Introduction to Nonsterile Compounding

Pharmacy Compounding

the preparation of a customized medication by a licensed pharmacist in response to a prescription from a licensed prescriber

purpose: to meet specific patient’s unique medical need(s)

When is compounding appropriate?

patient needs a specific strength that isn’t commercially available

patient cant swallow dosage form

child needs liquid form of adult medication

patient allergic to dye, preservative, or excipient

different flavor needed

commercial product unavailable or discontinued

drug shortage

compounding vs manufacturing

compounding is patient specific, manufacturing is market wide production

State board of Pharmacy

regulates pharm practice and compounding within state

FDA

oversees active pharmaceutical ingredients and federal drug requirements

DEA

Oversees controlled substances used in compounding

USP

establishes standards for preparing compounded products

PCAB

accredits qualifying compounding pharmacies

nonsterile preparations may include…

oral solutions and suspensions

creams

gels

ointments

suppositories

powders and capsules

limitations and risks

may not be clinically tested for safety, effectiveness, consistency, and quality

may also lack standardized labels, patient education handouts, and complete prescribing information

before compounding, the pharmacist should determine whether…

a commercial product can meet patient needs

concentration is reasonable

every ingredient is appropriate for patient

prep has suitable phys and chem properties

it makes sense

reliable formula and stability info is available

responsibilities of the compounder

ensure right strength

maintain acceptable quality and purity

use reliable info

select appropriate packaging

create complete and accurate labels

prevent cross contamination

• ESPECIALLY WITH hazardous drugs, strong allergens, and penicillin-type drugs

maintain complete documentation

veterinary compounding

compounder must understand:

• species-specific physiology

• species-specific metabolism

• veterinary drug regulations

• additional requirements for food-producing animals

just cuz its safe for humans doesn’t mean it is for animals!

Beyond use date vs expiration date

BUD: assigned to a compounded prep, commonly shorter and more conservative

expiration date: usually assigned by manufacturer using extensive stability testing