procedures - Personnel Cleansing/Garbing - QA program to ensure media-fill tests, filter integrity tests, finished prep release/checks, and environmental monitoring - Quality control program including monitoring compounding environment, quality of drugs made, and verifying products for accuracy and sterility

Question 26

Immediate Use of Compounded Products

Answer 26

- Ex: Use in ERs, ICUs, etc. - Used for emergency/immediate use - Must prep med within 1 hour and administer med within 1 hour of completing compounding

Question 27

Office Use of Sterile Compounds

Answer 27

- Requires written agreement with pharmacy and practitioner - Can be completed with Class C pharmacies or vets - Specific recordkeeping and recall procedures needed - "For Institutional/Office Use Only - NOT for Resale" or "Compounded Product" if distributed to Vets

Question 28

<800>

Answer 28

- USP Chapter 800 details practice/quality standards for handling hazardous drugs in HC settings - Includes compounding, storage, receipt, dispensing, administration, and disposal - Includes info on proper engineering controls, quality standards, training, labeling, packaging, transport, and disposal of hazardous drugs - NIOSH maintains list of hazardous drugs and antineoplastics used in HC - Became effective December 1, 2019 but currently ONLY informational until new <795> and <797> are finalized - TSBP hasn't adopted rules currently to require pharmacies to comply with USP <800>