Compounding

History

we be compounding shit since 2000 BC, before WW2, compounding was all pharmacy

• after we had bunch of big pharma

Compounding is …..

combining, mixing, or altering an existing drug dosage form to create new med tailored to needs of individual patient

• regulated by state board

• manufacturing by FDA

Compounding is not…..

According to SC Board

• reconstituting or manipulating commercial products that may require addition of ingredients

• making twenty or less compounds over any 30 day period

Why do we compound meds?

• cant use existing dosage form

• patients need different formulation

• current forms or combos don’t meet need of the patient

• other reasons

United states pharmacopeia

• nongovernmental, nonprofit scientific org

• objective, science based standards

• ensure quality of meds, dietayr supplements and some foods

• standards mandatory by law for meds

• enforceable by FDA

• section 2 of USP is pharm compounding

USP 795

Nonsterile compounding

USP 7

USP 1163

quality assurance in pharm compounding

USP 1176

prescription balances and volumetric apparatus

Non-sterile inspection

seperate from routine pharmacy inspection

1. drugs meet chem or acceptable grade

2. history of valid prescriptions

3. RPh-Patient-Prescriber relationship (TRIAD)

4. RPh responsible for monitoring/traning techs

5. CE in compounding

6. wear clean clothes

7. only authorized personnel

8. specifically designated area for CMPD

9. bulk drugs labeled and clean

10. adequate lighting, vent, and washing

11. area clean

12. trash disposed good

13. avoid cross contam

14. equipment protected from contam

15. equipment inspected and calibrated

16. formulas and logs maintained

17. components accurately weighed, measured, subdividied

18. procedures to monitor output

19. label excess product

20. excess product properly stored

21. records kept for 2 years

22. standard operating policies

why no like compounding

1. regulatory oversight less rigorous tha FDA approved

2. compounded products dont need to be tested

3. compounding pharms do not need to report adverse drug events

4. CMPD pharmacies may act as manufacturers

New england CMPD center

they sucked, gave people meningitis, laws got tougher

Where error comes from

1. error in measurement of ingredients

2. error in prepping the sample of the finished product for analysis

3. contamination of glassware

4. poor technique

Documentation in CMPD

vital, need to log EVERYTHING

• temp of room, inside fridge

• humidity

• preps

• maintnence

• cleaning each piece of equipment adn room

• dedicated personell