Lecture 30: USP <795> & Compounding Equipment for Non-Sterile Products

What does USP chapter <795> describe standards for?

Compounded nonsterile preparations (CNSPs)

What is nonsterile compounding?

Combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug or bulk drug substance to create a nonsterile medication

What does following the requirements in USP Chapter <795> minimize?

Minimizes harm, including death, to human & animal patients

What preparations must comply with <795>?

• Solid oral

• Liquid oral

• Rectal

• Vaginal

• Topical

• Nasal & sinus

• Otic

What are not considered compounding & are not required to meet <795>?

• Administration

• Nonsterile radio-pharmaceuticals

• Reconstitution

• Repackaging

• Splitting tablets

Who are affected by <795>?

ALL persons who prepare CNSPs & all places where CNSPs are prepared

• Pharmacists, technicians, nurses, physicians, veterinarians, dentists, naturopaths, & chiropractors

• Pharmacies, hospitals, & other HC institutions, patient treatment sites, & physicians’ or veterinarians’ practice sites

What are the responsibilities for all personnel involved under <795>?

1. Ensuring quality standards in chapter are continually & consistently applied

2. Identifying & remedying potential problems w/in their operations

What are the designated person(s) responsibilities under USP chapter <795>?

• Overseeing a training program

• Selecting components

• Monitoring & observing compounding activities

• Ensuring that standard operating procedures (SOPs) are fully implemented

• Establishing, monitoring, & documenting procedures

What must the designated person(s) be in SOP?

Identified

What were the updates for USP <795> effective Nov 1, 2023?

1. Training & competences

2. Personal hygiene & garbing

3. Monitoring & cleaning

4. Equipment & components

5. Master formulation & compounding records

6. Beyond use dates

What is important under the personnel training & evaluation?

Knowledge competency must be demonstrated at least every 12 months

What must a Master Formulation Record (MFR) include?

• Amounts of all components

• Calculation to determine & verify quantities &/or concentrations of components & strength/activity of API(s)

What must a Compounding Record (CR) include?

• Weight or measurement of each component

• MFR reference for the CNSP

What are the general steps in the compounding process (503A)?

1. Preparation

2. Compounding

3. Final check

4. Sign off

5. Clean up

What does USP Chapter <1251> weighing on an analytical balance go over?

Balance location requirements & balance position

What are types of weighing?

1. Weighing for quantitative analysis

2. Addition weighing

3. Dispense weighing

4. Gravimetric dosing

What are 3 terms to describe quality of a measurement?

• Trueness

• Precision (repeatability)

• Accuracy: combination of trueness & precision

  • When measurements are consistently close to the true value, they are considered accurate

What are commonly used to measure liquids?

• Graduated cylinders & conical graduates

  • Best to not measure a quantity <20-25% total volume of graduate

• Pipets

• Micropipets

• Droppers

• Graduated syringes

What are Wedgewood Mortar & Pestles?

Unglazed, provide strong grinding surface

• Best suited for powdering crystalline solids & other hard substances

What are glass mortars?

For liquid preparations

What are porcelain mortars?

Best for blending powders & pulverizing soft aggregates/crystals