Non-sterile Compounding Weeks 1-3

Non-sterile Compounding

• combining, admixing, diluting, pooling, or reconstituting other than as provided in the manufacturers labeling to create a non-sterile preparation

• USP 795

• capsules, powders, suspensions, solutions, ointments, lotions, gels, rectal, otic

Sterile Compounding

• combining, admixing, diluting, pooling, or reconstituting other than as provided in the manufacturers labeling to create a sterile preparation

• By passes bodies natural defense mechanisms

• USP 797

• IV meds, fluids, nutrition, Epidural, IM, SC, ophthalmic, inhaled

Legal Requirements: 503A

• Conditions which a licensed pharmacist may compound a drug product

  • for an individual patient

  • pursuant to a valid prescription

  • compounded in limited quantities

• 503A pharmacies are exempt from CGMP

• Bulk Products

  • comply with USP or NF

  • appear on FDA’s bulk drug list

Legal Requirements: 503B

• Established outsourcing facilities

• Subject to CGMP requirements

• May distribute drugs pursuant to pt specific prescription OR in response to an order from a health care provider such as a hospital that is not for an individual patient (office stock)

• beyond the scope of a normal hospital or community practice

Preparation

A compounded drug dosage form to which a compounder has introduced a drug

Product

Manufactured pharmaceutical dosage form

(ex. aspirin from Bayer)

Trituration

• Rubbing or grinding of a powder in a mortar with a pestle.

• Used for hard fracturable powders

Pulverization by Intervention

Solvent dissolves powder → then spread on slab or mortar → solvent evaporates → powder will recrystallize out of solution as fine particle

Levigation

• Triturating with small amounts of liquid that the solid is not soluble in

  • ex. mineral oil, glycerin

• Used when compounding powders into ointments or suspensions

Geometric Dilution

• Mixing small volume with equal volume of diluent

• That mixture is then combined with a larger volume of diluent, etc..

Powders BUD

180 days from compounding

What info (primary, secondary, tertiary) are we looking for in non-sterile compounding

• Compounding formulas

• Solubility & compatibility

• Standards; fed / state law

Types of Literature

• Primary

  • Original research published in journal articles

• Secondary

  • books, literature review articles

• Tertiary

  • textbooks, handbook, database (lexi, clin)

Suspension

• Liquid preparation that consists of solid particles dispersed in a liquid phase in which the particle are not soluble

Suspension BUD

• Cite stability info from USP monographs

• May have a BUD up to 180 days according to studies

  • If not, refer to <USP> 795:

    • non-preserved → refrigerated → 14 days

    • preserved → refrigerated/room temp → 35 days

Aqueous vs Non-aqueous Formulations

• Water = potential for hydrolysis or microbial growth

• Water activity (Aw) > 0.6 are considered aqueous

• Most oral suspensions are considered aqueous

• Most suspending vehicles contain water

  • simple syrup, cherry syrup

What is USP?

• Non-profit, non-regulatory or enforcement agency

  • However, regulatory bodies will use USP standards

USP 795 Scope and Introduction

• Designated person responsible for overseeing all aspects of compounding

  • Does not need to be a pharmacist

USP 795 Hygiene

• Must wear latex-free, powder-free gloves

• Wash arms with soap and water prior

795 Compounding Documentation

• Master Formulation Record

  • required for all compounds

  • must contain:

    • amount, storage, dose, BUD, etc…

• Compounding Record

  • required for all compounds

  • record of ingredients used to make compound

*The MFR and CR may be separate or combined documents*

795 BUD’s

Capsule Size → Rule of 7s

• Set up proportion

  • 15.43 grains / 1000 mg = x grains / y final capsule weight (mg)

• Subtract number from 7 and round to nearest whole number