chapter 4 (UMPJE) - USP

What does USP set standards for?

Identity, strength, quality, and purity of medications

USP 795

Nonsterile compounding

USP 797

Sterile compounding

USP 800

Hazardous drug handling

USP 825

Radiopharmaceuticals

CNSP include ... (5)

• Solid oral preparations

• Liquid oral preparations

• Topical preparations

• Nasal & sinus preparations intended for local application

• Otic preparations

USP 795 training & comptency

• Initially and every 12 months

• Hand hygiene and garbing

• Measuring and mixing

• Handling components and CNSPs

• Proper use of equipment

• Documentation of the compounding process

Temperature of storage areas must be monitored at least ____ when compounding occurs

daily

Hand hygeine with soap and water for at least ___ seconds

30

USP 795 Cleaning (4)

• Work surfaces at beg of each shift

• Floors daily when compounding occurs

• Walls & ceilings when visibly soiled

• Storage shelving every 3 months

Details concerning facilities, components, equipment, personel, storage, compounding, and other related elements

A. SOP

B. SDS

C. MFR

D. CR

A. SOP

standard operating procedure

The recipe created for each formulation of a CNSP. Allows for reproducibility of the CNSP for future compounding

A. SOP

B. SDS

C. MFR

D. CR

C. MFR

Master formulation record

Details of the specific CNSP such as lot number, expiration date of each component, personnel involved in compounding, the assigned BUD, etc

A. SOP

B. SDS

C. MFR

D. CR

D. CR

Compounding record

USP records must be retained and retrievable for at least ___ years or longer

2

T/F: only purified water should be used for CNSP

True - example is sterile water for irrigation bottles at work that we use

For USP 795, if no expiration date is provider the compounded must assign a date that is no longer than ___ years from the date of recipet

3

Examples of non-aqueous dosage forms

• tablets

• suppositories

• ointments

Examples of aqueous dosage forms

• oral solutions/suspensions

• lotions

• creams

USP 795 BUD CHART ****

AQUEOUS (Aw ≥ 0.6)

• Nonpreserved aqueous = 14 days fridge

• Preserved = 35 days

NON-AQUEOUS (Aw < 0.6)

• Oral liquid = 90 days

• Other non oral liquid dosage forms = 180 days

USP 797 immediate use is limited to simple transfer ≤___ different manufactured ingredients with a BUD of no more than 4 hrs

3

Sterile compounding area for 797 must have temp under ___ deg C and relative humidity under ___%

20 deg C, under 60%

USP 797 ISO to know **

• PEC (positive or negative pressure) = ISO 5

• SEC (buffer room) = ISO 7

• Ante room with hazardous (negative room) attached needs ISO 7

• Ante room without hazardous attached can have ISO 8

_____ gradients between rooms in a sterile compounding suite minimize the possibility of microbial contamination

Pressure

PEC and SECs must be certified every ____ months by a qualified technician

6

USP 797 training & competencies

• Initially and then every 12 months

• Hand hygiene, garbing

• Calculations, measuring, mixing

• Principles of movement

• Use of equipment

• Principles of HEPA unidirectional air flow

• Proper use of PEC

• Aseptic techique

• Cleaning

• Maintaining sterility

• Documentation

USP 797 fingertip/thumb test

• Initially, 3 sets of plates must be collected with no growth allowed on any of the 6 plates

• Done every 6 months for category 1 / 2

• Done every 3 months for category 3

• Done at least every 12 months if you just oversee and dont compound

USP 797 media fill test

• 1 set of plates

• Surface sample of compounding area

• Up to 3 CFU's may be recovered from both (not each) glove for a successful test

• Done every 6 months for category 1 / 2

• Done every 3 months for category 3

• Done at least every 12 months if you just oversee and dont compound

Single dose vial BUD (2)

• Up to 12 hours in ISO 5 PEC

• Up to 4 hours if opened outside of a ISO 5 PEC

Multi dose vial BUD is up to ___ days

28

USP 797 BUD CHART ***

• Immediate use (ER): 4 hr, 4 hr, 4 hr

• Category 1 (glovebox, OR pharm): 12 hr, 24 hr, N/A

• Category 2 (UCMC clean):

--> with any non-sterile component: 24 hr, 4 days, 45 days

--> only sterile components: 4 days, 10 days, 45 days

• Category 3 (additional req): 90 days, 120 days, 180 days

Category 3 CSP cannot exceed a BUD of ____ days even if the required testing shows stability and sterility

180

When should you clean hood for USP 797? (5)

• Beginning of each shift

• Before each batch

• Every 30 mins during compounding

• After spills

• With any contamination

What should be cleaned daily for USP 797?

• Floors

• Counters

• Other easily cleanable surfaces

What should be cleaned monthly for USP 797?

• Storage shelving

• Walls

• Ceilings

USP 797 air vs. surface sampling

• Air sampling every 6 months or every months if category 3

• Surface sampling monthly or every week if category 3

Storage of hazardous NIOSH table 1 must be negative pressure, vented to exterior facility, and have at least ___ ACPH.

12

Hazardous compounding extra PPE *

• 2nd layer of shoe covers

• 2nd disposable gown (change every 2-3 hours)

• Two ASTM gloves (changed every 30 minutes)

• Googles (only if splash hazard)

• N95 mask

Hazardous cleaning steps (4)

• Deactivation

• Decontamination

• Cleaning (detergent)

• Disinfecting (70% isopropyl alcohol)